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
This office action is a response to applicant’s communication submitted July 22, 2026, wherein claims 1 and 5 are amended and claim 4 is canceled. This application claims priority to foreign application CN202310268549.8, filed March 20, 2023.
Claims 1-3 and 5-15 are pending in this application.
Claims 1-3 and 5-15 as amended are examined on the merits herein.
Withdrawn Rejections
Applicant’s amendment, submitted July 22, 2026, with respect to the rejection of claims 4 and 5 under 35 USC 112(b) for stating an exclusionary proviso in an ambiguous manner, has been fully considered and found to be persuasive to remove the rejection as the claims have been amended so that the exclusionary proviso clearly requires exclusion of only one of the listed compounds from the composition. Therefore the rejection is withdrawn.
Applicant’s argument, submitted July 22, 2026, with respect to the rejection of claims 1-12 under 35 USC 102(a)(1) for being anticipated by Zhang Yucheng et al., has been fully considered and found to be persuasive to remove the rejection as Applicant persuasively argues that lactic acid is among the chelating agents excluded by the exclusionary proviso now appearing in base claim 1. Therefore the rejection is withdrawn.
The following rejections of record in the previous action are maintained:
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 5, 6, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ammon et al. (US pre-grant publication 2004/0204496, of record in previous action)
Independent claim 1 is directed to a disinfectant composition capable of killing endospores comprising polyhexamethyene biguanide. (PHMB) Ammon et al. discloses a composition for disinfecting bacterial endospore laden surfaces. (p. 1 paragraph 8) In one embodiment the biguanide is selected from a list including poly(hexamethylene biguanide). (p. 2 paragraph 18) Such a composition would anticipate present claim 1. Regarding claims 3-6 and 12, Ammon et al. discloses solutions of PHMB in water with no other components, which would anticipate there claims. (e.g. p. 3 table 1)
Regarding claim 13, p. 1 paragraph 8 of Ammon et al. specifically describes applying the composition to a surface, thereby anticipating this claim.
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 2, 11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ammon et al. (US pre-grant publication 2004/0204496, of record in previous action)
The disclosure of Ammon et al. is discussed above. Ammon et al. does not specifically describe a composition wherein the concentration of PHMB is greater than or equal to 0.5% as recited in claim 11. However, Ammon et al. does describe a concentration of 1000-150000 ppm, or 0.1-15.0%. It would have been obvious to one of ordinary skill in the art at the time of the invention to formulate a disinfectant composition having 5000 ppm or more of PHMB. One of ordinary skill in the art would have seen the disclosure of the overlapping range of 1000-150000 ppm as suggesting this overlapping range of 5000 or more, rendering the claimed range obvious.
Regarding claim 14, this claim further requires maintaining contact with the object being disinfected for at least 20 minutes. Examples 1-5 on pp. 5-7 disclose tests of antimicrobial activity after 24 hours, which his greater than 20 minutes. Furthermore, even if it is determined that the disclosure of 24 hour incubations in the examples does not specifically suggest a particular length of incubation time for practical use, examples 3-7 on pp. 7-9 show that for a solution containing only PHMB (solution 4 in tables 5-7) longer incubation times between 5 min and 30 seconds were associated with greater log reduction of bacterial endospores. Therefore one of ordinary skill in the art would have regarded the incubation time of the disinfectant on the surface as being a result-effective variable, and therefore would have found it to be obvious to determine the optimal value for this parameter.
Regarding claim 2, Ammon et al. does not specifically describe the kill log value of PHMB against B. subtilis var niger. However, looking to the data provided in the present disclosure, (e.g. pp. 13-17, tables 1 and 2) aqueous solutions of 0.2% or higher (2000 ppm or higher) of PHMB have at least this high log reduction against B. subtilis var niger. Since Ammon et al. suggests concentration of much higher than 2000 ppm of the disinfectant, the reference clearly suggests compositions that would have the claimed property, rendering such a composition obvious.
Therefore the invention taken as a whole is prima facie obvious.
Claims 7-10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ammon et al. as applied to claims 1-3, 5, 6 and 11-14 above, and further in view of Fernandes et al. (Reference of record in previous action)
The disclosure of Ammon et al. is discussed above. Ammon et al. does not disclose compositions further comprising chitosan oligosaccharides. However, Fernandes et al. discloses that Bacillus cereus is a common endospore-forming contaminant in need of disinfection. (p. 854 left column) Chitosan oligosaccharides are described as water soluble derivatives of chitosan that have promising antifungal and antibacterial activities. (p. 854 right column first paragraph) The effect of chitooligosaccaride on both spore and vegetative forms of B. cereus was evaluated. (p. 855 right column second and fifth paragraphs) Treatment with COS at a concentration of 0.25 or 0.5% caused loss of the protective exosporium which would be expected to render the cells more susceptible to other antimicrobial treatments. (p. 856 right column first paragraph, p. 859 right column second paragraph)
It would have been obvious to one of ordinary skill in the art at the time of the invention to include chitooligosaccharide at a concentration of 0.25 or 0.5% in the disinfectant compositions described by Ammon et al. One of ordinary skill in the art would have seen the disclosure of Fernandes et al. as suggesting that COS would act to sensitize bacterial endospores to other antimicrobial agents such as PHMB, thereby improving the efficacy of the composition described by Ammon.
Therefore the invention taken as a whole is prima facie obvious.
Response to Arguments
Applicant’s arguments, submitted July 22, 2026, with respect to the above grounds of rejection, have been fully considered and not found to be persuasive to remove the rejections. With respect to all of the rejections still of record, Applicant relies upon the argument that the incorporation of the limitations of claim 4 into claim 1 somehow overcomes all of the rejections based on Ammon US2004/0204496. However, no arguments touching the merits of the rejection are supplied. The examiner notes that claim 4 was previously rejected as anticipated by disinfectant compositions as described by Ammon consisting of only water and polyhexamethylene biguanide, and containing no further ingredients such as chelating agents or oxidizing agents. (See e.g. p. 3 table 1) Therefore the examiner sees no reason that such a composition would be seen by one skilled in the art as containing a chelating agent or oxidant so as to place it outside of the scope of presently amended claim 1. The rejections under 35 USC 103 are not separately traversed and are therefore seen to be proper for the same reason as the rejection under 35 USC 102.
Therefore all rejections still of record are deemed proper and maintained.
Conclusion
No claims are allowed in this action. THIS ACTION IS MADE FINAL. 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 ANDREA OLSON whose telephone number is (571)272-9051. The examiner can normally be reached M-F 6am-3:00pm.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 9/11/2026
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