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 .
Priority
The instant application, filed 05/19/2023, is a national stage entry of PCT/US2023/065198, filed 03/31/2023, which claims domestic priority to U.S. provisional application no. 63/325,827, filed 03/31/2022.
Amendment and Claim Status
The amendment filed on 05/09/2023 is acknowledged and entered.
Claims 13, 30, and 32 are amended;
Claims 10, 21-29, 31, 33, 36, 37, and 39-42 are cancelled;
Claims 1-9, 11-20, 30, 32, 34, 35, and 38 are pending.
Information Disclosure Statement
The Information Disclosure Statement filed on 03/05/2025 and 02/05/2025 are acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statements are considered.
Restriction/Election
Applicant’s election traverse of Group I in the reply filed on 02/13/2026 is acknowledged. Furthermore, the acknowledgment of the election of the following species, with traverse, is also acknowledged:
Species A: Applicant elects a naturopathic hair growth promoter (see claim 1)
Species B: Applicant elects a combination of sophorolipids (SLP) and mannosylerythritol lipids (MEL) (see claim 9)
Species C: Applicant elects Starmerella bambicola (see claim 11)
Species D: Applicant elects a foam (see claim 12)
Regarding the traversal of the restriction and election of species, Applicant’s arguments are hereby addressed. With respect to species A, pharmacologic and naturopathic hair growth promoters are structurally and functionally distinct classes requiring separate searches are not unified by the common feature of a biosurfactant composition, as that feature is known in the prior art as taught by Suzuki et al. (JP 4982822 B2, published July 25, 2012, cited on applicant IDS dated 03/05/2024), hereinafter Suzuki. With respect to species B, the combination of SLP and MEL will be searched. With respect to species C, the recited microorganisms span taxonomically distinct groups including yeasts, and spore forming bacteria that require separate searches. With respect to species D, the enumerated dosage forms are physically and functionally distinct formulation technologies requiring separate searches, and applicant’s reliance on dictionary definition does not establish equivalence for patent classification purposes. Finally, as this application is a national stage entry of PCT/US2023/065198, U.S. restriction practice does not apply. Rather the restriction practice relies on lack of unity demonstrated by the prior art’s disclosure of that which is instantly claimed. As the common technical feature across all species groups has been established as being known in the prior art by Suzuki, the claims lack unity a posteriori, and do not form a single general inventive concept under PCT rule 13.1.
Therefore, the requirement is still deemed proper and is therefore made FINAL.
In accordance with the MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP §803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species does not make contribution over the prior art of record.
Status of Claims
Claims 1-9, 11-20, 30, 32, 34, 35, and 38 are pending in the instant application. Claims 7-9, 13- 20, 30, 32, 34, 35 and 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 1-6, 11, and 12 read on an elected invention and species and are therefore under consideration in the instant application and examined on the merits as such.
Claim interpretation
The instant claims are subject to the following interpretation:
Claim 11 recites the elected species Starmerella bambicola as a species of microbe. For the purposes of this rejection, the recitation of “Starmerella bambicola” is interpreted to encompass “Candida bambicola,” It’s former taxonomical designation, and heterotypic synonym, according to the National Center for Biotechnology Information (NCBI) Taxonomy Browser (see cited reference). The two names refer to an identical organism, are indistinguishable, and are considered scientifically interchangeable. As such, any reference to either organism within the prior art or instant application, will be considered equivalent with respect to the teachings, under the broadest reasonable interpretation of the claims set forth in MPEP § 2111.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of pre-AIA 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.
Claim 1-3, 6, 11, and 12 are rejected under 35 U.S.C. § 103 as being unpatentable over Suzuki et al. (JP 4982822 B2, published July 25, 2012, cited on applicant IDS dated 03/05/2024), hereinafter Suzuki (citations drawn to the IP(dot)com translation), in view of Kim et al. (WO 2018101717 A1, published June 7, 2018), hereinafter Kim (citations drawn to the WIPO translation).
The instant claims are drawn to a topical foam composition comprising SLP and MEL, and naturopathic hair growth promoter, and a dermatologically acceptable carrier, and live or inactive cells of Starmerella bambicola.
Suzuki teaches a topical composition comprising MEL as an active glycolipid biosurfactants directed to hair loss prevention with SLP listed among suitable biosurfactants of the same class (page 3, see instant claims 1 and 2). Suzuki teaches several examples with water as a dermatologically acceptable carrier (pages 11-13). Suzuki teaches that two or more biosurfactants may be used in combination (page 4, see instant claim 3). The disclosure further teaches that the naturopathic hair growth-promoting agent (such as pentadecanoic acid glyceride, coleus extract, gentian extract, pine coconut extract, royal jelly extract, etc.) may be used as an active component combinable with the biosurfactants (page 9, see instant claim 1). Suzuki teaches that MEL by activity demonstrated an effective concentration of 1ng/mL to 1mg/mL (i.e. 0.001 ppm-1 ppm), with significant hair papilla cell activation (pages 11 and 12, see instant claim 6). Finally, Suzuki teaches mouse and foam among the suitable topical dosage forms for direct application to skin, scalp, and hair (pages 7 and 10, see instant claim 12).
Suzuki fails to teach specifically SLP as the elected second glycolipid biosurfactants for hair growth promotion. Suzuki also fails to teach a composition further comprising Starmerella (Candida) bambicola, and also fails to teach foam applicable to hair as an explicit dosage form.
The deficiencies of Suzuki are remedied by Kim, who teaches a topical cosmetic composition comprising SLP as the active ingredient for preventing hair loss and promoting hair growth (abstract, claim 1, see instant claims 2 and 3). SLP is taught to be in both linear and lactonic forms (see paragraphs [21-27] in WIPO translation). Kim specifically teaches (Starmerella) Candida bambicola ATCC22214 as the specific SLP producing yeast to be used within the composition (paragraphs [18] and [47], see instant claim 11). Finally, Suzuki teaches a hair cleansing foam as an explicit topical dosage form (paragraph [29], claim 8, see instant claim 12).
A person of ordinary skill in the art, prior to the effective filing date of the instant claims, would have been motivated to combine the teachings of Suzuki and Kim because both references are directed to glycolipid biosurfactants containing topical compositions for the purpose of hair loss prevention and hair growth promotion. Suzuki expressly lists SLP among suitable biosurfactants, and contemplates multi-biosurfactants combinations. A person of ordinary skill in the art would have had a reasonable expectation that supplementing MEL as taught by Suzuki with SLP as taught by Kim, would successfully and predictably yield the effective topical foam formulation for hair growth as instantly claimed without undue experimentation.
Furthermore, as both glycolipid biosurfactants are known to be useful for a common purpose, i.e. topical hair growth compositions, their combination is rendered obvious. According to MPEP 2144.06 (I), combining equivalents known for the same purpose is rendered obvious. The courts have said,
It 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, 850, 205 USPQ 1069, 1072 (CCPA 1980) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.).
As such, a person of ordinary skill in the art would have found it obvious to combine both SLP and MEL for the common purpose of creating a topical hair growth composition.
Regarding claim 6, drawn to MEL from 1 to 10 ppm, the claimed range lies within the amount taught by the prior art. It is noted that the courts have stated,
where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that,
“where 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Therefore, the claimed ranges overlap with those taught in the instant claims and merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Claim 4 and 5 are rejected under 35 U.S.C. § 103 as being unpatentable over Suzuki (see earlier citation) in view of Kim (see earlier citation), as applied to 1-3, 6, 11, and 12, above, and further in view of Farmer and Abilek (WO 2022036051 A1, effectively filed August 12, 2020, for purposes of 102 (a)(2), cited in Applicant IDS filed February 05, 2025), and Abilek and Farmer (WO 2021127339 A1, published March 24, 2021, cited in Applicant IDS filed March 05, 2024).
The instant claims are further drawn to a topical composition comprising a mixture of linear and lactonic SLP at a ratio of 70:30.
The teachings of Suzuki and Kim are as set forth above.
Kim teaches that SLP is in both linear and lactonic forms (see paragraphs [21-27] in WIPO translation), but neither Kim nor Suzuki teach a specific ratio of linear to lactonic SLPs. Furthermore, no specific amounts of SLP are taught by Suzuki or Kim.
The deficiencies of Suzuki and Kim are remedied by Farmer and Abilek, who teach a topical composition used to treat a variety of skin conditions, including hair loss (Abstract, page 6, line 12). Farmer and Abilek teach both SLP and MEL (claims 3 and 10) as components of the composition, and that SLP may comprise both lactonic and linear SLPs (page 31, lines 33-35). The disclosure teaches wherein the ratio of linear to lactonic SLPs may be 0:1 to 1:10, or 1:4 to 1:5. It is well-known in the art that the combination of linear (also known as acidic) and lactonic SLPs affects the functional properties of the composition, such as emulsion droplet size, viscosity reducing properties, and surface/interfacial tension reduction properties, as taught by Abilek and Farmer (page 2, lines 11-16). Finally, Farmer and Abilek teach that the composition may comprise 0.01% to about 1.0% by weight SLP, (i.e. 100-10,000 ppm SLP) (page 12 lines 26-27).
With respect to the instantly claimed ratio of claim 4, it is considered obvious and within the skill of an ordinary artisan to modify the ratios of linear to lactonic SLP in order to achieve the desired properties of the composition, as taught by the teachings of Abilek and Farmer. According to MPEP 2144.05 II, “where 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.” Thus an ordinary skilled artisan would have been motivated to optimize the ratio in order to achieve optimal properties of the composition. Thus modifying the ratio to arrive at the instant invention is rendered obvious in view of the cited prior art teachings.
Regarding claim 5, drawn to concentrations of SLP from 100 to 250 ppm, the claimed range lies within the amount taught by the prior art. It is noted that the courts have stated, where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. Thus, a person of ordinary skill in the art would necessarily have arrived at the claimed concentration by way of routine experimentation, and the claimed concentrations are rendered obvious over the overlapping ranges taught within the prior art.
Correspondence
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
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