DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 4, 6-9, 11-12 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 4 recites the limitation "the average size…" in line 1. There is insufficient antecedent basis for this limitation in the claim.
As for claims 6-8, the independent claim 1 recites that: Microneedles comprising: … The claim 1 is a device or structure claim; wherein claim 6 (depends on claims 1 & 5) requires the solvent evaporation method steps: i) preparing an oil phase by dissolving a drug and a surfactant-acting biodegradable polymer in an organic solvent; ii) forming an O/W emulsion by mixing the oil phase with a water phase in which a water-soluble polymer is dissolved; and iii) obtaining surface-modified microspheres by evaporating the solvent from the O/W emulsion. Claims 8 requires the mixing in step…
It is noted that the method limitations, i.e., preparing an oil phase…, forming an O/W emulsion…; evaporating the solvent… ; mixing in step… are in the device claims and these method limitations are considered as product-by-process. However, it is unclear to Examiner that which is/are limitations being considered as structure in the device claim. Applicant should provide a method steps in different form of the independent method claim. However, in that case, the restriction/Election will be conducted in future.
Claim 7 is also rejected due to its dependency.
Claim 9 recites the limitation "the soluble material… the group…" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the shape of the needle part …" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the length of the needle part …" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2. 4, 9, 11-12 & 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (US 2016/0129164).
Regarding claim 1, Lee discloses microneedles 20 comprising: a surface-modified microspheres 20P1/20P2 (e.g., a microsphere with a surface in which grooves such as a dimple structure, for example: porous microparticles are formed about 0.1-100 µm, para [0014] & Figs. 2-5B) containing a drug (i.e., pharmaceutical medical includes proteins, peptides, genes, antibodies, insulin…, paras [0015, 0050]),
wherein the surface-modified microspheres 20P1/20P2 are biodegradable (e.g., the biocompatible substance is a substance bio-degraded or dissolved in a living tissue when the biocompatible substance penetrates through a skin, para [0037]) and have a surface on which grooves such as a dimple structure or wrinkles are formed, see Figs. 2-5B), and the microneedles are soluble in the skin, para [0037]) and have improved residence time in the body.
With aspect to the limitation, i.e., improved residence time, it is a result of having drug and soluble of the microneedles in the skin. Therefore, the limitation, i.e., improved residence time is considered a functional limitation and only requires performing function. In this case, the surface-modified microspheres 20P1/20P2 are biodegradable and being bio-degraded in a living tissue when the biocompatible substance penetrates through a skin. Therefore, the microneedles have improved residence time in the body, e.g., stimulating generation of collagen and wrinkles quickly removed, also see para [0046, 0051].
Regarding claim 2, wherein the drug is one or more selected from a chemical such as an organic compound or inorganic compound, a peptide, a protein, an antibody, a nucleic acid, a cell, a gene, a vaccine, and a mixture thereof, paras [0015, 0050].
Regarding claim 4, wherein the average size of the microspheres is 50 µm or less (e.g., porous microparticles are formed about 0.1-100 µm, para [0014]).
Regarding claim 9, wherein the soluble material for forming microneedles is any one selected from the group consisting of alginic acid, chitosan, collagen, gelatin, hyaluronic acid, chondroitin (sulphate), dextran (sulphate), fibrin, agarose, pullulan, cellulose, polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polyvinyl alcohol (PVA), a vinylpyrrolidone-vinylacetate copolymer, hydroxypropyl cellulose, hydroxyethylcellu lose, hydroxypropylethylcellu lose, sodium carboxymethylcellulose, a polyalcohol, cyclodextrin, dextrin, trehalose, glucose, fructose, starch, sucrose, maltose, lactose, lactulose, fructose, turanose, melitose, melezitose, dextran, sorbitol, mannitol, and xylitol; derivatives thereof; and mixtures thereof, see paras [0012-0013, 0039, 0048].
Regarding claim 11, wherein a shape of the needle part of the microneedles has any one of a conical, pyramidal, spear-shaped, truncated, wedge-shaped, or blade-shaped, see Figs. 1A-B & 6A-7.
Regarding claim 12, wherein the length of the needle part of the microneedles is 500 to 1,000 µm, (i.e., 50 μm to about 1,500 μm, and diameter of the base unit 20D of the biocompatible matrix 20N may be from about 10 μm to about 1,000 μm, para [0035]).
Regarding claim 16, Lee discloses a transdermal microneedle patch 100A/100B (in Figs. 1-7) comprising the microneedles 20 comprising surface-modified microspheres 20P1/20P2 containing a drug according to claim 1, please see the rejection in claim 1 for more details.
Claims 1-3, 9, 11-12 & 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takada (US 2011/0046575)
Regarding claim 1, Takada discloses microneedles 1/61/71 in Figs. 1-5 comprising: a surface-modified microspheres containing a drug (active substance); Note: a surface 63/73 in which grooves 66/76a such as a dimple structure, a person skilled in the art would recognize that the grooves 66/76a can be formed in different shapes such as hollow sphere-shaped that considered as design choice purpose. In addition, Takada discloses that the microneedles are formed in porous material, see abstract, paras [0019, 0021];
Wherein the surface-modifed microspheres as biodegradable (absorbable into the skin of a patient, see abstract) and have a surface on which grooves 63/73 (or a porous material, see abstract, paras [0019, 0021], as mentioned in the Note above; and
The microneedles are soluble in the skin and have improved residence time in the body.
With aspect to the limitation, i.e., improved residence time, it is a result of having drug and soluble of the microneedles in the skin. Therefore, the limitation, i.e., improved residence time is considered a functional limitation and only requires performing function. In this case, the surface-modified microspheres are biodegradable and being bio-degraded in a living tissue when the biocompatible substance penetrates through a skin. Therefore, the microneedles have improved residence time in the body.
Regarding claim 2, wherein the drug is one or more selected from a chemical such as an organic compound or inorganic compound, a peptide, a protein, an antibody, a nucleic acid, a cell, a gene, a vaccine, and a mixture thereof, see abstract, paras [0009, 0129] .
Regarding claim 3, wherein the drug is insoluble in water (e.g., water-insoluble layer on a surface of the needle), see abstract.
Regarding claim 9, Takada discloses that wherein the soluble material for forming microneedles is any one selected from the group consisting of alginic acid, chitosan, collagen, gelatin, hyaluronic acid, chondroitin (sulphate), dextran (sulphate), fibrin, agarose, pullulan, cellulose, polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polyvinyl alcohol (PVA), a vinylpyrrolidone-vinylacetate copolymer, hydroxypropyl cellulose, hydroxyethylcellu lose, hydroxypropylethylcellu lose, sodium carboxymethylcellulose, a polyalcohol, cyclodextrin, dextrin, trehalose, glucose, fructose, starch, sucrose, maltose, lactose, lactulose, fructose, turanose, melitose, melezitose, dextran, sorbitol, mannitol, and xylitol; derivatives thereof; and mixtures thereof, see abstract, paras [0012-0014].
Regarding claim 11, wherein the shape of the needle part of the microneedles has any one of a conical, pyramidal, spear-shaped, truncated, wedge-shaped, or blade-shaped, see Figs. 1A-4C
Regarding claim 12, wherein the length of the needle part of the microneedles is 500 to 1,500 µm (which is in the claimed range of 500-1000 µm), see para [0109].
Regarding claim 16, Takada discloses a transdermal microneedle patch 100 (in Fig. 10) comprising the microneedles (in Figs. 1A-5) comprising surface-modified microspheres containing a drug according to claim 1, please see the rejection in claim 1 in Takada for more details.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 3 & 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2016/0129164).
Regarding claims 3 & 10, Lee discloses all claimed subject matter as required in the claims 1-2. Lee also discloses that the drug is fillers, para [0046], or proteins, peptides, insulin, or other various effective substances that area allowed to be used for pharmaceutical, medical, or cosmetic purposes, para [0050]. It is well-known in the art that some of the protein, peptides, insulin or cosmetic drug (such as tretinoin) are insoluble in water. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain the drug that being insoluble in water, or obtain a mixture of alginic acid and trehalose for forming microneedles, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 3 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2016/0129164) in view of Takada (US 2011/0046575).
Regarding claim 3, Lee discloses all claimed subject matter as required in the claims 1-2. Lee also discloses that the drug is fillers, para [0046], or proteins, peptides, insulin, or other various effective substances that area allowed to be used for pharmaceutical, medical, or cosmetic purposes, para [0050]. It is well-known in the art that some of the protein, peptides, insulin or cosmetic drug (such as tretinoin) are insoluble in water. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain the drug that being insoluble in water, or obtain a mixture of alginic acid and trehalose for forming microneedles, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Alternatively, Takada discloses a microneedle containing a drug; wherein the drug is insoluble in water (e.g., water-insoluble layer on microneedle surface, see abstract).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Lee with using the drug containing insoluble in water, as taught by Takada, in order to release the drug in a long period of time.
Claims 4-8 & 10 are rejected under 35 U.S.C. 103 as being unpatentable over Takada (US 2011/0046575).
Regarding claim 4, Takada discloses all the claimed subject matter as required. Takada discloses that a diameter D of a circle base part 2 (in Fig. 1A) is in a range of about 0.1-500µm, see para [0109]. Meanwhile, the groove 66/76a-b is less than a circle base part 2. Therefore, a person skilled in the art would recognize that the groove 66/76a-b would be less than 50 µm (Takada mentions that the circle base 2 is about 0.1-500 µm)
Regarding claim 5, It is noted that the product-by-process limitation, i.e., the microspheres are “prepared by any one method of solvent evaporation method, spray drying method, and sonication method” has not been given weight in determining the patentability of the device claim. See MEPE §2113.
Regarding claim 6, It is noted that the product-by-process limitations “wherein the solvent evaporation method comprises:
i) preparing an oil phase by dissolving a drug and a surfactant-acting biodegradable polymer in an organic solvent;
ii) forming an O/W emulsion by mixing the oil phase with a water phase in which a water-soluble polymer is dissolved; and
iii) obtaining surface-modified microspheres by evaporating the solvent from the O/W emulsion.” have not been given weight in determining the patentability of the device claim. See MEPE §2113.
Regarding claim 7, Takada discloses that wherein the surfactant-acting biodegradable polymer is any one of Tweens, poloxamers, poly(lactate-co-glycolate) (PLGA), poly(D,L-lactic acid) (PDLA), and a copolymer of poly(D,L-lactic acid- polycaprolactone, and the water-soluble polymer is any one of polyvinyl acetate (PVA), polyacrylic acid (PAA), polyvinylpyrrolidone (PVP), polyacrylamide (PAM), polyethylene oxide (PEO), polysorbate (Tween), and a poloxamer, see abstract, paras [0124-0126].
Regarding claim 8, It is noted that the product-by-process limitation, i.e., wherein the mixing in step ii) is performed at a speed of 5,000 to 12,000 rpm, and the evaporation in step iii) is performed under stirring at a speed of 800 to 1,000 rpm” has not been given weight in determining the patentability of the device claim. See MEPE §2113.
Regarding claim 10, Takada discloses that wherein the soluble material for forming microneedles is alginic acid, para [0028], however, Takada does not disclose that the mixture of alginic acid and trehalose.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain mixture of alginic acid and trehalose for forming microneedles, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 5-8 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lee et al. (US 2016/0129164).
Regarding claim 5, It is noted that the product-by-process limitation, i.e., the microspheres are “prepared by any one method of solvent evaporation method, spray drying method, and sonication method” has not been given weight in determining the patentability of the device claim. See MEPE §2113.
Regarding claim 6, It is noted that the product-by-process limitations “wherein the solvent evaporation method comprises:
i) preparing an oil phase by dissolving a drug and a surfactant-acting biodegradable polymer in an organic solvent;
ii) forming an O/W emulsion by mixing the oil phase with a water phase in which a water-soluble polymer is dissolved; and
iii) obtaining surface-modified microspheres by evaporating the solvent from the O/W emulsion.” have not been given weight in determining the patentability of the device claim. See MEPE §2113.
Regarding claim 7, wherein the surfactant-acting biodegradable polymer is any one of Tweens, poloxamers, poly(lactate-co-glycolate) (PLGA) (in para [0013, 0048]), poly(D,L-lactic acid) (PDLA), and a copolymer of poly(D,L-lactic acid- polycaprolactone, and the water-soluble polymer is any one of polyvinyl acetate (PVA), polyacrylic acid (PAA), polyvinylpyrrolidone (PVP), polyacrylamide (PAM), polyethylene oxide (PEO), polysorbate (Tween), and a poloxamer, see paras [0012-0013, 0039, 0048].
Regarding claim 8, It is noted that the product-by-process limitation, i.e., wherein the mixing in step ii) is performed at a speed of 5,000 to 12,000 rpm, and the evaporation in step iii) is performed under stirring at a speed of 800 to 1,000 rpm” has not been given weight in determining the patentability of the device claim. See MEPE §2113.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2016/0129164) in view of GAO (US 2021/0178138).
Regarding claims 17, Lee discloses all the claimed subject matter as required except for wherein the drug is tacrolimus.
GAO discloses a transdermal microneedle patch comprising: microneedles (it is well-known to provide a surface-modified microspheres, i.e., porous microneedle, paras [0007-008]) containing a drug; wherein the drug is tacrolimus, para [0089].
Since Lee and GAO are both from the same field of endeavor, the purpose disclosed by GAO would have been recognized in the pertinent art of Lee.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Lee with using the drug such as tacrolimus, as taught by GAO, in order to use for diagnosis, treatment prevention in eye diseases or cosmetic in health care purpose.
Regarding claim 18, it is well-known in the art that using tacrolimus for being treated of alleviation of atopic dermatitis or acne. Therefore, the limitation in claim 18 is considered as intended use purpose.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Takada (US 2011/0046575) in view of GAO (US 2021/0178138).
Regarding claims 17, Takada discloses all the claimed subject matter as required except for wherein the drug is tacrolimus.
GAO discloses a transdermal microneedle patch comprising: microneedles (it is well-known to provide a surface-modified microspheres, i.e., porous microneedle, paras [0007-008]) containing a drug; wherein the drug is tacrolimus, para [0089].
Since Takada and GAO are both from the same field of endeavor, the purpose disclosed by GAO would have been recognized in the pertinent art of Takada.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Takada with using the drug such as tacrolimus, as taught by GAO, in order to use for diagnosis, treatment prevention in eye diseases or cosmetic in health care purpose.
Regarding claim 18, it is well-known in the art that using tacrolimus for being treated of alleviation of atopic dermatitis or acne. Therefore, the limitation in claim 18 is considered as intended use purpose.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783