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 .
DETAILED ACTION
Claim Status
The amended claim set of 25 Sep 2024 has been entered and reviewed Claims 1-39, 43, 44, 46, 48-50, and 66-70 are cancelled.
Claims 42, 45, 47, and 51-65 have been amended.
Claims 40-42, 45, 47, and 51-65 are pending and under consideration.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09 Jan 2025 and 30 Jul 2025 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The use of the term “tween”, which is a trade name or a mark used in commerce, has been noted in this application on page 1 line 20. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 53 is objected to because of the following informalities: the word “is” is missing between “(Pdi)” and “less.” Appropriate correction is required.
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 62-64 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 62 recites the limitation "the high shear homogenization.” There is insufficient antecedent basis for this limitation in the claim.
Claim 63 recites the limitation "the high-pressure homogenization.” There is insufficient antecedent basis for this limitation in the claim.
Claim 64 recites the limitation "the high-pressure homogenization.” There is insufficient antecedent basis for this limitation in the claim.
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 40-42, 45, 47, 51, 52, 56, 63, and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Edelson et al. (WO 2009/158687, published 30 dec 2009) in view of Suzuki et al. (US 2010/0168405, published 01 Jul 2010, listed on IDS filed 30 Jul 2025) and Sanusi (Six Healthy Benefits Of Black Seed Oil On Your Hair Guardian Life, published 06 Oct 2019).
Edelson teaches systems and methods for treating disorders and conditions associated with the dermal level of the skin, such as hair loss, where the methods involve administering nanoemulsions comprising at least one therapeutic agent (abstract). Edelson teaches that nanoparticle compositions can deliver active agents efficiently and specifically to the dermis ([0003]). Edelson teaches that nanoparticle compositions comprising therapeutic agents may be incorporated within forms such as a microemulsion and a nanoemulsion ([00012]). Edelson teaches a premix from which nanoparticle compositions are prepared and which contain at least two immiscible materials and teaches an oil-in-water dispersion where oily particles are dispersed within an aqueous dispersion medium ([000107]). Edelson teaches that a premix will contain an aqueous dispersion medium and an oily medium that becomes dispersed in nanoparticle form in the dispersion medium ([000108]). Edelson teaches a variety of oils and combinations of oils for the compositions including, but not limited to rosemary ([000258]), rendering obvious claim 41. Edelson teaches that the oil ranges between 0-30% ([000121-000122]). Edelson teaches the inclusion of a variety of surfactants or emulsifying agents, including combinations of surfactants and natural detergents having high surfactant properties and phosphatidylcholines ([000114]), rendering obvious claim 42. Edelson teaches that the surfactant can range between 0-30% ([000124]). Edelson teaches that the nanoparticle compositions are prepared by exposure to high shear forces ([00011]), which may be generated by any method known in the art such as high pressure homogenization ([00051]), rendering obvious homogenizing to obtain the emulsion as in steps (c) and (d) of claim 40 and rendering obvious high shear homogenization (claim 56). Edelson teaches various pressure ranges including from about 25,000 to about 30,000 psi ([0051]), rendering obvious claims 63 and 64. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Edelson teaches forming uniform nanoparticle compositions ([000106]). Regarding claim 51, Edelson teaches that particles within the nanoparticle compositions have diameters that are smaller than various sizes including 600 nm, 500 nm, 400 nm, 300 nm, and 200 nm ([00014]). Regarding claim 52, Edelson teaches that the nanoparticle compositions are stable and that a stable composition is one for which the maximum particle size, range of particle sizes, and/or distribution of particle sizes is maintained for a period of time including times such as about 3 months, 4 month, 5 months or longer ([00092]). Edelson teaches the inclusion of buffering agents ([000250], [000256]) and various suitable aqueous media such as phosphate buffered saline ([000109]).
Edelson does not teach that the nanoemulsion comprises rhamnolipid or black cumin oil. These deficiencies are made up for in the teachings of Suzuki and Sanusi.
Suzuki teaches an activator including a biosurfactant as an active ingredient where the biosurfactant activates various cells and is effective for anti-aging, hair growth, and prevention of loss of hair ([0001], [0066]). Suzuki teaches that the biosurfactant used as an active ingredient in the activator of the present invention has a notable activating function on various cells and yields an excellent effect as an anti-aging agent and a hair-growth agent ([0082]) and prevents progression of loss of hair ([0144]). Suzuki teaches biosurfactants that can be used for the activator for the invention include rhamnolipid ([0104]). Suzuki teaches that the biosurfactants may be used singularly or two or more of the biosurfactants may be used in combination ([0112]). Suzuki teaches that it is preferable to use the biosurfactant activator in such a manner that the biosurfactant is mixed in cosmetics, quasi-drugs, drugs, and drinks and foods ([0132]). Suzuki teaches that the concentration with which the biosurfactant is mixed is suitably determined according to the degree of absorption, the degree of operation, the form of a product, the frequency of usage etc., and it is not particularly limited mixture concentration may be determined in a range that does not impair an operation for activating cells and in general the mixture concentration is preferably 0.001-50% by mass and further preferably 1-15% by mass with respect to the whole weight of the activator ([0132]). Suzuki teaches that the activator may be in various dosage forms including an emulsion ([0145], [0146], [0246]).
Sanusi teaches that black seed oil can help prevent and restore hair shedding and balding and that black seed oil is also known as black cumin seed oil (page 1 paragraph 1). Sanusi teaches that black seed oil consists of antioxidants and anti-inflammatory properties which help fight skin disease caused by bacteria and fungi, proteins, alkaloids and saponins which helps boost hair growth and slow down the ageing process in the cell (page 1 paragraph 1). Sanusi teaches that black seed oil curbs hair fall, soothes scalp condition, stimulates hair regrowth, conditions and softens hair, promotes blood circulation and prevents greying (pages 1-2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have a method of preparing a nanoemulsion comprising an oil and aqueous medium where the oil and aqueous mediums are homogenized to form an oil-in-water nanoemulsion and to include rhamnolipid from about 0-30% and black cumin seed oil from about 0-30% in the aqueous and oil phases. Rhamnolipid is a biosurfactant that can be used as an active agent in emulsions for hair growth as taught by Suzuki, thus making it an obvious addition to the nanomemulsions of Edelson which may be used for treating hair loss and include surfactants. Similarly, black cumin seed oil consists of antioxidants and anti-inflammatory properties that help boost hair growth making it an obvious addition as an oil to the oil/water nanoemulsion of Edelson which may be used for treating hair loss. It would be obvious to include the components with a reasonable expectation of success for their known benefits related to hair loss and Edelson teaches the inclusion of oils and surfactant components for the nanoemulsions. Surfactant and oil components are known from Edelson to be added from 0-30%, rendering obvious the amounts of claims 45 and 47. Overall, the addition of rhamnolipid, and black cumin seed oil represent obvious additions to the nanoemulsion of Edelson for their known ability to enhance the effectiveness of treating hair loss.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 53 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Edelson et al. (WO 2009/158687, published 30 dec 2009) in view of Suzuki et al. (US 2010/0168405, published 01 Jul 2010, listed on IDS filed 30 Jul 2025) and Sanusi (Six Healthy Benefits Of Black Seed Oil On Your Hair Guardian Life, published 06 Oct 2019) as applied to claims 40-42, 45, 47, 51, 52, 56, 63, and 64 above and further in view of Danaei et al. (Pharmaceutics 2018, 10, 57).
The teachings of Edelson, Suzuki and Sanusi are described supra.
Edelson, Suzuki and Sanusi do not teach a polydispersity index of less than about 0.15. This deficiency is made up for in the teachings of Danaei.
Danaei teaches that polydispersity index is used to describe the degree of non-uniformity of a size distribution of particles where a value of 0.0 represents a perfectly uniform sample and a value of 1.0 represents a highly polydisperse samples with multiple particle size populations (page 8 lines 11-15 and paragraph 2). Danaei teaches that for lipid-based carriers in drug delivery applications a polydispersity index of 0.3 and below is considered to be acceptable and indicates a homogenous population of phospholipids (page 8 paragraph 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have the method of forming the nanoemulsion composition made obvious over Edelson Suzuki and Sanusi and to have the dispersion with a polydispersity index of less than 0.3. Forming uniform nanoparticle compositions is known from Edelson and polydispersity represents the degree of non-uniformity of a size distribution and polydispersity index of less than 0.3 is suitable for drug delivery applications of lipid based carriers, as taught by Danaei, thus providing one of ordinary skill in the art motivation to form the nanoemulsion with a low polydispersity index, such as less than 0.3, in order to have a more uniform emulsion. Regarding claim 54, as described above, Edelson renders obvious stable compositions such as stable particle size distributions for periods such as about 3 months, 4 month, 5 months or longer, rendering obvious claimed the polydispersity index for 90 days or more.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Edelson et al. (WO 2009/158687, published 30 dec 2009) in view of Suzuki et al. (US 2010/0168405, published 01 Jul 2010, listed on IDS filed 30 Jul 2025) and Sanusi (Six Healthy Benefits Of Black Seed Oil On Your Hair Guardian Life, published 06 Oct 2019) as applied to claims 40-42, 45, 47, 51, 52, 56, 63, and 64 above and further in view of Soleymani et al. (Adv Pharm Bull, 2019, 9(4), 584-592).
The teachings of Edelson, Suzuki and Sanusi are described supra. Edelson, Suzuki and Sanusi do not teach the aqueous phase with a buffered solution of pH between 4-8. This deficiency is made up for in the teachings of Soleymani.
Soleymani teaches the enhancement of dermal delivery of finasteride using microemulsion systems (title). Soleymani teaches that finasteride is a pharmaceutical agent that treats hair loss (abstract). Soleymani teaches microemulsions with a pH in the range of 5.1-5.7 and teaches that this pH is suitable for the skin (page 589 left column).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have the method of preparing nanoemulsions, obvious over Edelson, Suzuki, and Sanusi, where the aqueous phase includes a buffered solution and to have the pH between 5.1-5.7. The inclusion of buffering agents and media such as phosphate buffered saline is known from Edelson. It is further known from Soleymani that a pH of 5.1-5.7 is suitable for skin for microemulsions directed to hair loss treatment. The formulations of Edelson are similarly used for hair loss applications, providing a reasonable expectation of success in using this pH range and it would be obvious to one of ordinary skill to have the pH between 5.1 and 5.7 as this is known to be suitable for the skin.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 57-62 are rejected under 35 U.S.C. 103 as being unpatentable over Edelson et al. (WO 2009/158687, published 30 dec 2009) in view of Suzuki et al. (US 2010/0168405, published 01 Jul 2010, listed on IDS filed 30 Jul 2025) and Sanusi (Six Healthy Benefits Of Black Seed Oil On Your Hair Guardian Life, published 06 Oct 2019) as applied to claims 40-42, 45, 47, 51, 52, 56, 63, and 64 above and further in view of Raikar et al. (Ind. Eng. Chem. Res. 2011, 50, 6089–6100).
The teachings of Edelson, Suzuki and Sanusi are described supra.
Edelson, Suzuki and Sanusi do not teach combining high shear and high pressure homogenization (claim 57) where high shear is followed by high pressure homogenization (claim 58) and the high pressure step is done multiple times (claims 59-61) or the rpm rate of high shear homogenization (claim 62). These deficiencies are made up for in the teachings of Raikar.
Raikar teaches that commonly used techniques for emulsification require the application of mechanical energy to the two immiscible phases (page 6089 left column). Raikar teaches that various types of processing equipment are available and that emulsification can be a single-step or multistep process depending on the application, and the choice of equipment is based on the energy intensities required for the various steps (page 6089 left column). Raikar teaches that oil-in-water emulsions are typically formed by first preparing a coarse emulsion using a low-intensity stator-rotor type device that mixes the various ingredients into a stable form and that this premix is then processed with a high-intensity device such as a high-pressure homogenizer, for a single pass or multiple passes until the target emulsion is obtained (page 6089 left column). Raikar teaches that controlling the emulsion microstructure is crucial to meeting quality specification and that as a consequence there is considerable motivation to develop robust predictive models for the homogenization process (page 6089 left column). Raikar teaches forming emulsions using a two step process where a premix was prepared with a stator-rotor device at 16,000 rpm (page 6090 left column bottom). Raikar further teaches using multiple passes where the emulsion was collected and reprocessed (page 6090 right column top). Raikar teaches varying emulsion properties with 1-5 passes of pressure homogenization (e.g. Fig 1, 2, 4, 7).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have homogenized the emulsion with high shear by mixing using a stator-rotor at 16,000 rpm and to follow this with multiple passes, such as 2-5, of high pressure homogenization. Homogenization of the emulsions may be done using high shear forces from any known method, such as high pressure, as known from Edelson. It is further known from Raikar that oil-in-water emulsions are typically formed by first forming a coarse emulsion with a stator-rotor device and that this is followed by a high-pressure homogenizer. Rotor stator devices may be used at 16,000 rpm and multiple passes of the homogenization may be done in order to reach the target emulsion. Thus, it is known in the art and would be obvious to one of ordinary skill to form emulsions in multiple steps including first homogenizing with high shear at 16,000 rpm and following with multiple passes (2-5) of high pressure homogenization. The claimed high shear/high pressure homogenization techniques and the use of multiple passes are standard methods for homogenizing emulsions which one of ordinary skill would employ in order to achieve the desired emulsion. As known from Raikar, controlling the emulsion microstructure is crucial for quality specifications, and it is known to form uniform nanoemulsions from Edelson, rendering it obvious to one of ordinary skill to use known techniques with a stator-rotor at 16,000 rpm followed multiple passes of high pressure in order to achieve the desired emulsion properties.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 65 is rejected under 35 U.S.C. 103 as being unpatentable over Edelson et al. (WO 2009/158687, published 30 dec 2009) in view of Suzuki et al. (US 2010/0168405, published 01 Jul 2010, listed on IDS filed 30 Jul 2025), Sanusi (Six Healthy Benefits Of Black Seed Oil On Your Hair Guardian Life, published 06 Oct 2019), Raikar et al. (Ind. Eng. Chem. Res. 2011, 50, 6089–6100) as applied to claims 40-42, 45, 47, 51, 52, and 56-64 above and further in view of Dhankhar (IOSRJEN Vol 04, Issue 05, May 2014).
The teachings of Edelson, Suzuki, Sanusi, and Raikar are described supra.
Edelson, Suzuki, Sanusi, and Raikar do not teach minimizing foam. This deficiency is made up for in the teachings of Dhankhar.
Dhankhar teaches homogenization fun0damentals (title) and that foaming can be a problem with rotor-stator homogenizers (page 4 top paragraph). Dhankhar teaches that keeping the tip of the homogenizer well submerged within the media and the use of properly sized vessels helps with the foaming problem (page 4 top paragraph).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have reduced or minimized the formation of foam during the homogenization of the emulsion. It is obvious to homogenize using techniques such as a rotor-stator homogenizer, but, as known from Dhankhar, foaming can be a problem when using this homogenization technique. It is further known from Dhankhar that the foaming can be reduced by using techniques such as keeping the tip well submerged and using properly sized vessels. Thus, it would have been obvious to one of ordinary skill in the art to minimize foam as this is a known problem during homogenization and there are known techniques for reducing the foaming problem.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/EDWIN COLEMAN MITCHELL/Examiner, Art Unit 1619
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