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 .
Claims Status
Applicants' arguments and amendments filed 10/02/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
New Rejections-necessitated by claim amendments
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.
Claim(s) 16-22 and 24-29 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Mynitti et al. (United States Patent Publication 2014/0309581).
Claim 1 recites a skin care composition, wherein the composition is capable of maintaining or promoting the vitality of bacteria on the skin surface, and wherein the composition (a) is an aqueous composition which is formulated for topical application to skin, and(b) has a theoretical osmolality of from 3000 mOsm/kg to 4000 mOsm/kg water or less. Regarding the recitation “capable of maintaining or promoting vitality of bacteria on a skin surface”, it must be noted that the 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 the intended use, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997Here, as discussed below, Mynitti et al. teach topical application to skin of a composition comprising water and overlapping osmolality ranges, thus is capable of meeting the intended use of the claim.
Mynitti et al. teach a polymeric solvating system which comprises metal ion sequestering agent, buffering agent and surfactant, see paragraph [0003]. The composition includes water in at least 50% by weight, at least 60% by weight or at least 75% by weight, see paragraph [0040]. The osmolality of the solvating system is greater than 900 milliosmoles, and is inclusive of from 1000-4000 milliosmoles (mOsm) per liter, see claim 1 and 15 and paragraphs [0004] and [0032]. For treating wounds, it is desirable to have a higher osmolarity to facilitate wound healing or treatment, see paragraph [0032]. Since the solvating system is an aqueous solution of water (see claim 1 and paragraph [0040]), the density is 1kg/L (water) and thus the aqueous solution of 4000 milliosmoles is approximately equal to about 4,000 mOsm/kg. A solvating system having an osmolality of from 1000-4000mOsm/kg overlaps the claimed range of from 3000-4000mOsm/kg, from 3200-3800mOsm/kg and from 3400-3600mOsm/kg. The solvating system is intended to be applied topically to the skin, see paragraphs [0041], [0047] and claims 13 and 24. The solvating system breaks down bacterial biofilms, see claim 16 and paragraph [0018]. A recitation of at least 75% water renders obvious the instantly claimed composition having over at least 30% water, at least 50% w/w/ water an at least 70% weight water. 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) . Regarding instant claim 24-25, less than 0.5% and less than 0.1% by weight of NaCL is inclusive of no sodium chloride (i.e. 0% by weight). The solvating system of Mynitti is silent to the teaching of sodium chloride, thus meets the claim. Regarding instant claims 26-27 wherein the composition comprises less than 5% by weight glycerol or less than 1% by weight glycerol, Mynitti is silent to the teaching of glycerol therefore meets the claim since the instant claims encompasses no glycerol. Mynitti et al. teach that the solvating system treats skin wounds which can be caused by diseases, see claim 24 and paragraph [0030]. Mynitti et al. teach that adjuvants such as antioxidants can be included with the solvating composition, see paragraph [0044].
Mynitti et al. teach aqueous compositions having high osmolality but does not disclose an amount that anticipates the claimed invention. Nevertheless, it would have been obvious to have provided an osmolality that overlaps the range from 3000 to 4000mOsm/kg, from 3200-3700 mOsm/kg or from 3400-3600m Osm/kg because Mynitti discloses that the aqueous solvating system which treats skin can comprise a high osmolality in overlapping ranges. 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).
Accordingly, instant claims 16-22 and 24-29 and 34 are renders obvious over the teachings of Mynitti et al.
Claims 23 and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Mynitti et al. (United States Patent Publication 2014/0309581) as applied to all claims 16-22 and 24-29 and 34 above, and further in view of Mynitti (hereafter Mynitti2-United States Patent publication 20160073628).
Regarding the recitation at claim 30 of “capable of maintaining or promoting vitality of bacteria on a skin surface”, it must be noted that the 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 the intended use, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997. Here, Mynitti et al. teach topical application to skin of a composition comprising water and overlapping osmolality ranges, thus is capable of meeting the intended use of the claim.
The teachings of Mynitti et al. are discussed above. As noted above Mynitti et al. suggests no NaCl or glycerol.
Mynitti et al. does not expressly teach that the solvating composition is in gel form.
Mynitti 2 teaches high osmolarity compositions which disrupt bacterial cell wall and kill bacteria and remove biofilms, see abstract and paragraph [0012].
The composition is formulated as a gel in order to control elution rate and to provide continuous application of the antimicrobial composition, see paragraph [0018]. The composition can be provided as a gel or paste for increased residence time, see paragraph [0096]. The osmolarity of the composition can be at least 3.5 osm/L which are aqueous so equivalent to 3000 mosm/kg, see paragraphs [0017], [0048] [0066]. The composition preferably has high osmolarity because this exerts higher pressure on bacterial cell walls and increases susceptibility to interruption by solvent or surfactant, see paragraphs [0012], [0061] and [0066].
It would have been prima facie obvious to provide the aqueous composition of Mynitti et al. as a gel form.
One of ordinary skill in the art would have been motivated to do so because Mynitti2 teaches that aqueous composition formulated as a gel increase residence time and help control elution rate while providing continuous application of the antimicrobial composition.
There would have been a reasonable expectation of success because both Mynitti and Mynitti2 teach aqueous formulations which treat bacteria on skin.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Mynitti et al. (United States Patent Publication 2014/0309581) as applied to all claims 16-22 and 24-29 and 34 above and further in view of in view of Mynitti (hereafter Mynitti2-United States Patent publication 20160073628) and Choi et al. (Propionibacterium acnes-Derived Extracellular Vesicles Promote Acne-Like Phenotypes in Human Epidermis).
Mynitti et al. teach that bacteria being treated include Propionibacterium acnes, see paragraph [0029].
However, Mynitti et al. does not expressly teach that the solvating system is for treating acne.
Mynitti 2 teaches high osmolarity compositions which disrupt bacterial cell wall and kill bacteria and remove biofilms, see abstract and paragraph [0012].
The composition is formulated as a gel in order to control elution rate and to provide continuous application of the antimicrobial composition, see paragraph [0018]. The composition can be provided as a gel or paste for increased residence time, see paragraph [0096]. The osmolarity of the composition can be at least 3.5 osm/L which are aqueous so approximately equivalent to 3000 mosm/kg, see paragraphs [0017], [0048] [0066]. The composition preferably has high osmolarity because this exerts higher pressure on bacterial cell walls and increases susceptibility to interruption by solvent or surfactant, see paragraphs [0012], [0061] and [0066]. The high osmolarity compositions treat acne which is caused by pathogenic bacteria that suppresses native bacteria, see paragraph [0060] and [0108].
Choi et al. teach that P. acnes contributes to the development of acne, see abstract and introduction.
It would have been prima facie obvious to utilize the solvating composition of Mynitti et al. for treating acne.
One of ordinary skill in the art would have been motivated to do so because Mynitti teaches treatment of wounds caused by P. acnes bacteria and Choi teaches that P. acnes contributes to the development of acne. Furthermore, per the teachings of Mynatti2, aqueous compositions with high osmolarity are useful in disrupting bacterial cells including treating acne.
Response to remarks
The amendment to the claims necessitate new grounds of rejections. Applicant’s remarks directed to Eberting are considered moot in view of the new rejections presented above which are necessitated by amendment to the osmolality range.
Conclusion
The amendments to the claims necessitated new grounds of rejections. 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).
Currently, no claims are allowed and all claims are rejected.
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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619