DETAILED ACTION
Status of the Claims
Claims 1-11 are pending in the instant application. Claim 11 has been withdrawn based upon Restriction/Election as discussed below. Claims 1-10 are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Restriction/Election
Applicant's election of Group I drawn to a facial mask in the reply filed on 01/15/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claim 11 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/15/2026.
Priority
The instant Application is a 371 of PCT/US2022/027091 filed 04/29/2022, and claims priority to the U.S. Provisional Application No. 63/181,733.
The U.S. effective filing date has been determined to be 04/29/2021, the filing date of the U.S. Provisional Application No. 63/181,733.
Information Disclosure Statement
The information disclosure statement submitted on 01/15/2026 was filed before the mailing date of the first office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Instant claims 3 recites “wherein the protrusions have a height in a range of about 200 nm to about 800 nm.” which is not disclosed in the as-filed Specification.
Claim Objections
Claims 2-10 are objected to because of the following informalities: The dependent claims capitalize the letter “Claim” which should not be capitalized. Claim 6 is further objected because the claim fails to end in a period (MPEP 608.01(m) – “Each claim begins with a capital letter and ends with a period.”) Appropriate correction is required.
Claim 10 is further objected to because the claim recites “PRPs” which is an abbreviation without the accompanying phrase platelet rich plasma. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Scope of the Claimed Invention:
Applicant claims a facial mask, comprising: a polymeric matrix having a plurality of protrusions configured for penetrating into stratum corneum of facial skin, and a plurality of exosomes distributed within said polymeric matrix, wherein said polymeric matrix is degradable when embedded within the skin so as to release said exosomes into the skin (instant claim 1). And further claims “The facial mask of Claim 1, wherein said protrusions have a height in a range of about 200 nm to about 800 nm.” (instant claim 3).
Disclosure of the Prior Art:
Donnelly et al. (“Optical coherence tomography is a valuable tool in the study of the effects of microneedle geometry on skin penetration characteristics and in-skin dissolution,” 2010, ELSEVIER; Journal of Controlled Release, Vol. 147, pp. 333-341) teaches that: “Microneedle arrays are minimally invasive devices that can be used to bypass the stratum corneum barrier and thus achieve enhanced transdermal drug delivery. Microneedles (MNs) (50–900 µm in height, up to 200 MN cm-2) in diverse geometries have been produced from silicon, metal, carbohydrates and polymers using various microfabrication techniques.” (p. 333, col. 1, lines 1-6). And that: “MNs
are long enough to penetrate the dermis, but are short and narrow enough to avoid stimulation of dermal nerves.” (p. 333, col. 2, lines 1-3). And further that: “MN arrays should be able to demonstrate sufficient strength to penetrate into the skin or other biological tissue without breaking or bending before or during insertion. The major factors accountable for MN performance are type of material, needle height, tip-radius, base diameter, needle geometry and needle density, which, in turn, determine the overall insertion and fracture force of the MN. However, the inherent elasticity and irregular surface of the skin remains a major challenge to the reproducibility of MN penetration. It has been shown that the skin can become folded around MN, which results in either partial or incomplete piercing depending upon MN height. Badran et al. highlighted that there was a positive correlation between MN height and penetration depth and diameter of MN-induced pores in excised full thickness human skin. Moreover, it has been shown that MN geometry can play an important role in the affect of drug penetration across the skin, with MN height and density appearing to be the most critical parameters. In particular, MN penetration depth has been reported as being the most significant factor in determining the effective drug permeability of skin.” (p. 334, col. 1, 2nd paragraph).
Verbaan et al. (“Improved piercing of microneedle arrays in dermatomed human skin by an impact insertion method,” 2008, ELSEVIER; Journal of Controlled Release, Vol. 128, pp. 80-88) teaches that: “The natural function of the skin is to protect the body against undesired influences from the environment. However, the skin barrier function is a major challenge for delivery of drugs via the skin. The barrier function is located in the outermost layer of the skin, the stratum corneum (SC), which consists of dead cells embedded in lipid regions. The SC thickness is only 10–20 µm.” (p. 80, col. 1, 1st paragraph). And that: “Previously, we described the use of assembled hollow metal microneedle arrays to bypass the barrier function of dermatomed human skin in vitro. The microneedle arrays were made from commercially available hypodermic needles, and have microneedle lengths of 550, 700 and 900 µm. Pretreatment of human skin with these assembled hollow metal microneedles resulted not only in the delivery of small compounds, but also large molecules such as high molecular weight dextrans. However, in these studies we were not able to pierce the skin with microneedles of 300µm length due to the elasticity of the skin resulting in a folding of the skin around the microneedle tip. Recently, this skin folding has been visualized by Martanto et al.” [emphasis added](p. 81, col. 1, 1st paragraph).
Disclosure of the Instant Application:
The instant Specification does not disclose the subject matter of instant claim 4 but rather discloses that: “In one aspect, a facial mask is disclosed, which comprises a polymeric matrix having a plurality of protrusions configured for penetrating into the stratum corneum of facial skin, and a plurality of exosomes that is distributed within the polymeric matrix, where the polymeric matrix is degradable when embedded within the skin and/or the physiological temperatures, e.g., 37° C. or higher, so as to release the exosomes into the skin.” (p. 1, lines 20-24). And that: “In some embodiments, the protrusions are shaped and sized so as to allow penetration thereof at least partially into the dermal layer. By way of example, the protrusions can have a height in a range of about 100 micrometers (microns) to about 800 microns, e.g., in a range of about 200 microns to about 600 microns.” (p. 1, lines 25-28). And further that: “The polymeric matrix 104 includes a base portion 106 from which a plurality of projections 110 (herein also referred to as "shafts" or "microneedles") extend. As discussed in more detail below, in many embodiments, the projections 110 are configured for penetration through the stratum corneum and the epidermis to be introduced at least partially into the dermal layer of the skin. By way of example, in some embodiments, the projections 110 can have a height (H) in a range of about 100 microns to about 800 microns, or 200 microns to about 400 microns and a base diameter (BD) in a range of about 300 microns to about 500 microns, e.g., 400 microns.” [emphasis added](p. 5, lines 14-21). And further that: “It is expected that the released exosomes/PRP will activate the stem cells residing in dermal and/or follicular tissue to help with hair growth. In some implementations of this embodiment, the height of the projections 403 can be in a range of about 100 to about 500 microns, e.g., in a range of about 200 to about 300 microns. Further, in some embodiments, the projections can be releasably coupled to the base layer of the polymeric matrix so that they can be released into the skin layer into which the projections penetrate. This allows removing the dermal patch after a certain period.” (p. 8, lines 15-21).
Discussion:
Applicants claim 1 reciting “a polymeric matrix having a plurality of projections configured for penetrating into stratum corneum of facial skin” and “wherein said protrusions have a height in the range of about 200 nm to about 800 nm.” (instant claim 3) is not consistent with the instant Specification which describes the “plurality of projections” as “microneedles” and describes the heights in microns an not in nanometers. This is consistent with the prior art teaching that microneedle heights needed to penetrate the stratum corneum (SC thickness is only 10–20 µm) is on the order of a couple hundred microns. Thus, one of ordinary skill would have appreciated that a microneedle array with microneedle heights in the range of “about 200 nm to about 800 nm” would not be “configured for penetrating into stratum corneum of facial skin”. Given the lack of any disclosure in the as-filed Specification of nanometer heights, it appears to be a clerical error, necessitating this grounds of rejection.
Claim Rejections - 35 USC § 112(b)
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 6 is 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 pre-AIA the applicant regards as the invention.
Claim 6 is rejected as being indefinite because the claim recites “The facial mask of claim 1, wherein said polymeric matrix layer comprises any of” which is indefinite because the claim lacks text beyond “comprises any of”. Thus it is unclear what is being limited by the claim. Appropriate clarification is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Instant claim 6 recites “The facial mask of claim 1, wherein said polymeric matrix layer comprises any of” which lacks text beyond “comprises any of”, and therefore does not further limit the base claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-2, 4, 6-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over AHMED (US 2018/0344999 A1; published December, 2018) in view of YI (WO 2019/088545 A1; published May, 2019; Clarivate Analytics Machine English language translation relied upon herein); GU (WO 2019/200063 A1; published October, 2019) and MENG (US 2017/0165194 A1; published June, 2017).
Applicants Claims
Applicant claims a facial mask, comprising: a polymeric matrix having a plurality of protrusions configured for penetrating into stratum corneum of facial skin, and a plurality of exosomes distributed within said polymeric matrix, wherein said polymeric matrix is degradable when embedded within the skin so as to release said exosomes into the skin (instant claim 1).
Determination of the scope
and content of the prior art (MPEP 2141.01)
AHMED teaches microneedle patches for transdermal delivery (title, see whole document), and particularly “microneedle patches for agent application on a mammal skin. The microneedle patch may comprise a patch scaffold having a surface, and a plurality of microneedles disposed on the surface. Each of the microneedles may be capable of piercing the skin 50 μm to 1000 μm deep, and comprises a composite material comprising polyvinylpyrrolidone (PVP) and one or more additional copolymers selected from the group consisting of maltose, leucine, and dileucine.” (abstract)(instant claim 1, “a plurality of protrusions configured for penetrating into stratum corneum of facial skin”).
AHMED teaches “The microneedle patch can also be used to delivery agents to a skin, for cosmetic or pharmaceutical purposes. In this respect, the patch can be provided in the form of a facial mask (or part of a facial mask), for example. The cosmetic or pharmaceutical agents packaged in the microneedle patch can be delivered into the skin, rendering desired effects on the skin. The cosmetic or pharmaceutical agents include, without limitation, agents capable of improving the look, nutrition, or health of the skin or ameliorating a condition or disease of the skin.” [emphasis added]([0039])(instant claim 1, “A facial mask, comprising: a polymeric matrix having a plurality of protrusions configured for penetrating into stratum corneum of facial skin”). AHMED teaches that: “The current MNPs1 are also associated with several limitations which hinder their clinical application. For instance, the dissolving microneedles have strict mechanical performance requirements. The microneedles need sufficient mechanical strength to perforate the stratum corneum.” ([0006]).
AHMED teaches that: “Use of the novel microneedle patch, as disclosed herein, may involve pressing the microneedle patch to a person's skin such that each of the microneedles loaded with an agent pierces the skin. In some embodiments, the microneedles may have dimensions so as to pierce the skin about 50 µm to about 1000 µm deep. The biocompatible composite material of the microneedles dissolves upon insertion into the skin, thereby delivering the agent at a precise, controlled location within the dermal layers of the skin. The location of the agent within each microneedle may also be tailored according to the methods disclosed herein, thereby allowing for controlled rates of agent release.” [emphasis added]([0036])(instant claim 22). And that: “In some embodiments, the microneedles 102 may each have a maximum length (height, hn) ranging from about 20 µm to about 1000 µm, […].” ([0049]).
AHMED teaches that: “In some embodiments, the composite material may comprise one or more additional components such as chitosan. For instance, in one embodiment, the composite material may comprise PVP, chitosan, and one or more copolymers selected from maltose, leucine, and dileucine.” ([0061])(instant claims 6 & 8).
AHMED teaches that “Also provided herein, in one embodiment, is a method for delivering a cosmetic or pharmaceutical agent to a mammal skin, the method comprising applying the microneedle patch on the skin and allowing the cosmetic or pharmaceutical agent of the patch to be delivered to the skin.” ([0023]).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of AHMED is that AHMED does not expressly teach “a plurality of exosomes distributed within said polymeric matrix”.
YI teaches that: “Provided in the present invention is an exosome kit for enhancing transdermal permeation of exosomes, comprising an iontophoresis device, a mask pack and a mask sheet or patch on which a composition containing exosomes as an active ingredient is coated or deposited. The present invention facilitates the application of exosomes, which can function as a functional cosmetic product or a quasi-drug, to the skin, and allows exosomes to penetrate deeply into the skin while effectively passing through the skin barrier. Therefore, the present invention can exhibit excellent effects when applied to skin treatment for alleviating deteriorated skin conditions or returning the same to a normal state, and can exhibit excellent effects on skin disease treatment allowing a skin state in a diseased state to be mitigated, alleviated, or return to a normal state.” (Abstract, see whole document).
YI teaches that: “The skin has a three-layer structure of epidermis, dermis, and subcutaneous fat. The stratum corneum of the epidermis, which is located at the outermost part of the skin, suppresses moisture evaporation of the skin and acts as a skin barrier. However, the skin barrier of the stratum corneum has a problem of impairing the penetration of the active ingredient when the functional cosmetic or the medicinal product is applied to the skin, thereby deteriorating the efficacy of the functional cosmetic or the medicinal product.” (p. 2, §BACKGROUND-ART, 1st paragraph). And that: “The inventors of the present invention have developed an exosomic kit for transcutaneous permeation enhancement of exosomes which greatly promotes transdermal permeation of exosomes while repeatedly studying the new application fields of exosomes and medical or cosmetic techniques Thus completing the present invention.” (p. 3, 2nd paragraph).
YI teaches that: “The present invention has the effect of facilitating skin application of exosomes that can function as functional cosmetics or medicines, and penetrating deeply into the skin while allowing the exosomes to pass the skin barrier effectively. Therefore, the present invention can be applied to a skin beauty which improves a poor skin condition or restores to a normal state, and can exhibit an excellent effect. In addition, the present invention provides an effect of treating a skin disease which alleviates, It is possible to exhibit an excellent effect.” [emphasis added] (p. 7, §ADVANTAGEOUS-EFFECTS). YI teaches a face mask – “The "exosome kit 100" having the above-described structure is applied once to the face of a person having a flushing symptom and a severe skin trouble (hereinafter referred to as "case 1 ") to alleviate or alleviate skin troubles and flushing symptoms” (p. 10, last paragraph). And that: “12 is a perspective view showing a configuration of the exosomes kit 100 according to one embodiment of the present invention.” (p. 38, Figure 12, in WO 2019/088545 A1, as originally published). YI does not teach exosomes in a microneedle array, however, GU teaches microneedle arrays including exosomes.
GU teaches: “Compositions comprising polymeric networks comprising combinations of small molecule hair growth agents and natural products (e.g,, vesicles, such as stem cell-derived exosomes) are described. The polymeric network can, for example, comprise keratin crosslinked via intermolecular disulfide bonds. Alternatively, the polymeric network can comprise keratin or a derivative thereof and another crosslinked hydrophilic polymer. Microneedles, microneedle arrays, and skin patches comprising the compositions are also described, as are methods of treating hair loss and/or promoting hair growth using the microneedles, microneedle arrays and/or skin patches.” (abstract, see whole document).
GU teaches that: “In some embodiments, the presently disclosed subject matter provides a composition comprising: (a) a hydrophilic polymer network comprising keratin or a derivative thereof; (b) a natural product selected from the group comprising vesicles, stem cells, and vesicle-derived molecules, optionally wherein the vesicles are exosomes, further optionally wherein the natural product comprises mesenchymal stem cell (MSC)-derived exosomes; and (c) a small molecule hair growth agent.” And that: “In some embodiments, the hydrophilic polymer network comprises a keratin hydrogel.” (p. 4, lines 11-19).
GU teaches that: “The array can also include other layers attached to the base of the array (i.e., on the side of the array opposite to the microneedle tips). For instance, in some embodiments, the array can further include a protective backing layer to protect the other array components from moisture or other external contaminants as well as mechanical injury, such as from scratching. In some embodiments, the protective backing layer comprises a water-resistant or water-proof plastic film. In some embodiments, the array can include an adhesive backing layer (e.g., so that the array can be attached to another material or to a subject being treated) or a tinted layer (e.g., tinted with a color selected to match a human skin or hair color so that the array can blend better with the skin or hair color of the subject being treated with a patch comprising the array). In some embodiments, the array can include a removable backing layer.” [emphasis added](p. 24, lines 13-25)(instant claim 7).
GU teaches that: “The amount of vesicles (e.g., exosomes) or other natural product and/or the amount of small molecule therapeutic (e.g., UK5099) can vary, e.g., depending upon the size of the microneedle array patch prepared from the composition. As an example, for a microneedle patch comprising a 15 x 15 needle array, wherein each array has an approximately 300 µm base diameter and a height of about 600 µm, the added amount of vesicles (e.g., exosomes) can be between about 0.01 milligram (mg) and about 2 mg. The amount of small molecule hair growth agent (e.g., UK5099) can be between about 0.05 microgram (µg) and about 1 mg (e.g., about 0.05, 0.1, 0.5, 1.0, 5.0, 10, 50, 100, 200, 300, 400, 500, 600, 700, 800, 800, or about 1000 μg). These amounts can be increased when a larger patch is prepared.” (instant claim 4).
MENG teaches cosmetic and facial regeneration compositions derived from potentiated adipose derived cells and supernatants thereof (title, see whole document). MENG teaches that: “This patent discloses new data supporting superior collagen induction by cosmetically useful preparations derived from adipose stem cells that have been manipulated for superior growth factor and anti-aging properties. In one embodiment cellular mixtures derived from adipose tissue are composed, induced to produce regenerative factors, with said regenerative factors harvested and compounded into cosmetic preparations. In one embodiment, the invention provides for manufacture of adipose derived regenerative factor (ARDF), which may be utilized as a cosmetic and skin rejuvenating agent.” (abstract).
MENG teaches that: “The epidermis is the outer layer of the skin, which serves to protect the body against numerous external environment factors such as mechanical traumas, temperature, pathogenic microorganisms, xenobiotics, and UV radiation.” ([0002]). MENG teaches that: “Although knowledge exist regarding means of skin self-renewal, means of inducing regeneration of skin in older subjects has been limited. The purpose of the current invention is to provide skin regenerative agents using extracts derived from adipose derived stem cell and other cellular populations.” ([0008]). MENG teaches that: “Membrane microvesicles (MMV) are fragments of phospholipid bilayer plasma membrane ranging from 30 nm to 1000 nm shed from almost all cell types. MMV, therefore are a subtype of membrane-vesicles, and play a role in intercellular communication and can deliver mRNA, siRNA, and proteins between cells.” ([0010]). And that: “In contrast to MMV, exosomes are vesicles of 30-100 nm in diameter, which are actively secreted by a wide range of cell types under both normal and pathological conditions. Exosomes can be regarded as a sub-class of MMV.” ([0011]). And further that: “Although exosomes have been previously utilized in the area of regenerative medicine, such as in treatment of heart failure in animal models, the use of exosomes from adipose tissue has not been previously disclosed for cosmetic and skin regeneration purposes.” ([0012]).
MENG teaches that: “The invention belongs to the field of stem cell biology, more specifically, the invention belongs to the field of skin regeneration, more specifically the invention pertains to the use of adipose derived components and secreted factors for the purposes of skin regeneration and rejuvenation.” ([0013]).
To this end MENG claims: “A composition useful for enhancing skin appearance obtained by the steps of: a) extracting one or more cellular populations from adipose tissue possessing regenerative properties; b) exposing said cells to conditions allowing for production of regenerative factors; c) extracting said regenerative factors; d) concentrating said regenerative factors; e) admixing said regenerative factors in a solution useful for topical application.” (claim 1). And further: “The composition of claim 1, wherein said regenerative factors are exosomes.” (claim 16)(instant claims 1 & 4). And further; “The composition of claim 1, wherein said composition is admixed with platelet rich plasma.” (claim 25)(instant claim 10, PRPs = platelet rich plasmas).
Specifically regarding instant claim 4, it would have been prima facie obvious to include a therapeutically effective amount of the cosmetic and/or pharmaceutical active ingredient for delivery through the skin being an exosome as suggested by Yi and MENG both teaching delivery of exosomes through the skin for skin rejuvenation (returning skin to a normal state). And one of ordinary skill would have more likely than not arrived at the claim number of exosomes contained in said facial mask based on the same composition (facial mask incorporating exosomes) and intended use skin rejuvenation (returning skin to a normal state). MPEP §2144.05(II) – “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’”
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
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 produce a facial mask including a microneedle array including a cosmetic and/or pharmaceutical active ingredient for delivery through the skin, as suggested by AHMED, the cosmetic and/or pharmaceutical active ingredient for delivery through the skin being an exosome as suggested by Yi and MENG both teaching delivery of exosomes through the skin for skin rejuvenation (returning skin to a normal state), with a reasonable expectation of success as GU teaches microneedle arrays including exosomes, and produce the instantly claimed invention because the microneedle array would have been effective and less invasive than other techniques, and not require external power as with the iontophoresis device of YI or a standard skin injection.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because microneedle facial masks and microneedle-exosome compositions were known in the art and their combination would have require no more then an ordinary level of skill in the art. Therefore, the invention as a whole would have been 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, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over AHMED in view of YI; GU and MENG as applied to claims 1-2, 4, 6-8 and 10 above, and further in view of ROLANDI (US 2014/0194379 A1; published July, 2014).
Applicants Claims
Applicant claims a facial mask, comprising: a polymeric matrix having a plurality of protrusions configured for penetrating into stratum corneum of facial skin, and a plurality of exosomes distributed within said polymeric matrix, wherein said polymeric matrix is degradable when embedded within the skin so as to release said exosomes into the skin (instant claim 1). Applicant further claims the facial mask wherein said protrusions have a height in a range of about 200 nm to about 800 nm (instant claim 3).
Determination of the scope
and content of the prior art (MPEP 2141.01)
AHMED teaches microneedle patches for transdermal delivery, as discussed above and incorporated herein by reference.
YI teaches an exosome kit for enhancing transdermal permeation of exosomes, comprising an iontophoresis device, a mask pack and a mask sheet or patch on which a composition containing exosomes as an active ingredient is coated or deposited, as discussed above and incorporated herein by reference.
GU teaches compositions comprising polymeric networks comprising combinations of small molecule hair growth agents and natural products (e.g,, vesicles, such as stem cell-derived exosomes), and microneedle arrays, and skin patches comprising the compositions, as discussed above and incorporated herein by reference.
MENG teaches cosmetic and facial regeneration compositions derived from potentiated adipose derived cells and supernatants thereof, including exosomes and platelet rich plasma, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of AHMED et al. is that AHMED et al. do not expressly teach said protrusions have a height in a range of about 200 nm to about 800 nm.
ROLANDI teaches “Methods for the production chitin nanofibers and uses
thereof. Furthermore, methods for the production of chitin nanofibers and the fabrication of chitin nanofiber structures and devices.” (abstract, see whole document). ROLANDI teaches that: “In certain embodiments, the chitin nanofiber microneedle array may comprise individual microneedles that have heights of approximately 40 nm up to approximately 3 mm.” ([0048]). MPEP §2144.05(I) – “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
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 produce a facial mask including a microneedle array including a cosmetic and/or pharmaceutical active ingredient for delivery through the skin, as discussed above, and further to include microneedles in a range suggested by ROLANDI (“heights of approximately 40 nm up to approximately 3 mm”).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because microneedle facial masks and microneedle-exosome compositions were known in the art and their combination would have require no more then an ordinary level of skill in the art. Therefore, the invention as a whole would have been 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, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over AHMED in view of YI; GU and MENG as applied to claims 1-2, 4, 6-8 and 10 above, and further in view of LIM (US 2010/0112058 A1; published May, 2010).
Applicants Claims
Applicant claims a facial mask, comprising: a polymeric matrix having a plurality of protrusions configured for penetrating into stratum corneum of facial skin, and a plurality of exosomes distributed within said polymeric matrix, wherein said polymeric matrix is degradable when embedded within the skin so as to release said exosomes into the skin (instant claim 1). Applicant further claims the facial mask has a thickness of about 0.5 mm to about 2 mm (instant claim 5).
Determination of the scope
and content of the prior art (MPEP 2141.01)
AHMED teaches microneedle patches for transdermal delivery, as discussed above and incorporated herein by reference.
YI teaches an exosome kit for enhancing transdermal permeation of exosomes, comprising an iontophoresis device, a mask pack and a mask sheet or patch on which a composition containing exosomes as an active ingredient is coated or deposited, as discussed above and incorporated herein by reference.
GU teaches compositions comprising polymeric networks comprising combinations of small molecule hair growth agents and natural products (e.g,, vesicles, such as stem cell-derived exosomes), and microneedle arrays, and skin patches comprising the compositions, as discussed above and incorporated herein by reference.
MENG teaches cosmetic and facial regeneration compositions derived from potentiated adipose derived cells and supernatants thereof, including exosomes and platelet rich plasma, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of AHMED et al. is that AHMED et al. do not expressly teach the facial mask has a thickness.
LIM teaches a hydrogel mask pack having good skin-care effects (title, abstract, see whole document). LIM teaches that: “Generally, a mask pack for skin care has been formed using a nonwoven fabric in which an extract having skin-care effects, water or cosmetic water is included.” ([0002]). LIM teaches that: “In some example embodiments, the hydrogel mask pack may adjust a thickness according to a material and concentration of the material used for forming the hydrogel mask pack. The hydrogel mask pack may preferably have about 0.1 mm to about 3 mm of the thickness, and more preferably have about 0.3 mm to about 0.7 mm of the thickness.” ([0058])(instant claim 5).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
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 produce a facial mask including a microneedle array including a cosmetic and/or pharmaceutical active ingredient for delivery through the skin, as discussed above, and further to produce a facial mask with a known thickness such as 0.1 to 3 mm, as taught by LIM.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because microneedle facial masks and microneedle-exosome compositions were known in the art and their combination would have require no more then an ordinary level of skill in the art. Therefore, the invention as a whole would have been 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, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over AHMED in view of YI; GU and MENG as applied to claims 1-2, 4, 6-8 and 10 above, and further in view of GEANEY (US 4,004,584; published Jan, 1977).
Applicants Claims
Applicant claims a facial mask, comprising: a polymeric matrix having a plurality of protrusions configured for penetrating into stratum corneum of facial skin, and a plurality of exosomes distributed within said polymeric matrix, wherein said polymeric matrix is degradable when embedded within the skin so as to release said exosomes into the skin (instant claim 1). Applicant further claims the facial mask further comprising an adhesive border for securing the mask to a subject’s face (instant claim 9).
Determination of the scope
and content of the prior art (MPEP 2141.01)
AHMED teaches microneedle patches for transdermal delivery, as discussed above and incorporated herein by reference.
YI teaches an exosome kit for enhancing transdermal permeation of exosomes, comprising an iontophoresis device, a mask pack and a mask sheet or patch on which a composition containing exosomes as an active ingredient is coated or deposited, as discussed above and incorporated herein by reference.
GU teaches compositions comprising polymeric networks comprising combinations of small molecule hair growth agents and natural products (e.g,, vesicles, such as stem cell-derived exosomes), and microneedle arrays, and skin patches comprising the compositions, as discussed above and incorporated herein by reference.
MENG teaches cosmetic and facial regeneration compositions derived from potentiated adipose derived cells and supernatants thereof, including exosomes and platelet rich plasma, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of AHMED et al. is that AHMED et al. do not expressly teach an adhesive border for securing the mask to a subject’s face.
GEANEY teaches a facially-worn breathing filter, and specifically a facial mask, “the mask portion comprising a principal portion of flexible material impervious to the passage of air therethrough and having a window portion of a filter layer and one or more support layers secured therein. The borders of the mask portion have an inner layer of adhesive material for attaching the mask portion to the upper lip, jaws and throat of the wearer and the window portion is adapted to be worn over or adjacent to the mouth of the wearer.” [emphasis added](title, abstract, see whole document).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
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 produce a facial mask including a microneedle array including a cosmetic and/or pharmaceutical active ingredient for delivery through the skin, as discussed above, and further to include an adhesive border to secure the mask to the users face as suggested by GEANEY.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because microneedle facial masks and microneedle-exosome compositions were known in the art and their combination would have require no more then an ordinary level of skill in the art. Therefore, the invention as a whole would have been 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, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-10 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-10 of copending Application No. 18/776,599 (hereafter ‘599). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Copending ‘599 claim 1 a facial mask, comprising a polymeric matrix having a plurality of protrusions configured for penetrating into stratum corneum of facial skin, and a plurality of exosomes distributed within said polymeric matrix, wherein said polymeric matrix is degradable when embedded within the skin so as to release said exosomes into the skin. Claims 2- 20 are also identical to instant claims 2-10.
Conclusion
Claims 1-10 are pending and have been examined on the merits. The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter (instant claim 3). Claims 2-10 are objected to; claim 3 is rejected under 35 U.S.C. 112(a)(Written Description); claims 6 is rejected under 35 U.S.C. 112(b); claim 6 is rejected under 35 U.S.C. 112(d); claims 1-10 are rejected under 35 U.S.C. 103; and claims 1-10 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-10 of copending Application No. 18/776,599 (Statutory Obvious Double Patenting). No claims allowed at this time.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
1 Microneedle patches.
2 The stratum corneum has thickness is only 10–20 µm below which is the epidermal layer.