DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment and Request for Continued Examination (RCE) filed on 06/18/26 have been entered in the case. Claims 1-5, 7-9, 11, 13-18 are pending for examination; claims 6, 10 are cancelled.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 7-8, 13, 15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Takada (US 2011/0028905) in view of Mikszta et al. (US 2005/0008683) with evidence Oh (US 2010/0233093).
Regarding claim 1, Takada discloses a method of delivering one or more bioactive materials via transdermal insertion into a subject comprising:
inserting a dissolvable microneedle array 5a (Fig. 10) at a target skin area of the subject (e.g., a microneedle and a microneedle array formed from a self-dissolving base, see abstract).
The dissolvable microneedle array 5a comprising:
one or more bioactive materials 5 & 7a-7c, para [0098] & Fig. 7;
a base portion 58; and
a plurality of microneedles 23 (in Fig. 7) extending from the base portion 6, wherein the one or more bioactive materials 5 & 7a-7c are present in a higher concentration in the plurality of microneedles than in the base portion 6 such that the one or more bioactive materials are concentrated in the top half L2 (Fig. 7) of each of the plurality of microneedles.
Note: the base portion 6 does not contain drug, paras [0087, 0089]. Therefore, the one or more bioactive materials 5 & 7a-7c are present in a higher concentration in the plurality of microneedles than in the base portion 6.
wherein the base portion 6 and the plurality of microneedles comprise a plurality of layers 5 & 7a-7b of dissoluble biocompatible material, para [0103];
wherein the dissoluble biocompatible material defines a shape of the plurality of microneedles, the one or more bioactive materials are contained in the plurality of layers 5 & 7a-7c, and at least some of the plurality of layers that contain the one or more bioactive materials are spatially separated from others of the plurality of layers that contain the one or more bioactive materials, see Fig. 7;
wherein the one or more bioactive materials 5 & 7a-7c comprise one or more viral and a therapeutically effective amount of substance, i.e. drug agent(s),
wherein the one or more virals and the therapeutically effective amount of drug agent are delivered simultaneously.
Note: as seen in Fig. 3, a top-half of the microneedle (L length) is inserted into the skin 8; a person skilled in the art would recognize that the top half of the microneedle (L2 length in Fig. 7) contains
multiple layers 5 & 7a-7c with different drugs, i.e., viral, vaccine, drugs on the microneedles that being inserted into the skin of the patient at same time).
Takada does not specifically disclose that the viral is a viral vector(s) and doxorubicin.
Mikszta discloses a method for delivering one or more bioactive materials via transdermal insertion into a patient comprising: inserting a dissolvable microneedle array (i.e., biodegradable material, para [0084]) at a target skin area of a subject, paras [0025, 0079]; the microneedle array comprising: one or more bioactive materials comprise one or more viral vectors, (para [0136], bacteriophage DNA, baculovirus, a recombinant virus expression vector (e.g., cauliflower mosaic virus, CaMV; tobacco mosaic virus, TMV) or from mammalian viruses (e.g., the adenovirus late promoter; para [0139], ... an adenovirus is used as an expression vector) and therapeutic effective amount of doxorubicin, in para [0164], viral vaccines, para [0173].
In addition, the anti-cancer agents (including doxorubicin, in para [0164]), many compositions (bioactive agents, in para [0164]) are useful in the treatment of variety of cancers (listed in para [0161-0162]) including skin cancer or cutaneous tumor or tumor metastatic such as: basal cell carcinoma, squamous cell carcinoma, melanoma...; wherein the anti-cancer agents (the bioactive agents) that listed in para [0164] that including doxorubicin. It is further noticed that it is well-known in the art that doxorubicin agent is being treated of a cutaneous tumor or a tumor metastatic to the skin); wherein using the microneedle array for delivering the bioactive materials into a patient.
Furthermore, Mikszta discloses that more than one substance are be administered in combination with a therapeutically or prophylactically effective amount of one or additional therapeutic agents known to those skilled in the art for the treatment and/or prevention of other diseases, para [0117, 0177].
Conclusion: for all reasons and evidence above, Mikszta clearly teaches that the viral vectors and the effective amount of doxorubicin can be combined together for delivering into a patient for treating certain diseases.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify a method of Takada with providing a combination of viral vector and a therapeutically effective amount of doxorubicin, as taught by Mikszta, in order to treat various tumor/cancers such as breast cancer, skin cancer, squamous cell carcinoma, melanoma and also prevent the spreading of the cancers.
Evidence: Oh discloses a bioactive material, i.e. doxorubicin being treated a cutaneous tumor to the skin (i.e., squamous cell carcinoma, para [0061-0062]) or a tumor metastatic to the skin (i.e. breast cancer, malignant melanoma, para [0061-0062]). In other words, Oh is another evidence to confirm with Mikszta (as discussed above) that a therapeutically effective amount of doxorubicin is being used for treating cutaneous tumor to the skin or a tumor metastatic to the skin.
It is noted that Oh relies on the material, i.e. doxorubicin for treating skin cancer, but does not use or rely on using any device in Oh to modify Takada nor Mikszta’s device for delivering the doxorubicin.
Regarding claims 2-4, Takada in view of Mikszta discloses the invention substantially as claimed invention. Takada further discloses that the target substances, i.e., peptide and protein, para [0049]. It is well-known in the art that these peptides and protein for being treated to the patient has a cutaneous tumor or a tumor metastatic to skin. In addition, Mikszta discloses that the patient has cutaneous tumor is basal cell carcinoma, melanoma, para [0157], a tumor metastatic to skin, para [0314].
Regarding claim 5, Takada in view of Mikszta discloses the invention substantially as claimed invention. Takada discloses that wherein substantially all of the one or more bioactive materials 5 & 7a-7c are located in the plurality of microneedles so that the base portion 6 is substantially formed without any bioactive materials contained therein, paras [0087, 0089].
Regarding claim 7, Takada in view of Mikszta discloses the invention substantially as claimed invention. Takada further discloses that wherein the plurality of microneedles are pre-formed to have a shape that comprises a first cross-sectional dimension at a top portion 5, a second cross-sectional dimension at a bottom portion 6, and a third cross- sectional dimension at an intermediate portion 7, wherein the intermediate portion 7 is located between the top portion 5 and the bottom portion 6, and wherein the one or more bioactive materials 5 & 7a-7c are substantially concentrated in the area at or above the intermediate portion, see Fig. 7.
Regarding claim 8, Takada in view of Mikszta discloses the invention substantially as claimed invention. Takada further discloses that wherein the one or more bioactive materials 5 & 7a-7c are substantially concentrated in the area at or above the intermediate portion 5 & 7, see Fig. 7.
Regarding claim 13, Takada in view of Mikszta discloses the invention substantially as claimed invention. Mikszta discloses that the one or more viral vector comprises an adenovector (e.g., adenovirus is used as an expression vector, paras [0136 & 0139]).
Regarding claim 15, Takada in view of Mikszta discloses the invention substantially as claimed invention. Mikszta further discloses that the dosage of the formulation (including doxorubicin, in para [0164]) is at least 100 micrograms, para [0094].
Regarding claim 16, this claim is being rejected using same analysis as noted above with regard to claims 1-2.
Regarding claim 17, Takada in view of Mikszta discloses the invention substantially as claimed invention. Mikszta discloses that the formulations are delivered at a targeted depth just under the stratum corneum and encompassing the epidermis and upper dermis, para [0081]. In other words, Mikszta discloses a method of delivering one or more bioactive materials via transdermal insertion comprises penetrating a stratum corneum of the skin to deliver the materials to an epidermis and/or dermis of the skin to provide localized skin delivery of the therapeutically effective amount of doxorubicin to the subject without systemic exposure.
Claim 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Takada (US 2011/0028905) in view of Mikszta et al. (US 2005/0008683) and further in view of Falo, Jr. et al. (US 2011/0098651).
Regarding claim 9, Takada in view of Mikszta discloses the invention substantially as claimed invention. Takada further discloses that wherein each of the plurality of microneedles generally tapers to a point 2 above the intermediate portion but does not disclose that each microneedle generally tapers to a smaller cross-sectional dimension below the intermediate portion.
Falo discloses a microneedle array, Figs. 21-23 comprising: microneedles are pre-formed to have a shape that comprises a first cross-sectional dimension at a top portion, a second cross-sectional dimension at a bottom portion, and a third cross-sectional dimension at an intermediate portion, wherein the intermediate portion is located between the top portion and the bottom portion. Falo discloses that a greater amount of the bioactive material delivered by configured the microneedle to hold or store the bioactive material in the wider section. The larger cross-sectional dimension of the intermediate portion can carry the bulk of the bioactive component, para [0116]. Thus, the one or more bioactive material(s) is/are substantially concentrated in the area at or above the intermediate portion.
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It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify a shape of the microneedle device of Takada in view of Mikszta with a shape of the microneedle (including a first cross-sectional dimension at a top portion, a second cross-sectional dimension at a bottom portion, and a third cross-sectional dimension at an intermediate portion); one or more bioactive material being substantially concentrated in the area at or above the intermediate portion, as taught by Falo, in order to fully delivery amount of bioactive material within the skin. For example: if the microneedle being inserted in half length, it is waste medicine if the bioactive material being coated the entire length of the microneedle. It is known in the art that most if the method of inserting microneedle being inserted in half length (or above the intermediate portion). Therefore, the biomaterial being coated in or above the intermediate portion for avoid wasting the drug.
Claims 11, 14 & 16 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Takada (US 2011/0028905) in view of Mikszta et al. (US 2005/0008683) and further in view of Singh et al. (US 2008/0269685).
Regarding claims 11, 14 & 16, Takada in view of Mikszta discloses the invention substantially as claimed invention. Takada discloses that the dissoluble biocompatible material, as listed in paras [0104-0106], except for the limitation that the dissoluble biocompatible material is carboxymethylcellulose; the dissolvable microneedle array has a moisture content of 5% or less.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain the carboxymethylcellulose being used for dissoluble biocompatible material, 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.
In addition, Singh further discloses that wherein the dissoluble biocompatible material is carboxymethylcellulose, para [0033]; the dissolvable microneedle array has a moisture content of 5% or less, (para [0097], moisture contents of about 2-5%).
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the method of Takada in view of Mikszta by providing carboxymethylcellulose as the dissoluble biocompatible material containing 5% or less moisture in the microneedle array, as taught by Singh, in order to accelerate microneedle degradation and increase adhesion via the moisture content of the microneedle.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of claim(s) 1 under Signh in view of Mikszta et al. and in view of Falo have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Takada in view of Mikszta.
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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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
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