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 .
Claim Objections
Claims 9 and 22 are objected to because of the following informalities: they have inconsistent spelling. Claim 9 recites “didecyldimethyl ammonium quaternary cation”. Claim 2 recites “didecyl dimethyl ammonium chloride.”
Claim 12 is objected to because of the following informalities: “to1” has been written as one instead of two words.
Claim 16 is objected to because of the following informalities: there is a missing “a” before “basic compound” in “wherein the disinfectant composition does not contain a pH adjuster or basic compound”.
Appropriate correction is requested.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is directed to: “A method for destroying viruses and/or bacteria on an adjacent surface comprising:
applying a disinfectant composition to a surface contaminated with a virus or a hospital bacterium, the disinfectant composition containing only a single type of antimicrobial agent, the antimicrobial agent comprising a carbonate or a bicarbonate salt of a quaternary ammonium cation or a dimethyl dialkyl quaternary ammonium chloride combined with water, the carbonate or bicarbonate salt of the quaternary ammonium cation or the dimethyl dialkyl quaternary ammonium chloride being present in the antimicrobial composition at a concentration of greater than about 200 ppm and less than about 500 ppm.”
Claim 1 is vague and indefinite because it is unclear what “adjacent surface” means, and how this is different from just “surface”. Further, there is inconsistent claim term use in the claims, i.e. claims 7, 19 and 20 recite “the surface”, not “the adjacent surface”.
The limitation “the antimicrobial agent comprising a carbonate or a bicarbonate salt of a quaternary ammonium cation or a dimethyl dialkyl quaternary ammonium chloride combined with water” is vague and ambiguous because it is unclear if “a carbonate or a bicarbonate salt” applies only to of a quaternary ammonium cation or to both it and to a dimethyl dialkyl quaternary ammonium chloride. This is further evident give the language of dependent claims 9 and 22. Claim 9 appears to point that it is the latter, as it recites “wherein the carbonate or bicarbonate salt of the quaternary ammonium cation is a carbonate or bicarbonate salt of a didecyldimethyl ammonium quaternary cation”. Claim 22 appears to recite that it is the former, because it recites “wherein the antimicrobial agent is didecyl dimethyl ammonium chloride.” Based on that, either claim 9, or claim 22, are further rejected for lack of antecedent basis.
It is further difficult to decipher from the Specification which one is being claimed, because the Specification discloses testing and efficacy of both. See, e.g. [00048].
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Claim 1 recites that the disinfectant composition containing only a single type of antimicrobial agent. Paragraph [0008] of the specification gives guidance on this claim term. “The disinfectant composition contains only a single type of anti-microbial agent. The anti-microbial agent is generally a quaternary ammonium compound. More particularly, the anti-microbial agent is a dimethyl dialkyl ammonium compound, such as dimethyl didecyl ammonium chloride. In another aspect, the anti-microbial agent comprises a carbonate or a bicarbonate salt of a quaternary ammonium cation combined with water.” Paragraph [0021] further provides: “[0021] As described above, the disinfectant composition of the present disclosure generally contains only a single type of anti-microbial agent. More particularly, the disinfectant composition only contains a carbonate and/or bicarbonate salt of a quaternary ammonium cation or only contains dimethyl didecyl ammonium chloride. In one aspect, the disinfectant composition only contains a carbonate and/or a bicarbonate salt of a quaternary ammonium cation as the anti-microbial agent and contains no other anti-microbial agents”
Based on the above, one possible interpretation of claim 1 is that it require a single type of an antimicrobial agent, which is a quaternary ammonium compound, wherein this term requires that it be either a dimethyl dialkyl ammonium compound, or a carbonate or a bicarbonate salt of a quaternary ammonium cation. Further in relation to this interpretation, the claim term carbonate or bicarbonate salt is not required, but is an embodiment of the one type.
However, Applicant’s own specification appears to be inconsistent on this issue, because other paragraphs appear to expressly provide that from the two compounds named above, it is also possible to have a mixture. See, e.g., [0019]: “The anti-microbial agent contained within the disinfectant composition is a quaternary ammonium compound, such as a carbonate and/or bicarbonate salt of a quaternary ammonium compound or a dimethyl didecyl ammonium chloride, or mixtures thereof.”
Claim 2 recites “A method as defined in claim 1, further comprising the step 2. of allowing the disinfectant composition to air-dry on the surface without the need of a potable water rinse.” This is vague and indefinite because it is unclear how this claim differs from claim 1 and how to practice this step. Claim 1 does not require a step of a potable water rinse, and “allowing the disinfectant composition to air-dry on the surface” is not an active step.
Claim 5 recites the limitation “the Norovirus”. There is no antecedent basis for this limitation in the claim.
Claim 7 recites “one or less growth” which is vague and ambiguous because it is unclear what this means, i.e. less than one is zero growth. Further, how is growth for a microorganism measured as one or less? Further, what does it mean “out of 60 samples tested”? Claim 7 does not even require an additional active step of testing per se, let alone testing of 60 samples.
Claim 8 recites:
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The claim is vague and ambiguous because it is unclear if this refers to a combination of compounds, or to just alternative embodiments. Claim 1 does not appear to support a combination, but the two embodiments in claim 8 are introduced with “and”. Moreover, claim 1 recites that the disinfectant composition contains only a single type of antimicrobial agent. The claim is further vague and ambiguous because it lacks antecedent basis as to the claimed compounds. In this regard, what is a “C8 to C20 diakyl” when claim 1 recites “diakyl” only as “dimethyl dialkyl quaternary ammonium chloride”? Further, what is “C1 to C3 dialkyl ammonium cation”, when claim 1 only recites “dialkyl” as “dimethyl dialkyl quaternary ammonium chloride”, and when the reference to “an ammonium quaternary cation” in found in claim 1 not with reference to dialkyl, with “a quaternary ammonium cation”, which is further with a different word order.
Claim 9 is impossible to interpret because it combines within it two completely separate claims.
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Claim 15 recites “wherein the disinfectant composition does not contain a surfactant”. This is vague and indefinite because the compounds of claim 1, from which claim 15 depends, are surfactants by nature.
Claim 16 recites “wherein the disinfectant composition does not contain a pH adjuster or basic compound”. This is vague and indefinite because a basic compound is by nature a pH adjuster, so it is unclear how the two differ.
Claim 21 recites:
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The claim is vague and ambiguous because it is not complete of itself, and instead points to 40 CFR § 180.940 without even properly incorporating it by reference. Moreover, whether a chemical substance is exempted from the requirement of a tolerance when used in accordance with good manufacturing practice as ingredients in an antimicrobial pesticide formulation is not a determination, which is made by the PTO. Moreover, the reference is subject to a legal interpretation of a regulatory provision, which is made by a different agency, which further renders the claim vague and indefinite.
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.
Claims 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Anonymous, Technical Bulletin: Clean Quick® Quaternary Broad Range Sanitizer, 2011-04-07, updated February 14, 2013, pages 1-2 (“CQ”1), and further in view of Anonymours, Lonza Product Information Carboquat® H, USAD-33662, 2009-06-08, pages 1-3 (“Lonza”, of record).
Claim interpretation
The Examiner incorporates by reference her interpretation of Applicant’s claims from the 35 USC 112(b) rejection above.
Rejection
CQ describes the product and use of "Clean Quick", which is a disinfectant concentrate that contains a single type of antimicrobial agent, namely a quaternary ammonium cation. The antimicrobial agent has three dimethyl dialkyl ammonium chloride compositions of claim 1 in concentrations of amounting to 8.448%, of which one of the three ingredients is specifically Applicant’s claim 22 ingredient dodecyl dimethyl ammonium chloride. (page 1, "Active Ingredients", see the first three).
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It also contains alkyl (C14, 50%, C12, 40%, C16, 10%) dimethyl benzyl ammonium chloride, which makes up 5.632%. The issue presented is alkyl (C14, 50%, C12, 40%, C16, 10%) dimethyl benzyl ammonium chloride a quaternary ammonium compound, which is included within the meaning of a quaternary ammonium compound of Applicant’s claims? The answer is that it is not bialkyl per se, but as can be seen from the structure of it, it is a blend of alkyl dimethyl benzyl ammonium chlorides with C12, C14 and C16 chain lengths. Alkyl (C14, 50%, C12, 40%, C16, 10%) dimethyl benzyl ammonium chloride is what is commonly known as Lysol®- a widely used cationic surfactant and quaternary ammonium compound, which is also known by the alternative name benzalkonium chloride.
Of note, Applicant’s specification does not preclude benzalkonium compounds. See, e.g., “[0024] In other embodiments, however, the carbonate/bicarbonate salts of quaternary ammonium cations may be selected from dioctyldimethylammonium carbonate, decyloctyldimethylammonium carbonate, benzalkonium carbonate, benzethonium carbonate, stearalkonium carbonate, cetrimonium carbonate, behentrimonium carbonate, dioctyldimethylammonium bicarbonate, decyloctyldimethylammonium bicarbonate, benzalkonium bicarbonate, benzethonium bicarbonate, stearalkonium bicarbonate, cetrimonium bicarbonate, behentrimonium bicarbonate, and mixtures of one or more such carbonate salts.”
Thus, the dialkyl dimethyl ammonium chloride ingredients are 60% total, and the additional ingredient alkyl (C14, 50%, C12, 40%, C16, 10%) dimethyl benzyl ammonium chloride is 40%.
Before use, this concentrate is diluted with water at 1:256 (550 ppm active quot, which equals 330 ppm dimethyl dialkyl ammonium chloride ppm), 1:352 (400 ppm active quot, which equals 240 ppm dimethyl dialkyl ammonium chloride ppm), 1:704 (200 ppm active quot, which equals, and 1:938 (200 ppm active quot, which equals 120 ppm dimethyl dialkyl ammonium chloride ppm) (page 1, "Dilution Use").
It is used to clean hard surfaces by application with a cloth, mop, or sponge (i.e. an adjacent surface) or through application onto a surface followed by rubbing with a brush, sponge or cloth, and for non-food surfaces, it is not necessary to rinse with potable water. It can also be sprayed. (page 1, "General Use Directions").
The disinfectant is effective against bacteria and viruses (page 2, "Efficacy"). They include, inter alia, norovirus, coronavirus, and Pseudomonas aeruginosa.
Since CQ discloses the same method with the same composition, it will achieve the same result of producing a 3-log reduction, per Applicant’s claims 5 and 6, and the same growth on an AOAC germicidal spray test, per Applicant’s claim 7.
The disinfecting composition does not contain a further chelating agent, or a further surfactant, or a further pH adjuster or basic compound. In accordance with the above, in the absence of a further pH adjuster or basic compound, it also has the pH range of Applicant’s claim 13.
As was noted above, CQ is not limited to just a single type of an antimicrobial agent. CQ further does not disclose a carbonate or bicarbonate salt of a quaternary ammonium cation, per Applicant’s claim 19. CQ further does not specifically disclose a dilution with water of about 120 to 1 about 135 to 1.
Lonza discloses that Carboquat® H is Didecyl dimethyl ammonium carbonate/ Didecyl dimethyl ammonium bicarbonate. It discloses that it is its intended use is an active ingredient raw material for antimicrobial formulations such as disinfectants and sanitizers used on hard, nonporous surfaces. (p. 1). Lonza reports that it is freely soluble in water.
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to combine the teachings of CQ and Lonza in order to practice Applicant’s claimed invention with a reasonable expectation of success. The skilled artisan would have been motivated to do so because the art discloses practicing Applicant’s claimed method with either a single ingredient, or in combination with other quaternary ammonium compounds, for the same use of disinfecting of surfaces. With respect to rations of dilution with water, it is noted that CQ discloses varying the ratio, and showing efficacy across a broad spectrum. As the ratio is a known result-effective variable it would have been obvious to a person of skill in the art before the effective filing date to optimize it in order to optimize the disinfecting properties across an array of bacteria and/ or viruses.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
1 Applicant has made only the first of two pages of CQ of record. The Examiner accordingly makes the entire reference of record.