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 .
Election/Restrictions
Applicant's election with traverse of Group I and the species where the surfactant comprising a polyethylene glycol compound and a fatty acid moiety is a polyethylene glycol alkyl ester and both a phosphate compound and metal salt are present in the reply filed on April 14, 2026 is acknowledged. The traversal is on the grounds that the applicant disagrees with the common technical feature identified by the restriction requirement. This is not found persuasive because the functional limitation of microbial virulence suppression the applicant touts as the technical feature is inextricably bound to the components in the composition. A composition with the components and concentrations that are instantly claimed and that are common across all the invention groups was taught by Albrecht et al. (previously cited). Contrary to the applicant’s argument, the presence of components that the instant claims did not recite or the absence of testing in the manner the instant applicant chose does not indicate a distinction between the technical feature common to all the invention groups and the prior art teachings. The instant open claim language permits unrecited components and the applicant provides no guidance that anything more than the recited components at the recited proportions is necessary for the microbial virulence suppression that is claimed.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-3, 11, and 16-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
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 4-6, 8, 10, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abelson et al. (US PGPub No. 2006018398) as evidenced by the Tween® 80 Safety Data Sheet (2016).
Abelson et al. disclose an aqueous composition envisioned for topical application to the eye that comprises magnesium chloride hexahydrate (metal salt), calcium chloride dihydrate (metal salt), potassium chloride (metal salt), polysorbate 80 at 0.5 mg/ml (0.05 wt%), sodium phosphate dibasic anhydrous (phosphate compound at 0.15 mg/ml, hydroxypropyl methyl cellulose (thickener), and benzalkonium chloride (antiseptic) (see paragraph 67-table following paragraph 69). Polysorbate 80 is a fatty acid ester of the 18 carbon fatty acid, oleic acid (PEG alkyl ester), and a polyethylene glycol compound in the form of a polyoxyethylene sorbitan (see Tween® 80 Safety Data Sheet page 1; instant claims 4-5 and 10). The phosphate compound concentration corresponds to 1 mM (as calculated by the examiner; see instant claims 6 and 8). Further, Abelson et al. describe the composition to be a suspension (dispersion) (see paragraphs 70-75; instant claim 15). While silent in regard to microbial virulence suppression, the composition of Abelson et al. has the instantly claimed components at the instantly claimed proportions and in the instantly claimed configuration. According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Thus the claimed microbial virulence suppression functionality would be present, absent evidence to the contrary. Therefore claims 4-6, 8, 10, and 15 are anticipated by Abelson et al. as evidenced by the Tween® 80 Safety Data Sheet.
Claims 4-6, 10, and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cow et al. (US PGPub No. 2018/0243205) as evidenced by the Tween® 80 Safety Data Sheet.
Cow et al. disclose an aqueous liquid or suspension composition that comprises polysorbate 80 at 1 g/L (0.1 wt%), magnesium sulfate heptahydrate (metal salt), calcium chloride dihydrate (metal salt), zinc sulfate heptahydrate (metal salt), potassium dihydrogen phosphate (phosphate compound) at 0.2 g/L, manganese sulfate monohydrate (metal salt), iron III chloride (metal salt), cobalt II chloride hexahydrate (metal salt), and copper sulfate heptahydrate (see paragraph 67-table following paragraph 69; as calculated by the examiner; instant claims 4-6 and 13-15). Polysorbate 80 is an fatty acid ester of the 18 carbon fatty acid, oleic acid (PEG alkyl ester), and a polyethylene glycol compound in the form of a polyoxyethylene sorbitan (see Tween® 80 Safety Data Sheet page 1; instant claims 4-5 and 10). The phosphate compound concentration corresponds to 1.47 mM (as calculated by the examiner; see instant claims 6 and 8). While silent in regard to microbial virulence suppression, the composition of Cow et al. has the instantly claimed components at the instantly claimed proportions and in the instantly claimed configuration. According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Thus the claimed microbial virulence suppression functionality would be present, absent evidence to the contrary. Therefore claims 4-6, 10, and 13-15 are anticipated by Cow et al. as evidenced by the Tween® 80 Safety Data Sheet.
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.
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.
Claims 4-6, 8, 10, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Abelson et al. in view of Friedman et al. (US PGPub No. 2018/0236077), Dor et al. (US PGPub No. 2006/0182771), and Harding et al. (US Patent No. 5,705,144) as evidenced by Tween® 80 Safety Data Sheet.
Abelson et al. disclose an aqueous composition envisioned for topical application to the eye that comprises magnesium chloride hexahydrate (metal salt), calcium chloride dihydrate (metal salt), potassium chloride (phosphate compound), polysorbate 80 at 0.5 mg/ml (0.05 wt%), sodium phosphate dibasic anhydrous (phosphate compound at 0.15 mg/ml, hydroxypropyl methyl cellulose (thickener), and benzalkonium chloride (antiseptic) (see paragraph 67-table following paragraph 69). Polysorbate 80 is an fatty acid ester of the 18 carbon fatty acid, oleic acid (PEG alkyl ester), and a polyethylene glycol compound in the form of a polyoxyethylene sorbitan (see Tween® 80 Safety Data Sheet page 1; instant claims 4-5 and 10). The phosphate compound concentration corresponds to 1 mM (see instant claims 6 and 8). Further, Abelson et al. describe the composition to be a suspension (dispersion) (see paragraphs 70-75; instant claim 15). They more generally teach the presence of a surfactant which they exemplify as polysorbate 80 (polyoxyethylene sorbitan monooleate) and tyloxapol (see paragraph 42).
Friedman et al. teach that Tyloxapol has a hydrophilic-lipophilic balance (HLB) of 12.9 (see table 3).
Dor et al. teach surfactants envisioned for application to the eye and they include Tween® 21 and Tween® 80 (polysorbate 80; polyoxyethylene sorbitan monooleate) (see abstract and paragraph 128). Harding et al. teach that Tween® 80 has an HLB of while the Tween® 21 (polyoxyethylene sorbitan monolaurate) has an HLB of 13.3 (see Table 2). Tween® 21 is a fatty acid ester of the 12 carbon fatty acid, lauric acid (PEG alkyl ester), and a polyethylene glycol compound in the form of a polyoxyethylene sorbitan.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exchange Tween® 21 for the Tween® 80 surfactant of Abelson et al. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Here the exemplified surfactants of Abelson et al. have an HLB that ranges from 12.9 to 15, in light of Dor et al., Harding et al., and Friedman et al. Given that Tween® 21 was known to be suitable in eye compositions, is structurally similar to the exemplified polysorbate 80, and has an HLB within the range of the surfactants already considered by Abelson et al., the substitution would have been an obvious modification. While silent in regard to microbial virulence suppression, the composition of Abelson et al has the instantly claimed components at the instantly claimed proportions and in the instantly claimed configuration. According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Thus the claimed microbial virulence suppression functionality would be present, absent evidence to the contrary. Therefore claims 4-6, 8, 10, 12, and 15 are obvious over Abelson et al. in view of Friedman et al., Dor et al., and Harding et al. as evidenced by the Tween® 80 Safety Data Sheet.
Claims 4-7, 9-10, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Cow et al. as evidenced by the Tween® 80 Safety Data Sheet.
Cow et al. teach a topical composition comprising a cell extract that is conditioned media from a desired cell population (see abstract). The media employed comprises water as well as polysorbate 80 at 1 g/L (0.1 wt%), magnesium sulfate heptahydrate (metal salt) at 0.05 g/L, calcium chloride dihydrate (metal salt) at 0.146 g/L , zinc sulfate heptahydrate (metal salt) at 0.0425 g/L, potassium dihydrogen phosphate (phosphate compound) at 0.2 g/L, manganese sulfate monohydrate (metal salt) at 0.00338 g/L, iron III chloride (metal salt) at 0.00054 g/L, cobalt II chloride hexahydrate (metal salt) at 0.007 g/L, and copper sulfate heptahydrate at 0.007 g/L (see paragraph 67-table following paragraph 69; as calculated by the examiner; instant claims 4-6 and 13-15). Polysorbate 80 is an fatty acid ester of the 18 carbon fatty acid, oleic acid (PEG alkyl ester), and a polyethylene glycol compound in the form of a polyoxyethylene sorbitan (see Tween® 80 Safety Data Sheet page 1; instant claims 4-5 and 10). The phosphate compound concentration corresponds to 1.47 mM (as calculated by the examiner; see instant claims 6 and 8). In addition, the metal salt concentrations in the media correspond to magnesium sulfate at 203 mM, calcium chloride at 993 mM, zinc sulfate at 147 mM, manganese sulfate at 20 mM, iron III chloride at 33 mM, cobalt II chloride at 29 mM, and copper sulfate at 24 mM which provides 1449 mM total metal salt, excluding the phosphate compound (as calculated by the examiner). Cow et al. go on to teach collecting the media after culture, filtering, and at times diluting it with additional unused media, prior to inclusion in a final formulation (see paragraph 22 and examples 10-11). They exemplify a skin care composition that includes a thickener in the form of a cellulose derivative, a component they suggested for gel forms, and include 3 wt% of the cell extract/filtrate (see paragraph 44 and example 11; instant claim 15). Cow et al. teach the cell extract/filtrate to be included at a preferred concentration of 0.1 to 10 wt% (see paragraph 33). While a full example of each embodiment that follows from the teachings of Cow et al. is not detailed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the proportion of the cell extract/filtrate in the exemplified skin care composition within the taught range because they suggest to do so. This yields a 0.1 to 10 wt% proportion of the cell extract/filtrate which comprises the culture media and therefore corresponds to the total metal salts ranging from about 1.449 to 144.9 mM in the compositions (see instant claims 7 and 9). This range overlaps with or meets the instantly claimed ranges, thereby rendering the instantly claimed ranges obvious. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). Although silent in regard to microbial virulence suppression, the composition rendered obvious by Cow et al. have the instantly claimed components at the instantly claimed proportions and in the instantly claimed configuration. According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Thus the claimed microbial virulence suppression functionality would be present, absent evidence to the contrary. Therefore claims 4-7, 9-10, and 13-15 are obvious over Cow et al. as evidenced by the Tween® 80 Safety Data Sheet.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615
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