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 .
Application Status
The action is written in response to applicant’s correspondence received on 3/11/2026. Claims 1-19 and 35 are currently pending in the instant application.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. KR10-2021-00255554, filed on 2/25/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restriction
Applicant’s election of the inventions of Group III, drawn to a composition comprising miR-3199, is acknowledged.
Claims 2-3, and 5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable or generic linking claim. Election was made without traverse in the reply filed on 3/11/2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 1, 4, 6-19, and 35 are currently under examination.
Drawings
The drawings are objected to because Figs. 1-12 of the instant application lack eligible features due to pixelation, for example, the Y- and X-axis of Fig. 1 cannot be determined. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Though some elements of the colored photographs are more eligible, color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Currently, FIGS. 10a and 10e contain sequences that do not have an associated SEQ ID NO in either the drawings or in the brief description of the drawings in the instant specification.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
For the instant application, applicant uses improper section headings such as ‘BACKGROUND ART’ instead of ‘BACKGROUND OF THE INVENTION’ or ‘DESCRIPTION’ instead of ‘BRIEF SUMMARY OF THE INVENTION’.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Hyperlinks can be found in paragraph 0220 and paragraph 0291.
The use of the term GreenStarTM, which is a trade name or a mark used in commerce, has been noted in this application. 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 Rejections - 35 USC § 112
Scope of Enablement
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.
Claims 1, 4, 6-19, and 35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an in-vitro method of changing the color of a gray hair follicle to brown color by administering miRNA 3199 to the gray hair follicle in cell culture, , does not reasonably provide enablement for alleviating hair graying, promoting hair growth, and/or preventing or alleviating hair loss in a subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
It is noted that the instant claims are drawn to a composition, but they recite an intended use. The enablement rejection is set forth to address the intended use of the composition.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the specification coupled with information known in the art without undue experimentation (United States vs Telectronics., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is needed is not based upon a single factor but rather is a conclusion reached by weighing many factors. These factors were outlined in Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and again in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988), and the most relevant Wands factors are indicated below:
As stated in MPEP §2164.01(a), “there are many factors to consider when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any experimentation is ‘undue’.” These factors include, but are not limited to:
The nature of the invention;
The breadth of the claims;
The state of the prior art;
The level of skill in the art;
The level of predictability in the art;
The amount of direction provided by the inventor;
The presence or absence of working examples;
The quantity of experimentation necessarily needed to make or use the invention based on the disclosure.
See In re Wands USPQ 2d 1400 (CAFC 1988).
Further MPEP §2164.01(c) recites, “When a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation. See In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (claiming a chimeric gene capable of being expressed in any cyanobacterium and thus defining the claimed gene by its use).”
Nature of the Invention
Claim 1 recites a composition for alleviating hair graying, promoting hair growth, and/or preventing or alleviating hair loss, comprising miR-3199 as an active ingredient. Since claim 1 recites “alleviating, promoting, or preventing”, the composition is directed towards administration and observing a therapeutic effect, wherein this affect is preventing or alleviating the loss of hair, or promoting hair growth, or preventing hair graying.
Breadth of the Claims
Regarding claim 1, the composition for observing a therapeutic effect is defined as having miR-3139, miR-3189, miR-3199, or miR-8485 as an active ingredient or a double-stranded oligonucleotide construct with a R, wherein R represents one of the miRs, or nanoparticles comprising the double-stranded oligonucleotide construct. Though a subject is not recited, the claim does recite a therapeutic effect. Therefore, the broadest interpretation is that the composition can be administered to both in vitro and in vivo models to observe an effect. Looking to the specification for guidance, paragraph 0045 and 0199 does recite a subject, but does not define what a subject is. The working examples used are in vitro cell lines and the instant application does recite the use of human miRNAs, therefore, a possible candidate for a subject would be a human.
State of the Prior Art
At the time of filing, the state of the prior art shows androgenetic alopecia is a common, genetic, hair loss disorder affecting up to 80% of males by age 80. In a review article by York et al. (A review treatment of male pattern hair loss, Expert Opinion on Pharmacotherapy, Volume 21, Issue 5, pgs. 603-612, published 2020), York describes that the currently available medical treatments like finasteride and minoxidil are effective in arresting the progression of the disease, however, they allow only partial regrowth at its best (see section titled ‘Expert opinion’).
York does not disclose miRNAs as a treatment for androgenetic alopecia, however, Paul et al. (Current insight into the functions of microRNAs in common human hair loss disorders: a mini review, Human Cell, Volume 34, pgs. 1040-1050, published 2021) discloses miRNAs for use of treating human hair loss. Paul discloses that though increased knowledge of the miRNA-controlled regulatory networks will play a crucial role in better comprehension of the development of the disease (androgenetic alopecia), this tool is still novel in its infancy, so in-depth research of its mechanism and functional significance within the disease is still required for clinical management. Paul does disclose miRNA regulation of targeted genes of interest in human dermal papilla cells and mice models, Paul does not provide evidence of miRNAs being administered to a subject in vivo, potentially a human subject, where the loss of hair is prevented and/or alleviated.
Furthermore, Nemeth et al. (Non-coding RNAs in disease: from mechanisms to therapeutics, Nature Reviews Genetics, Volume 25, pgs. 211-232, published 11/15/2023) discloses that though ncRNAs have demonstrated therapeutic potential in vitro and in vivo, their limited bioavailability in vivo presents a major challenge to their clinical translation. To overcome the problems of a short half-life, off-target effects, and low transfect efficiency, advanced drug delivery strategies are urgently required (see section ‘Challenges of non-coding RNA therapeutics). Nemeth concludes that understanding the full range of ncRNA functions in human disease still necessitates extensive investigation and clarification (see conclusions and outlook).
The Amount of Direction Provided by the Inventor and Working Examples
Looking to the instant specification for guidance, applicant provides a list of human miRNAs tested in the present invention (see paragraph 0230). For working examples, cell culture containing human melanoma M21 and SK-MEL-28 cells were used (see paragraph 0232 and 0242) and transfected with miRNAs and followed by a screening of melanin production. Furthermore, 4 miRNAs were tested on plucked human gray hair to evaluate melanogenic function. The cut hair were cultured from the hair root and the results showed that the miRNA treated hair follicles showed that the grey hair exhibited a widening of the out root sheath of hair follicles as well as increased length and change of color (see paragraph 0265 and 0266). However, all working examples presented by the applicant were in vitro experiments done in multiple cell lines or hair follicles and the applicant does not provide experiments with an in vivo subject or animal model.
The Quantity of Undue Experimentation
In light of the limited amount of research into miRNA treatments for androgenetic alopecia in a subject, the quantity of experimentation necessarily needed to make or use the invention as claimed, with regards to claims 1, 4, 6-19, and 35, is considerably high.
One skilled in the art would have to conduct extensive experiments which include in vivo animal models, potentially human models, and record a measurable amount of significant improvement in hair growth, or the prevention of hair loss altogether.
Conclusion of 35 U.S.C. 112(a) Enablement Analysis
After applying the Wands factors ana analysis to claims 1, 4, 6-19, and 35, taking into consideration the factors outlined above, it is concluded that the specification is not fully enabled as discussed above. Under the broadest interpretation of claim 1 and the functional language of a therapeutic effect, there is no evidence that the composition presented have been applied to a subject in vivo, wherein there is an observable change in hair color, growth, or prevention of hair loss. Therefore, claims 1, 4, 6-19, and 35 are rejected under 35 U.S.C. 112(a) for failing to disclose sufficient information to enable a person of skill in the art to use the invention commensurate in scope with these claims.
Indefiniteness
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 7, 11, and 35 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.
Regarding claims 7 and 11, applicant does not disclose in the claims, or the instant specification, the units associated with molecular weight. It is unclear what the units of the molecular weights recited in the instant claims refers to.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 35 recites the broad recitation (hair lotion, hair cream, hair pack, etc.), and the claim also recites (hair nutrition cream, hair moisture cream, hair nutrition pack) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Improper Markush Groups
Claim 1 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of a ‘composition with an active ingredient’ is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The groupings do not share a single structural similarity.
Regarding claim 1, applicant claims a composition comprising an active ingredient where the active ingredient is a miRNA, selected from miR-3139, miR-3189, miR-3199, or miR-8485. Between these four different miRNAs, they do not share a single structural similarity as they are encoded by different nucleotides and do not share a core structure.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 and 4 are rejected under 35 U.S.C. 101 as being drawn to a product of nature. The claimed invention is directed to microRNAs, specifically miR-3199, without significantly more. The claims recites a composition for a therapeutic effect on hair growth or loss, wherein miR-3199, is an active ingredient and the composition can comprise of only miR-3199, as indicated by the use of “or” in claim 1. This judicial exception is not integrated into a practical application because it is drawn to a naturally occurring product. The claims do not include additional elements to amount to significantly more than the judicial exception because though claim 1 recite a non-naturally occurring double-stranded oligonucleotide construct, the use of said construct is optional given the use of ‘or’ in the claim language. Therefore, a standalone, naturally occurring miRNA-3199 would suffice as meeting the limitations of the claim, as written. Claim 4 provides SEQ ID NOs: 15 and 16, are fragments with 100% identity to the naturally occurring Homo sapiens mRNA 3199-1. Fragments of naturally occurring RNA are considered product of nature. Please see MPEP § 2106.04(b). Alignment of SEQ ID NO: 15 and 16 with the human miR 3199-1 are shown below.
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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.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoge et al. (WO 2014/113089 A2, published 7/24/2014).
Regarding claims 1 and 4, Hoge teaches an isolated signal-sensory polynucleotide comprising a region encoding an oncology-related polypeptide of interest that functions, when translated to send a death or survival signal. Such death or survival signals include those which alter (increase or decrease) the expression of one or more proteins, nucleic acids, or non-coding nucleic acids, or alter the binding properties of biomolecules within the cell, and/or perturb the cellular microenvironment in a therapeutically beneficial way (see paragraph 0011). Hoge teaches miRs and their binding sites in Table 9, wherein the section below Table 9 discloses miR-3199. Hoge further teaches SEQ ID NO: 3105 which has 100% identity and length to SEQ ID NO: 15 and SEQ ID NO: 4126 which has 100% identity and length to SEQ ID NO: 16.
Though Hoge does not describe the use of a composition with miR-3199 to alleviate hair graying, promoting hair growth, or preventing and/or alleviating hair loss, the preamble of the claim cannot introduce structural limitations not present in the body of the claim unless explicitly stated. As the claim limitations in the body of the claim does not introduce the intended use of the composition in the preamble, the preamble does not carry any patentable weight regarding claim 1, see MPEP § 2111.02.
Furthermore, Hoge teaches the structure of miR-3199 as the SEQ ID NOs: 15 and 16 of claim 4 are disclosed to 100% identity in Hoge. In the event a structure is recited in the reference is substantially identical to that of the claims, the claimed properties or functions are presumed to be inherent, see MPEP § 2112.01. Though Hoge does not teach the use of miR-3199 to treat hair loss, since the structure is disclosed to 100% identity, the use of miR-3199 to treat hair loss is presumed to be an inherent function of the structure.
In view of the foregoing, claims 1 and 4 are anticipated by Hoge.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6-19 are rejected under 35 U.S.C. 103 as being unpatentable over Hoge et al. (WO 2014/113089 A2, published 7/24/2014) in view of Shim et al. (EP 3,505,630 A1, published 7/3/2019) and Zhang et al. (Use of small RNA as antiaging cosmeceuticals, J. Cosmet. Sci, Issue 64, pgs. 455-468, published 2013).
Regarding claims 6-19, Hoge teaches the composition of claim 1, wherein the composition comprises of miR-3199, as described above.
Hoge does not teach wherein the composition of claim 1 contains a hydrophilic and hydrophobic materials or a structure disclosed as formula (1).
Regarding claim 1, Shim teaches wherein the double-stranded oligo RNA structure comprising at least one miRNA is represented by formula (1): A-X-R-Y-B (see paragraph 0016).
Regarding claims 6, Shim teaches where the hydrophilic material is represented by (A)n, (Am-J)n, or (J-Am)n, in which A represents a hydrophilic material monomer, n represents 1 to 200, m represents 1 to 15, and J represents a linker that links m hydrophilic material monomers to another, or links m hydrophilic material monomers to oligonucleotides (see paragraph 0051).
Regarding claim 7, Shim teaches wherein the hydrophilic material may be a cationic or non-ionic polymer material having a molecular weight of 200 to 10,000 (see paragraph 0055).
Regarding claim 8, Shim teaches where RNA oligos are simply bonded to a hydrophilic substance polyethylene glycol (PEG) as a biocompatible polymer (see paragraph 0013).
Regarding claim 9, Shim teaches where the preferred hydrophilic material monomer structure is compound (1), where G is selected from CH2, O, S, or NH) (see paragraph 0059 and Table 1).
Regarding claim 10, Shim teaches where the linker (J) is preferably selected from the group consisting of PO3-, SO3, and CO2 (see paragraph 0061).
Regarding claim 11, Shim teaches where the hydrophobic material (B) has a molecular weight of 250 to 1,000 (see paragraph 0065).
Regarding claim 12, Shim teaches where the hydrophobic material may be a steroid derivative, a glyceride derivative, glycerol ether, polypropylene glycol, C12-C50 unsaturated or saturated hydrocarbon, etc. (see paragraph 0066).
Regarding claim 13, Shim teaches where the sterol derivative is selected from the group consisting of cholesterol, cholestanol, cholic acid, cholestanyl formate, and cholesteryl amine (see paragraph 0067).
Regarding claim 14, Shim teaches where the glyceride derivative is selected from mono-, di-, and tri-glycerides and the like (see paragraph 0067).
Regarding claim 15, Shim teaches where the covalent bond or linker-mediated covalent bond (X or Y) may be non-degradable or degradable bond (see paragraph 0070).
Regarding claim 16, Shim teaches where the non-degradable bond can include an amide or a phosphoryl bond (see paragraph 0070).
Regarding claim 17, Shim teaches where the degradable bond includes a disulfide bond, an acid-degradable bond, an ester bond, an anhydride bond, a biodegradable bond, or an enzyme-degradable bond (see paragraph 0070).
Regarding claim 18, Shim teaches where the composition of treating cancer comprising the miRNA as an active ingredient may be a pharmaceutical composition (see paragraph 0080).
Regarding claim 19, Hong and Shim does not teach where the composition of claim 1 and the composition of claim 19 is a cosmetic composition.
However, regarding claim 19, the composition of claim 1 is fully taught by the combined arts of Hoge and Shim. Therefore, a “cosmetic” composition is an inherent property that flows from the structure of the composition of claim 1, absent objective evidence to the contrary. Furthermore, in the instant claim, there is no additional structural element recited for a “cosmetic” composition. All the limitations of claim 19 are met by the combined arts because the patentability of a product or composition claim is determined by the structure being claimed, not the intended use or purpose.
It would have been obvious to one with ordinary skills in the art, before the effective filing date of the claimed invention, to have combined the teachings of Hoge and Shim to arrive at a composition comprising of miR-3199 with a structure of formula (1) A-X-R-Y-B, comprising of hydrophilic and hydrophobic materials, linkers, and bonds.
One would expect a reasonable chance of success as Shim shows the structure of formula (1) can be used to effective delivery miRNA into cells to observe an effect. For a working example, Shim discloses tumor cells administered with certain miRNAs resulted in almost no cluster formation (see paragraph 0090).
One would be motivated to do so as Hoge and Shim both disclose miRNA can be used to send signals to cells in order to alter the expression of one or more proteins, nucleic acid, or non-coding nucleic acids (see Hoge, Summary of the Invention). Shim discloses that the unique features of miRNA, such as the ability for miRNA to be produced in many ways, miRNAs can be configured to the bind to the coding region or the 5’- and 3’-UTR of a coding region (primarily binding to the 3’-UTR) whereas siRNAs cause degradation of target mRNAs regardless of 5’-UTR, 3’-UTR and coding parts, and since miRNAs target using seed region sequences with limited size, the entire miRNA does not have to be perfectly complementary to the target gene. MiRNAs can simultaneously control several types of mRNA with one miRNA. This is useful where miRNAs simultaneously inhibit the expression of many cancer-inducing genes (see paragraph 0008 of Shim).
Furthermore, Shim discloses where there needs to be an effective method for transferring miRNAs without the degradation of miRNAs in the living body (see paragraph 0012). To improve intracellular deliver efficiency of RNA oligos, techniques for securing the stability of oligos and securing efficient cell membrane permeability through oligo conjugates wherein the RNA oligos are simply bonded to a hydrophilic substance with a covalent bond or linker-mediated covalent bond have been developed. To further solve the drawbacks of low in vivo stability and non-favorable delivery to target organs, double-stranded oligo RNA structures which hydrophilic and hydrophobic substances are bonded to double-stranded oligo RNAs are disclosed (see paragraph 0012 and 0013).
Though Hoge and Shim do not mention treating hair loss or promoting hair growth with miRNA, it is well known in the art that hair loss, or androgenetic alopecia, is hereditary and caused by genetic factors (see review articles recited in the 112(a) scope of enablement rejections above). Applicant is reminded that the preamble carries patentable weight only when necessary to define essential features of the invention, and not intended use (see MPEP § 2111.02), and since the entire structural limitations of the invention are disclosed in Hoge and Shim, miR-3199 can alter the genes associated with hair loss as it is an inherent function of the taught structure. One would be motivated to modify miR-3199 disclosed in Hoge with the composition taught by Shim, to alter the expression of various genes associated with hair loss as a treatment and to effectively deliver the miRNA in a composition that offers higher in vivo stability and favorable delivery to target organs.
In view of the foregoing, claims 6-19 are rejected under 35 U.S.C. 103 as being prima facie obvious, before the effective filing date.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID YU whose telephone number is (571)272-1118. The examiner can normally be reached Monday-Friday 7:30 am -5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ram Shukla can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.T.Y./Examiner, Art Unit 1635
/RAM R SHUKLA/Supervisory Patent Examiner, Art Unit 1635
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