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 .
Response to Arguments
Applicants' arguments, filed 9/26/2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 presently being applied to the instant application.
Election/Restrictions
Newly submitted claims 42-43 remain directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: these claims newly introduced in the amendment filed 5/8/2024, are drawn to a distinct product having a distinct combination of agents relative to claim 41 (claim 42), and a method, in place of a composition (claim 43).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 42-43 remain withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 30-36, 40-41, 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz (UK Patent Application Publication GB 2532302 A, Published 05/18/2016; cited in a prior Office action) in view of Lutz (US Patent 6080789, Published 06/27/2000; cited in a prior Office action), and Walker (“Chapter 5: Quaternary Ammonium Compounds”; 2002; in Handbook of Topical Antimicrobials; 1st Ed., CRC Press; eBook ISBN 9780429221729; pp. 99-116; cited in a prior Office action); as evidenced by Koninklijke (EP Patent Application Publication 2333105 A1, Published 06/15/2011; cited in a prior Office action).
Claims 37-39 have been canceled.
The claims are directed to a composition comprising a first biocide such as dodecyl dimethyl ammonium carbonate/bicarbonate and a second biocide, one or more nonionic surfactant such as octyl and/or dodecyl glucoside having a HLB of 8-14, having a pH of the composition is 6 to 13, and wherein the ratio of first biocide to second biocide is 1:5 to 5:1. The claims are further directed to the composition comprising an emollient. The claims are further directed to a method of disinfecting an object comprising contacting the object with the composition.
Schwartz et al. teach exemplary cationic surfactant may be selected from quaternary ammonium surfactants, which may be exemplified by alkyltrimethylammonium salts (e.g., cetyltrimethylammonium chloride (CTAC)) (21:15-19); Schwartz teaches an antimicrobial composition comprising 0.001-4% polylysine, 0.008-12% octyl-glucoside, 0.012-16% decyl-glucoside, 0.002-4% benzalkonium chloride, and 0.004-4% didecyldimethylammonium chloride, the composition further comprising at least 30% water, and other excipients (page 34, lines 4-33). The composition can include lubricating agents (emollient) (page 42, line 20-22). A method for combating contamination of a site with a microorganism, said method comprising contacting the side and/or microorganism with an antimicrobial preparation of the invention (page 36, lines 8-13). The site or location of the microorganism is not restricted; the microorganism may be present on a surface; the surface is not limited and includes any surface on which a microorganism may occur; the surface may be biotic or abiotic, and inanimate (or abiotic) surfaces include any such surface which may be exposed to microbial contact or contamination (page 36, lines 23-27).
Koninklijke teach octylglucoside has a HLB of 12.6 (paragraph 0046).
Schwartz lacks a teaching of the pH of the composition. Herve also lacks a teaching wherein the first biocide is didecyldimethylammonium carbonate.
Lutz teach a method of disinfecting a substrate (abstract). The composition can comprise a solvent such as propylene glycol (column 5, line 1). Carbonate quats display good tolerance to hard water compared with other quats (column 5, lines 2-3). The preferred carbonate quat is didecyldimethylammonium carbonate (column 2, lines 65-67). The composition preferably has a pH 9.85 (column 5, lines 40-56).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instant invention to adjust the pH of the composition of Schwartz and have a reasonable expectation of success. One would have been motivated to do so in order to provide a disinfecting composition with a preferred pH.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instant invention to substitute didecyldimethylammonium chloride in the composition of Schwartz with didecyldimethylammonium carbonate preferred by Lutz and have a reasonable expectation of success. One would have been motivated to do so to have disinfecting composition having good tolerance to hard water.
Regarding the benzyl ammonium halide, claim 30 no longer embraces this compound. However, an alternate biocidal Quaternary Ammonium Compound (QAC) biocide would have been obvious to substitute.
Walker teaches Quaternary Ammonium Compound (QAC) that occupy a unique niche in the world of antimicrobial compounds (99: first paragraph); the first reports of quaternary ammonium compounds with biocidal activity appeared in 1916; since that time, QACs have grown in popularity and been utilized extensively as active ingredients in many types of products. As a group, QACs are effective across a broad spectrum of microorganisms, including bacteria, certain molds and fungi, and viruses (99, last paragraph). QACs also behave as surfactants (100: second paragraph). The first antimicrobial quaternary amines were rather simple, with three methyl groups and on linear, saturated alkyl group attached to a single, positively charged nitrogen atom (alkyltrimethylammonium chloride (100: 5th paragraph, Figure 1):
PNG
media_image1.png
95
406
media_image1.png
Greyscale
This group of QACs are alkyl quaternary ammonium halides; the alkyl chain length includes C8-C12 (claim 37).
Walker also discusses benzyl ammonium halides (see third structure in Figure 1), and benzalkonium chloride, the most well-known of all the QACs.
Thus, both Walker and Schwartz teach alkyl quaternary ammonium halides; Schwartz exemplifies cetyltrimethylammonium chloride (CTAC), alternate to benzalkonium chloride. It would have been obvious to further modify the Schwartz p. 34 formulation by substitution of CTAC in place of the benzalkonium chloride in the lead composition of p. 34, together with the didecyldimethylammonium carbonate preferred by Lutz, preferred by Lutz substituted in place of didecyldimethylammonium chloride in the lead composition of Schwartz, giving a composition of the instant amended claims. Amounts of first and second biocide amounts include the range to 4%, which would have been obvious to employ, i.e., a weight ratio of 1:1
With regard to claims 32-34 and 40 are intended use limitations. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Therefore, the instant claims are rendered obvious by the teachings of the prior art.
Examiner construed the recited fractional inhibitory concentrations of claims 30 & 31, 41 & 44 to be characteristic of the required components of claim 30, absent evidence to the contrary.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Regarding the amendments to claims 30, 41, 44, Schwartz does not teach the named second biocide components, such as didecylmethylpoly(oxyethyl)ammonium propionate. The claims are further directed to a composition comprising, in one alternative, didecylmethylpoly(oxyethyl)ammonium propionate.
Lichtenberg et al. teach a disinfectant composition comprising 2.0% didecylmethylpoly(oxyethyl)ammonium propionate with a pH of 9.85 (paragraphs 0046-0055). The compositions are characterized by an excellent bactericidal and in particular fungicidal action even in small application concentrations and are suitable for use as both disinfectants and preservative agents (abstract).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instant invention to combine the compositions of Schwartz and Lichtenberg et al. and have a reasonable expectation of success. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Schwartz and Lichtenberg et al. are both directed to disinfecting compositions. Therefore, the instant claims are rendered obvious by the teachings of the prior art.
Examiner acknowledges the 2% amount of didecylmethylpoly(oxyethyl)ammonium propionate is just below the recited at least 3% endpoint of second biocide, required by amended claim 30. As discussed in MPEP 2144.05 (I), 2nd paragraph, 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. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). 2% is within “merely close” to at least 3%, rendering the claimed amount prima facie obvious.
Applicant argues that claim 1 [sic, presumed to be intended as a reference to amended claim 30] allegedly patentably defines over the cited references {claim 1 has been canceled}. Applicant further argues that reliance on Lichtenberg fails to cure the deficiencies of Swartz, reliant on Ex parte Richard (in Application 12/195,806), because this requires modifying Schwartz to achieve excellent bactericidal properties, s property that they already possess.
The Examiner has reviewed the Ex parte Richard PTAB Decision referred to in the argument, but fails to identify that the fact pattern is closer to the instant case, compared to the cited In re Kerkhoven case, in which "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06 (I). This case deals with the combination of equivalents known for the same purpose, which renders the combination prima facie obvious.
Applicant further argues that the claimed composition encompasses biocides that act synergistically, i.e., they have a total effect that is greater than the biocide properties of only one of the biocides acting alone. Examiner notes that the sum of fractional inhibitory concentrations of each combination of biocides appear to be the sum of the two biocides, which does not establish synergy that is unexpected. See discussion of synergism at MPEP 716.02 (a):
"A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness ... of the claims at issue." In re Corkill, 771 F.2d 1496, 226 USPQ 1005 (Fed. Cir. 1985). In Corkhill, the claimed combination showed an additive result when a diminished result would have been expected. This result was persuasive of nonobviousness even though the result was equal to that of one component alone. Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating "synergism"). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991) (Evidence showing greater than additive sweetness resulting from the claimed mixture of saccharin and L-aspartyl-L-phenylalanine was not sufficient to outweigh the evidence of obviousness because the teachings of the prior art lead to a general expectation of greater than additive sweetening effects when using mixtures of synthetic sweeteners.).
In the instant case, while synergism is stated (including in the specification), the Examiner is unable to determine the effect is greater than the sum of each of the effects taken separately. It is Applicant’s burden to establish that results are unexpected and significant (MPEP 716.02(b) (I)), and Applicants have burden of explaining proffered data (MPEP 716.02(b) (II)). This is not met by a statement alleging that synergy is present without establishing explanation of why synergy is established by the data argued.
Even if Applicant provides additional information in explanation to establish synergy between the three sets of two specific biocidal compounds, the claims recite many other combinations of three or more compounds, recited generically in classes, or as alternatives; the additional nonionic surfactant or surfactant combination (or more embodiment of independent claims) embrace at least 14 classes of nonionic surfactant, which may reasonably be expected to potentiate other biocide compounds, already required by the claims.
MPEP 716.02 establishes that unexpected results must be commensurate in scope with the claims which the evidence is offered to support. This is not the case for any independent claim, in terms of specific combinations of two compounds, or concentrations, when present, let alone when additional recited compounds are recited. Applicant’s arguments do not address or establish how any of these considerations are satisfied.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/ Primary Examiner, Art Unit 1614
Prosecution Insights