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 § 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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Morishita (JP 2013075880 A), as evidenced by Arslan 2013 (https://asianpubs.org/index.php/ajchem/article/view/25_3_10) and Dziadek 2018 (https://link.springer.com/article/10.1007/s00217-018-3055-y).
Regarding claim 1, Morishita teaches a composition comprising one or more selected from the group consisting of raspberry fruit extract, Argania spinosa leaf extract, and pine bark extract (claims on lines 23-27, page 14). Morishita teaches Rubus idaeus as an example of the raspberry fruit extract genus plant (Lines 44-46, page 2). As evidenced by Arslan, resveratrol is present in fruits including raspberry (Rubus idaeus) (Table 1 in right column on page 2); therefore, resveratrol is inherent to raspberry fruit extract, so Morishita’s raspberry fruit extract would read on the instantly claimed resveratrol. Morishita elaborates that the pine bark extract is obtained by extracting the bark of Pinus pinaster and gives Pycnogenol as an example (lines 45-48, page 3), which reads on Pycnogenol as disclosed by the instant specification to be an example of Pinus pinaster bark extract (lines 10-11, page 3) as well as the instantly claimed Pinus pinaster bark extract.
Regarding claim 2, Morishita teaches the composition can further comprise cherry leaf extract (lines 23-27, page 14). As evidenced by Dziadek, sweet cherry leaves (cherry leaves) are a rich source of polyphenolic compounds, which exhibit antioxidant activity (lines 36-40 in the left column on page 1422), so they read on the instantly claimed one or more additional antioxidant agents.
Morishita renders the instant claims obvious but does not teach with sufficient specificity to anticipate.
At the time of filing, a person of ordinary skill in the art would know that the composition in Morishita is obvious over the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Here a skilled artisan would be motivated to rearrange the teaching of Morishita to arrive at the instant claimed invention.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Morishita as evidenced by Arslan and Dziadek (as applied above to claims 1-2), in view of Pauly (US 7105184 B2).
As applied above, Morishita, as evidenced by Arslan and Dziadek, teaches the limitations of claim 1.
Morishita does not teach that the Argania spinosa leaf extract is present in an amount of about 0.0001% to about 1% by weight of the composition or in an amount of about 0.001% by weight of the composition.
Pauly teaches a method involving a composition containing an extract of Argania spinosa leaves (claim 1) in an amount of from 0.01 to 25% by weight (claim 2), which overlaps with the range of about 0.0001% to about 1% by weight in instant claim 3, and reads on about 0.001% in instant claim 4 with routine optimization.
Therefore, before the effective filing date of the claimed invention, it would be obvious to a person having ordinary skill in the art to take the composition taught by Morishita, and adjust the percentage of Argania spinosa leaf extract as taught by Pauly, to improve oral hygiene and odor control.
Morishita teaches an oral composition for preventing foul breath (Abstract). Pauly teaches its application can be oral in the form of tablets, dragees, capsules, juices, solutions and granules (lines 1-2, column 5) and that its composition can be in the form of deodorant (lines 60-61, column 9). Use of Pauly’s teaching to improve Morishita’s composition is an obvious modification and within the purview of the skilled artisan. One of ordinary skill in the art would find the results predictable because as taught by Pauly, an extract from the leaves of the plant Argania spinosa as in example 3 with a concentration of 0.01% by weight is able to increase the GSH content in human fibroblasts by 28% (lines 43-46, column 27). Since 0.01% is within the overlap range, that and similar amounts of Argania spinosa extract would be expected to yield significant cosmetic results as predicted.
Regarding instant claim 3, at the time of filing, the person of ordinary skill in the art would know that Pauly's ranges are obvious over the instant claims. Therefore, Pauly obviates that presently claimed. "In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists" (See MPEP 2144.05 (I) regarding obviousness of ranges).
Regarding instant claim 4, at the time of filing, the person of ordinary skill in the art would know that Pauly’s ranges are obvious over the instant claims. It would be obvious to adjust the percentage of Argania spinosa leaf extract taught by Pauly to match that of the claimed invention, because it would be considered routine optimization. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Morishita as evidenced by Arslan and Dziadek (as applied above to claims 1-4), in view of Hansenne (US 20090053337 A1).
As applied above, Morishita, as evidenced by Arslan and Dziadek, teaches the limitations of claim 1.
Morishita does not teach that the Pinus pinaster bark extract is present in an amount of about 0.0001% to about 1% by weight of the composition or in an amount of about 0.001% by weight of the composition.
Hansenne teaches a composition comprising an extract of Pinus pinaster bark (claim 11), wherein the extract is present in the composition in an amount of from about 0.01 to about 10% by weight, based on the weight of the composition (claim 15, Inventive Composition Example listed after [0020]), which overlaps with the range of about 0.0001% to about 1% by weight in instant claim 5, and reads on about 0.001% in instant claim 6 with routine optimization.
Therefore, before the effective filing date of the claimed invention, it would be obvious to a person having ordinary skill in the art to take the composition taught by Morishita, and adjust the percentage of Pinus pinaster bark extract taught by Hansenne in order to manage waste. Morishita teaches especially in the oral cavity and pharynx, various tissues constitute complex forms, so food residues that can be sources of methyl mercaptan are likely to remain, and plaques and other bacteria that are difficult to physically and chemically remove (waste) (lines 20-22, page 1), and Morishita’s composition provides an inhibitor for methylmercaptan (produced as a result of the waste) (Abstract). Hansenne teaches its composition seeks to improve the skin barrier function of compromised skin [0001] because skin is responsible for elimitating waste, and when the skin becomes damaged, its ability to perform that function is compromised [0002]. Use of Hansenne’s teaching to improve Morishita’s composition is an obvious modification and within the purview of the skilled artisan. One of ordinary skill in the art would find the results predictable because Hansenne teaches a composition that has not only 1.00% Pinus pinaster bark extract but also other compounds (Inventive Composition Example listed after [0020]), and this composition showed a statistically significant level of reduction in trans-epidermal water loss experienced by compromised skin after only 2 weeks (p=0.015), so similar results would be expected with a similar percentage of Pinus pinaster bark extract with other compounds added, such as described in the instant claims.
Regarding instant claim 5, at the time of filing, the person of ordinary skill in the art would know that Hansenne's ranges are obvious over the instant claims. Therefore, Hansenne obviates that presently claimed. "In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists" (See MPEP 2144.05 (I) regarding obviousness of ranges).
Regarding instant claim 6, at the time of filing, the person of ordinary skill in the art would know that Hansenne’s ranges are obvious over the instant claims. It would be obvious to adjust the percentage of Pinus pinaster bark extract as taught by Hansenne to match that of the claimed invention, because it would be considered routine optimization. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Morishita as evidenced by Arslan and Dziadek (as applied above to claims 1-6), in view of Carson (US 6270780 B1).
As applied above, Morishita, as evidenced by Arslan and Dziadek, teaches the limitations of claim 1.
Morishita does not teach that the resveratrol is present in an amount of about 0.0001% to about 1% by weight of the composition or in an amount of about 0.001% by weight of the composition.
Carson teaches a composition comprising resveratrol in an amount of from 0.00002 to 10 wt. % (claim 1a and composition #3 in Table 6A in column 14, which references the Base Formula table in column 13), which encompasses the range of about 0.0001% to about 1% by weight in instant claim 7 as well as about 0.001% in instant claim 8.
Therefore, before the effective filing date of the claimed invention, it would be obvious to a person having ordinary skill in the art to take the composition taught by Morishita and adjust the percentage of resveratrol as taught by Carson in order to create gels, creams, or sprays/aerosols (Morishita lines 2-9, page 4; Carson lines 50-51 and 53-55, column 6)Use of Carson’s teaching to improve Morishita’s composition is an obvious modification and within the purview of the skilled artisan. One of ordinary skill in the art would find the results predictable because Carson teaches a composition that has not only 0.1% resveratrol but also other compounds (composition #3 in Table 6A in column 14, which references the Base Formula table in column 13), and this composition showed that resveratrol significantly reduced the irritation induced by composition #2 (lines 23-26, column 14), so similar significant cosmetic results would be expected with a similar percentage of resveratrol with other compounds added, such as described in the instant claims.
Regarding instant claims 7-8, at the time of filing, the person of ordinary skill in the art would know that Carson's ranges are obvious over the instant claims. Therefore, Carson obviates that presently claimed. "In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists" (See MPEP 2144.05 (I) regarding obviousness of ranges).
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Morishita as evidenced by Arslan and Dziadek (as applied above to claims 1-10), in view of Pauly, Hansenne, and Carson.
As applied above, Morishita, as evidenced by Arslan and Dziadek, teaches the limitations of claim 1.
Morishita does not teach that at least two of the antioxidant agents are present in equal amounts, or that equal amounts of Argania spinosa leaf extract, Pinus pinaster bark extract and resveratrol are present in the composition.
Morishita does not teach the composition is applied topically or a method comprising the step of applying the cosmetic composition onto the skin/hair of a subject in need thereof.
Regarding instant claims 9 and 10, Pauly teaches a method involving a composition containing an extract of Argania spinosa leaves (claim 1) in an amount of from 0.01 to 25% by weight (claim 2); Hansenne teaches a composition comprising an extract of Pinus pinaster bark (claim 11), wherein the extract is present in the composition in an amount of from about 0.01 to about 10% by weight, based on the weight of the composition (claim 15, Inventive Composition Example listed after [0020]); and Carson teaches a composition comprising resveratrol in an amount of from 0.00002 to 10 wt. % (claim 1a and composition #3 in Table 6A in column 14, which references the Base Formula table in column 13). It would be obvious for one of ordinary skill in the art to utilize routine optimization and choose an amount that is covered by all the ranges (for example 1 wt.%), and create a composition where two or more of the antioxidant agents listed in claim 1 are of that amount, resulting in at least two of the antioxidant agents being present in equal amounts or equal amounts of Argania spinosa leaf extract, Pinus pinaster bark extract, and resveratrol being present in the composition, as stated in instant claims 9 and 10, respectively.
Regarding instant claim 12, Pauly teaches a method comprising contacting the skin or the hair of an individual with a composition containing an extract of Argania spinosa leaves (claim 1); Hansenne teaches a method of applying onto skin a composition containing an extract of Pinus pinaster bark (claim 1); and Carson teaches a cosmetic method comprising applying to the skin the composition comprising resveratrol (claim 1).
Regarding claim 11, the applications taught by Morishita, Hansenne, Carson in regards to instant claim 12 would also be considered topical since they are applied directly to the skin. Further, Pauly teaches that the application can be topical (line 1, column 5), and Carson teaches that its compositions are intended for topical application (lines 36-37, column 3).
Therefore, before the effective filing date of the invention, a person having ordinary skill in the art would be motivated to combine Argania spinosa leaf extract, Pinus pinaster bark extract, and resveratrol as taught by Morishita, and apply it to the skin, as taught by Pauly, Hansenne, and Carson for each component separately. Pauly, Hansenne, and Carson’s compositions are all taught for the same purpose of skincare. As stated in MPEP 2144.06, "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846 (CCPA 1980). In this case there are three compositions but the same argument applies.
Regarding instant claims 9 and 10, at the time of filing, the person of ordinary skill in the art would know that Pauly, Hansenne, and Carson’s amounts are obvious over the instant claims. It would be obvious to adjust the amounts of Argania spinosa leaf extract, Pinus pinaster bark extract and resveratrol to match that of the claimed invention, because it would be considered routine optimization. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144).
Conclusion
Claims 1-12 are rejected.
No claims are allowed.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/ALLY S LIU/Examiner, Art Unit 1611
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