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 Status
Claims 1-9 are rejected.
No claims are allowed.
Maintained Claim Rejections - 35 USC § 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 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.
1. Claims 1-3, 5, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Meyer et al., (US 2015/0064122 A1, March 5, 2015) (hereinafter Meyer).
Meyer teaches a skin or hair whitening mixture, comprising alkandiols (Claim 1), such as 1,3-propanediol (Claim 3), in an amount of 0 to about 60% b.w. (Claim 5(c)). Preferred active ingredients for skin and/or hair lightening include ascorbic acid ([0155]) and caffeine ([0157]), in an amount of 0.0001 to 20 wt. %, based on the total weight of the preparation ([0158]). Sodium metabisulfite (i.e., an inorganic salt) may be included in an amount of 0.15% by weight ([0218]). The preparation can contain water in an amount of 5 to 80% b.w., based on the total weight of the preparation ([0205]). The preparation may be a solution (i.e., single aqueous phase ([0202]). Hyaluronic acid may be present ([0184]). EDTA (i.e. ethylenediaminetetraacetic acid) may be present in an amount of 0.1% by weight (i.e., meeting about 0.2%) ([0215]). The inventive composition may be used in a non-therapeutic method for whitening human skin or hair by topical administration of a working amount of the composition (Claim 16). The composition may further comprise antioxidants ([0023]) and retinal, retinoic acid and its derivatives ([0173]).
Meyer discloses a solution (i.e., single aqueous phase) ([0202]) containing ascorbic acid ([0155]), caffeine ([0157]), water ([0186]), and sodium metabisulfite (i.e., an inorganic salt, [0218])). Together these would provide a composition as claimed instantly. The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
Regarding the limitation of claim 1 “at least 0.2 % by weight of an inorganic salt”, Meyer discloses examples comprising sodium metabisulfite (i.e., an inorganic salt) in an amount of 0.15% by weight. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05. An amount of 0.2% is so close to an amount of 0.15% that a person of ordinary skill in the art would have expected the two amounts (0.2% and 0.15%) to have the properties. Thus, an amount of 0.2% would have been obvious.
2. Claims 4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Meyer et al., (US 2015/0064122 A1, March 5, 2015) (hereinafter Meyer) in view of Yu et al., (US 5,492,935 A, Feb 20, 1996) (hereinafter Yu).
As discussed above, Meyer makes obvious the limitations of claim 1 but does not teach wherein the composition comprises about 0.5 % by weight of sodium bisulfite based on the total weight of the composition.
However, Yu discloses compositions containing retinal or its derivative that may be administered topically to the affected areas of the skin for improving age spots and disturbed keratinization (abstract). The composition may comprise vitamin C (i.e., ascorbic acid, Claim 10). In the topical preparations, retinal and its derivatives may be formulated in an aqueous solution (col. 3, lines 62-64). When retinal and its derivatives are formulated in aqueous form, sodium bisulfite may be added as an antioxidant to stabilize retinal and its derivatives in the aqueous composition (col. 3 line 66- col 4 line 3). The concentration of antioxidant may range from 0.01 to 1% (col. 4, lines 11-12). The composition may be used also to treat pigmented skin spots (i.e., skin in need of treatment for skin brightening or lightening) (Claim 6).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Meyer discloses wherein the composition comprises antioxidants and retinal. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 0.01 to 1% sodium bisulfite into the composition of Meyer since it is a known and effective antioxidant and amount thereof for stabilizing retinal as taught by Yu.
Response to Applicant’s Arguments
Applicant argues that only by selecting from Meyer’s optional ingredients, in long and various lists and locations in Meyer, can one identify claimed ingredients. And those ingredients are not disclosed for use together.
Applicant’s argument has been fully considered but found not to be persuasive. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP 2123. Therefore, one of ordinary skill in the art would have used the optional ingredients disclosed by Meyers. Also, having to select from various lists and locations in a reference does not mean the claimed invention is nonobvious since combining prior art elements supports a conclusion of obviousness. See MPEP 2143(I)(A). As such, Applicant’s argument is unpersuasive.
Applicant argues that the successful formulation of ascorbic acid in an aqueous vehicle is not predictable.
Applicant’s argument has been fully considered but found not to be persuasive. The arguments of counsel cannot take the place of evidence in the record. See MPEP 716.01(c). Applicant has not provided any objective evidence supporting Applicant’s assertion. Therefore, since Applicant’s argument is merely speculative, Applicant’s argument is unpersuasive.
Applicant argues that paragraph [0202] actually discloses that emulsions are preferred for compositions containing Meyer's mixture.
Applicant’s argument has been fully considered but found not to be persuasive. A prior art reference is evaluated for all that it reasonably suggests and is not limited to preferred embodiments. See MPEP 2123. As such, Applicant’s argument is unpersuasive.
Applicant argues that Meyer does not teach or suggest a single phase aqueous composition because paragraph [0202] actually discloses that "solutions" of the mixture are in oil, not water.
Applicant’s argument has been fully considered but found not to be persuasive. Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment See MPEP 2123. Meyer teaches that a solution, e.g. in oil, and an impregnating solution for cosmetic wipes are preferred formulations of the composition ([0202]) and the formulation contains water in an amount of 5 to 80% b.w., based on the total weight of the preparation ([0205]). Therefore, because the composition may be a solution and comprise up to 80% water, the composition may be a single phase aqueous solution. The use of the abbreviation “e.g.” signals that an example follows. Thus, Meyer is suggesting that an oil solution is an example of a solution but is not limiting the type of solution only to oil solutions. Further, Meyer makes no such exemplary suggestion for the impregnating solution for cosmetic wipes. Thus, one of ordinary skill in the art would understand that the composition of Meyer may be an aqueous solution.
Applicant argues that Yu does not cure the deficiencies as discussed above.
The Examiner submits that the arguments above have been addressed and are unpersuasive. Therefore, the rejection with Yu is maintained.
For the foregoing reasons the rejection has been maintained.
Conclusion
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 Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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/S.J.K./Examiner, Art Unit 1614
/TRACY LIU/Primary Examiner, Art Unit 1614