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 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 5-9 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 5-9 are directed to a “use” without setting forth any steps involved in the process. See MPEP 2173.05 (q).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 5-9 are rejected under 35 U.S.C. 101 because the claims fail to properly claim a process, machine, manufacture or composition of matter. See MPEP 2173. 05 (q).
Claim Rejections - 35 USC § 102/103
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 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.
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.
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.
Claims 1, 4, 5, 7 and 8 are rejected under 35 U.S.C. 102(a)1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as unpatentable over Wang (CN 106265436 A, published on January 4, 2017, cited in IDS).
Wang discloses a skin sanitizer gel that provides skin health and long-lasting antimicrobial protection. The reference teaches a disinfecting solution comprising chlorhexidine gluconate (chlorhexidine digluconate), and an inclusion agent which prevents the cationic antimicrobial agent from reacting with anionic agents such as carbomer and surfactant. The inclusion (clathration) agent is chosen from alpha-cyclodextrin, beta-cyclodextrin and gamma-cyclodextrin. See translation, p. 2. 7th sentence from the bottom. The composition contains 20-40wt % of a cosolvent (e.g., ethanol) in water. Although there is no specific mention in the reference that the cationic active is “nanoencapsulated”, the reference discloses that the disinfectant solution is produced by dissolving chlorhexidine gluconate and the inclusion agent in water at an elevated temperature. See Example, step 2, solution B. Such process indicates that the inclusion of the cationic active occurs at the molecule level, and it is viewed that the encapsulation is in nanoscale, unless shown otherwise. See the present claim 1.
Regarding claim 4, Wang teaches that a carbomer thickening agent is used in the amount of 0.1 – 1 wt %. See translation, p, 2, 10th sentence from the bottom.
Regarding claim 5, Wang teaches the composition is in the form of flowing or non-flowing, viscous liquid, which suggest gel form. See examples.
Regarding claims 7 and 8, the phrases “for topical use” and “for environmental treatment and surface disinfection”, respectively, denote merely state intended uses and purposes and therefore are treated as non-limiting preambles. See MPEP 2111.02. Patentable weight is given only to the preamble only to the extent that a prior art is suitable and capable of performing the recited use. As the Wang composition is suitable for disinfecting skin, it is also suitable and capable for topical use and environmental treatment.
Claims 1, 2, 7 and 8 are rejected under 35 U.S.C. 102(a)1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as unpatentable over Friedman (US 4774329 A, published on March 9, 1993; US equivalent of CA 1314225, cited in IDS).
Friedman discloses a controlled-release antimicrobial composition which prevents cetylpyridinium chloride, a water-soluble antimicrobial, from dissolving and washing away too quickly when applied to wounds. The composition comprises a complex of cyclodextrin cavity and cetylpyridinium chloride, which suggests that the complex is in the form of encapsulation. See col. 3, lines 22 – 38. Since formation of the complex occurs at molecular level, it is viewed that the cationic active is encapsulated at nanoscale, unless shown otherwise.
Regarding claim 2, Friedman further teaches that the amount of cetylpyridinium chloride to cyclodextrin molecular in the solution is about 1:1 to 4:1. See col, 3, lines39 47.
Regarding claims 7 and 8, the phrases “for topical use” and “for environmental treatment and surface disinfection”, respectively, denote merely state intended uses and purposes and therefore are treated as non-limiting preambles. See MPEP 2111.02. Patentable weight is given only to the preamble only to the extent that a prior art is suitable and capable of performing the recited use. As the Friedman composition is suitable for treating wounds, it is also safe, suitable and capable for topical use and environmental treatment.
Claims 1, 2 and 5-9 are rejected under 35 U.S.C. 102(a)1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as unpatentable over Gallopo et al. (EP 0306455 A1, published on March 8, 1989, cited in IDS) (“Gallopo” hereunder).
Gallopo teaches aqueous-based, anti-bacterial oral preparations comprising cyclodextrin- chlorhexidine digluconate complexes and additives. See abstract. The reference teaches that such complex increases the water solubility of the cationic active and masks its bitter taste. See col. 2, lines 9 - 29. The complex is formed by dissolving chlorhexidine or its salts and a molar excess of cyclodextrin in deionized water at elevated temperature. Since formation of the complex occurs at molecular level, it is viewed that the cationic active is encapsulated at nanoscale, unless shown otherwise.
Regarding claims 2 and 9, the intended applications of the complexes include mouthwash, spray, rinse, toothpaste, etc. See col. 5, lines 24 – 43.
Regarding claims 5 and 6, Gallopo teaches to use colloidal silica and alkali metal aluminosilicate complexes to make clear gels. See col. 5, lines 44-49.
Regarding claims 7 and 8, the phrases “for topical use” and “for environmental treatment and surface disinfection”, respectively, denote merely state intended uses and purposes and therefore are treated as non-limiting preambles. See MPEP 2111.02. Patentable weight is given only to the preamble only to the extent that a prior art is suitable and capable of performing the recited use. The Gallopo composition is suitable for the topical treatment of oral cavities, and it follows that it is also safe, suitable and capable for environmental treatment.
Claim Rejections - 35 USC § 103
Claim 3 are rejected under 35 U.S.C. 103 as unpatentable over Gallopo as applied to claims 1, 2 and 5-9 as above, and further in view of Persello (US 5413844 A) and Wang.
Gallopo fails to teach sodium lauryl sulfate.
Persello teaches that dentifrice compositions typically include “usual” oral detergents including sodium lauryl sulfate. See col. 6, lines 53 – 58; Example 4.
Wang further teaches that forming complexes of the cationic disinfect chlorhexidine gluconate and the inclusion agent enables the cationic disinfectant to coexist with an anionic thickening agent. See translation, abstract. Such teaching implies that other anionic components such as sodium lauryl sulfate can be successfully incorporated into the Gallopo composition which similarly comprises chlorhexidine digluconate-cyclodextrin complexes.
Given the teachings of Gallopo to make oral rinse or toothpaste, one of ordinary skill in the art before the effective filing date would have been obviously motivated to look to prior art such as Persello and make dentifrice compositions comprising the chlorhexidine digluconate. As the latter teaches that detergent such as sodium lauryl is usually used to make a dentifrice, incorporating the detergent for oral cleaning effects would have been prima facie obvious. Since Wang suggests that anionic components can coexist with chlorhexidine digluconate-cyclodextrin complexes, the skilled artisan would have had a reasonable expectation of successfully combining the teachings of the references and incorporating sodium lauryl sulfonate to the Gallopo composition to make a stable dentifrice with detersive properties.
Conclusion
No claims are allowed.
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/GINA C JUSTICE/ Primary Examiner, Art Unit 1617
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