DETAILED ACTION
This Office Action is in response to Applicant’s Amendment and Remarks filed on 18 February 2026 in which claims 5 and 10 were canceled, and claims 1-4, 8 and 11-20 were amended to change the scope and breadth of the claims.
Claims 1-4, 6-9 and 11-20 are pending in the current application and are examined on the merits herein.
The Declaration of Dr. Tristan Alexander Cogan (hereinafter The Declaration), submitted by Applicant on 19 February 2026 under 37 CFR §1.132 is acknowledged and will be further discussed below.
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 .
Withdrawn Objection
Applicant’s amendment, filed 18 February 2026, with respect to the objection of claim 8, has been fully considered and is persuasive because claim 8 has been amended to delete “comprising the nanoparticles”, which was redundant. The objection is hereby withdrawn.
Applicant’s amendment, filed 18 February 2026, with respect to the rejection of claims 1-9 and 13-20 under 35 U.S.C. § 112(b), second paragraph, for indefiniteness, has been fully considered and is persuasive because claims 2, 3, and 14 has been amended to delete “when provided”. Claim 5 has been canceled. Furthermore, claim 2 has been amended to clearly recite one range of active component. The rejection is hereby withdrawn.
Applicant’s amendment and arguments, filed 18 February 2026, with respect to the rejection of the claims as being unpatentable over US Patent No. 11,351,134, has been fully considered and is persuasive. Applicant argues the claims of the ‘134 Patent do not recite an alkaline suspension.
The argument is found persuasive. It is also noted the claims of the ‘134 Patent are directed towards an acidic or neutral suspension. Furthermore, there is no teaching, suggestion or motivation to prepare the composition of the ‘134 Patent as an alkaline suspension, with a reasonable expectation of success in arriving at a composition having broad spectrum activity. The rejection is hereby withdrawn.
Response to Arguments
Applicant's arguments and Declaration, filed 19 February 2026, have been fully considered but they are not persuasive.
In paragraph 7 of the Declaration, Applicant argues “Paragraph [0092] and Tables 1 and 2 describe compositions containing 12-aminododecanoic acid, 12-amino-1-dodecanoic acid methyl ester, or sucrose monolaurate (see also para. [0088]-[0091]), all of which are active lauric acid derivatives that exhibit a Log P value less than 4, and when prepared as compositions under the correct circumstances unexpectedly have broad spectrum antibacterial activity against Gram-positive bacteria, such as S. aureus, S. epidermidis, and S. pneumoniae, and Gram-negative bacteria, such as E. coli, as is claimed”.
Since Applicant has not provided data showing compositions 12-aminododecanoic acid, 12-amino-1-dodecanoic acid methyl ester, or sucrose monolaurate, and having activity against Gram-positive and Gram-negative bacteria, it is not clear what “correct circumstances” are necessary to arrive at the unexpected broad spectrum antibacterial activity.
In paragraph 8 of the Declaration, Applicant attests that each of 12-aminododecanoic acid, 12-amino-1-dodecanoic acid methyl ester, and sucrose monolaurate have been prepared in alkaline conditions, and evaluated as compositions comprising lecithin components and chitosan, displayed broad spectrum antibacterial activity, such that the 12-aminododecanoic acid, 12-amino-1-dodecanoic acid methyl ester, and sucrose monolaurate were active against Gram-positive bacteria and Gram-negative bacteria.
The above arguments are not found persuasive. It is not clear what conditions were present that allowed the 12-aminododecanoic acid, 12-amino-1-dodecanoic acid methyl ester, and sucrose monolaurate to have broad spectrum activity in alkaline pH. This is particularly critical when alleging unexpected results. See MPEP 716.02(b), "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness.".
Without a clear description of the experimental conditions performed to arrive at the unexpected results, it is impossible to determine whether the claims are commensurate in scope with the conditions needed to arrive at the unexpected results. See MPEP 716.02(c), “Evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention.
In paragraph 9 of the Declaration, Applicant contends “while some component ratios are disclosed, compositions may suitably be prepared in which the active component may comprise up to 30 wt.% of a total composition, or when the active component is combined with lecithin components, such a combination may make up to 50 wt.% of a final composition”.
The above arguments are not found persuasive. As discussed above, without a detailed explanation for the experimental conditions (reagents, amounts used, pH, bacteria tested, etc.), it is not possible to determine if the results may be limited to specific conditions and/or whether those conditions are commensurate in scope with the present claims. Currently, there is no objective evidence to compare the present claims with the argued unexpected broad spectrum activity.
In paragraph 9 of the Declaration, Applicant also argues “a ratio of chitosan to lecithin components when combined (lecithin components having been previously combined with active components) may be in a range from between 0.7:1 to 1:0.7, chitosan to lecithin components, respectively, as is claimed.
The above arguments are not found persuasive, because the above range does not appear to be recited in the claims.
In paragraph 10 of the Declaration, Applicant has generally described how experiments were performed. However, it is unclear what total amounts of each component were used in each experiment, and how they compare the amounts and ranges presently claimed.
For the above stated reasons, said claims are properly rejected under 35 U.S.C. 112(a). Thus, the rejection is hereby maintained.
Modified Rejections
The following are new ground(s) or modified rejections necessitated by Applicant's amendment, filed on 18 February 2026, in which claims 5 and 10 were canceled, and the limitations in pending claims 1-4, 8 and 11-20 as amended now have been changed. Therefore, rejections from the previous Office Action, dated 18 August 2025, have been modified and are listed below.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6-9 and 11-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a nanoparticle containing composition having broad spectrum antimicrobial action comprising sucrose monolaurate and lecithin, the outer layer of the particle contains glycol chitosan (aka hydroxyethyl chitosan), and prepared under basic conditions (pH 9) having 1 part sucrose monolaurate, 9 parts lecithin and 10 parts glycol chitosan, does not reasonably provide enablement for a composition in a form of an alkaline suspension comprising 12-amino-1-dodecanoic acid methyl ester or 12-amino-1-dodecanoic acid, chitosan and lecithin. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The nature of the invention: The nature of the invention is a formulation having specific fatty acid derivatives with broad spectrum biocidal activity. Specifically, the composition comprises a particulate of 12-aminododecanoic acid, 12-amino-1-dodecanoic acid methyl ester or sucrose monolaurate, with lecithin and coated with glycol chitosan (or hydroxyethyl chitosan).
(3) The relative skill of those in the art: The relative skill of those in the art is high. The preparation and use of compositions comprising fatty acid derivatives for antimicrobial purposes is well known.
(2) and (4) The state of the prior art/The predictability or unpredictability of the art: James-Meyer et al. (WO 2016/061561, of record) teach lauric acid derivatives have improved biocidal activity when formulated with lecithin, and coated with a polysaccharide including chitosan. The amine of chitosan has a pKa of about 6.5, and is positively charged at an acidic pH. However, these “active compositions do not prevent growth or are less effective against Gram-negative bacteria” (para [0015]).
Zhao et al. (Food Chemistry, 2015, vol. 187, pp. 370-377, cited in previous Office Action) teach sucrose monolaurate was active against Gram-positive and Gram-negative bacteria, including E. coli (abstract; Table 1; p.374, first para).
Wagh et al. (Applied and Environmental Microbiology, 2012, pp. 3465-3468, cited in previous Office Action) teach sucrose monolaurate was not active against E. coli, a Gram-negative bacteria (table 2).
(5) The breadth of the claims: The breadth of the claims includes an active component being selected from the group consisting of 12-amino-1-dodecanoic acid methyl ester, 12-amino-1-dodecanoic acid, sucrose monolaurate, a salt or ester thereof, the active component having a partition coefficient, P, and hydrophobic with its logP value being less than 4.
Claim 1 includes lecithin, and chitosan, in the form of an alkaline suspension comprising nanoparticles of undescribed chemical characteristics. Furthermore, while the preamble states the composition has broad spectrum antimicrobial action, the claim actually only requires that the formulation has growth inhibitory action against at least one Gram-positive bacteria or a Gram-negative bacteria.
Claim 1 as amended still does not require having activity against both Gram-positive and Gram-negative bacteria.
(6) and (7) The amount of direction or guidance presented/The presence or absence of working examples:
According to the Specification, the active lauric acid derivative and lecithin must be buffered at a pH of 4, 5, 6, 7 or 9 (para [00100]-[00101]). The prepared particulates is then coated with chitosan.
According to this section of the Specification, aqueous formulations of each active component had no inhibitory activity against any bacteria tested (p.37, para [00108]).
In another preparation method, each lauric acid derivative was suspended in chloroform, and then mixed with water, followed by evaporating the chloroform. The pH was acidic or neutral. None of the active components had any inhibitor activity against any bacteria tested (para [00109]).
In a further preparation, 12-aminododecanoic acid or 12-amino-1-dodecanoic acid methyl ester was suspended in chloroform, mixed with water, the chloroform evaporated, and lecithin added in a solution of acetic acid. The pH of the solution was neutral. Chitosan was added, and the samples sonicated. Some mixtures were buffered at a pH 9, pH 7 or pH 5. The samples were then filtered and sterilized.
A similar process was repeated for the data observed in tables 1-3. The mixtures contained about 1 part active component to about 9 parts lecithin to about 10 parts chitosan.
According to Table 1, 12-aminododecanoic acid, 12-amino-1-dodecanoic acid methyl ester and sucrose monolaurate were formulated with lecithin and chitosan at pH 5 or 7 levels and tested for antimicrobial efficacy against Gram-positive bacteria and Gram-negative bacteria. This particular mixture only had activity against Gram-positive bacteria.
According to Table 2, 12-aminododecanoic acid, 12-amino-1-dodecanoic acid methyl ester and sucrose monolaurate are prepared with chitosan at pH 7 or 9, and the mixtures were active against Gram- negative bacteria.
According to Table 3, other lauric acid derivatives only had activity against Gram-positive bacteria, when the mixture was prepared at pH 5 or 7. These derivatives did not have activity against Gram-negative bacteria regardless if it was prepared at pH 5, 7 or 9.
According to Table 5, sucrose monolaurate was prepared with 1 part sucrose monolaurate, about 9 parts lecithin in an acetate buffer, mixing and sonicating, and then adding about 10 parts chitosan solution. The mixture is buffered at pH 9. The particulated forms were found to have activity against Gram-positive and Gram-negative bacteria.
Table 5 only shows the formulation having sucrose monolaurate had broad spectrum activity when it had been prepared at a pH 9 (pH > 7). And as discussed above, Zhao et al. (Food Chemistry, 2015, vol. 187, pp. 370-377, cited in previous Office Action) teach sucrose monolaurate was active against Gram-positive and Gram-negative bacteria, including E. coli (abstract; Table 1; p.374, first para).
However, there is no evidence to show 12-aminododecanoic acid or 12-amino-1-dodecanoic acid ester have both gram (+) and gram (-) activity at an alkaline pH.
(8) The quantity of experimentation necessary: In order to practice the invention with the full range of lauric acid derivatives claimed at alkaline conditions, one skilled in the art would undertake a novel and extensive research program to show that Gram-positive and Gram-negative bacteria growth can be inhibited by the claimed formulation.
There are no disclosed examples of an alkaline suspension comprising 12-amino-1-dodecanoic acid methyl ester or 12-amino-1-dodecanoic acid, chitosan and lecithin and having broad spectrum activity.
The experimentation involved would therefore be significant, undue and unpredictable.
Genentech, 108 F.3d at 1366, sates that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Therefore, in view of the Wands factors, as discussed above, particularly the breadth of the claims, Applicants fail to provide information sufficient to practice the claimed invention.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699