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 .
Election/Restriction
Applicant elected, without traverse, Group I, claims 1-17, drawn to a biocidal composition, and species : 1) 4-isothiazolin-3-one biocidal active compound: 1,2-benzisothiazolin-3-one; 2) pyrithione compound - sodium pyrithione; and 3) product species - 1,2-benzisothiazolin-3-one and sodium pyrithione, on 05/26/2026.
It’s noted NO species is elected for cystamine enhancer. Instant specification discloses cystamine enhancer having structure of compound I (See [0017])
PNG
media_image1.png
59
489
media_image1.png
Greyscale
and identifies cystamine dihydrochloride (R1=R2=H) as cystamine enhancer (See[0036]-[0037]).
Claims 1-17 read on elected invention.
Claim 18 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claim Status
Claims 1-18 are pending.
Claim 18 is withdrawn.
Claims 1-17 are currently under examination in this office action.
Priority
This instant application 18/551,205, filed on 09/19/2023, is a national stage of PCT/US2022/020948 filed on 03/18/2022, which claims benefit of US provisional application No. 63/163,266 filed 03/19/2021.
Information Disclosure Statement
The information disclosure statements 09/19/2023, 02/06/2025, 01/22/2026 are in compliance with the provisions of 37 CFR1.97. Accordingly, the reference listed in IDS are being considered by the Examiner. Reference written in foreign language is considered to the degree of English abstract or patent family of foreign patent.
Claim Objections
Claims 15 is objected to because of the following informalities:
Claim 15 recites “no less than one parts per million” which should be singular.
Specification
Instant specification discloses cystamine enhancer having structure of compound I (See [0017]) , (C2) should be (CH2):
PNG
media_image1.png
59
489
media_image1.png
Greyscale
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 10, 12, 14, 20, 30, 32, 34. It’s not clear what these reference numbers refer to.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 the invention, 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 it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-17 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(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Instant claims are drawn to a biocidal composition, comprising: one or both of a 4-isothiazolin-3-one biocidal active compound and a pyrithione biocidal active compound; and a cystamine enhancer. Instant specification discloses cystamine enhancer having structure of compound I (See [0017])
PNG
media_image2.png
165
489
media_image2.png
Greyscale
PNG
media_image3.png
93
516
media_image3.png
Greyscale
Instant Spec discloses cystamine dihydrochloride (R1=R2=H) as cystamine enhancer (See[0036]-[0037]). Instant Spec does not disclose any other cystamine enhancer with defined R1 and R2 as alkyl, alkenyl, alkylaryl group, etc. Instant Spec does not disclose any embodiment/working example/assay, wherein cystamine compound I enhances the biocidal activity of 4-isothiazolin-3-one biocidal active compound and/or a pyrithione biocidal active compound. In absence of any working example comprising cystamine compound I, an ordinary skilled in the art would not know if the activity of 4-isothiazolin-3-one or pyrithione is improved or decreased by cystamine compound I. In absence of sufficient representative examples of cystamine enhancer, an ordinary skilled in the art would not know the applicant possess the full scope of instant claimed “cystamine enhancer” genus.
Instant Spec does not disclose any working example of biocidal composition comprising -isothiazolin-3-one, a pyrithione biocidal active compound, a cystamine enhancer and water in the form of aqueous dispersion to fully support instant claim 10. Instant Spec does not disclose any working example of biocidal composition comprising 4-isothiazolin-3-one and sodium pyrithione as recited in claim 14. In absence of sufficient representative examples of biocidal composition comprising cystamine enhancer, an ordinary skilled in the art would not know the applicant possess the full scope of instant claimed biocidal composition and product genus.
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.
Claims 1-17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 recites a biocidal composition, comprising: one or both of a 4-isothiazolin-3-one biocidal active compound and a pyrithione biocidal active compound; and a cystamine enhancer. It’ not clear if the biocidal composition comprising one or both of 4-isothiazolin-3-one, or both 4-isothiazolin-3-one and pyrithione biocidal active compound, or one or both of pyrithione. The term “cystamine enhancer” is also vague and ambiguous. Cystamine itself is a defined compound, however the scope of the term “cystamine enhancer” in absence of structure and definition thereof is not clear. The unclarity renders the metes and bounds of claim 1 uncertain. Claims 2-17 are also rejected due to dependency on claim 1.
Claim 16 recites variety of product, wherein the product is a paint, a coating, ..., an ink, or a disinfectant. It’s not clear what’s encompassed by construction chemical product , the pre-product or intermediate of the chemical industry, auxiliary for leather and/or textile and/or photochemical industry, etc. The scope of claim 16 is indefinite.
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, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9 and 11-17 are rejected under 35 U.S.C. § 103 as unpatentable over Brown et al. (WO2015077209A1, hereafter “Brown’209”), in view of O’neil (WO2016046523 A1, Applicant’s IDS dated 02/06/2025).
Brown’209 disclosed a biocidal composition comprising a first biocide comprising an isothiazolinone, a second biocide comprising a pyrithione, and a biocide enhancing agent, wherein he biocide enhancing adjuvant/agent may comprise an amine, amine salt, amine oxide, or mixtures thereof(See abstract, [0007]-[0011], Examples 1-5, Table 1-9; claims 1-24 ).
Regarding the isothiazolone biocidal active compound of instant claims 2-3, Brown’209 disclosed variety of 4-isothiazolin-3-one, e. g. 1,2-benzisothiazolin-3-one (BIT), N-(n-butyl)-1,2-benzisothiazolin- 3-one (BBIT), etc. (See [0019]-[0022], [0080], Examples 1-5, Table 1-9; claims 7 and 19).
Regarding the pyrithione biocidal compound of instant claims 5-6, Brown’209 disclosed pyrithione also known as 2-mercaptopyridine-N-oxide or 2-pyridinethiol-1-oxide, and variety of pyrithiones, e.g. sodium pyrithione, zinc pyrithione, etc. (See [0025], Examples 1-5, Table 1-9; claim 8).
Regarding the biocide enhancing adjuvant/agent, Brown’209 teaches compound of formula
PNG
media_image4.png
115
151
media_image4.png
Greyscale
, wherein R1 is a linear, branched or cyclic C6-40 saturated or unsaturated group; and
R2 and R3 are each independently of one another H or linear, branched or cyclic saturated or unsaturated group or R2 and R3 are both taken together in combination with a nitrogen atom to which they are attached to form a cyclic or heterocyclic group, optionally substituted. Brown’209 teaches
variety of amine, e.g. 1-dodecylamine, cocodimethylamine oxide, 4- dodecylmorpholine, Iauryl dimethyl amine, Bis (3-aminopropyl) dodecylamine, or mixtures thereof ( See [0028]-[0037], Examples 1-5, Table 1-9; claim 9).
Regarding claim 4, Brown’209 teaches the ratio of the first biocide 4-isothiazolin-3-one to the biocide enhancer from about 1:600 to about 1:2... from about 1:10 to about 1:3 (See [0059], claim 3, 15 ). Brown’209 also teaches the weight ratio of the first biocide isothiazoline to the second biocide pyrithione from about 1:200 to about 10:1(See [0058], claim 2).
Regarding the product of instant claims 11, 16 and 17, Brown’209 teaches biocidal composition
formulated as a concentrate and/or incorporated into different products, e.g. paint, a latex emulsion, a polymer emulsion, an adhesive, a sealant, a caulk, a mineral or pigment slurry, a printing ink, a pesticide formulation, a household product, a personal care product, a metal working fluid, and the like (See [0072]-0074]; Example 3).
Regarding claims 12, 13 and 15, Brown’209 teaches the first biocide (i.e. 4-isothiazolin-3-ones ) in an amount less than about 200 ppm, and at least 5 ppm, such as at least 10 ppm, 20 ppm, etc. (See [0060]) (which reads on instant claim 12). Brown’209 teaches the second biocide (i.e. pyrithiones) may be present in an amount from about 20 ppm to about 500 ppm, from about 25 ppm to 180 ppm, etc. (See [0060] ) (which reads on instant claim 13). Brown’209 also teaches the amine enhancer in an amount from about 100 ppm to about 3,000 ppm, e.g. greater than about 200 ppm, 300ppm, etc. (See [0060] ) (which reads on instant claim 15).
Regarding claim 7, Brown’209 teaches various amount of pyrithione (e.g. from about 20 ppm to about 500 ppm ) and amine enhancer (e.g. greater than about 200 ppm) (See [0060], Example 1-2). A skilled artisan would have known to explore different amount of pyrithione and amine enhancer wherein the ratio of amine enhancer to pyrithione would read on instant claim 7. For example, the ratio of amine enhancer to pyrithione could have been calculated as about 3:1 (200ppm/ 62.5ppm in Table 1). Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05.
Brown’209 collectively teaches biocidal compositions comprising 4-isothiazolin-3-one biocidal active compound (e.g. 1,2-benzisothiazolin-3-one BIT), pyrithione in combination with amine component/biocidal enhancer.
Brown’209 is silent about cystamine.
O’neil teaches cystamine and derivative for prevention and treatment of bacterial/ fungal infection or disease/ condition, e.g. microbial biofilm, etc. (See abstract, page 4, lines 10-26; , Example 1, claims 1-39). O’neil teaches embodiments against variety of pathogen( See page 4, lines 28-34; page 5, lines 1-31) and explicitly teaches antimicrobial activity of cystamine HCl against P. Aeruginosa (See Example 1 ). O’neil teaches cystamine in combination with antibiotic agent (See page 6, line 13-15; page 28, lines 1-31). O’neil teaches cystamine may be used as disinfectant or biocide in combination with other disinfecting agents for different product, e.g. medical devices and indwelling devices, peritoneal dialysis tubing, draining device and the like (See page 12, lines 8-13). O’neil teaches formulation comprising cystamine and adjuvant/solvent (e. g. water) ( See page 24, lines 31-24) and in the form of aqueous dispersion, emulsion, suspension, etc. ( See page 24, lines16-17)(which read on instant claims 8 and 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biocidal composition comprising 4-isothiazolin-3-one, pyrithion and amine biocidal enhancer taught by Brown’209 with cystamine as the amine biocidal enhancer, and arrive at the instant invention with reasonable expectation of success. At the time of instant invention, it’s already known that biocidal composition comprising 4-isothiazolin-3-one, pyrithion and an amine biocidal agent/enhancer could be made as taught by Brown’209. It’s also known cystamine is antimicrobial agent that could be used as biocide as taught by O’neil. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. A skilled artisan would be motivated to explore incorporating cystamine as the amine biocidal component and reasonably expect biocidal composition comprising 4-isothiazolin-3-one and pyrithion and cystamine would exhibit enhanced/improved biocidal activity.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art together with optimization based on general knowledge of biocidal composition. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-17 are rejected under 35 U.S.C. § 103 as unpatentable over Brown et al. (WO2015077209A1, hereafter “Brown’209”), in view of O’neil (WO2016046523 A1, Applicant’s IDS dated 02/06/2025), and further in view of Colon et al. (US 9756859B1).
The collective teachings of Brown’209 and O’neil are elaborated in preceding 103 rejection and applied as before. Brown’209 collectively teaches biocidal compositions comprising 4-isothiazolin-3-one biocidal active compound (e.g. 1,2-benzisothiazolin-3-one BIT), pyrithione in combination with amine component/biocidal enhancer. O’neil collectively teaches antimicrobial/antibacterial cystamine could be used as biocide and formulated in the form of aqueous dispersion. Brown’209 and O’neil are silent about water content in aqueous dispersion recited in claim 10.
Colon teaches stable aqueous dispersions of biocides comprising 1,2- benzisothiazolin-3- one (BIT) and water, for providing resistance to microbiological attack in both a wet state and a dry film state (See abstract, Col.2, lines 40-55; Examples 1-10; claims 1-17). Colon teaches various amount of 1,2- benzisothiazolin-3- one (BIT) (e.g. 1%-12% ) (See claim 1) and water, wherein water content is at least 20% , not more than 80% based on total weight of the aqueous dispersion. In certain embodiments , the aqueous dispersion comprises from 40 % to 60 % by weight water(See Col. 5, lines 16-34, 45- 50; claim 12 and 17). Colon teaches the aqueous dispersions comprising 1,2- benzisothiazolin-3- one (BIT) useful for imparting resistance to microorganism growth, including bacterial, fungal and algae growth, in a wide variety of products, e.g. paint, adhesives, textiles, leather, etc. (See Col. 9, lines 16-48; Examples 1- 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biocidal composition comprising 4-isothiazolin-3-one, pyrithion and amine biocidal enhancer taught by Brown’209, based on beneficial teachings of O’neil and Colon, and arrive at the instant invention with reasonable expectation of success. At the time of instant invention, it’s already known that biocidal composition comprising 4-isothiazolin-3-one, pyrithion and an amine biocidal agent/enhancer could be made as taught by Brown’209. It’s also known cystamine is antimicrobial agent that could be used as biocide as taught by O’neil. Colon teaches stable aqueous dispersions of biocides comprising 1,2- benzisothiazolin-3- one (BIT) and water that could be used in variety of product. A skilled artisan would be motivated to explore incorporating cystamine as the amine biocidal enhancer and reasonably expect biocidal composition comprising 4-isothiazolin-3-one and pyrithion and cystamine would exhibit enhanced/improved biocidal activity.
As stated in MPEP 2144.05, " It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions". The difference between instant claimed invention and Brown’209 is cystamine wherein cystamine is considered as equivalent of amine component taught by Brown’209. A skilled artisan would reasonably expect the combination of isothiazolinone, pyrithione with cystamine exhibit enhanced biocidal efficacy because O’neil teaches antimicrobial cystamine could be used as biocide .
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art together with optimization based on general knowledge of biocidal composition. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 11-14 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of U.S. Patent No. 10721934 (family member of WO2015077209A1), in view of O’neil (WO2016046523 A1, Applicant’s IDS dated 02/06/2025).
Reference claims are directed to a composition for preserving a product having biocidal properties, comprising: a first biocide comprising an isothiazolin-3-one present in the product in an amount of 15 ppm to 25 ppm; second biocide comprising zinc pyrithione present in the product in an amount of 50 ppm to 180 ppm; and a biocide enhancing agent comprising cocodimethylamine oxide, N, N-dimethyloctyl amine-n-oxide, or mixtures thereof, present in the product in an amount of 410 ppm to 1200 ppm, wherein the first biocide and the biocide enhancing agent are present in the composition at weight ratio of from about 1:600 to about 2:1.
Reference claim 3 recites a second biocide enhancing agent comprising an amine, an amine salt, or an amine oxide.
Reference claim 6 recites the first biocide comprises 1,2-benzisothiazolin-3-one...N-butyl-1,2-benzisothiazolin-3-one, or mixtures thereof.
Reference claim 7 recites the second biocide comprises sodium pyrithione, zinc pyrithione etc. or mixtures thereof.
Reference claims are silent about cystamine.
As elaborated in preceding 103 rejection and applied as before, O’neil collectively teaches antimicrobial/antibacterial cystamine could be used as biocide and formulated in the form of aqueous dispersion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reference biocidal composition comprising 4-isothiazolin-3-one, pyrithion and amine biocidal enhancer with cystamine as the amine biocidal enhancer, and arrive at the instant invention with reasonable expectation of success. A skilled artisan would be motivated to explore incorporating cystamine as the amine and reasonably expect cystamine as an amine component would enhance the biocidal effect of reference biocidal composition.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached on (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.M./Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
Prosecution Insights