DETAILED ACTION
Notice of 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 .
Status of the Claims
The amendments filed 5/06/2025 have been entered.
Response to Arguments
Applicant’s arguments, filed 5/06/2025, have been fully considered.
Applicant first traverses the rejection of claims under 35 U.S.C. 103(a) based on Gan et al (US 2016/0008270; of record). As argued by Applicant, although “Gan discloses a composition that comprises Undaria pinnatifida extract in Table 2” and further states that “the compositions described herein” can reduce the appearance of dark spots on the skin, “Gan… does not examine the effectiveness of this composition in a method to reduce the appearance of hyperpigmented skin” and “does not demonstrate that a composition comprising Undaria pinnatifida extract exhibits dark spot-reducing functionality” (Applicant Arguments, Page 4).
Applicant’s argument, which contradicts the plain language of Gan et al, is not found persuasive. Gan et al specifically state that “the compositions described herein” can be “applied to dark spots on skin, uneven skin, or hyperpigmented skin” and “reduces the appearance of dark spots on the skin… reduces excess pigmentation of the skin” and so on (Paragraph 0015). Subsequently, Gan et al explicitly describe therein “Non-Limiting Examples of Compositions” (Paragraph 0082) including a composition comprising Undaria pinnatifida extract (Paragraph 00083, Table 2). A person of ordinary skill in the art would have understood that the composition comprising Undaria pinnatifida extract described therein by Gan et al can, in fact, be “applied to dark spots on skin, uneven skin, or hyperpigmented skin” and “reduces the appearance of dark spots on the skin… reduces excess pigmentation of the skin” and so on, as specifically asserted by Gan et al.
Applicant, however, further argues that “[m]illions upon millions of hypothetical compositions that include Undaria pinnatifida extract can be constructed” as well as “millions upon millions of hypothetical compositions that do not include Undaria pinnatifida extract” based on Gan et al and, considering that “no composition… with Undaria pinnatifida extract was examined for its ability to reduce the appearance of hyperpigmented skin, a person of skill in the art would not be able to determine which compositions of Gan are effective in reducing the appearance of hyperpigmented skin” (Applicant Arguments, Page 5).
Again, Applicant’s argument, which contradicts the plain language of Gan et al, is not found persuasive. As discussed above, Gan et al specifically state that “the compositions described herein” can be “applied to dark spots on skin, uneven skin, or hyperpigmented skin” and “reduces the appearance of dark spots on the skin… reduces excess pigmentation of the skin” and so on (Paragraph 0015). Subsequently, Gan et al explicitly describe therein “Non-Limiting Examples of Compositions” (Paragraph 0082) including a composition comprising Undaria pinnatifida extract (Paragraph 00083, Table 2). A person of ordinary skill in the art would have understood that the composition comprising Undaria pinnatifida extract described therein by Gan et al can, in fact, be “applied to dark spots on skin, uneven skin, or hyperpigmented skin” and “reduces the appearance of dark spots on the skin… reduces excess pigmentation of the skin” and so on, as specifically asserted by Gan et al.
Applicant next argues that “[i]t appears that the rationale being used… to ascribe reduction of skin hyperpigmentation activity to Undaria pinnatifida extract is based on improper hindsight” wherein the Action “appears to have discounted the very large number of possible combinations of Gan and focused on a secondary component that may further be included in the many possible compositions of Gan” (Applicant Arguments, Page 5). As argued by Applicant “[i]t is well-settled that a prior art reference ‘must clearly and unequivocally disclose’ Applicant’s claimed invention without performing a selection process that is in essence a ‘needle-in-a-haystack’ approach… Such a picking and choosing effort is not a viable basis to maintain the present obviousness rejection” (Applicant Arguments, Pages 5-6).
At the outset, the basis of the rejection does not ascribe reduction of skin hyperpigmentation activity to Undaria pinnatifida extract, per se. Rather, reduction of hyperpigmentation activity is ascribed to the composition of Gan et al and, in particular, the composition of Table 2, which comprises Undaria pinnatifida extract. And there is no picking and choosing from among “[m]illions and millions of hypothetical compositions that include Undaria pinnatifida extract” since Gan et al explicitly disclose a composition comprising Undaria pinnatifida.
For all the foregoing reasons, Applicant’s arguments are not found persuasive. The rejection of claims based primarily on Gan et al is MAINTAINED.
Applicant next traverses the rejection of claims based on Florence et al (US 8,444,959; of record), which teach the administration of related compositions that do not include Undaria pinnatifida extract for the treatment of hyperpigmentation, in further view of Kim et al (Interdiscip Toixcol 7:89-92, 2014) which teach Undaria pinnatifida extract in the treatment of hyperpigmentation disorders. As argued by Applicant, the claims have been amended to require that the composition comprise “aqueous Undaria pinnatifida extract” whereas Kim et al teach an ethyl acetate extract of Undaria pinnatifida.
It is found persuasive that water and ethyl acetate would not be considered predictably interchangeable solvents in the extraction of a substance such as Undaria pinnatifida. As such, the rejection of claims is WITHDRAWN.
Lastly, the rejection of claims on the grounds of non-statutory double patenting is WITHDRAWN in view of Applicant’s filing of a terminal disclaimer over U.S. 9,913,799.
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.
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 1-8 are MAINTAINED rejected under 35 U.S.C. 103(a) as being unpatentable over Gan et al (US 2016/0008270; of record).
As amended, claim 1 is drawn to a method for reducing the appearance of hyperpigmented skin (more specifically, senile lentigo, aka age spots or liver spots (claim 2)) in a person, the method comprising topically applying to hyperpigmented skin of the person a composition (more specifically, in the form of an emulsion (claim 7), even more specifically, an oil-in-water emulsion (claim 8)) comprising:
an effective amount of aqueous Undaria pinnatifida extract;
caprylic/capric triglyceride;
squalane;
dimethicone; and
butyrospermum parkii (shea) butter;
wherein topical application of the composition reduces the appearance of the hyperpigmented skin.
Gan et al teach “compositions useful for… reducing the appearance of dark spots of hyperpigmentation” comprising “cosmetic ingredients such as lactobacillus ferment; Ferula foetida root extract; Helianthus annuus (sunflower) seed extract [and] Terminalia ferdinandiana fruit extract” (Abstract) – wherein “the lactobacillus ferment, Ferula foetida root extract, Helianthus annuus (sunflower) seed extract, and/or Terminalia ferdinandiana fruit extract is an aqueous extract” (Paragraph 0009) – which “can be incorporated into all types of vehicles… include[ing] emulsions (e.g., water-in-oil, water-in-oil-in-water, oil-in-water…” (Paragraph 0042), for the treatment of “a variety of skin conditions” such as “lentigo… age spots…” and so on (Paragraph 0018), and “a method… comprising applying a topical skin composition of the disclosure to skin in need thereof”, in particular “to dark spots on skin, uneven skin, or hyperpigmented skin” wherein “the topical skin composition reduces the appearance of dark spots on the skin” (Paragraph 0015).
Specifically, Gan et al disclose as one of the “non-limiting examples of… compositions” (Paragraph 0082, Example 1) a composition comprising Undaria pinnatifida extract in an amount of 0.01 wt.% and further comprising “[a]ny of the additional ingredients (or combination thereof) described in the specification” (Paragraph 0083, Example 1, Table 2). Significantly, Gan et al teach each of the instantly claimed ingredients as “Additional Ingredients” (Paragraph 0045): caprylic/capric triglyceride, squalene, dimethicone (Paragraph 0052) and butyrospermum parkii (shea) butter (Paragraph 0076).
In view of all of the foregoing, it would have been prima facie obvious to formulate the instantly claimed composition to be administered for reducing the appearance of hyperpigmented skin. First, considering that Gan et al teach that the “the lactobacillus ferment, Ferula foetida root extract, Helianthus annuus (sunflower) seed extract, and/or Terminalia ferdinandiana fruit extract is an aqueous extract” (Paragraph 0009), it would have been obvious to a person of ordinary skill in the art that the Undaria pinnatifida extract in said formulation can also be an aqueous extract. And second, regarding the inclusion of caprylic/capric triglyceride, squalene, dimethicone and butyrospermum parkii (shea) butter, as stated by the Court in KSR v. Teleflex (127 S,Ct. 1727 (2007)), “[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”.
As such, claims 1-2 and 7-8 are rejected as prima facie obvious.
Claims 3-4 and 5-6 are drawn to the method of claim 1, wherein the composition further comprises:
fructose, palmitic acid, hydrogenated lecithin, fragrance, and disodium EDTA (claim 3);
butylene glycol, sodium hydroxide, tocopherol, xanthan gum, sodium benzoate, and citric acid (claim 4);
tocopheryl acetate (claim 5); and
water (claim 6).
At the outset, the composition at Paragraph 0083, Example 1, Table 2, taught by Florence et al comprises water. And, as discussed above, the composition may further comprise “[a]ny of the additional ingredients (or combination thereof) described in the specification” (Paragraph 0083, Example 1, Table 2). Significantly, Gan et al further teach each of the instantly claimed ingredients as “Additional Ingredients” (Paragraph 0045): fructose (Paragraph 0051), palmitic acid (Paragraph 0052), hydrogenated lecithin (Paragraph 0052), fragrance (Paragraph 0047), disodium EDTA (Paragraph 0072), butylene glycol (Paragraph 0076), sodium hydroxide (Paragraph 000047), tocopherol (Paragraph 0052), xanthan gum (Paragraph 0071), sodium benzoate (Paragraph 0074), citric acid (Paragraph 0047), and tocopheryl acetate (Paragraph 0052).
As such, claims 3-4 and 5-6 are rejected as prima facie obvious. As stated by the Court in KSR v. Teleflex (127 S,Ct. 1727 (2007)), “[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”.
Conclusion
Any new ground(s) of rejection presented in this Office action are necessitated by Applicant’s amendments to the claims. 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).
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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611