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
Applicant’s election without traverse of Group II, claims 42-53 drawn to a topical composition in the reply filed on 09/09/2025 is acknowledged. Examiner respectfully submits that Applicants did not respond to the species election set forth in the restriction requirement mailed on 06/10/2025, however in view of the art cited below the species election is currently withdrawn.
Claims 15-18,20,22-25,29-34, and 36-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/09/2025.
Claims 42-53 are under current examination.
Information Disclosure Statements
Information Disclosure Statement (IDS) filed on 07/26/2023 and 08/22/2024 have been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Claim Objections
For readability of the claims and claim language consistency with claim 42, claims 47-48 should recite “ingredient” and not “substance”.
Claim 50 is objected to because of the following informalities: Claim 50 recites “[polymers, mineral”. It is believed the bracket before polymers is a typographical mistake. Appropriate correction is required.
Claim 51 recites “wherein the composition 1s”. It is believed that Applicants meant to recite “wherein the composition is”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 45-46 and 50-51 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 45 recites “the composition of claim 42, comprising “0.001-50% wt% MEL and 0.001-50 wt% SLP. Here, it is unclear if the SLP and MEL is meant to encompass the glycolipids of claim 42 or if the claim further comprises MEL and SLP in addition to the glycolipids of claim 42. It is suggested that claim 45 can depend from claim 44 and can recite comprising 0.001-50 wt % of the MEL and 0.001-50 wt % of the SLP.
Claim 46 recites a ratio of acidic SLP to lactonic SLP ranges from 20/80 to 80/20 without specifying what the ratio is. It is unclear if this is volume ratio, weight ratio or what the ratio is meant to encompass. For the purpose of examination this will be interpreted as a weight ratio.
Claim 46 recites wherein “the SLP comprise”. There is insufficient antecedent basis for this limitation in the claim because claim 46 depends from claim 42 and claim 42 recites glycolipids and not SLP.
Claim 50 recites the limitation "the adjuvants and/or additives" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 49 from which claim 50 depends recites “one or more cosmetic adjuvants and/or additives”. Therefore, it is unclear if “the adjuvants” in claim 50 is referring back to the one or more than one adjuvants and/or additives of claim 49.
Claim 51 recites formulated as a liquid, cream, gel, ointment, wipe, lotion, soap, shampoo, conditioner, spray. Here, it is unclear if the composition is formulated as all of these or if the formulation is meant to be a selection from a liquid, cream, gel, ointment, wipe, lotion, soap, shampoo, conditioner, or spray. For the purpose of examination the claim is interpreted as a selection for how the composition is formulated.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 42-45, 47, and 49-53 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Farmer et al. (United States Patent 11759544).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 42 recites a topical composition for promoting the healing of a wound and/or scar, the composition comprising a blend of glycolipids, a skin-active ingredient and a dermatologically acceptable vehicle, and further comprising live or inactive cells of yeast selected from the group consisting of Wickerhamomyces anaomalus, Starmerella bombicola, lileyerozyma guilliermondii, and Pseudozyma aphidis.
Farmer et al. teach a topical therapeutic composition comprising glycolipids of SLP and MEL together with cellular components of Starmerella bombicola, cellular components of Pseudozyma aphidis, lactoferrin and a dermatologically-acceptable carrier, see claim 1. The microorganisms can be live or inactive, see claims 5 and 11 and column 3, lines 58-63 and column 9, lines 35-65. The composition further comprises skin active substances including keratolytic agents, see claims 1-2. The composition can further contain aloe vera extract, see claim 3. The composition can comprise a wound dressing, see claim 4 and Example 1 and page 17 at line 32. The composition comprises either live or inactivated microorganisms, see column 4, lines 38-44. In preferred embodiments the MEL is from 0.01-50% or from .05-10 or from 0.1-2%, see column 11, lines 6-10. In some embodiments, the SLP can be present from 0.01-50%,0.05-10 or from 0.1-2% by weight, see column 11, lines 24-30. The topical composition can further comprise additional adjuvants and additives commonly included in skin care compositions, such as, for example, organic solvents, stabilizers, silicones, thickeners, softeners, sunscreens, moisturizers, or fragrances, see column 13 at lines 51-57. The composition may be formulated in a variety of product forms, such as, for example, a lotion, cream, serum, spray, aerosol, liquid cake, ointment, essence, gel, paste, patch, pencil, powder, towelette, soap, shampoo, conditioner, stick, foam, mousse, elixir or concentrate. In preferred embodiments, the composition is formulated so that is particularly suitable for topical administration to the skin, see column 16, lines 9-15.
Claim(s) 42-45, 47, and 49-53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farmer et al. (WO2019/227034A1-published 11/28/2019).
Claim 42 recites a topical composition for promoting the healing of a wound and/or scar, the composition comprising a blend of glycolipids, a skin-active ingredient and a dermatologically acceptable vehicle, and further comprising live or inactive cells of yeast selected from the group consisting of Wickerhamomyces anomalus, Starmerella bombicola, lileyerozyma guilliermondii, and Pseudozyma aphidis.
Framer et al. teach compositions for topical use of healing wounds and/or scars comprising one or more microorganisms and/or microbial growth bi-products. Examples of the growth bi products are glycolipid biosurfactants, see page 5, lines 1-26. Biosurfactants include SLP, and MEL, see page 5. In some embodiments the composition comprises live or inactivated microorganism as the one or more microorganisms including Stermerella bombicola, Wickerhamomyces anomalus, Myerozyma guilliermondii and/or Pseudozyma aphidis, see page 6, lines 6-9. The composition may include skin actives such as keratolytic agents, desquaming agents, anesthetics, keratinocyte proliferation enhancers, collagenase inhibitors, elastase inhibitors, depigmenting agents, anti-inflammatory agents, steroids, anti-acne agents, and AGE inhibitors, see claim 9. The composition further includes aloe vera, see claim 10. The composition can further comprise adjuvants and additives for topical use including organic solvents, silicones, pH adjusters, chelating agents, gelling agents, proteins, vitamins, emollients, oils, hydroxy acids, exfoliants, viscosity modifiers, polymers, minerals, insect repellents, lubricants, preservatives, botanicals, essential oils, clarifying agents, non-biological surfactants, antioxidants, thickeners, softeners, sunscreens, moisturizers, colorants, and fragrances, see page 6, lines 19-21 and page 17, lines 1-8 and claim 8. The composition may be incorporated into a wound dressing, see claim 15. The topical composition is formulated as a lotion, cream, ointment, gel, wipe, soap, shampoo, conditioner, or spray, see claim 14 and page 16, lines 5-7, page 19 lines 26-30.
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.
Claims 42-53 are rejected under 35 U.S.C. 103 as being unpatentable over Framer et al. (WO2019/033989) in view of Heike et al. (United States Patent Publication 2017/0071842 IDS filed 8/22).
Framer et al. teach compositions for topical use of healing wounds and/or scars comprising one or more microorganisms and/or microbial growth bi-products. Examples of the growth bi products are glycolipid biosurfactants, see page 5, lines 11-26. Biosurfactants include SLP, and MEL, see page 5. In some embodiments, the composition comprises live or inactivated microorganism as the one more microorganisms including Starmerella bombicola, Wickerhamomyces anomalus, Myerozyma guilliermondii and/or Pseudozyma aphidis, see page 6, lines 6-9. The composition may include skin actives such as keratolytic agents, desquaming agents, anesthetics, keratinocyte proliferation enhancers, collagenase inhibitors, elastase inhibitors, depigmenting agents, anti-inflammatory agents, steroids, anti-acne agents, and AGE inhibitors, see claim 9. The composition further includes aloe vera, see claim 10. The composition can further comprise adjuvants and additives for topical use including organic solvents, silicones, pH adjusters, chelating agents, gelling agents, proteins, vitamins, emollients, oils, hydroxy acids, exfoliants, viscosity modifiers, polymers, minerals, insect repellents, lubricants, preservatives, botanicals, essential oils, clarifying agents, non-biological surfactants, antioxidants, thickeners, softeners, sunscreens, moisturizers, colorants, and fragrances, see page 6, lines 19-21 and page 17, lines 1-8 and claim 8. The composition may be incorporated into a wound dressing, see claim 15. The topical composition is formulated as a lotion, cream, ointment, gel, wipe, soap, shampoo, conditioner, or spray, see claim 14 and page 16, lines 5-7, page 19 lines 26-30. The concentration of MEL in the composition can comprise from 0.01-50% or 0.05-10% by weight or 0.1-2% by weight, see page 13, lines 30-33. The concentration of the SLP can comprise from 0.01-50%, from 0.05-10% or from 0.1-2% by weight of the composition, see page 14, lines 5-10.
Framer teaches that the composition may have other components including carriers, pH modifiers, buffers, local anesthetic agents, agents that promote wound healing, agents that help degrade biofilm, anti-microbial agents, agents that stop bleeding and/or promote clot formation, and other therapeutic 15 and non-therapeutic components known to, e.g., heal, replenish, rejuvenate, moisturize, protect and/or improve the healing, appearance and/or functioning of the skin. For example, in certain embodiments, the composition can further comprise vitamins, minerals, botanicals, extracts, essential oils, retinoids, anti-comedo agents, moisturizers, and/or sunscreens, see page 6, lines 12-18.
Although antimicrobial agents are not taught with sufficient specificity, it would have been prima facie obvious to include any one of the other components suggested by Framer as Framer teaches that anti-microbial agents may be added as the other components with the composition.
The SLP can comprise acidic or lactone form. In one embodiment, the SLP in acidic form can be from 0.001-90% by weight, see page 14, lines 9.
Framer however does not expressly teach that the SLP comprises a blend of acidic and lactonic SLP with a ratio of 20/80 to 80/20 of acidic to lactonic.
Heike teachings cosmetic compositions comprising sophorolipid with a mixture of acidic form of 20-60% by weight with the balance being lactone form, see claims 1, 5-6 and [0036]-[0039]. Such biosurfactants have prebiotic activity, see paragraph [001]. The biosurfactant composition is to inhibit the growth of the undesired skin bacteria, and not to affect the growth of the desired skin bacteria or to even promote said growth of the desired skin bacteria, see paragraph [0022].
It would have been prima facie obvious to provide the SLP of Framer with 20-60% acidic and the balance being lactone (i.e. 40-80%). This amount overlap and renders obvious the claimed range from 20/80 to 80/20 of acidic to lactonic SLP.
One of ordinary skill in the art would have been motivated to do so because the SLP of Heike is taught to provide skin cleaning without affecting the growth of desirable bacteria on a skin surface.
There would have been a reasonable expectation of success given Framer teaches SLP which can be acidic or lactonic for topical application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 42-53 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11759544 in view of Framer et al. (WO2019/033989) and Heike et al. (United States Patent Publication 2017/0071842).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of Patent ‘544 recite topical compositions comprising MEL and SLP biosurfactants and Starmerella bombicola, or Pseudozyma aphidis. The composition can comprise aloe vera and be in the form of a wound dressing. Both the instant claims and that of Patent ‘544 are directed to a topical therapeutic composition comprising glycolipids of SLP and MEL together with cellular components of Starmerella bombicola, cellular components of Pseudozyma aphidis, lactoferrin and a dermatologically-acceptable carrier, see claim 1 of Patent ‘544. The microorganisms can be live or inactive, see claims 5 and 11 and column 3, lines 58-63 and column 9, lines 35-65 of Patent ‘544. The composition further comprises skin active substances including keratolytic agents, see claims 1-2. The composition can further contain aloe vera extract, see claim 3. The composition can comprise a wound dressing, see claim 4 and Example 1 and page 17 at line 32 . In preferred embodiments the MEL is from 0.01-50% or from .05-10 or from 0.1-2%, see column 11, lines 6-10. In some embodiments, the SLP can be present from 0.01-50%,0..05-10 or from 0.1-2% by weight, see column 11, lines 24-30. In some embodiments, the topical composition can further comprise additional adjuvants and additives commonly included in skin care compositions, such as, for example, organic solvents, stabilizers, silicones, thickeners, softeners, sunscreens, moisturizers, or fragrances, see column 13 at lines 51-57. The composition may be formulated in a variety of product forms, such as, for example, a lotion, cream, serum, spray, aerosol, liquid cake, ointment, essence, gel, paste, patch, pencil, powder, towelette, soap, shampoo, conditioner, stick, foam, mousse, elixir or concentrate. In preferred embodiments, the composition is formulated so that is particularly suitable for topical administration to the skin, see column 16, lines 9-15.
The difference between Patent ‘544 and the instant claims is that the instant claims require an antimicrobial substance and the ratio of acidic to lactonic SLP is from 20/80-80/20.
However, Framer teaches that the composition may have other components including carriers, pH modifiers, buffers, local anesthetic agents, agents that promote wound healing, agents that help degrade biofilm, anti-microbial agents, agents that stop bleeding and/or promote clot formation, and other therapeutic 15 and non-therapeutic components known to, e.g., heal, replenish, rejuvenate, moisturize, protect and/or improve the healing, appearance and/or functioning of the skin. For example, in certain embodiments, the composition can further comprise vitamins, minerals, botanicals, extracts, essential oils, retinoids, anti-comedo agents, moisturizers, and/or sunscreens, see page 6, lines 12-18.
Heike teachings cosmetic compositions comprising sophorolipid with a mixture of acidic form of 20-60% by weight with the balance being lactone form, see claims 1, 5-6 and [0036]-[0039]. Such biosurfactants have prebiotic activity, see paragraph [001]. The biosurfactant composition is to inhibit the growth of the undesired skin bacteria, and not to affect the growth of the desired skin bacteria or to even promote said growth of the desired skin bacteria, see paragraph [0022].
It would have been obvious to provide an antimicrobial as compositions which treat wounds can have further active agents including ant-microbial agents per the teachings of Framer.
Heike teachings cosmetic compositions comprising sophorolipid with a mixture of acidic form of 20-60% by weight with the balance being lactone form, see claims 1, 5-6 and [0036]-[0039]. Such biosurfactants have prebiotic activity, see paragraph [001]. The biosurfactant composition is to inhibit the growth of the undesired skin bacteria, and not to affect the growth of the desired skin bacteria or to even promote said growth of the desired skin bacteria, see paragraph [0022].
It would have been obvious to provide the SLP of Patent ‘544 with 20-60% acidic and the balance being lactone (i.e. 40-80%). This amount is suggested by Heike to provide sufficient
skin cleaning without affecting the growth of desirable bacteria on a skin surface.
Claim 42-53 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4,6, and 12-13 of U.S. Patent No. 11278490 in view of Framer et al. (WO2019/033989) and Heike et al. (United States Patent Publication 2017/0071842).
Both the instant claims and that of Patent ‘490 recite compositions which comprise yeast cells including Wickerhamomyces anomalus with MEL or SLP biosurfactant, wherein the composition further comprises a skin active agent and preservatives which is inclusive of antimicrobials and pH adjusters. Further adjuvants or additives can be included with Patent ‘490 claims.
The claims of Patent ‘490 do not recite aloe vera, that the composition can be in liquid or ointment form, that the MEL and SLP can be present at the claimed amounts and the ratio of acidic to lactonic is 80/20 to 20/80.
Framer et al. teach compositions for topical use of healing wounds and/or scars comprising one or more microorganisms and/or microbial growth bi-products. Examples of the growth bi products are glycolipid biosurfactants, see page 5, lines 11-26. Biosurfactants include SLP, and MEL, see page 5. In some embodiments, the composition comprises live or inactivated microorganism as the one more microorganisms including Starmerella bombicola, Wickerhamomyces anomalus, Myerozyma guilliermondii and/or Pseudozyma aphidis, see page 6, lines 6-9. The composition may include skin actives such as keratolytic agents, desquaming agents, anesthetics, keratinocyte proliferation enhancers, collagenase inhibitors, elastase inhibitors, depigmenting agents, anti-inflammatory agents, steroids, anti-acne agents, and AGE inhibitors, see claim 9. The composition further includes aloe vera, see claim 10. The composition can further comprise adjuvants and additives for topical use including organic solvents, silicones, pH adjusters, chelating agents, gelling agents, proteins, vitamins, emollients, oils, hydroxy acids, exfoliants, viscosity modifiers, polymers, minerals, insect repellents, lubricants, preservatives, botanicals, essential oils, clarifying agents, non-biological surfactants, antioxidants, thickeners, softeners, sunscreens, moisturizers, colorants, and fragrances, see page 6, lines 19-21 and page 17, lines 1-8 and claim 8. The composition may be incorporated into a wound dressing, see claim 15. The topical composition is formulated as a lotion, cream, ointment, gel, wipe, soap, shampoo, conditioner, or spray, see claim 14 and page 16, lines 5-7, page 19 lines 26-30. The concentration of MEL in the composition can comprise from 0.01-50% or 0.05-10% by weight or 0.1-2% by weight, see page 13, lines 30-33. The concentration of the SLP can comprise from 0.01-50%, from 0.05-10% or from 0.1-2% by weight of the composition, see page 14, lines 5-10. Framer teaches that the composition may have other components including carriers, pH modifiers, buffers, local anesthetic agents, agents that promote wound healing, agents that help degrade biofilm, anti-microbial agents, agents that stop bleeding and/or promote clot formation, and other therapeutic 15 and non-therapeutic components known to, e.g., heal, replenish, rejuvenate, moisturize, protect and/or improve the healing, appearance and/or functioning of the skin. For example, in certain embodiments, the composition can further comprise vitamins, minerals, botanicals, extracts, essential oils, retinoids, anti-comedo agents, moisturizers, and/or sunscreens, see page 6, lines 12-18.
Heike teachings cosmetic compositions comprising sophorolipid with a mixture of acidic form of 20-60% by weight with the balance being lactone form, see claims 1, 5-6 and [0036]-[0039]. Such biosurfactants have prebiotic activity, see paragraph [001]. The biosurfactant composition is to inhibit the growth of the undesired skin bacteria, and not to affect the growth of the desired skin bacteria or to even promote said growth of the desired skin bacteria, see paragraph [0022].
It would have been obvious to provide the SLP of Patent ‘490 with 20-60% acidic and the balance being lactone (i.e. 40-80%).
One of ordinary skill in the art would have been motivated to do so because the SLP of Heike is taught to provide skin cleaning without affecting the growth of desirable bacteria on a skin surface.
It would have further been obvious put the composition in liquid or ointment form because Framer teaches that topical compositions can be formulated as such which comprise glycolipids and yeast microorganisms.
It would have been obvious to add aloe vera to the claims of Patent ‘490 because Patent ‘490 claims the addition of further additives/adjuvants and Framer teaches that aloe vera can be added to topical compositions having glycolipids and yeast microorganisms.
Claim 42-53 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11759414 in view of Framer et al. (WO2019/033989) and Heike et al. (United States Patent Publication 2017/0071842).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of Patent ‘414 recite topical compositions comprising MEL and SLP biosurfactants.
The clams of Patent ‘414 do not claim the yeast cells as instantly claimed of Wickerhamomyces anomalus, Starmerella bombicola, lileyerozyma guilliermondii or Psseudozyma aphidis together with SLP or MEL glycolipids or the presence of aloe vera. The claims of Patent ‘414 do not recite the amount of MEL or SLP and a ratio of lactonic to acidic forms, wherein the composition further comprises antimicrobial (preservative) and wherein the topical formulation can be in a liquid, cream, gel, wipe, lotion, soap, shampoo, spray formulated as a wound dressing.
Framer et al. teach compositions for topical use of healing wounds and/or scars comprising one or more microorganisms and/or microbial growth bi-products. Examples of the growth bi products are glycolipid biosurfactants, see page 5, lines 11-26. Biosurfactants include SLP, and MEL, see page 5. In some embodiments, the composition comprises live or inactivated microorganism as the one more microorganisms including Starmerella bombicola, Wickerhamomyces anomalus, Myerozyma guilliermondii and/or Pseudozyma aphidis, see page 6, lines 6-9. The composition may include skin actives such as keratolytic agents, desquaming agents, anesthetics, keratinocyte proliferation enhancers, collagenase inhibitors, elastase inhibitors, depigmenting agents, anti-inflammatory agents, steroids, anti-acne agents, and AGE inhibitors, see claim 9. The composition further includes aloe vera, see claim 10. The composition can further comprise adjuvants and additives for topical use including organic solvents, silicones, pH adjusters, chelating agents, gelling agents, proteins, vitamins, emollients, oils, hydroxy acids, exfoliants, viscosity modifiers, polymers, minerals, insect repellents, lubricants, preservatives, botanicals, essential oils, clarifying agents, non-biological surfactants, antioxidants, thickeners, softeners, sunscreens, moisturizers, colorants, and fragrances, see page 6, lines 19-21 and page 17, lines 1-8 and claim 8. The composition may be incorporated into a wound dressing, see claim 15. The topical composition is formulated as a lotion, cream, ointment, gel, wipe, soap, shampoo, conditioner, or spray, see claim 14 and page 16, lines 5-7, page 19 lines 26-30. The concentration of MEL in the composition can comprise from 0.01-50% or 0.05-10% by weight or 0.1-2% by weight, see page 13, lines 30-33. The concentration of the SLP can comprise from 0.01-50%, from 0.05-10% or from 0.1-2% by weight of the composition, see page 14, lines 5-10. Framer teaches that the composition may have other components including carriers, pH modifiers, buffers, local anesthetic agents, agents that promote wound healing, agents that help degrade biofilm, anti-microbial agents, agents that stop bleeding and/or promote clot formation, and other therapeutic 15 and non-therapeutic components known to, e.g., heal, replenish, rejuvenate, moisturize, protect and/or improve the healing, appearance and/or functioning of the skin. For example, in certain embodiments, the composition can further comprise vitamins, minerals, botanicals, extracts, essential oils, retinoids, anti-comedo agents, moisturizers, and/or sunscreens, see page 6, lines 12-18. The SLP can comprise acidic or lactone form. In one embodiment, the SLP in acidic form can be from 0.001-90% by weight, see page 14, lines 9.
Heike teachings cosmetic compositions comprising sophorolipid with a mixture of acidic form of 20-60% by weight with the balance being lactone form, see claims 1, 5-6 and [0036]-[0039]. Such biosurfactants have prebiotic activity, see paragraph [001]. The biosurfactant composition is to inhibit the growth of the undesired skin bacteria, and not to affect the growth of the desired skin bacteria or to even promote said growth of the desired skin bacteria, see paragraph [0022].
It would have been obvious to provide a combination of the yeast cells of Patent ‘414 together with SLP or MEL in the ratios disclosed by Heike and amounts in Fraser.
One of ordinary skill in the art would have been motivated to do so because the SLP of Heike is taught to provide skin cleaning without affecting the growth of desirable bacteria on a skin surface at the specified ratios.
It would have been obvious in view of Framer to provide the topical formulation as a wound dressing or lotion or cream or ointment or gel or wipe form given these are suitable administration forms for topical formulations as suggested by Framer. It would have been additionally obvious to provide an anti-microbial to protect the topical formulation from being contaminated with bacteria as such additional agents are taught by Fraser to be present with topical formulations containing glycolipids and yeast microorganisms. It would have been obvious to provide the formulation of Patent ‘414 with aloe vera as Framer teaches aloe vera can be added as a further additive for compositions containing glycolipids and yeast cells.
Claim 42-53 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12233152 in view of Framer et al. (WO2019/033989) and Heike et al. (United States Patent Publication 2017/0071842).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of Patent ‘152 recite topical compositions comprising MEL and SLP biosurfactants with cells of Starmerella bombicola or Pseudozyma aphidis for topical use for the skin.
The claims of Patent ‘152 do not claim the amount of MEL or SLP and a ratio of lactonic to acidic forms, wherein the composition further comprises antimicrobial (preservative) and wherein the topical formulation can be in a liquid, cream, gel, wipe, lotion, soap, shampoo, spray formulated as a wound dressing or the presence of aloe vera.
Framer et al. teach compositions for topical use of healing wounds and/or scars comprising one or more microorganisms and/or microbial growth bi-products. Examples of the growth bi products are glycolipid biosurfactants, see page 5, lines 11-26. Biosurfactants include SLP, and MEL, see page 5. In some embodiments, the composition comprises live or inactivated microorganism as the one more microorganisms including Starmerella bombicola, Wickerhamomyces anomalus, Myerozyma guilliermondii and/or Pseudozyma aphidis, see page 6, lines 6-9. The composition may include skin actives such as keratolytic agents, desquaming agents, anesthetics, keratinocyte proliferation enhancers, collagenase inhibitors, elastase inhibitors, depigmenting agents, anti-inflammatory agents, steroids, anti-acne agents, and AGE inhibitors, see claim 9. The composition further includes aloe vera, see claim 10. The composition can further comprise adjuvants and additives for topical use including organic solvents, silicones, pH adjusters, chelating agents, gelling agents, proteins, vitamins, emollients, oils, hydroxy acids, exfoliants, viscosity modifiers, polymers, minerals, insect repellents, lubricants, preservatives, botanicals, essential oils, clarifying agents, non-biological surfactants, antioxidants, thickeners, softeners, sunscreens, moisturizers, colorants, and fragrances, see page 6, lines 19-21 and page 17, lines 1-8 and claim 8. The composition may be incorporated into a wound dressing, see claim 15. The topical composition is formulated as a lotion, cream, ointment, gel, wipe, soap, shampoo, conditioner, or spray, see claim 14 and page 16, lines 5-7, page 19 lines 26-30. The concentration of MEL in the composition can comprise from 0.01-50% or 0.05-10% by weight or 0.1-2% by weight, see page 13, lines 30-33. The concentration of the SLP can comprise from 0.01-50%, from 0.05-10% or from 0.1-2% by weight of the composition, see page 14, lines 5-10. Framer teaches that the composition may have other components including carriers, pH modifiers, buffers, local anesthetic agents, agents that promote wound healing, agents that help degrade biofilm, anti-microbial agents, agents that stop bleeding and/or promote clot formation, and other therapeutic 15 and non-therapeutic components known to, e.g., heal, replenish, rejuvenate, moisturize, protect and/or improve the healing, appearance and/or functioning of the skin. For example, in certain embodiments, the composition can further comprise vitamins, minerals, botanicals, extracts, essential oils, retinoids, anti-comedo agents, moisturizers, and/or sunscreens, see page 6, lines 12-18.
The SLP can comprise acidic or lactone form. In one embodiment, the SLP in acidic form can be from 0.001-90% by weight, see page 14, lines 9.
Heike teachings cosmetic compositions comprising sophorolipid with a mixture of acidic form of 20-60% by weight with the balance being lactone form, see claims 1, 5-6 and [0036]-[0039]. Such biosurfactants have prebiotic activity, see paragraph [001]. The biosurfactant composition is to inhibit the growth of the undesired skin bacteria, and not to affect the growth of the desired skin bacteria or to even promote said growth of the desired skin bacteria, see paragraph [0022].
It would have been obvious in view of Framer to provide the topical formulation as a wound dressing or lotion or cream or ointment or gel or wipe form given these are suitable administration forms for topical formulations as suggested by Framer. It would have been additionally obvious to provide an anti-microbial to protect the topical formulation from being contaminated with bacteria as such additional agents are taught by Fraser to be present with topical formulations.
It would have been obvious to provide the SLP of Patent ‘152 with lactonic to acid in the amounts claimed because the SLP of Heike in overlapping ratios is taught to provide skin cleaning without affecting the growth of desirable bacteria on a skin surface. It would have been obvious to provide the formulation of Patent ‘152 with aloe vera as Framer teaches aloe vera can be added as a further additive for compositions containing glycolipids and yeast cells.
Claims 42-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6,9,11,12, 32 and 34-35 of copending Application No. 18/252,213 (reference application) in view of Framer (WO2019/033989).
Claim 42-53 are directed to an invention not patentably distinct from claim 1-6,9,11,12, and 32-35 of commonly assigned Application No. 18/252,213 Specifically, while the claims at issue are not identical, they are not patentably distinct from each other.
Both the instant claims and those of Application ‘213 are topical formulations comprising SLP and MEL. The composition of Application ‘213 like the instant claims further comprises live or inactive cells including Wickerhamomyces anomalus. The linear (aka acidic SLP) to lactonic SLP is 70:30 in Application ‘213 reading on a ratio of 80:20 to 20:80 claimed. Both Applications formulate the composition as a gel, ointment, cream soap or spray. The SLP can be present at .01% and the MEL at .001% by weight.
The claims of Application 213 do not recite further adjuvants including antimicrobials or the presence of aloe vera.
Framer et al. teach compositions for topical use of healing wounds and/or scars comprising one or more microorganisms and/or microbial growth bi-products. Examples of the growth bi products are glycolipid biosurfactants, see page 5, lines 11-26. Biosurfactants include SLP, and MEL, see page 5. In some embodiments, the composition comprises live or inactivated microorganism as the one more microorganisms including Starmerella bombicola, Wickerhamomyces anomalus, Myerozyma guilliermondii and/or Pseudozyma aphidis, see page 6, lines 6-9. The composition may include skin actives such as keratolytic agents, desquaming agents, anesthetics, keratinocyte proliferation enhancers, collagenase inhibitors, elastase inhibitors, depigmenting agents, anti-inflammatory agents, steroids, anti-acne agents, and AGE inhibitors, see claim 9. The composition further includes aloe vera, see claim 10. The composition can further comprise adjuvants and additives for topical use including organic solvents, silicones, pH adjusters, chelating agents, gelling agents, proteins, vitamins, emollients, oils, hydroxy acids, exfoliants, viscosity modifiers, polymers, minerals, insect repellents, lubricants, preservatives, botanicals, essential oils, clarifying agents, non-biological surfactants, antioxidants, thickeners, softeners, sunscreens, moisturizers, colorants, and fragrances, see page 6, lines 19-21 and page 17, lines 1-8 and claim 8. The composition may be incorporated into a wound dressing, see claim 15. The topical composition is formulated as a lotion, cream, ointment, gel, wipe, soap, shampoo, conditioner, or spray, see claim 14 and page 16, lines 5-7, page 19 lines 26-30. The concentration of MEL in the composition can comprise from 0.01-50% or 0.05-10% by weight or 0.1-2% by weight, see page 13, lines 30-33. The concentration of the SLP can comprise from 0.01-50%, from 0.05-10% or from 0.1-2% by weight of the composition, see page 14, lines 5-10. Framer teaches that the composition may have other components including carriers, pH modifiers, buffers, local anesthetic agents, agents that promote wound healing, agents that help degrade biofilm, anti-microbial agents, agents that stop bleeding and/or promote clot formation, and other therapeutic 15 and non-therapeutic components known to, e.g., heal, replenish, rejuvenate, moisturize, protect and/or improve the healing, appearance and/or functioning of the skin. For example, in certain embodiments, the composition can further comprise vitamins, minerals, botanicals, extracts, essential oils, retinoids, anti-comedo agents, moisturizers, and/or sunscreens, see page 6, lines 12-18.
It would have been obvious to add antimicrobial agents with the topical composition of Application ‘213 because such adjuvants and additional active agents are taught per the teaching of farmer to be used with topical compositions comprising SLP, MEL and one or more microorganisms including Wickerhamomycels anomalus. The addition of the antimicrobial would impart antimicrobial properties to the topical formulation. It would have been obvious to provide the formulation of Application ‘213 with aloe vera as Framer teaches aloe vera can be added as a further additive for compositions containing glycolipids and yeast cells.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 18/252,213 discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 42-50 and 52-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6,9,11,12, 32 and 34-35 of copending Application No. 18/446026 (reference application) in view of Framer (WO2019/033989) and Heike et al. (United States Patent Publication 2017/0071842).
Claim 42-50 and 52-53 are directed to an invention not patentably distinct from claims 1-6,9,11,12, 32 and 34-35 of commonly assigned Application No. 1844026. Specifically, while the claims at issue are not identical, they are not patentably distinct from each other.
Both the instant claims and those of Application ‘026 are topical formulations comprising SLP and MEL including wound dressings which further comprise antimicrobial agent and aloe vera.
The difference between the ‘026 claims and the instant claims is that the instant claims have aloe vera and a yeast microbes present including microorganisms including Starmerella bombicola, Wickerhamomyces anomalus, and wherein the SLP is a ratio of acidic to lactonic and the amounts of SLP and MEL.
Framer et al. teach compositions for topical use of healing wounds and/or scars comprising one or more microorganisms and/or microbial growth bi-products. Examples of the growth bi products are glycolipid biosurfactants, see page 5, lines 11-26. Biosurfactants include SLP, and MEL, see page 5. In some embodiments, the composition comprises live or inactivated microorganism as the one more microorganisms including Starmerella bombicola, Wickerhamomyces anomalus, Myerozyma guilliermondii and/or Pseudozyma aphidis, see page 6, lines 6-9. The composition may include skin actives such as keratolytic agents, desquaming agents, anesthetics, keratinocyte proliferation enhancers, collagenase inhibitors, elastase inhibitors, depigmenting agents, anti-inflammatory agents, steroids, anti-acne agents, and AGE inhibitors, see claim 9. The composition further includes aloe vera, see claim 10. The composition can further comprise adjuvants and additives for topical use including organic solvents, silicones, pH adjusters, chelating agents, gelling agents, proteins, vitamins, emollients, oils, hydroxy acids, exfoliants, viscosity modifiers, polymers, minerals, insect repellents, lubricants, preservatives, botanicals, essential oils, clarifying agents, non-biological surfactants, antioxidants, thickeners, softeners, sunscreens, moisturizers, colorants, and fragrances, see page 6, lines 19-21 and page 17, lines 1-8 and claim 8. The composition may be incorporated into a wound dressing, see claim 15. The topical composition is formulated as a lotion, cream, ointment, gel, wipe, soap, shampoo, conditioner, or spray, see claim 14 and page 16, lines 5-7, page 19 lines 26-30. The concentration of MEL in the composition can comprise from 0.01-50% or 0.05-10% by weight or 0.1-2% by weight, see page 13, lines 30-33. The concentration of the SLP can comprise from 0.01-50%, from 0.05-10% or from 0.1-2% by weight of the composition, see page 14, lines 5-10. Framer teaches that the composition may have other components including carriers, pH modifiers, buffers, local anesthetic agents, agents that promote wound healing, agents that help degrade biofilm, anti-microbial agents, agents that stop bleeding and/or promote clot formation, and other therapeutic 15 and non-therapeutic components known to, e.g., heal, replenish, rejuvenate, moisturize, protect and/or improve the healing, appearance and/or functioning of the skin. For example, in certain embodiments, the composition can further comprise vitamins, minerals, botanicals, extracts, essential oils, retinoids, anti-comedo agents, moisturizers, and/or