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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/15/2026, has been entered.
Preliminary matter:
In view of the amendment claim 29 so that claim 29 now depends from claim 21, the Requirement for Restriction mailed on 01/13/2023, is hereby withdrawn. Claim 29 is hereby rejoined with claims 21-23, 26 and 34-41.
Status of the Claims
Claims 21-23, 26, 29 and 34-41 are pending.
Applicants’ arguments, filed on 01/15/2026, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments filed on 01/15/2026, have been entered into the record. Applicants have amended claims 21 and 29. Applicants have cancelled claims 27-28 and 30. Claim 29 remains withdrawn from Therefore, claims 21-23, 26, 29 and 34-41 are subject of the Office action below.
Claim Rejections - 35 USC § 112-2nd Paragraph
Maintained/New Grounds of Rejection Necessitated by Applicants’ Amendments
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 21-23, 26, 29 and 34-41 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. Claims 22-23, 26, 29 and 34-41 depend from the rejected claim 21 and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth below.
As per MPEP 2173.02, “[d]uring prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude (emphasis added). See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc).”
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate (emphasis added). See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
Claim 21 recites “wherein the composition achieves at least 4-log kill of a gram-negative and/or, gram-positive microbial population on the surface”, however, a person skilled in the art cannot reasonably determine the meets and bounds of the of the composition that the Applicants are claiming. This is because, it is not clear from either the specification or the common teachings in the art how this limitation further limits the claim. For example, it is not clear if this limitation is limiting to a certain patient population, the active ingredient(s), or an unnamed excipient. The specification does not teach or provide a nexus between the functional result that Applicants claim to achieve by the claimed composition with any particular component of the formulation or the manner in which it is administered.
There is no description as to the pharmaceutical approach that makes this result possible (i.e., what cause “achieves at least 4-log kill of a gram-negative and/or, gram-positive microbial population on the surface”), nor do Applicants teach any quaternary ammonium compound(s), fatty acid(s) and diluent(s) or chemical approaches to avoid. Furthermore, it is unclear to one skilled in the art as to, for example:
1) what composition of claim 21, would not “achieves at least 4-log kill of a gram-negative and/or, gram-positive microbial population on the surface”; and
2) what composition of claim 21, would “achieves at least 4-log kill of a gram-negative and/or, gram-positive microbial population on the surface”.
Thus, a person of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claims.
For the purpose of examination, spraying of a composition of claim 21 would be included in the interpretation of “wherein the composition achieves at least 4-log kill of a gram-negative and/or, gram-positive microbial population on the surface”.
It is recommended that Applicants amend claim 21 to either delete the limitation “wherein the composition achieves at least 4-log kill of a gram-negative and/or, gram-positive microbial population on the surface”, or recite specific composition that performs the recited function of “wherein the composition achieves at least 4-log kill of a gram-negative and/or, gram-positive microbial population on the surface”, in order to overcome the rejection. Appropriate correction is required.
This lack of clarity makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected. Appropriate correction is required.
Response to the Applicant’s Arguments
Applicants rained several arguments (see § C, pages 6-8 of Remarks), alleging that the rejection is improper on the ground that:
1) Applicants merely cite MPEP § 2173.02, including a list of case law citations therein (see pages 6-7 of Remarks).
Response:
Applicants’ response fails to link MPEP § 2173.02 and the legal concepts to the facts of the application under examination.
2) The specification at Tables 5, 7-8, pages 53-55, Examples 3-4 and the declaration of Derrick Anderson filed on 11/06/2024, allegedly describe the pharmaceutical approach that makes “wherein the composition achieves at least 4-log kill of a gram-negative and/or, gram-positive microbial population on the surface”. Please see pages 7-8 of Remarks.
Response:
A review of the instant specification (including Tables 5, 7-8, pages 53-55, Examples 3-4) and the declaration of Derrick Anderson filed on 11/06/2024, fails to reveal a composition within the limitation of claim 21, that: i) would not “achieves at least 4-log kill of a gram-negative and/or, gram-positive microbial population on the surface”; or ii) would “achieves at least 4-log kill of a gram-negative and/or, gram-positive microbial population on the surface”. There is no description as to the pharmaceutical approach that makes this result possible (i.e., what cause “achieves at least 4-log kill of a gram-negative and/or, gram-positive microbial population on the surface”), nor do Applicants teach any quaternary ammonium compound(s), fatty acid(s) and diluent(s) or chemical approaches to avoid. Thus, a person of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claims.
The Applicants have not properly addressed the specific grounds of rejection as discussed in the previous Office action and reiterated above.
For the reasons above, and those made of record in the previous Office action, the rejections are maintained.
Claim Rejections - 35 USC § 103
Maintained/New Grounds of Rejection Necessitated by Applicants’ 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, 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.
The rejection of claims 21-23, 26, 35-36 and 38-41, is maintained and claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Hodge of record (U.S. Pub. No. 20130255729), for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated.
Independent claim 21 is drawn to a method for killing microbes on a surface soiled with milk soils, comprising spraying to the surface, an antimicrobial composition having a pH of between about 2 to about 4, and comprising:
i) from about 4000 ppm to about 10000 ppm of a quaternary ammonium compound selected from the group consisting of the list disclosed therein; and
ii) a C5-C11 fatty acid component selected from the group consisting of the list disclosed therein.
Similar to claim 21, Hodge discloses sprayable antimicrobial composition (see ¶ 0013), that can comprise a quaternary ammonium compound or mixtures of quaternary ammonium compounds as a surfactant or mixtures of surfactants, and at least one acid. Please see abstract, ¶s 0005, 0024,0031-0032, 0036 and 0077, Tables 1-3. The composition can be sprayed on a surface (see ¶s 0003 and 0013), which necessarily encompasses a surface soiled with milk soils.
“The sprayable compositions can be used in any environment where it is desirable to have larger droplet sizes dispensed from a transient trigger sprayer. For example, the sprayable composition can be used in institutional applications, food and beverage applications, heath care applications, vehicle care applications, pest elimination applications, and laundering applications. Such applications include but are not limited to laundry and textile cleaning and destaining, kitchen and bathroom cleaning and destaining, carpet cleaning and destaining. Vehicle cleaning and destaining, cleaning in place operations, general purpose cleaning and destaining, surface cleaning and destaining, particularly hard surfaces, glass window cleaning, air freshening or fragrancing, industrial or household cleaners, antimicrobial cleaning. Methods of using the sprayable compositions are also provided.” Emphasis added, please see ¶ 0013.
Hodge discloses that suitable concentration range of the components of the concentrate sprayable composition includes between approximately 0.1 wt% (1, 000 ppm) and 30 wt% (300, 000 ppm) by weight surfactant and between approximately 7 wt% and 75 wt% of at least one acid. Please see ¶ 0024.
In an embodiment of the invention:
a) the pH of the composition is 4.5 or lower (see ¶ 0026).
b) the quaternary ammonium compound is, for example, benzalkonium chloride (n-tetradecyldimethylbenzylammonium chloride, see ¶ 0032), which is identical to the Applicants’ elected compound (see reply filed on 02/15/2023 and Office action mailed on 06/27/2023).
c) the at least one acid includes a fatty acid antimicrobial agent and suitable fatty acids include medium chain fatty acids, including C6-C16 alkyl carboxylic acids (e.g., hexanoic acid, butyric acid, octanoic acid, heptanoic acid, nonanoic acid, decanoic acid and dodecanoic acid). Please see ¶ 0027.
The claimed “from about 4000 ppm to about 10000 ppm”, overlaps or lies within the range disclose by Hodge because Hodge teaches range of 1000 pm and 300,000 ppm. Please see discussions above.
The claimed composition pH of between about 2 to about 4, overlaps or lies within the range disclose by Hodge because Hodge teaches pH of 4.5 or lower. Please see discussions above.
A prima facie case of obviousness exists in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" (see MPEP § 2144.05). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP § 2144.05).
In the instant case, because the instantly claimed: i) “at least about 4000 ppm”; and ii) “pH of between about 2 to about 4”, lies inside a range disclosed by the prior art (see discussions above), a prima facie case of obviousness exists.
It is noted that no criticality (emphasis added), has been demonstrated in the specification with regard to the claimed “from about 4000 ppm to about 10000 ppm”, and pH between about 2.5 and about 3.5.
Therefore, the selection of a specific amount of at least one cationic surfactant and at least one nonionic surfactant, would have been routinely determined and optimized in the pharmaceutical art.
It would have been obvious for a person skilled in the art to allow the sprayed composition to remain in contact with the surface containing the microbes for a sufficient amount of time (e.g., about 15 seconds to an hour (claim 21) or 15 seconds to about 5 minutes (claim 36)), in order to achieve maximum killing of the microbes by the antimicrobial composition.
Factors determining contacting time include, but not limited to: i) the concentration, type and number of active agent(s) employed (e.g., a quaternary ammonium compound or mixtures of quaternary ammonium compounds); and ii) number of microbes on the surface (e.g., greater the number, greater killing time needed with same composition concentration).
For each application of the antimicrobial composition, the specify amount of a quaternary ammonium compound and an acid component employed, can in each case be determined by an artisan of the ordinary skill through test series following the requisite guidelines set forth in the Hodge disclosure.
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
Accordingly, at the time of the instant invention, a person skilled in the art would have readily envisaged a method for killing microbes on a surface (e.g., a surface soiled with milk soils), with a sprayable antimicrobial composition having a pH of 4.5 or lower (e.g., pH of between about 2 to about 4), and comprising: i) a quaternary ammonium compound (e.g., benzalkonium chloride); and ii) a fatty acid antimicrobial agent (e.g., hexanoic acid), in the disclosure of Hodge. The skilled artisan would have had a reasonable expectation that the spraying of microbes on a surface (e.g., a surface soiled with milk soils), with the composition, would kill the microbes on the surface.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Regarding claim 21, the recited intended outcome of a method of claim 21 resulting in achieving at least 4-log kill, is not given any patentable weight because the recited outcome is simply expressing the intended result of a process positively recited. Please see MPEP § 2111.04, citing Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003).
In the instant case Hodge discloses a method of claim 21 (see discussions above). Therefore, the method of Hodge must necessarily produce the same outcomes of achieving at least 4-log kill. This is because the outcome recited is a natural process that flows from the microbes on the surface and the sprayed composition of claim 21.
Therefore, claims 21 and 36 are obvious over Hodge.
Regarding claims 22 and 26, Hodge discloses that the concentrate sprayable composition comprising a quaternary ammonium compound in an amount between approximately 1, 000 ppm and 300, 000 ppm (see discussions above), which can be diluted with water to form ready to use solutions (see ¶ 0024).
Regarding claim 23, the claimed pH between about 2.5 and about 3.5, overlaps or lies within the range disclose by Hodge because Hodge discloses a pH of 4.5 or lower (see discussions above).
A prima facie case of obviousness exists in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" (see MPEP § 2144.05). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP § 2144.05).
In the instant case, because the instantly claimed pH between about 2.5 and about 3.5, lies inside a range disclosed by the prior art (see discussions above), a prima facie case of obviousness exists.
Regarding claim 29, the recitation of “wherein the acid component solubilizes the one or more milk soils”, is a property of a composition of claim 21. Since Hodge discloses a composition of claim 21 (see discussions above), the composition of Hodge must necessarily exhibit the same properties recited in claim 29.
An inherent characteristic may “be part of the prior art in an obviousness analysis even if the inherent characteristic was unrecognized or unappreciated by a skilled artisan.” Endo Pharm. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 1381 (Fed. Cir. 2018).
Therefore, claim 29 is obvious over Hodge.
Regarding claim 35, Hodge discloses surfaces including window, industrial and household surfaces. Please see ¶ 0013.
Regarding claim 38, although Hodge discloses nonanoic acid (see discussions above), Hodge is not explicit in disclosing isononanoic acid. However, the claimed invention would have been obvious over Hodge, because the claimed isononanoic acid (a C9 alkyl carboxylic acid), is an isomer of nonanoic acid (a C9 alkyl carboxylic acid). Such a small difference in structure is considered to be a homolog of the other compound and is considered obvious:
“Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious).” Please see MPEP 2144.09, section II
In the instant case, isononanoic acid and nonanoic acid are presumed to possess similar properties and there is a reasonable expectation that a composition of Hodge comprising isononanoic acid, would similarly exhibit an antimicrobial utility.
The claimed “about 0.1 wt% to about 30 wt%”, overlaps or lies within the range disclose by Hodge because Hodge teaches between approximately 7 wt% and 75 wt% of at least one acid. Please see discussions above.
A prima facie case of obviousness exists in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" (see MPEP § 2144.05). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP § 2144.05).
In the instant case, because the instantly claimed “about 0.1 wt% to about 30 wt%”, lies inside a range disclosed by the prior art (see discussions above), a prima facie case of obviousness exists.
It is noted that no criticality (emphasis added), has been demonstrated in the specification with regard to the claimed acid component in the amount of “about 0.1 wt% to about 30 wt%”.
Regarding claim 39, Hodge discloses at least one surfactant (see ¶ 0005), including anionic, nonionic, cationic, and amphoteric surfactants (see ¶ 0028).
Regarding claim 40, Hodge discloses that at least one surfactant can be at a concentration of between approximately 0.1 wt% and 30 wt % (¶ 0024).
Regarding claim 41, Hodge discloses that the sprayable composition may include other functional ingredients such as: i) chelating agents (see ¶ 0018); and ii) dyes/odorants (see ¶ 0050).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited reference.
The rejection of claims 21 and 34 under 35 U.S.C. 103 as being unpatentable over Hodge of record, as applied to claim 21 above, and further in view of Fazlara of record (American-Eurasian J. Agric & Environ Sci, 2012), is maintained for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated.
The limitations of claim 21, as well as the corresponding teachings of Hodge, are described above and are hereby incorporated into the instant rejection.
Claim 34 is similar to claim 21, however, claim 34 differs slightly from claim 21 in that claim 34 requires specific microbes selected from the group consisting of the list disclosed therein.
Hodge differs from claim 34 only insofar as Hodge is not explicit in teaching specific microbes selected from the group consisting of the list disclosed in claim 34.
However, the claim invention would have been obvious over Hodge, because at the time of the instant invention, it was known in the art a composition comprising a quaternary ammonium compound of claim 21, can kill a microbe of claim 34.
For example, Fazlara teaches a method of killing microbes including gram-positive bacteria (Staphylococcus aureus, Listeria monocytogenes and Bacillus cereus) and gram-negative bacteria (Salmonella typhimurium, Escherichia coli and Pseudomonas aeruginosa), with benzalkonium chloride. Please see abstract, Tables 1-2 and discussions therein.
Benzalkonium chloride is the Applicants’ elected compound (see discussions above).
Therefore, at the time of the instant invention, a person skilled in art would have found it obvious to modify Hodge with Fazlara, in order to arrive at the invention of claim 34. One skilled in the would have had a reasonable expectation that the spraying of microbes on a surface, including gram-positive bacteria (Staphylococcus aureus, Listeria monocytogenes and Bacillus cereus) and gram-negative bacteria (Salmonella typhimurium, Escherichia coli and Pseudomonas aeruginosa), with a sprayable antimicrobial composition having a pH of 4.5 or lower, and comprising: i) a quaternary ammonium compound (e.g., benzalkonium chloride); and ii) a fatty acid antimicrobial agent (e.g., hexanoic acid), would kill the microbes.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
The rejection of claims 21, 34 and 37 under 35 U.S.C. 103 as being unpatentable over Hodge of record, as applied to claim 21 above, and further in view of: 1) Bratescu of record (US Pub. No. 20040071653); and 2) USEPA of record (Published 05/13/2004), is maintained for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated.
The limitations of claim 21, as well as the corresponding teachings of Hodge, are described above and are hereby incorporated into the instant rejection.
Claim 34 is similar to claim 21, however, claim 34 differs slightly from claim 21 in that claim 34 requires specific microbes selected from the group consisting of the list disclosed therein.
Claim 37 is similar to claim 21, however, claim 37 differs slightly from claim 21 in that claim 37 requires a blend of alkyl dimethyl benzyl ammonium chloride and alkyl dimethyl ethylbenzyl ammonium chloride.
Although Hodge discloses that mixtures of quaternary ammonium compounds such as n-alkyl (C12-C18) dimethylbenzyl ammonium chloride (see ¶s 0031-0032), can employed in the formulation of a sprayable antimicrobial composition, Hodge differs from claims 34 and 37 only insofar as Hodge is not explicit in disclosing: i) a blend of alkyl dimethyl benzyl ammonium chloride and alkyl dimethyl ethylbenzyl ammonium chloride (claim 37); and ii) microbes recited in claim 34.
However, the claim invention would have been obvious over Hodge, because at the time of the instant invention, it was known in the art a blend of alkyl dimethyl benzyl ammonium chloride and alkyl dimethyl ethylbenzyl ammonium chloride, can kill a microbe of claim such as E. coli. For example:
1) Bratescu discloses that a blend of alkyl dimethyl benzyl ammonium chloride and alkyl dimethyl ethylbenzyl ammonium chloride, commercially available as BTC® 2125M P40, can be employed in the formulation of an antimicrobial formulation. Please see ¶s 0117-0122. Similar to Hodge (see discussions above), Bratescu discloses that the composition pH can be between about 2 and about 10 (see ¶ 0249). The composition can be employed to inhibit the growth of microorganisms such as E. coli and P. aeruginosa (see abstract and ¶ 0271).
2) USEPA (see page 3), discloses the following ingredients in BTC® 2125M P40:
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The n-alkyl in the BTC® 2125M P40, are within the C12-C18 limitation discussed in Hodge (see discussions above). BTC® 2125M P40 can be sprayed on a surface to kill microbes such as E. coli and S. aureus (see pages 4-5).
Therefore, at the time of the instant invention, a person skilled in art would have found it obvious to employed a blend of alkyl dimethyl benzyl ammonium chloride and alkyl dimethyl ethylbenzyl ammonium chloride (e.g., BTC® 2125M P40), in an antimicrobial composition of modify Hodge with a reasonable expectation that the spraying of the composition on a surface containing microbes, including gram-positive bacteria (Staphylococcus aureus, Listeria monocytogenes and Bacillus cereus) and gram-negative bacteria (Salmonella typhimurium, Escherichia coli and Pseudomonas aeruginosa), would kill the microbes.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Response to Applicants’ Arguments/Remarks
Applicants raised several arguments (see§ IV, pages 9-12 of Remarks), alleging that the claimed invention is non-obvious the cited prior art on the grounds that:
1) Applicants respond by merely citing §s 904 and 2141, including a list of case law citations (see pages 9-11 of Remarks).
Response
Applicants’ response fails to link the MPEP §s 904 and 2141 and the legal concepts to the facts of the application under examination.
2) Applicants have amended claim 21 to recite the limitation of: i) a surface soiled with milk soils; and ii) a quaternary ammonium compound present in an amount of from about 4000 ppm to about 10000 ppm. Please see pages 9-10 of Remarks.
Response
The newly introduced limitation of: i) a surface soiled with milk soils; and ii) a quaternary ammonium compound present in an amount of from about 4000 ppm to about 10000 ppm, have been addressed in the discussions above. The Examiner, therefore, applies the same response hereto.
3) None of Hodge, Fazlara, Bratescu, USEPA or combination thereof, suggest or teach the claimed invention (see pages 10-11 of Remarks).
Response
The reasons for the Office’s reliance on the Hodge, Fazlara, Bratescu and USEPA references in order to reject the claimed invention, are set forth in the rejections above. The Examiner, therefore, applies the same reasons hereto.
4) Fazlara, Bratescu and USEPA, cannot be employed to address the deficiency in the teachings of Hodge because, amended claim 21 is allegedly non-obvious over Hodge (see pages 11-12 of Remarks).
Response
Each of the limitations of amended claim 21, has been addressed in the rejections above. Therefore, the use of Fazlara, Bratescu and USEPA, in order to address the deficiency in the teachings of Hodge, is proper.
For the reasons above, and those made of record in the previous Office action, the rejections are maintained.
Non-Statutory Obviousness-Type Double Patenting-Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
1) The rejection of claims 21-23, 26 and 34-41, is maintained and claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Nos: i)10,426,162 (‘162 patent); ii) 11,406,103 (‘103 patent); and iii) 11,540,512 (‘512 patent), for the reasons of record set forth in the previous Office action.
Response to Applicants’ Arguments/Remarks
Applicants raised several arguments (see § VI, pages 12-13 of Remarks), alleging that the nonstatutory double patenting rejection is improper on the grounds that:
A) Applicants respond by merely citing MPEP §s 804(II)(B) and MPEP § 802(1), including a list of case law citations (see page 5 of Remarks).
Response
Applicants’ response fails to link the MPEP §s 804(II)(B) and MPEP § 802(1), and the legal concepts to the facts of the application under examination.
B) The claims of the instant invention differ from the claims of ‘162 patent, ‘103 patent and ‘512 patent, in at least one of design, operation or effect because the ‘162 patent claims are drawn to a composition, whereas, instant patent claims (e.g., claim 21), are directed to a method for killing microbes on a surface soiled with soils (see page 13 of Remarks);
Response
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the above cited patents are similarly drawn to the same subject matter, which is an antimicrobial composition comprising a quaternary ammonium compound and an acid component, and a method of killing microbes with the composition.
For example, the claims of the instant application are drawn to a method for killing microbes on a surface soiled with soils, with an antimicrobial composition having a pH between about 2 to about 4 and comprising a quaternary ammonium compound and a fatty acid component, whereas, the claims of the ‘162 patent, are directed to: i) an antimicrobial composition having a pH of about 1 to about 12 and comprising a quaternary ammonium compound and a C6-C18 alkoxylated or unalkoxylated linear or branched fatty acid component (claims 1-10, 16-17); and ii) a method for killing microbes on a substrate (which necessarily encompasses a surface soiled with milk soils), with the composition (claims 11-12).
Therefore, the invention of the instant claims and ‘162 patent claims are connected in any of design, operation or effect.
Similar to instant claim 41, ‘162 patent claim 10 also requires that the composition further comprises the same additional functional ingredient recited in instant claim 41. Therefore, at least one examined application claim (instant claim 41), is not patently distinct from ‘162 patent claim 10.
Although the ‘162 patent is not explicit in claiming: i) spraying the composition; and ii) a quaternary ammonium compound at a concentration of about 4000 ppm to about 10,000 ppm, the claimed invention, would have been obvious over the ’162 patent.
This is because a patent’s "disclosure may be used…to answer the question whether claims merely define an obvious variation of what is earlier disclosed and claimed." AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust, 112 USPQ2d 1001, 1012 (Fed. Cir. 2014) (quoting In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008).
In the instant case, the ‘162 patent discloses that: i) the composition can be applied by spraying (see column 41, lines 53-65); and ii) suitable concentrations of the quaternary ammonium compound include concentrations between about 1 ppm 10,000 ppm (see column 17, lines 51-54). These aspects of the instant claims are, therefore, obvious over the ‘162 patent.
The AbbVie court explicitly noted that the Federal Circuit has “repeatedly approved examination of the disclosed utility of the invention claimed in an earlier patent to address the question of obviousness” and that “a later expiring patent is not patentably distinct from an earlier expiring patent if it merely claims a disclosed utility of the earlier claimed invention." Id. For example, when the claims in a later-expiring patent "merely recite methods of administering" the compositions claimed in the earlier patent, they are not patentably distinct over the claims of the earlier expiring patent." Id. (quoting Pfizer, Inc. v. Teva Pharms. USA, Inc., 86 USPQ2d 1001, 1008 (Fed. Cir. 2008)).
Furthermore, for double patenting of previously disclosed, but newly claimed utility, please see Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010).
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
2) The provisional rejection of claims 21-23, 26 and 34-41, is maintained and claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Application Nos: 1) 18/052,786; 2) 15/445,431; 3) 17/302,350; 4) 18/053,987; 5) 18/051,245; and 6) 18/053,987, for the reasons of record set forth in the previous Office action.
Response to Applicants’ Arguments/Remarks
Applicants have not properly addressed the specific grounds of rejections as discussed in the previous Office action setting. Applicants request that the obvious-type double patenting rejections be held in abeyance. Please see page 13 of Remarks.
Response
Applicants’ comments are acknowledged. However, the rejections will be maintained until a terminal disclaimer is filed or the claims are amended to obviate the rejections.
For the reasons above, and those made of record in the previous Office action, the rejections are maintained.
Conclusion
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629