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
Claims 1-19 are pending.in the Claim Set filed 9/27/2025.
Claim 20 is cancelled.
Herein, claims 1-19 are for examination.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 1-19 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a New Matter rejection.
Applicants have amended Claim 1 in the Claim Set filed 9/27/2025, to recite the following:
1. (Currently Amended) A method for dispensing a biocide, comprising the
steps of:
packaging contents in a container, said contents comprising said biocide and a solvent, said biocide comprising a protonated polymer comprising repeating charged units, said contents comprising a total cationic charge density in a range of 0.001 to less than 0.1
In the reply filed 9/27/2025, Applicants argue that support for the amendment can be found, as follows:
Applicant amends Claim 1 to require that the total cationic charge density is in a range of 0.001 to less than 0.1 meq/g. Support for the amendment is found in the application as filed at least at page 63, lines 15-19 reading, “the charge density referring to the total cationic charge, of the contents 4820 is 0.001 to 0.999 meq/g. Optionally and preferably, the total cationic charge of the contents 4820 is greater than 0.001, 0.005, 0.01, 0.02, or 0.03 meq/g or meq/ml and less than 100, 50, 25, 10, 7, 5, 3, 1, 0.9, 0.8, 0.5, 0.2, 0.1, 0.07, or 0.05 meq/g or meq/ml.
Particularly, Instant Claim 1 requires:
at least ten percent of said total cationic charge density from charges of non-quaternary amines of said protonated polymer.
However, there is no requirement in the Specification on page 63 for this limitation: at least ten percent of said total cationic charge density from charges of non-quaternary amines of said protonated polymer (Specification on page 63 does not even optionally mention this limitation). Thus, the amendment total cationic charge density in a range of 0.001 to less than 0.1 meq/g that also requires at least ten percent of said total cationic charge density from charges of non-quaternary amines of said protonated polymer constitutes new matter.
Furthermore, it is noted: Specification on page 63, lines 15-19 requires that total cationic charge of the contents 4820 is greater than 0.001, 0.005, 0.01, 0.02, or 0.03 meq/g or meq/mL and less than 100, 50, 25, 10, 7, 5, 3, 1, 0.9, 0.8, 0.5, 0.2, 0.1, 0.07, or 0.05 meq/g or meq/ml.
Whereas, instant claims recite: total cationic charge density in a range of 0.001 to less than 0.1 meq/g, of which includes a total cationic charge density of 0.001 meq/g (i.e., a range that includes a range of 0.001 is broader than a range that is greater than 0.001 meq/g, as is required by the Specification on page 63.
For reference in Specification at page 63 to contents 4820: Figures 48A and 48B, shown below
Specification on page 63, lines 15-19 state the following:
Still referring to Figure 48A and Figure 48B, optionally and preferably the charge density, referring to the total cationic charge, of the contents 4820 is 0.001 to 0.999 meq/g. Optionally and preferably, the total cationic charge of the contents 4820 is greater than 0.001, 0.005, 0.01, 0.02, or 0.03 meq/g or meq/mL and less than 100, 50, 25, 10, 7, 5, 3, 1, 0.9, 0.8, 0.5, 0.2, 0.1, 0.07, or 0.05 meq/g or meq/ml.
Drawings filed 5/14/2024, shown below: spray bottle 4800, shown below:
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Specification on page 62 states (in part):
Example I
Referring now to Figure 48(A-C), a first treatment method is illustrated. Referring still to Figure 48A, a spray bottle 4800 is illustrated for delivery of the tuned polymer 210, such as in a formulation solution. The spray bottle 4800 includes a container 4720. Contents 4820 of the container 4720 include at least a solvent 4730 and the tuned cationic polymer 302, which is optionally suspended and/or dissolved in the solvent 4730. Contents 4820 optionally include any number of formulation components, such as a buffer, scent, an inactive ingredient, an emulsifier, a stabilizer, a thickener, and/or an antioxidant. Generally, any dispenser 4840 is used to dispense the contents 4820 of the container 4720, such as into the air and/or onto a substrate as a spray/ mist/ liquid/ foam.
Thus, it can be seen that the contents 4820 (spray bottle) is 0.001 to 0.999 meq/g, of which is broader than that which is instantly claimed, i.e., even before the instant claim amendment, which claim 1 previously recited: total cationic charge density in a range of 0.001 to 0.95 meq/g.
Furthermore, Specification on page 63, lines 15-19 requires that total cationic charge of the contents 4820 is greater than 0.001, 0.005, 0.01, 0.02, or 0.03 meq/g or meq/mL and less than 100, 50, 25, 10, 7, 5, 3, 1, 0.9, 0.8, 0.5, 0.2, 0.1, 0.07, or 0.05 meq/g or meq/ml.
Whereas, instant claims recite: total cationic charge density in a range of 0.001 to less than 0.1 meq/g, of which includes a total cationic charge density of 0.001 meq/g (i.e., a range that includes a range of 0.001 is broader than a range that is greater than 0.001 meq/g, as is required by the Specification on page 63.
All claim amendments must be supported by the original disclosure, e.g., amendment to instant claim 1 fails to provide sufficient support for: a total cationic charge density in a range of 0.001 to less than 0.1 meq/g, at least ten percent of said total cationic charge density from charges of non-quaternary amines of said protonated polymer; and dispensing said biocide from said container.
M.P.E.P. §2163 states that "[n]ew or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g. In re Lukach 442 F.2d 967, 169 USPQ (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972).
Thus, the disclosure does not provide support for the claim amendments by changing the scope of the disclosure; thereby, constituting new matter.
The remaining claims are rejected as depending from a rejected claim.
Claim Rejections - 35 USC § 103
Maintained Rejections and made again necessitated by Claim Amendments
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.
The rejection of claims 1, 3-12, 15, 16, 17, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Inventor Champ et al (US 2009/0226394) in view of Amin et al (The Effect of Cationic Charge Density Change on Transfection Efficiency of Polyethylenimine, Iran J Basic Med Sci p.250, February 2013) [Amin] and Lan et al (WO2016086012) [Lan] is maintained and made again necessitated by claim amendments.
Regarding claims 1, 8, 10 and 12,
Champ teaches a method of using of a cationic polymer as a biocidal active substance, wherein no other biocidal active substances are concomitantly used, wherein the cationic polymer is polyethylenimine (PEI), wherein the biocidal active substance kills microorganisms, such as bacteria, fungi, yeasts, algae or viruses, or prevent at least their reproduction and/or growth ([0003]; [0032]). Champ teaches the biocide is preferably an aqueous PEI solution (i.e., water solvent) [0025]. Champ teaches that the nitrogen atom N may be a primary, secondary or tertiary nitrogen atom, wherein some of the N atoms carry a positive charge, i.e., are quaternized. Champ teaches that quaternization of the N atoms is achieved by adjusting the pH in the acidic range so that the corresponding part of the N atoms are protonated. Champ teaches that quaternization of the polyethylenimines can also be carried out, for example, with alkyl halides, such as methyl chloride, ethyl chloride, hexyl chloride, benzyl chloride or lauryl chloride, and with, for example, dimethyl sulfate. Champ teaches the polyethylenimine comprises from 0.1 to 22 milliequivalents of cationic groups per gram of polyethylenimine. MPEP 2144.05: "A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0. 75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.)." Moreover, the range of less than 0.1 meq/g includes a range of 0.099 meq/g, which is close enough to 0.1 meq/g as taught by Champ, that one skilled in the art would have expected them to have the same properties.
Further, as taught by Champ, protonation of corresponding part of the N by adjusting the pH in the acidic range (e.g., using a mineral acid: HCl) would provide protonation of secondary amines (i.e., amines that are non-quaternary amines, in accordance with Instant Drawings: Fig. 33A-D). Thus, it would necessarily follow that acidification (i.e., protonation) of PEI would produce a pH of less than 7 (neutral pH). (Abstract; [0009-0014]; [0026-0029]; See Table 1 [0033]).).
Amin teaches there is a relationship between the pH of PEI and the positive charge density on PEI. Amin teaches that the PEI protonation degree at pH value of 7.4 is 20% which increased to 45% at pH value of 5 (Abstract; p.151. See entire document).
Accordingly, Champ teaches acidification of PEI that would encompass a pH of less than 7, so that at least ten percent (i.e., includes five percent) of said total cationic charge density from charges of non-quaternary amines (i.e., protonation of secondary would be provided as a result of PEI is acidified. Moreover, it would have been well within the purview of one of ordinary skill in art to optimize the pH of the PEI by adjusting the amount of acid, e.g., hydrochloric acid, to provide a pH of about 7.4 to produce PEI protonation degree of about 45%, thus providing at least ten percent and/or less than fifty percent of said counterion comprising chloride having a reasonable expectation of success in view of Champ and Amin, as a whole. Optimization of parameters is a routine practice that would be obvious to a person of ordinary skill in the art to employ and reasonably expect success; See In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). A prior art reference is relevant for all that it teaches to those of ordinary skill in the art." In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992).
Champ and Amin differ from the claims in that the documents do not teach a method for dispersing a biocide, e.g., polyethylenimine (PEI) from a spray bottle,
However, Lan cures the deficiency.
Lan teaches surface disinfectant with residual biocidal property (Abstract). Particularly, Lab teaches that the disinfectant is contained in spray bottle (p.20). Lan teaches that the advantage of dispersing the disinfectant in a spray bottle is that that the disinfectant may be sprayed until the surface are is completely covered (p.20).
Thus, it would have been obvious to provide a method for dispensing a biocide, comprising the steps of packaging contents in a container the polyethylenimine, e.g., biocide, as taught by Champ. One skilled in the art would have recognized the advantage of doing so because by using a spray bottle to disperse the biocidal agent, e.g., PEI, the surface area to be decontaminated can be completely covered with the biocide to effectively remove the antimicrobial materials from the targeted surface are having a reasonable expectation of success.
Regarding claim 3,
Champ teaches the polyethylenimine is used in the form of an aqueous dispersion or solution, wherein biocidally treated substrates are obtainable by coating, impregnating or otherwise treating the desired substrates with the polyethylenimine the solution or dispersion thereof. The treatment with the solution or dispersion can be affected at room temperature; after drying, the substrate has a corresponding treatment. The amount of polymer is preferably from 0.001 to 1000 mg, particularly preferably from 0.1 to 10 mg, of polymer per square meter of surface of the substrate to be treated with the biocide. Thus, it would have been well within the purview of one skilled in the art to provide an aqueous solution contained in spray bottle comprising formulating, prior to said step of packaging, said protonated polymer with protonated polyethylenimine comprising at least ten percent of said protonated polymer by mass, wherein delivering a dose of said contents from said container, said dose comprising a total cationic charge, said protonated polyethylenimine comprising at least twenty percent of said total cationic charge in view of the teachings of Champ, Amin and Lan, as a whole.
Regarding claim 4,
Champ teaches using the PEI biocidal agent to treat viruses [0032], which when broadly interpreted would comprise non-enveloped viruses, absence evidence to the contrary.
Regarding claims 5-7, 9, 15-17 and 19,
The teachings of Champ, Amin and Lan, as a whole, are described above.
Thus, it would have been prima facie obvious to incorporate polyethylenimine into a container as a component of a protonated (acidified secondary amines) polyethylenimine.
Further, Amin teaches providing PEI solutions by adjusting the pH value of each solution was adjusted to 5, 7, and 10 using HCl (1N) (i.e., hydrochloric acid), wherein the chloride was removed using a dialysis membrane (10000 cut off, spectra/p or membrane) against DDW for 18 hr, and then measuring the pH measured again and further adjusting the pH to obtain desired pH values (p.151, right col. top).
Accordingly, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the pH values PEI using HCl at targeted desired pH values wherein the chloride ions (counterions) are removed (i.e., using dialysis membrane) prior to adding to the spray bottle. Moreover, Amin explicitly teaches the removal of the chloride ion by the process of using a specific dialysis membrane (10000 cut off, spectra/por membrane) for 18 hours, so that it would follow that concentration of remaining chloride ion remaining would be less than 900 ppm and/or less than fifty percent of chloride ions (i.e., less than 50 percent encompasses zero chloride ion) having a reasonable expectation of success, absence evidence to the contrary. Moreover, it would have been well within the purview of one of ordinary skill in art to reduce the concentration of chloride counterion by at laest ten percent to provide a concentration of to less than 900 ppm and performing the step of protonating prior to said packaging.
Moreover, in accordance with the cited prior art, it would have been well within the purview of one of ordinary skill in art to optimize the pH of the PEI by adjusting the amount of acid, e.g., hydrochloric acid, to produce PEI protonation of the nitrogens of said PEI solution of least five percent, and/or less than fifty percent of said counterion comprising chloride having a reasonable expectation of success in view of Champ and Amin, as a whole. Optimization of parameters is a routine practice that would be obvious to a person of ordinary skill in the art to employ and reasonably expect success; See In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). Moreover, it would have been well with the purview of those skilled in the art to raise the pH of a solution of said protonated polymer to greater than five prior to said step of packaging; and removing, greater than ten percent of chloride anions in said solution; and reducing, after said step of removing, said pH of said solution by at least one-half of a pH unit. One skilled in the art would have been motivated to do so in order to optimize, i.e., increase, the availability of the protonated amine sites comprising reducing the concentration of the chloride counterions, to enhance the antimicrobial properties of the pronated PEI solution having a reasonable expectation of success.
Regarding claim 11,
Champ teaches the polyethylenimine comprises from 0.1 to 22 milliequivalents, preferably from 4 to 10 milliequivalents, of cationic groups per gram of polyethylenimine, of which overlaps with the claimed total cationic charge of 0.001 to 0.95 meq/g, so that is would necessarily follow that the activity coefficient of the protonated PEI solution dispensed from a container as taught by Champ and Lan, as a whole, would have a coefficient activity value of about at 0.7 having a reasonable expectation of success.
Regarding claim 18,
The teachings of Champ, Amin and Lan, as a whole, are described above.
However, Champ, Amin and Lan differ from claim 18 in that the documents do not teach a method for treating a substrate with said biocide, said step of treating inactivating greater than fifty percent of non-enveloped viruses on said substrate in less than ten minutes.
Particularly, Champ teaches the use of a cationic polymer as a biocidal active substance, wherein no other biocidal active substances are concomitantly used, wherein the cationic polymer is polyethylenimine (PEI), wherein the biocidal active substance kills microorganisms, such as bacteria, fungi, yeasts, algae or viruses, or prevent at least their reproduction and/or growth ([0003]; [0032]), wherein the substrates treated with the biocide is, e.g., substrates for medical applications, applications in the sanitary or hygiene sector, in the food sector, in particular in food packagings, or substrates for various industrial applications, in particular filters, e.g. for air conditioning systems ([0002]; [0030]).
Further, the method for dispensing a biocide, e.g., protonated PEI solution, as taught by Champ, Amin and Lan, as a whole, is structurally and chemically indistinguishable from the claimed method of dispensing a biocide. Thus, it would necessarily follow that delivering a dose and treating a substrate with the protonated PEI solution would inactivate greater than fifty percent of non-enveloped viruses on said substrate in less than ten minutes. This property or properties would be the natural result of the combination of the prior art elements. Lack of recognition of this property by those skilled in the art is thus not dispositive. Moreover, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979).
All the claimed elements herein are known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide a method for dispensing a biocide, as instantly claimed, and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the claimed invention as a whole would have been obvious to one of ordinary skill as evidenced by Champ, Amin and Lan, as a whole.
The rejection of claims 13 and 14 under 35 U.S.C. 103 as being unpatentable over Inventor Champ et al (US 2009/0226394) in view of Amin et al (The Effect of Cationic Charge Density Change on Transfection Efficiency of Polyethylenimine, Iran J Basic Med Sci p.250, February 2013) [Amin] and Lan et al (WO2016086012) [Lan] as applied to claims 1, 3-12, 15 and 18 above and further in view of Carmona et al (Removal of chloride ions from an industrial polyethylenimine flocculant shifting it into an adhesive promoter using the anion exchange resin Amberlite IRA-420, Reactive & Functional Polymers p.1218 May 2008 [Carmona] is maintained and made again necessitated by claim amendments
The teachings of Champ, Amin and Lan, as a whole, are described above.
The prior art of Champ, Amin and Lan, as whole, make obvious prior to packaging the biocide: protonated PEI solution, protonating at least ten percent of all nitrogens in a first mass of said protonated polymer with hydrochloric acid, said step of protonating yielding chloride counterions to repeating protonated sites of said protonated polymer.
However, Champ, Amin and Lan differ from the claims in that the documents do not teach further exchanging at least ten percent of said chloride ions for hydroxide ions non chloride counterions with an anion exchange material, said hydroxide ions reacting with an acid to form water.
Carmona cures the deficiency.
Carmona teaches several methods for chloride removal from polyethylenimine solutions could be applied. These methods available for the removal of chlorides are ion exchange, adsorption, liquid extraction, membrane technologies, etc. The ion exchange process seems to be most suitable for small-scale applications because of its simplicity, effectiveness, selectivity, recovery and relatively low cost [8–9]. The ion exchange process involves passage of the water solution of protonated polyethylenimine through a resin bed containing strong-base anion exchange resins on which chloride ions are exchanged for hydroxyl ions, i.e., hydroxide ions, and the water formation takes place by neutralization of the protons with the hydroxyl ions eluted until the resin exchange capacity is exhausted (Abstract; p.1219; See entire document). One skilled in the art would have been motivated to do so in order to optimize, i.e., increase, the availability of the protonated amine sites comprising reducing the concentration of the chloride counterions, thus, enhancing the antimicrobial properties of the pronated PEI solution having a reasonable expectation of success.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide a method for dispensing a biocide, as instantly claimed, and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the claimed invention as a whole would have been obvious to one of ordinary skill as evidenced by Champ, Amin, Lan and Carmona, as a whole.
Response to Arguments
Applicants argue that Champ only teaches a polymer with 0.1 to 22 meq/g., whereas Applicants have amended Claim 1 to require that the total cationic charge density is in a range of 0.001 to less than 0.1 meq/g. Accordingly, the current rejection of Claim 1 and all claims dependent therefrom under 35 U.S.C. § 103(a) as being unpatentable over Champ in view of Amin in further view of Lan is deemed to be overcome.
Applicant’s arguments have been fully considered but they are not persuasive, because Champ teaches the polyethylenimine comprises from 0.1 to 22 milliequivalents of cationic groups per gram of polyethylenimine. MPEP 2144.05: A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0. 75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.)." Moreover, the range of less than 0.1 meq/g includes a range of 0.099 meq/g, which is close enough to 0.1 meq/g as taught by Champ, that one skilled in the art would have reasonably expected them to have the same properties.
If the prior art creates a prima facie case of obviousness because the values are so close, the burden shifts to applicants to demonstrate that the claimed range produces an unexpected result. Also, See In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) explaining that "slightly different ranges" between claims and prior art are obvious absent a showing the claimed range is critical.
MPEP 716.02(d) II. DEMONSTRATING CRITICALITY OF A CLAIMED RANGE
To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). Applicants have not presented results demonstrating that the unexpected results lie inside the entire scope of the claimed invention compared to results that fall outside the claimed range.
Applicants bear the burden to establish that the results are unexpected and significant. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). See MPEP 716.02(b).
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Champ et al (US 2009/0226394) in view of Amin et al (The Effect of Cationic Charge Density Change on Transfection Efficiency of Polyethylenimine, Iran J Basic Med Sci p.250, February 2013) [Amin] and Lan et al (WO2016086012) [Lan] as applied to claims 1, 3-12, 15, 16, 17, 18 and 19 above and further in view of Gao et al (Studies on the preparation and antibacterial properties of quaternized polyethyleneimine, J. Biomate, Sci. Polymer Edn, p.531, 2007).
The teachings of Champ, Amin and Lan, as a whole, are discussed above.
The cited reference do not teach incorporating into said biocide a quaternary ammonium salt, as recited in amended claim 2.
However, Guo and Lan, as a whole, cure the deficiencies.
Gao teaches quaternized polyethlyenenimine (QPEI) possesses outstanding antibacterial activity because of combination effect of the antibacterial groups on the macromolecular chains (Abstract; p.532; see entire document).
Gao teaches polycationic antimicrobials, which bear quaternary ammonium have high charge density and excellent processability, exhibit outstanding high antimicrobial activity p.532, bottom: first para.; see Scheme 1: preparing QPEI; p.533). Gao teaches antibacterial properties of QPEI for E. Coli (p.534).
Gao teaches QPEI causes the number of viable cells of E. coli to decrease rapidly in a short time (about 2 min) and at a low dosage (about 5 mg/1). The experiment results show clearly that QPEI possesses very strong antibacterial ability. Gao teaches the quaternary ammonium groups on the macromolecular chains of QPEI so that combination effect of antibacterial groups results in the high antibacterial activity of QPEI (p.537-538). Further, Gao teaches that the antibacterial mechanism of QPEI can be explained as follows. First, relying on electrostatic interaction, QPEI is absorbed onto the surface of bacterial cells and penetrates through cell wall. Then, QPEI combines with the protein layer and analogous fat layer of cell membrane, and blocks normal exchange of ions and substance between the bacteria and environment. Furthermore, the combination of QPEI and cell membrane causes leakage of intracellular contents, leading to cell death (p.543, top para.)
In addition, as described above, Lan (WO2016086012) also teaches a disinfectant formulation comprising a biocide wherein the biocide is a quaternary ammonium compound (QAC) (p.13). In Particular, Lan teaches that the biocide is polydiallyldimethylammonium chloride (polyDADMAC) (p.14, lns.19-20; claim 16, 23). Thus, the teachings of Lan makes prima facie obvious that polydiallyldimethylammonium chloride (quaternary ammonium salt) is a microbial agent.
Thus, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a quaternary ammonium salt into the biocide composition as taught by Champ, Amin and Lan, as a whole. One skilled in the art would have been motivated to do so in to provide a composition having enhance antimicrobial activity having a reasonable expectation of success. Before the effective filing date of the claimed invention, one skilled in the art would have recognized that by incorporating a quaternary ammonium salt (polyDADMAC) in a formulation comprising polyethyleneimine would enhance the antibacterial activity of the formulation having a reasonable expectation of success.Moreover, one skilled in the art would have recognized that polyDADMAC would be an excellent choice, since Lan teaches that polyDADMAC isa microbial agent.
All the claimed elements herein are known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide a method for dispensing a biocide, as instantly claimed, and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the claimed invention as a whole would have been obvious to one of ordinary skill as evidenced by Champ, Amin, Lan and Gao, as a whole.
Response to Arguments
Applicants argue that Champ teaches in the first line of the abstract and in the first sentence of paragraph [0001] that, emphasis added, "[t]he use of a cationic polymer as a biocidal active substance, wherein no other biocidal active substances, in particular no quaternary ammonium salts, are concomitantly used". Thus, Champ teaches away from the claimed invention, as amended. In view of the above described amendment of parent Claim 1, the current rejection of Claims 13 and 14 under 35 U.S.C. § 103(a) as being unpatentable over Champ in view of Amin in further view of Lan in still further view of Carmona is rendered moot.
Applicant’s arguments have been fully considered but they are not persuasive, because Champ generally teaches that no quaternary ammonium salts. Further, Champ did not necessarily exclude quaternization of the polyethylenimines (PEI). In fact, Champ teaches quaternization of the polyethylenimines can also be carried out, for example, with alkyl halides, such as methyl chloride, ethyl chloride, hexyl chloride, benzyl chloride or lauryl chloride, and with, for example, dimethyl sulfate [0012]. Moreover, Champ did specifically exclude polydiallyldimethylammonium chloride (polyDADMAC), which is known microbial agent as taught by Lan. Moreover, Gao teaches quaternized polyethlyenenimine (QPEI) possesses outstanding antibacterial activity because of combination effect of the antibacterial groups on the macromolecular chains. Moreover, Gao specifically teaches polycationic antimicrobials, which bear quaternary ammonium have high charge density and excellent processability, exhibit outstanding high antimicrobial activity p.532, bottom: first para.; see Scheme 1: preparing QPEI; p.533). Gao teaches antibacterial properties of QPEI for E. Coli. Additionally, Gao teaches the quaternary ammonium groups on the macromolecular chains of QPEI so that combination effect of antibacterial groups results in the high antibacterial activity of QPEI (p.537-538). Further, Gao teaches that the antibacterial mechanism of QPEI can be explained as follows. First, relying on electrostatic interaction, QPEI is absorbed onto the surface of bacterial cells and penetrates through cell wall. Then, QPEI combines with the protein layer and analogous fat layer of cell membrane, and blocks normal exchange of ions and substance between the bacteria and environment. Furthermore, the combination of QPEI and cell membrane causes leakage of intracellular contents, leading to cell death (p.543, top para.). Therefore, one skilled in the art would have recognized the tremendous advantage of incorporating polyDADMAC in a biocide composition comprising PEI in further view of the teachings of Gao and Lan, as a whole. Teaching another way is not the same as teaching away’.
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.
The provisional rejection of claims 1-19 on the ground of nonstatutory double patenting as being unpatentable over claims 1,2, 5-7, 10, 16, 18 and 19 of copending Application No. 18/742,592 [herein ‘592] is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and the ‘592 claims are both directed to common subject matter.
Instant Claims are directed to a method for dispensing a biocide, comprising the steps of: packaging contents in a container, said contents comprising said biocide and a solvent, said biocide comprising a protonated polymer comprising repeating charged units, said contents comprising a total cationic charge density in a range of 0.001 to 0.1 meq/g, at least ten percent of said total cationic charge density from charges of non-quaternary amines of said protonated polymer; and dispensing said biocide from said container; treating a substrate with said biocide, said step of treating inactivating greater than fifty percent of non-enveloped viruses on said substrate in less than ten minutes; incorporating a polyethylenimine into said container as a component of said protonated polymer; protonating said polyethylenimine with hydrochloric acid in a solution; removing at least ten percent of chlorides added to said solution in said step of protonating; and performing said steps of protonating and removing prior to said step of packaging; yielding chloride counterions to protonated secondary amine sites of said polyethylenimine; and reducing a concentration of said chloride counterions by at least ten percent to a concentration of to less than 900 ppm; and performing said step of protonating prior to said step of packaging; formulating said protonated polymer with counterions, less than fifty percent of said counterions comprising chloride; formulating said protonated polymer with a polymer backbone chain comprising at least two carbons and at least one nitrogen per monomer of said protonated polymer; controlling an activity coefficient, γ, of a protonated site of said protonated polymer, to a value greater than 0.7; delivering protonated polyethylenimine from said container, wherein a total cationic charge of a total concentration of said protonated polyethylenimine in said container represents at least fifty percent of said total cationic charge density in said container; protonating at least ten percent of all nitrogens in a first mass of said protonated polymer with hydrochloric acid, said step of protonating yielding a total mass of said protonated polymer and chloride; and reducing a chloride mass of said total mass by at least ten percent; formulating said protonated polymer with a protonated polyethylenimine, said protonated polyethylenimine comprising at least ten percent of said protonated polymer by mass; delivering a total cationic charge in a range of 0.05 to 0.95 C/ml per delivery dose from said container; and, raising a pH of a solution of said protonated polymer to greater than five; performing said step of raising prior to said step of packaging; removing, after said step of raising said pH of said solution to greater than five, greater than ten percent of chloride anions in said solution; and reducing, after said step of removing, said pH of said solution by at least one-half of a pH unit.
‘592 claims are directed to a method for forming an antibacterial/antiviral material, comprising the steps of: dispensing a dose of dispensed contents from a container, said dose of dispensed contents comprising a cationic polymer, a solvent, cationic sites, and anionic sites, said cationic sites in said dose of dispensed contents comprising a total cationic charge; reducing a concentration of said solvent in said dose of dispensed contents by mass through evaporation; forming a film comprising said total cationic charge in a range of 0.001 to 10.0 coulombs per square inch, wherein polymer cationic sites of said cationic polymer of said dose comprises greater than sixty percent of said total cationic charge; and inactivating, with said film, at least one of: at least 95% of a gram positive bacteria population within 30 minutes; at least 95% of a gram negative bacteria population within 30 minutes; at least 95% of an enveloped virus population within 30 minutes of contact; at least 95% of a non-enveloped virus population within 30 minutes of contact; and at least 94% of a Clostridium difficile bacteria population within 24 hours of contact; delivering said dose of said dispensed contents with a total cationic charge density in a range of 0.005 to 0.3 meq/g; delivering both a polyalkylenimine and a polydiallyldimethyl ammonium chloride from said container in said step of dispensing, wherein a total cationic polymer charge of secondary amines exceeds a total quaternary ammonium compound charge in said film; delivering at least one of polyalkylenimine and a polydiallyldimethylammonium chloride at a concentration of at least five hundred parts per million from said container in said step of dispensing; reducing a concentration of chloride ions from a solution containing said polyalkylenimine by at least ten percent prior to adding said polyalkylenimine into said container; performing said step of protonating prior to a step of packaging said polyalkylenimine in said container, wherein a solution containing polyethylenimine by at least ten percent prior to adding said polyethylenimine into said container.
It would have been obvious to provide a method for dispensing a biocide, in particular, polyethyleneimine, because the biocide is polyethyleneimine is recited in both Instant Claims and the ‘592 claims. Further, ‘592 claims are directed to protonating polyethyleneimine with hydrochloric acid comprising reducing a concentration of chloride ions from a solution containing polyethylenimine by at least ten percent prior to adding said polyethylenimine into said container; Instant Claims are also directed to protonating said polyethylenimine with hydrochloric acid in a solution; removing at least ten percent of chlorides added to said solution in said step of protonating; and performing said steps of protonating and removing prior to said step of packaging contents in a container. Furthermore, it would have been well within the purview of one skilled in the art to provide a PEI formulation for dispersing in a spray bottle a composition comprising a specific PH with less than 10 percent chloride ion to obtain an activity coefficient, y, of a protonated site of said protonated polymer. e.g., PRE, to a value greater than 0.7. by adjusting the protonation of the backbone nitrogen, and delivering protonated polyethylenimine (PEI) from said container, as instantly claimed in view the ‘592 claims, because the ‘592 claims and Instant Claims are dispersed from a container having similar antimicrobial activity to inactivate non-enveloped viruses. Instant Claims do not recite further dispensing polydiallyldimethyl ammonium chloride with PEI, however, Instant Claims recite the transitional term ‘comprising’ and are open-ended and do not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. V. H. J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004).
Thus, Instant Claims are obvious in view of the subject matter as recited in the '592 claims, wherein Instant claim and ‘592 claims are both directed a method for dispensing biocide, wherein the biocide is polyethyleneimine and at least one quaternary ammonium compound is dispensed from a container
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The provisional rejection of claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,6, 9-11 and 14 of copending Application No. 18/885,695 [herein ‘695] is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and the ‘695 claims are both directed to common subject matter.
Instant Claims are directed to a method for dispensing a biocide, comprising the steps of: packaging contents in a container, said contents comprising said biocide and a solvent, said biocide comprising a protonated polymer comprising repeating charged units, said contents comprising a total cationic charge density in a range of 0.001 to 0.1 meq/g, at least ten percent of said total cationic charge density from charges of non-quaternary amines of said protonated polymer; and dispensing said biocide from said container; treating a substrate with said biocide, said step of treating inactivating greater than fifty percent of non-enveloped viruses on said substrate in less than ten minutes; incorporating a polyethylenimine into said container as a component of said protonated polymer; protonating said polyethylenimine with hydrochloric acid in a solution; removing at least ten percent of chlorides added to said solution in said step of protonating; and performing said steps of protonating and removing prior to said step of packaging; yielding chloride counterions to protonated secondary amine sites of said polyethylenimine; and reducing a concentration of said chloride counterions by at least ten percent to a concentration of to less than 900 ppm; and performing said step of protonating prior to said step of packaging; formulating said protonated polymer with counterions, less than fifty percent of said counterions comprising chloride; formulating said protonated polymer with a polymer backbone chain comprising at least two carbons and at least one nitrogen per monomer of said protonated polymer; controlling an activity coefficient, γ, of a protonated site of said protonated polymer, to a value greater than 0.7; delivering protonated polyethylenimine from said container, wherein a total cationic charge of a total concentration of said protonated polyethylenimine in said container represents at least fifty percent of said total cationic charge density in said container; protonating at least ten percent of all nitrogens in a first mass of said protonated polymer with hydrochloric acid, said step of protonating yielding a total mass of said protonated polymer and chloride; and reducing a chloride mass of said total mass by at least ten percent; formulating said protonated polymer with a protonated polyethylenimine, said protonated polyethylenimine comprising at least ten percent of said protonated polymer by mass; delivering a total cationic charge in a range of 0.05 to 0.95 C/ml per delivery dose from said container; and, raising a pH of a solution of said protonated polymer to greater than five; performing said step of raising prior to said step of packaging; removing, after said step of raising said pH of said solution to greater than five, greater than ten percent of chloride anions in said solution; and reducing, after said step o