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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 22 December 2025 has been entered.
Applicant’s amendment of 22 December 2025, in which claims 36, 44 have been amended, and new claims 58-61 have been added, is acknowledged.
Claims 36, 38-50, 56-61 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Claims 49-50, 56-57 are withdrawn as being drawn to a non-elected invention.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, 58-61 are being examined on their merits herein.
Response to arguments of 22 December 2025
On 22 December 2025, Applicant has amended independent claims 36, 44 by adding the limitation “and wherein the antimicrobial composition provides antimicrobial activity for at least 7 days”.
Applicant’s arguments (Remarks of 22 December 2025, pages 6-7) against the rejection of claims 36, 39-44, 46-48 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Li, as evidenced by Munoz-Bonilla, have been considered.
Applicant argues (pages 6-7) that neither Li, nor Munoz-Bonilla recite that the antimicrobial composition provides antimicrobial activity for at least 7 days.
In response, the recitation “wherein the antimicrobial composition provides antimicrobial activity for at least 7 days” in claims 36, 44, is a property of the composition. Li as evidenced by Munoz-Bonilla anticipate the instant composition.
“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.
“When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.I, II.
The rejection is herein maintained.
Applicant’s arguments (pages 7-12) against the rejection of claims 36, 38-48 under 35 U.S.C. 103 over Hollis, in view of Stanojevic and Hu, have been considered.
Applicant argues (page 8, last paragraph, page 9, first paragraph) that prior art does not teach the newly added limitation that the antimicrobial composition provides antimicrobial activity for at least 7 days. In response, Hollis, in view of Stanojevic and Hu render instant composition obvious, the property of such a claimed composition will also be rendered obvious by the prior art teachings, since the properties, are inseparable from its composition. Therefore, if the prior art teaches the composition or renders the composition obvious, then the properties are also taught or rendered obvious by the prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ 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 or render obvious the same properties as the instantly claimed product.
Applicant argues (page 9, second paragraph) lack of motivation to combine the teachings of Hollis with Stanojevic and Hu, because Hollis teaches that the polymers disclosed are effective at low concentrations, and the composition has minimal toxicity.
This argument is not persuasive. The instant claims do not recite the concentration of the polymer in the product/composition. Further, the motivation to combine sodium benzoate and a quaternary ammonium containing polymer taught by Hollis is not related to the concentration or toxicity of the polymer; rather, the motivation to combine is based on the fact that sodium benzoate is antibacterial and the polymer has antibacterial properties. Therefore, one of ordinary skill in the art would have reasonably expected that combining sodium benzoate and a quaternary ammonium-containing polymer taught by Hollis, 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).
Applicant argues (page 9, last paragraph, page 10, first paragraph) no reasonable expectation of success. Applicant invokes the Declaration under 37 CFR 1.132, signed by Ms. Erika Milczek, Ph.D., co-inventor, submitted on 19 May 2025, which had been considered on 08/20/2025, and argues (Milczek Declaration, point 5) that sodium benzoate at 1% or less, is ineffective as an antimicrobial agent at or above neutral pH.
Applicant argues (page 10, last two paragraphs) unexpected results.
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.
Dr. Milcez presents 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)
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.
Analysis of the data presented in view of the rejections made to the claims; note that the claims were examined to the extent they read on the elected species.
The rejection of claims 36-48, 51-55 36, 38-48 under 35 U.S.C. 103 over Hollis, in view of Stanojevic and Hu, based on the motivation to combine instant elected species polymer CAS 25988-97-0 (Hollis) and sodium benzoate (Stanojevic). Applicant has shown synergy data with a combination of polymer CAS 25988-97-0 (Hollis, called polymer 2 in the instant Specification, instant elected species) and sodium benzoate.
Yet, Hollis teaches other polymers as antimicrobial, beyond the instant elected species. Hollis teaches polymers of the invention derived from the condensation polymerization of an organic dihalo alkyl compound and/or an epihalohydrin with one or more amines, amino compounds or ammonia; specific examples are given. For these polymers taught by Hollis, which are part of the rejection, Applicant has provided no synergy data in combination with sodium benzoate. A modified rejection is being made below.
Further, even if such synergy data for combinations of sodium benzoate and the polymers in Hollis were presented, the examiner had indicated (office action mailed on 08/20/205) that the data presented in the specification is not commensurate with the full scope of the claimed invention.
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." Thus, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ289,296 (CCPA 1980). See MPEP 716.02(d).
Applicant (Remarks of 22 December, page 10, last paragraph, page 11, first paragraph) now cites MPEP 716.02(d)(I) and argues that nonobviousness of a genus or claimed range may be supported by data showing unexpected results of a species or narrower range under certain circumstances. The nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof. In re Kollman, 595 F.2d 48, 201 USPQ 193 (CCPA 1979)
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.
This argument is not persuasive.
The instant claims are drawn to a composition comprising sodium benzoate and
any secondary ammonium-containing polymer, or
any tertiary ammonium-containing polymer, or
any quaternary ammonium-containing polymer, or a copolymer thereof.
There are hundreds of quaternary ammonium containing polymers (polyquats) on the market.
There are thousands of known polymers containing tertiary ammonium groups; this vast number is due to the fact that tertiary ammonium motifs can be incorporated into almost any polymer architecture (linear, branched, cross-linked) through various synthetic pathways.
There are also secondary ammonium polymers, such as protonated polyethyleneimines, ionene polymers, or specialized vinyl and acrylic polymers.
Thus, the full scope of the claims covers thousands of combinations of sodium benzoate with a wide range of structurally distinct secondary, tertiary and quaternary ammonium containing polymers.
Applicant has shown synergy with a number of tested compositions of sodium benzoate and ammonium containing polymers. There is no adequate basis for reasonably concluding that the great number and variety of compositions included in the claims would behave in the same manner as the tested compositions.
Therefore, the broad claims in the instant application cannot be supported by the unexpected results/synergy presented by Applicant for a limited number of compositions comprising sodium benzoate and an ammonium containing polymer.
Applicant’s arguments (pages 12-16) against the rejection of claims rejection of claims 36, 38-48 under 35 U.S.C. 103 over Shair and Merianos, in view of Stanojevic and Hu, have been considered.
Applicant’s argument (page 14) related to the composition providing antimicrobial activity for at least 7 days has been addressed above.
Regarding the establishment of unexpected results, a few notable principles are well settled. It is applicant’s burden to explain any proffered data and establish how any results therein should be taken to be unexpected and significant. See MPEP 716.02 (b). The claims must be commensurate in the scope with any evidence of unexpected results. See MPEP 716.02 (d). Further, A DECLARATION UNDER 37 CFR 1.132 must compare the claimed subject matter with the closest prior art in order to be effective to rebut a prima facie case of obviousness. See, MPEP 716.02 (e).
In this case, the closest prior art 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; and Stanojevic teaches that sodium benzoate is an antibacterial. The polymers taught by Shair and Merianos are encompassed by the genus of polymers in the instant claims. The data presented by Applicant is limited to combinations of sodium benzoate and a number of specific polymers (Table 3, Specification).
Shair and Merianos refer to ammonium containing polymers made by reacting dimethyl amine with epichlorohydrin. Applicant has shown synergy data with combinations of sodium benzoate and a number of dimethylamine/epichlorohydrin polymers (Table 3, polymers 2, 3, 4, 5). It is unclear whether the data in the Specification refer to polymers taught by Shair and Merianos.
Further, even if Applicant ‘s data supported synergy with compositions of sodium benzoate and dimethylamine/epichlorohydrin polymers (Shair, Merianos), the claims as written (see explanation above) are not commensurate in scope with the claimed invention.
For these reasons, the rejection of claims 36, 38-48 under 35 U.S.C. 103 over Shair and Merianos, in view of Stanojevic and Hu, is herein maintained, and a modified rejection is made below, based on Applicant’s amendment of 22 December 2025.
Claims 36, 38-48, 58-61 have been examined to the extent they read on the elected species, CAS#25988-97-0 as the specific ammonium-containing cationic polymer, or other dimethylamine-epichlorohydrin copolymers; and sorbic acid as the specific additional antimicrobial ingredient, and the following objections and rejections are made below.
Applicant’s amendment of 22 December 2025 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 58-60 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 58-60 are drawn to “the method of claim 36”; yet, claim 36 does not recite a method. Rather, claim 36 is drawn to a product. As such, there is insufficient antecedent basis for the recitation “the method” of claims 58-60, in claim 36.
Appropriate correction is required.
In the interest of compact prosecution, claims 58-60 are interpreted to be drawn to the product of claim 36.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL--The specification shall contain a written description of theinvention, and of the manner and process of making and using it, in such full, clear, concise,and exact terms as to enable any person skilled in the art to which it pertains, or with which itis most nearly connected, to make and use the same, and shall set forth the best modecontemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of themanner and process of making and using it, in such full, clear, concise, and exact terms as toenable any person skilled in the art to which it pertains, or with which it is most nearlyconnected, to make and use the same, and shall set forth the best mode contemplated by theinventor of carrying out his invention.
Claims 36, 38-48, 58-61 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as toreasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claims 36, 44 recite that the antimicrobial composition provides antimicrobial activity for at least 7 days.
The original Specification discloses compositions where the antimicrobial activity is measured on day 2 and on day 7 (see [0120], Table 21; [0126], [0128]; [0111], Example 4; Example 5, Table 15); or at day 2, day 7, and day 18 ([0121], Tables 22 A-E); or at day 2, day 7, and day 14 ([0122], Table 23); or at day 2, day 7, day 14 and day 28 ([0116], Tables 18A-E).
The original Specification does not specifically disclose that the antimicrobial composition provides antimicrobial activity for at least 7 days, as in instant claims 36, 44. There is no range of at least 7 days in the original Specification; rather, the Specification exemplifies specific compositions where the antimicrobial activity is at day 7, or at day 2, or at day 14, or at day 18, or day 28. The limitation antimicrobial activity for at least 7 days in claims 36, 44 does not meet the written description requirement because the phrase “at least” has no upper limit and causes the claim to read literally on embodiments outside the interval disclosed. This is new matter and does not have support in the specification. In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976).
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, 39-44, 46-48, 58-61 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Li et al. (CN114795989, priority 9 May 2022, published 29 July 2022, cited in IDS), as evidenced by Munoz-Bonilla et al. (Progress in Polymer Science 2012, 37, 281-339, cited in PTO-892 of 01/17/2025).
Li (CN114795989) teaches (Comparative Example 1) 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-10, 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 0.3%, 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. The product further comprises additional antimicrobial chemical EDTA, as in instant claims 42, 43, 46, 47.
While Li does not teach that the composition is antimicrobial, polyquaternium-10 is known to have antimicrobial properties, as evidenced by Munoz-Bonilla. Munoz-Bonilla teaches (page 283, left column, last paragraph) that polymers with quaternary ammonium groups (polyquaternium-10 is such a polymer) are the most explored kind of polymeric biocides. Munoz-Bonilla teaches that most bacterial cell walls are negatively charged, containing phosphatidylethanolamine (70%) as the major component; hence most antimicrobial polymers are positively charged; it is generally accepted that the mechanism of the bactericidal action of the polycationic biocides involves destructive interaction with the cell wall and/or cytoplasmic membranes.
Regarding the limitation “wherein the antimicrobial composition provides antimicrobial activity for at least 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 Li.
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, 58-61 are rejected under 35 U.S.C. 103 as being unpatentable over Hollis et al. (EP 0422948, published 25 January 1995, 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).
Hollis teaches broadly (page 3, lines 29-44) that ionene polymers of the invention are cationic polymers in which a substantial proportion of the atoms providing the positive charge are quaternized nitrogens located in the main polymeric chain or backbone. Thus, Hollis teaches antimicrobial compositions comprising quaternary ammonium containing polymers.
Hollis evaluates the effectiveness of said polymer in preventing the adhesion of bacterial cells at pH 7 (page 4, Table), which is within the ranges in instant claims 36, 41, 44, 59, 60.
Hollis teaches that the application is in industrial aqueous processes and water handling systems (page 2, lines 9-10), thus in industrial cleaning and/or industrial and recreational water, as in instant claims 40, 48.
Hollis teaches (page 3, lines 29-44) that the polymers of the invention are derived from the condensation polymerization of an organic dihalo alkyl compound and/or an epihalohydrin with one or more amines, amino compounds or ammonia. The alkyl groups of the amines or amino compounds have from 1 to about 20 carbon atoms. Suitable amines or amino compounds include dialkylamino trialkylamines, dialkylamino alkylamines, alkyldiamines, dialkylamines and ditertiary amines.
Hollis teaches (page 3, lines 42-45) that the efficacy of ionene polymers of the invention are related more to the structure of the polymer than to its molecular weight. Thus, ionene polymers with molecular weights ranging from about 1,000 to 2,000,000 are suitable, preferably from about 1,000 to 100,000. The molecular weight of the polymers taught by Hollis overlaps with the range in instant claim 45.
Hollis specifically teaches (page 5, lines 6-13, and page 3, lines 50-58) the following polymers:
Product A: N,N,N′,N′-Tetramethyl-1,2-ethanediamine polymer with 1,1′-oxybis[2-chloroethane], (CAS Reg. No. 31075-24-8), 60% (w/w) aqueous solution, 3,000 average molecular weight;
Product B: N,N,N′,N′-Tetramethyl-1,2-ethanediamine polymer with (chloromethyl)oxirane, 60% (w/w) aqueous solution, 3,000 average molecular weight;
Product D: 1,1′-(Methylimino)[3-chloro-2-propanol] polymer with N,N,N′,N′-tetramethyl-1,2--ethanadiamine, 25% (w/w) aqueous solution, 60,000 average molecular weight.
Hollis does not teach an antimicrobial composition comprising a polymer of the invention and sodium benzoate less than 1%, as in instant claims 36, 44, or 0.2% to 1% wt., as in the instant claims 58, 60, 61.
Hollis does not teach an additional antimicrobial such as sorbic acid, present in the composition, 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).
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 Hollis, 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 taught by Hollis, because Hollis teaches that said polymer is 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 taught by Hollis, 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 at least 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, 58-61 are rejected as prima facie obvious.
Claims 36, 38-48, 58-61 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).
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.
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); 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.
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 at least 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, 58-61 are rejected as prima facie obvious.
Conclusion
Claims 36, 38-48, 58-61 are rejected.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629