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
Filing Receipt and Priority
The filing receipt mailed 10/06/2023 states that the instant application is a 371 application of PCT/DK2021/050342, filed 11/23/2021. The filing receipt also states that the application claims foreign benefit of EPO application 20209331.6 filed 11/23/2020.
The certified copy of the EPO application submitted 05/22/2023 supports the instant claims. Therefore, the effective filing date is 11/23/2020.
Information Disclosure Statement
The information disclosure statements received 11/03/2025 and 05/22/2023 have been considered.
Restriction/Species Election
Applicant’s election of Group II with traverse in the reply received 12/08/2025 has been acknowledged. Applicant’s additional election of the species n-butyldiethanolamine (NBDA) is also acknowledged.
Applicant in their traversal argues that “the instant application does not present a serious search burden on the Examiner.”
Applicant further states “Gernon does not teach any special technical feature of the claimed embodiments…”. Applicant continues “Embodiments of the currently amended claims are drawn to a microbially stable composition or product comprising a class of compounds not previous recognized as having any biocidal effect….Still further, Gernon emphasizes that the biocide enhancer must always be present in addition to the biocide, the underlying reason being the notion that a biocide need be present in order for the biocide enhancer to provide any enhancement…Gernon thereby does not contemplate compositions wherein the biocidal or preservative effect is provided exclusively by the pertinent compound, which is therein [in Gernon] only described as a biocide enhancer…”.
Regarding the search burden, the search burden only applies to US applications, not 371 applications. The instant application is a 371 application, as stated above in the section Filing Receipt and Priority, which requires Unity of Invention to be present, which is presently not the case.
The special technical feature of Group (I) is the compound defined in claim 1, which the specification on page 2, lines 17-19 define as a biocide. The limitation “wherein the biocide is a fungicide, algaecide…” is a property of the compound and does impart patentability.
The MPEP section 2112, sub-section I. states:
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)
The special technical feature of Group (II) is a microbially stable composition or product comprising the biocide of Group (I). The special technical feature of Group (III) is the method of substituting or replacing a conventional biocide with the biocide of Group (I).
Even if, arguendo, the biocide is the special technical feature of Groups (I-III), then the Gernon reference breaks unity of invention as previously noted and discussed above.
Additionally, applicant’s election of the compound NBDA is disclosed in combination with biocide KATHON 886MW within Gernon (WO2007/032918, of the record). See p. 10-11, para. [0019]-[0023]. Gernon refers to NBDA as butyldiethanolamine (BDEA). This disclosure breaks unity as the composition of Gernon is suitable for treating a number of fluids as discussed in Gernon, para. [0013].
Therefore, the restriction is made final.
Claims 1-6 and 12-13 are hereby withdrawn from further consideration as being drawn to non-elected inventions.
Claim Objections
Claim 7 has an open parentheses after “log units”.
Rejections
Claim Rejections - 35 USC § 112a
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.
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 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 of carrying out his invention.
Written Description
Claims 7, 9, 11, and 15-18 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.
Applicant has elected n-butyldiethanolamine as the biocide of their claimed composition. The instant claims also state “wherein the biocide provides: elimination of microbial activity, a long-term provision of microbe-free environment, and/or a resistance to post/production contamination”.
Gernon (cited above) teaches NBDA as a biocide enhancer in combination with a biocide. Applicant in their arguments traversing the restriction states “Gernon directly stipulates that biocide enhancers within the meaning of Gernon are not to be considered as biocides…”.
Gernon additionally discloses NBDA in a composition comprising NBDA and a second component wherein the NDBA has a concentration of 1,000 PPM (0.1 weight percent). This concentration falls within the concentration claimed in instant claim 16. Therefore, the concentration taught in Gernon is considered an effective amount.
Considering the teachings of Gernon and the argument presented by applicant, either the NBDA compound has biocidal properties as in the instant claims or the NBDA compound does not have biocidal properties. As applicant has argued that the NBDA compound is simply a biocide enhancer at the concentration disclosed, then the instant claims cannot have the biocidal properties claimed.
For the purpose of examination, this action assumes the NBDA has biocidal properties.
Claim Rejections - 35 USC § 112b
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.
Indefinite Term
Regarding claims 7, 9, and 18, the phrase, "such as", “e.g.”, and “in particular” render the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Broader Range followed by Narrower Range
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation “comprising one or more peroxide(s) wherein the one or more peroxide is provided in a concentration of 0.001-2.0, 0.002-1.5, 0.005-1.0, 0.01-1, or 0.05-0.5% by weight”. The first range is the broadest range and each successive range is narrower than the preceding one. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Indefinite Term
Claim 18 states “The composition or product according to claim 7, wherein the composition or product does not comprise one or more of a conventional biocide selected from the group consisting of: (i) isothiazoline, (ii) halogens and/or halogen comprising compounds or compositions, (iii) heavy metals including salts, (iv) phenolic biocide, (v) other compounds.”
The instant specification does not explicitly define “other compounds”. The claims and instant specification provide only an exemplary compound in “formaldehyde”. Therefore, the examples are non-limiting. The broadest reasonable interpretation of “other compounds” includes any and all other compounds including carriers, excipients, emulsifiers, etc. Parent claim 7 is drawn to a composition or product. The instant specification p. 18, l. 1 states that “composition” and “product” can be used interchangeably. Considering this, claim 7 is drawn to a composition comprising NBDA. A composition implies a second compound, which is directly contradicted by the exclusion of “other compounds” in claim 18. This contradiction makes the claim indefinite as one of ordinary skill would not clearly know the metes and bounds of claim 18.
For the purpose of examination, this limitation will not be included in examination until applicant amends or provides more clarification for “other compounds.”
Art Rejection
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.
Claim(s) 7, 11, and 15-17 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Gernon (WO2007/032918).
Regarding claims 7, 11, and 15-16, Gernon on p. 10-11, para. [0019]-[0023] discloses a composition comprising NBDA in combination with the biocide KATHON 886MW.
Regarding claims 15, Gernon’s combination does not specify the inclusion of an organic solvent.
Regarding claim 16, Gernon’s disclosure in para. [0021] indicates that the BDEA (NBDA) was combined with amine in a concentration of 1,000 PPM. 1,000 PPM is equivalent to 0.1 weight percent.
Regarding claims 7 and 17 which recite “wherein said composition or product is an in-can product…”, this limitation is considered an intended use because it merely recites a purpose for what the composition is without further claiming components or ingredients that make the composition distinct from its parent claim. The claim limits the scope of intended uses, but otherwise, the compositions of both claims are identical.
Further, regarding the properties of NBDA, the MPEP section 2112, sub-section I. states:
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)
Claim(s) 7, 11, and 15-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chowdhury (Journal of Molecular Liquids, 155, 2010, 1-7).
Chowdhury on p. 3, Fig. 1 discloses graphs showing the viscosities of mixtures comprising alkanolamines at concentrations between 0 and 1 molar ratio in water. Chowdhury on p. 1, sec. Experimental discloses that one of the tested alkanolamines is n-butyldiethanolamine. The teaching of an aqueous solution of NBDA embraces the elements of claims 7, 11, and 15-18.
Claim 7 is drawn to a composition comprising NBDA wherein the composition is a composition or product that is a personal care product, home care product, etc. This listing of products merely recites intended uses. A similar but shorter listing is found in claim 17. The additional limitations listed in bullets x-z are also properties of the NBDA compound and would be inherent to any compound and/or composition comprising the NBDA compound. The MPEP section 2112, sub-section I. states:
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)
Regarding claims 15 and 18, the disclosure in Chowdhury does not include any other organic compound, solvent, or conventional biocide.
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, 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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 7, 9, 11, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gernon (WO2007/032918) in view of Baldry (Journal of Applied Bacteriology, 1983, 54, 417-423).
Discussion regarding the inherent properties of the compound NBDA from the 102 rejection over Gernon above are incorporated here.
Instant claim 7 states “A microbially stable composition or product comprising the biocide according to claim 1, wherein saif composition or product is a personal care product…wherein the biocide provides: (x) elimination of microbial activity, such as a reduction in viable cell count by at least 3, 4, 5, or 6 log units; (y) a long-term provision of a microbe-free-environment (e.g. < 10 VCC mL or g); and/or (z) resistance to postproduction contamination.
Dependent claim 9 further claims the addition of hydrogen peroxide and/or peroxides in a number of concentrations by weight percent.
Dependent claim 11 specifies that the microbial stability is provided by the elected compounds NBDA.
Dependent claim 16 specifies NBDA in a concentration of 0.1-10% by weight.
Dependent claim 17 claims intended uses including wherein the composition or product is an in-can product selected from the group consisting of paint, coatings, lacquers, etc. See claim for full listing.
Dependent claim 18 excludes isothiazolines, halogens and/or halogen-comprising compounds and/or compositions, heavy metals and heavy metal salts, phenolic biocides, and “other compounds”.
Regarding claims 7, 11, and 15-16, Gernon on p. 10-11, para. [0019]-[0023] teaches a composition comprising NBDA at a concentration of 1,000 ppm (0.1 weight %) in combination with the biocide KATHON 886MW.
Regarding bullets (x), (y), and (z), of claim 7, these are properties of the biocide, NBDA. A composition comprising NBDA would therefore also have these properties.
Regarding the “in-can” limitations of claim 7 and 17, this limitation is considered an intended use because it merely recites a purpose for what the composition is without further claiming components or ingredients that make the composition distinct from its parent claim.
Gernon does not explicitly discuss hydrogen peroxides or other peroxides or peroxide containing compositions. This is addressed by Baldry.
Baldry is a review of the bactericidal, fungicidal, and sporicidal properties of hydrogen peroxide (title). Baldy on p. 1244, left col., para. 1 states “The antimicrobial properties of peroxygen compounds have been recognized for many years and a variety of applications been developed. Dilute solutions of hydrogen peroxide are used as antiseptics and the sporicidal activity of this substance has led to use in aseptic packaging techniques” Chowdhury on p. 419 teaches the bacteriostatic activities of hydrogen peroxide.
Gernon on p. 2-3, para. [0006] states “This invention provides highly effective antimicrobial compositions that employ certain combinations of alkylalkanolamines and alkylbisalkanolamines in the presence of a biocide.” Where Gernon teaches compositions comprising NBDA and KATHON 886MW, one of ordinary skill in the art would find it obvious to replace the KATHON 886MW with hydrogen peroxide in order to provide the biocide enhancing properties to hydrogen peroxide, which is a known biocide.
Regarding claim 9, Chowdhury on p. 420, Table 4 teaches concentrations of its hydrogen peroxide solutions which are 290 mmol/l and 880 mmol/l (equivalent to 0.29M – 0.88M). Further, the MPEP section 2144.05, subsection II states:
The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
“[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Therefore, the concentrations of hydrogen peroxide in claim 9 would be obvious to one of ordinary skill in the art.
NBDA is well known within the art and is commonly used with other biocidal compounds in antimicrobial compositions to enhance the biocidal properties. Hydrogen peroxide is well known within the art to be a biocidal compound. One of ordinary skill in the art would therefore find it obvious to combine the hydrogen peroxide biocide with the biocide enhancer NBDA as Gernon teaches that NBDA can predictably enhance the biocidal properties of hydrogen peroxide.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to combine NBDA with hydrogen peroxide in place of KATHON 886MW to arrive at the instant claims with a reasonable assumption of success. One of ordinary skill would find motivation to make the combination in Gernon which teaches that NBDA can enhance the biocidal properties of other biocides including hydrogen peroxide.
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 7, 9, 11, and 15-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-5 and 8-13 of copending Application No. 18/865,477 (reference application) in view of Baldry (Journal of Applied Bacteriology, 1983, 54, 417-423).
The reference claims are drawn to compositions comprising N-butyldiethanolamine in similar composition or products as claimed in instant claims 7 and 17, with similar properties as those claimed in instant claims 7. The reference claims require only the NBDA compound and do not explicitly claim organic solvents, organic compounds, or other compounds as characterized in instant claims 15 and 18. The instant claims would be obvious at least over the reference claims by themselves and in view of Chowdhury which discusses hydrogen peroxide as applied to instant claim 9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624