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 .
Status of Claims
The claim amendments filed 21 July 2026 is acknowledged. Claims 1, 3, 7, 10, 17, 19, 21, 27-28, 36, and 38 have been amended. Claims 1-43 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-20, in the reply filed on 21 July 2026 is acknowledged. Applicant further elected, without traverse, citric acid as the acid and glyoxylic acid as the aldehyde.
Applicant’s election with traverse of emollients as the additional additive in the reply filed on 21 July 2026 is acknowledged. The traversal is on the ground(s) that the additives are not the feature that generates chlorine dioxide, that the instant specification states that the additive selection may be left to a formulator based on preference, relative concentration, desirability for a particular raw material, or pH stability at paragraph [0044] of the instant specification. Applicant argues that selection of the additives is routine. This is not found persuasive because restriction/election requirement is not based on whether a specific feature is the primary feature of the application, but rather on whether the disclosed species are mutually exclusive and patentably distinct. The different additives provide different properties (e.g., adjust pH, provide moisturizing, forms a film, cause foaming, etc.). In addition, these species are not obvious variants of each other based on the current record.
The requirement is still deemed proper and is therefore made FINAL.
Claims 21-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement, with respect to the species election of the additional additive(s), in the reply filed on 21 July 2026.
Claims 1-20 are examined herein to the extent that the acid is citric acid, the aldehyde is glyoxylic acid and the additive is an emollient, e.g., applicant’s elected species.
Information Disclosure Statement
The information disclosure statement (IDS) filed 11/15/2023 and 12/12/2023 have been considered by the Examiner. A signed and initialed copy of the IDS is included with the instant Office Action.
Claim Rejections – 35 USC § 103
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over ALLIGER (US 6,039,934; Date of Patent: 21 March 2000) in view of DONG (“Aqueous chlorine dioxide generated with organic acids have higher antimicrobial efficacy than those generated with inorganic acids”, International Journal of Food Microbiology, 369, 9 pages, available online 14 March 2022) and SOOKRAM (US 2012/0295940 A1, publication date of 22 November 2012).
Alliger is primarily directed towards chlorine dioxide compositions comprising including water, an acid and a water-soluble chlorite salt (abstract).
Regarding claims 1-2, Alliger discloses chlorine dioxide generating composition comprising a chlorite-containing part (A) and an acid-containing part (B), where the chlorite-containing part comprises a water-soluble chlorite salt in solution (column 3, lines 21-26). Alliger discloses that the acid includes organic acid including citric (column 5, lines 1-7).
Regarding claims 3 and 5, Alliger discloses an amount of an acid including 1.3% of the part B composition (Examples 1 and 2).
Regarding claim 6, Alliger discloses that the pH of the acid range from about 1.5 to about 5.5 (column 9, lines ).
Regarding claim 8, Alliger discloses that the salt of chlorite includes sodium chlorite (column 4, lines 64-65).
Regarding claim 9, Alliger discloses that the concentration of sodium chlorite in the chlorite containing composition is about 0.1% to about 5% (column 7, lines 8-12).
Regarding claim 11, Alliger discloses that the pH of the chlorite containing composition is greater than 11 (column 9, lines 32-36).
Regarding claim 12, Alliger discloses that the amount of chlorine dioxide produced within the initial 15 minute is greater than 5 ppm and include 100 ppm or more (column 3, lines 44-53 ).
Regarding claim 13, Alliger discloses that the initial pH of the chlorine dioxide composition after combining parts A and B ranges from including 1.8 to about 5.5 (column 3, lines 34-44).
Regarding claims 14-15, Alliger discloses an amount of an acid including 0.48% and 1.3% of the part B composition and 2% of sodium chlorite in the part A composition (e.g., 0.48:2 and 1.3:2) (Examples 1-3, respectively). Alliger discloses that the concentration of sodium chlorite in the chlorite containing composition is about 0.1% to about 5% (column 7, lines 8-12).
Regarding claim 18, Alliger discloses that the composition in the 3-4 pH range kill all bacteria (e.g., including E. coli) within one minute (e.g., column 8, lines 15-16).
Regarding claim 20, Alliger discloses that the viscosity including fall within the range of about 100 cps to about 1,000 cps (e.g., mPas) for including teat-dip (column 5, lines 57-59).
Alliger does not specifically teach that the acid composition comprises glyoxylic acid (e.g., elected species of aldehyde). Alliger does not specifically teach that the chlorine dioxide composition comprises a quantity of the chlorite salt and the aldehyde that are unreacted and that the reaction between the chlorite salt and the aldehyde continues to generate chlorine dioxide composition for at least seven days after combining the acidic composition and the chlorite composition. The deficiencies are made up for by the teachings of Dong and Sookram.
Dong is primarily directed towards aqueous chlorine dioxide generated with organic acids have higher antimicrobial efficacy than those generated with inorganic acids (abstract).
Regarding claim 1, Dong discloses that weak acids release H+ over time until an equilibrium is reached, and the endpoint of the reaction between NaClO2 and weak acids would produce ClO2 (page 2, first column, second paragraph). Dong discloses that organic acids are well-known antimicrobials that may provide synergetic effects along with the produced ClO2 (page 2, first column, second paragraph). Dong discloses that from 6 days to 7 days, the reactions of organic acids reached the equilibrium (e.g., acid and chlorite unreacted and continues to generate chlorine dioxide for at least seven days) (page 5, first column, first paragraph).
Sookram is primarily directed towards composition for control or in preventing mastitis in a domesticated animal (abstract).
Regarding claims 1 and 4-5, Sookram teaches organic acid that are suitable biocides include glyoxylic acid (paragraphs [0028-0031]).
Regarding claims 7 and 10, Sookram teaches a composition for control of mastitis in domesticated animals that include emollient system (e.g., emollients) (paragraph [0002]). Sookram teaches emollients are substances that soften and moisturize the skin (paragraph [0071]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a chlorine dioxide generating composition by mix a part A composition comprising sodium chlorite and a part B composition comprising organic acid including citric acid and glyoxylic acid; wherein the amount of chlorine dioxide produced within the initial 15 minute is including 100 ppm or more. The person of ordinary skill in the art would have been motivated to make those modifications to obtain a chlorine dioxide generating composition with increased antimicrobial efficiency and stability by using organic acids including citric acid as taught by Dong and include other organic acids including glycolic acid that are suitable as biocides as taught by Sookram, and reasonably would have expected success because Alliger discloses chlorine dioxide generating composition comprising a chlorite-containing part (A) and an acid-containing part (B), where the chlorite-containing part comprises a water-soluble chlorite salt in solution (column 3, lines 21-26). Alliger discloses that the acid includes organic acid including citric (column 5, lines 1-7). Dong discloses that weak acids release H+ over time until an equilibrium is reached, and the endpoint of the reaction between NaClO2 and weak acids would produce ClO2 (page 2, first column, second paragraph). Dong discloses that organic acids are well-known antimicrobials that may provide synergetic effects along with the produced ClO2 (page 2, first column, second paragraph). Dong discloses that from 6 days to 7 days, the reactions of organic acids reached the equilibrium (e.g., acid and chlorite unreacted and continues to generate chlorine dioxide for at least seven days) (page, first column, first paragraph). Sookram teaches organic acid that are suitable biocides include glyoxylic acid (paragraphs [0028-0031]).
Regarding the recitation that “the chlorine dioxide composition comprises a quantity of the chlorite salt and the aldehyde that are unreacted” and “the reaction between the chlorite salt and the aldehyde continues to generate chlorine dioxide composition for at least seven days after combining the acidic composition and the chlorite composition”, in light of the disclosure of Alliger and the teachings of Dong and Sookram, it would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a chlorine dioxide generating composition by mix a part A composition comprising sodium chlorite and a part B composition comprising organic acid including citric acid and glyoxylic acid; wherein the amount of chlorine dioxide produced within the initial 15 minute is including 100 ppm or more (column 3, lines 21-26 and column 5, lines 1-7 of Alliger; page 2, first column, second paragraph and page 5, first column, first paragraph; paragraphs [0028-0031] of Sookram). Dong discloses that weak acids release H+ over time until an equilibrium is reached, and the endpoint of the reaction between NaClO2 and weak acids would produce ClO2 (page 2, first column, second paragraph). Dong discloses that organic acids are well-known antimicrobials that may provide synergetic effects along with the produced ClO2 (page 2, first column, second paragraph). Dong discloses that from 6 days to 7 days, the reactions of organic acids reached the equilibrium (e.g., acid and chlorite unreacted and continues to generate chlorine dioxide for at least seven days) (page 5, first column, first paragraph). The method which is prima facie obvious in light of the disclosure of Alliger and the teachings of Dong and Sookram, is substantially the same as the instantly claimed method, therefore, the method which is prima facie obvious in light of the disclosure of Alliger and the teachings of Dong and Sookram necessarily has the same characteristics, e.g., chlorine dioxide composition comprises a quantity of the chlorite salt and the glyoxylic acid that are unreacted and the reaction between the chlorite salt and the glyoxylic acid continues to generate chlorine dioxide composition for at least seven days after combining the acid composition and the chlorite composition. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "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). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). MPEP 2112.01 (I).
Regarding the amount of organic acid including citric acid and glyoxylic acid (e.g., claims 3, 5, 14-16 and 19), Alliger discloses an amount of the acid in solution effective to produce an initial pH upon mixing parts A and B of less than about 5.5 and to produce chlorine dioxide generating composition (column 3, lines 22-30). Dong discloses that organic acids are well-known antimicrobials that may provide synergetic effects along with the produced ClO2 (page 2, first column, second paragraph). Sookram teaches organic acid that are suitable biocides include glyoxylic acid (paragraphs [0028-0031]). The amount of organic acid including citric acid and glyoxylic acid (e.g., aldehyde) is an art-recognized result-effective variable, e.g., provides pH less than 5.5, produce chlorine dioxide generating composition at desired concentration, and provides additional antimicrobial effect, which a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal of organic acid to add in odor to best produce a chlorine dioxide generating composition with desired concentration of chlorine dioxide and additional antimicrobial effect. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Regarding the chlorine dioxide concentration (e.g., claim 12 and 17), Alliger discloses that the amount of chlorine dioxide produced within the initial 15 minute is greater than 5 ppm and include 100 ppm or more (column 3, lines 44-53 ). Alliger discloses that the composition in the 3-4 pH range kill all bacteria (e.g., including E. coli) within one minute (e.g., column 8, lines 15-16). The concentration of chlorine dioxide is an art-recognized result-effective variable, e.g., kills bacteria, which a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal chlorine dioxide to generate initially in order to best provide desired antimicrobial activity. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Thus, the claimed invention as a whole is clearly prima facie obvious over the teachings of the prior art.
Conclusion and Correspondence
No claims are found allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P NGUYEN whose telephone number is (571)270-5877. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/John P Nguyen/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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