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 filed on 01/16/26 have been entered in the case. Claims 1-18 are pending for examination.
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 1-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Singh et al. (US 2008/0269685) in view of Mikszta et al. (US 2005/0008683) & Falo, Jr. et al. (US 2011/0098651) with evidence Oh (US 2010/0233093).
Regarding claim 1, Singh discloses a method of delivering one or more bioactive materials via transdermal insertion into a patient comprising:
inserting a dissolvable, i.e., biodegradable microneedle array, para [0032-0033, 0088] & Figs. 1, at a target skin area of the subject, para [0003 & 0018-0019], the dissolvable microneedle array comprising:
one or more bioactive materials (one or more polymers in a solvent and an active ingredient, paras [0032-0033], also see Figs. 5A-5C);
a base portion 54, 78 or 90 (in Fig. 5A-5B); and
a plurality of microneedles 70/80 extending from the base portion78/90, wherein the one or more bioactive materials are present in a higher concentration in the plurality of microneedles than in the base portion (e.g., the microprojections themselves fall entirely within layer 52, para [0063]; wherein a higher concentration of active in the projections, para [0062]; wherein the layer 54 (in the base portion) does not contain any microprojections, i.e., bioactive material. Therefore, the layer 52 has higher concentration of the bioactive material than the base portion. Alternatively, layer 72 has a higher concentration of drug substance than layer 74; layer 78 encompasses the portion of the microprojections not contained in layers 72 or 74, para [0064]. Therefore, the bioactive material at the layer 72 has higher concentration than the base portion 78. In addition, Singh discloses in para [0069] that the microneedle array is fabricated by applying a first solution comprising the active is cast so that it fills the cavities of a mold partially or fills no more than cavities, then applying a second solution with a lower or zero concentration of active and drying the first and second solutions. In other words, the bioactive agent is located on/in the microneedles 76/88 and the base portion being formed without including any agent or bioactive material therein. Singh also discloses that layer 84 contains active agent; wherein layer 82 serves to control the rate at which the active agent is released from the deposit layer 84, the layer 86 formed of material eroding more rapidly to separate the microneedle in use, para [0065]. In other words, there is no bioactive material being formed at the base portion. Therefore, the one or more bioactive materials are present in a higher concentration in the plurality of microneedles than in the base portion);
wherein the one or more bioactive materials comprise one or more viral vectors (antiviral agent, para [0082], vaccines listed in para [0086]).
Singh does not disclose that the one or more bioactive material comprises a therapeutically effective amount of doxorubicin; wherein the one or more viral vectors and the therapeutically effective amount of doxorubicin are delivered simultaneously, as required in the claimed invention.
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], ... where the substance to be administered is a protein or a fragment thereof, any recombinant DNA technology known to one skilled in the art may be used to produce the protein. ... bacteriophage DNA, plasmid DNA or cosmid DNA expression vectors containing nucleic acid coding sequence encoding a protein, ... a recombinant virus expression vector (e.g., baculovirus) containing the protein of interest coding sequence; plant cells infected with a recombinant virus expression vector (e.g., cauliflower mosaic virus, CaMV; tobacco mosaic virus, TMV) or transformed with a recombinant plasmid expression vector (e.g., Ti plasmid) containing the protein of interest coding sequence; or mammalian cells (e.g., COS, CHO, BHK, 293, 3T3) harboring recombinant expression constructs containing promoters derived from the genome of mammalian cells (e.g., metallothionein promoter) or from mammalian viruses (e.g., the adenovirus late promoter; the vaccinia virus 7.5K promoter) 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 Singh 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 Singh nor Mikszta’s device for delivering the doxorubicin.
Sing in view of Mikszta does not disclose that the one or more viral vectors and the therapeutically effective amount of doxorubicin are delivered simultaneously, as required in the claimed invention.
Falo discloses a method of delivering one or more bioactive materials via transdermal insertion into a subject comprising:
inserting a dissolvable microneedle array at a target skin area of the subject,
one or more bioactive materials;
a base portion; and
a plurality of microneedles extending from the base portion,
wherein the one or more bioactive materials comprise one or more viral vectors (vaccines, paras [0021,0052] or proteins, para [0072]) and a therapeutically effective amount of chemotherapeutic for treating cutaneous tumor, paras [0104, 0101, 0109];
wherein the one or more viral vectors and the therapeutically effective amount of chemotherapeutic for treating cutaneous tumor are delivered simultaneously (e.g., multiple bioactive agents can be delivered in a single microneedle array (path), para [0103]).
Giving such a teaching by Falo, a person having ordinary skill in the art would have easily recognizes that modifying the method and device of Sing in view of Mikszta with providing a method of delivering one or more viral vector and a therapeutically effective amount of chemotherapeutic (e.g., doxorubicin, as disclosed by Mikszta), as taught by Falo, would provide the benefit of delivering more than one therapeutic drugs at same time for enhancing the treatment in certain diseases.
Regarding claim 2, Singh in view of Mikszta and Falo discloses the invention substantially as claimed invention. Singh further discloses that the peptides and proteins are used with microneedle arrays are tumor necrosis factor, colony stimulating factors, … melanocyte stimulating hormone, thyroid hormone, thyroid stimulating hormone, …, para [0084]. It is well-known in the art that these peptides and protein listed in the para [0084] for being treated to the patient has a cutaneous tumor (e.g., tumor necrosis factor, colony stimulating factor, thyroid stimulating hormone, pancreozymin…) or a tumor metastatic to skin (e.g., melanocyte stimulating hormone) or any combination thereof.
In addition, Mikszta discloses that the patient has a tumor metastatic to skin, para [0314].
Regarding claims 3-4, Singh in view of Mikszta and Falo discloses the invention substantially as claimed invention. As discussed in the claim 2 above, Singh discloses that the peptides and proteins comprises: melanocyte stimulating hormone, para [0084], also see para [0157] in Mikszta.
It is well-known in the art that the melanocyte stimulating hormone is being treated for skin cancer such as: basal cell carcinoma, squamous cell carcinoma, melanoma.
Regarding claim 5, Singh in view of Mikszta and Falo discloses the invention substantially as claimed invention. As discussed in the claim 1 above, Singh discloses that the one or more bioactive materials are located in the plurality of microneedles so that the base portion is substantially formed without any bioactive materials contained therein.
Regarding claim 6, Singh in view of Mikszta and Falo discloses the invention substantially as claimed invention. Singh discloses that wherein the one or more bioactive materials are locally concentrated in the plurality of microneedles so that the one or more bioactive materials are generally present only in an upper half (at layer 62 in Fig. 5A) of respective microneedles in the microneedle array, para [0063].
Regarding claim 7, Singh in view of Mikszta and Falo discloses the invention substantially as claimed invention. As shown in Fig. 5B in Singh, the plurality of microneedles are pre-formed to have a shape that comprises a first cross-sectional dimension at a top portion 72, a second cross-sectional dimension at a bottom portion 78, and a third cross-sectional dimension at an intermediate portion 74, wherein the intermediate portion 74 is located between the top portion 72 and the bottom portion 78, and wherein the one or more bioactive materials are substantially concentrated in the area at or above the intermediate portion 74 (e.g., layers 72 & 74 contains drug substance but the layer 78 does not contain the drug that contained in layers 72 or 74, para [0064]).
Regarding claim 8, Singh in view of Mikszta and Falo discloses the invention substantially as claimed invention. Singh further discloses that the one or more bioactive materials are substantially concentrated in the area at or above the intermediate portion 74.
Regarding claim 9, Singh in view of Mikszta and Falo discloses the invention substantially as claimed invention.
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 Singh in view of Mikszta and Falo 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.
Regarding claim 10, Singh in view of Mikszta and Falo discloses the invention substantially as claimed invention. Singh further discloses that each of the plurality of microneedles comprises a plurality of layers 72& 74 or 82 & 86 of dissoluble biocompatible material, in Fig. 5B.
Regarding claim 11, Singh in view of Mikszta and Falo discloses the invention substantially as claimed invention. Singh further discloses that wherein the dissoluble biocompatible material is carboxymethylcellulose, para [0033] in Singh.
Regarding claim 12, Singh in view of Mikszta and Falo discloses the invention substantially as claimed invention. Singh further discloses that the one or more bioactive component comprises at least two different bioactive materials. Note: as discussed, the layers 72 &72 (or layers 82, 84, 86) have different concentrations. Therefore, the one or more bioactive component comprises at least two different bioactive materials, also see paras [0081-0082] in Singh.
Regarding claim 13, Singh in view of Mikszta and Falo discloses the invention substantially as claimed invention. Singh in view of Mikszta also discloses that the bioactive material comprises at least one viral vector. However, Singh in view of Mikszta does not disclose that the viral vector comprises adenovector. It would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain an adenvector, 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.
Regarding claim 14, Singh in view of Mikszta and Falo discloses the invention substantially as claimed invention. Singh further discloses that the dissolvable microneedle array has a moisture content of 5% or less, (para [0097], moisture contents of about 2-5%).
Regarding claim 15, Singh in view of Mikszta and Falo 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].
In addition, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the amount of at least 100 micrograms of doxorubicin, since it has been held that discovering the amount of doxorubicin involves only routine skill in the art. For example: the amount of the doxorubicin is being used to base on the condition of the patients such as: age, weight, a stage of cancer in the patient.
Regarding claim 16, Singh discloses a method of treating a cutaneous tumor (by using the drugs such as: anti-cancer agent, para [0082], tumor necrosis factor, colony stimulating factors, thyroid stimulating hormone… It is noted that it is well-known in the art that the drugs listed in para [0084] being treated for many types of cutaneous tumor) or tumor metastatic (by using the drug such as: melanocyte stimulating hormone) comprising:
selecting a subject that has skin cancer (e.g., the para [0084] list the drug, i.e., melanocyte stimulating hormone, of using to delivery into a patient. It is well-known in the art that the melanocyte stimulating hormone is being used to treat for skin cancer); and
delivering two or more bioactive materials (one or more polymers in a solvent and an active ingredient, paras [0032-0033], also see Figs. 5A-5C) via transdermal insertion (via microneedle array) into a patient by applying a dissolvable (biodegradable, para [0032]) microneedle array to the patient,
the dissolvable microneedle array comprising: the two or more bioactive materials (one or more polymers in a solvent and an active ingredient, paras [0032-0033], also see Figs. 5A-5C);
a base portion 54, 78 or 90 (in Fig. 5A-5B); and
a plurality of microneedles 70/80 extending from the base portion, the one or more bioactive materials being present in a higher concentration in the plurality of microneedles than in the base portion (e.g., the microprojections themselves fall entirely within layer 52, para [0063]; wherein a higher concentration of active in the projections, para [0062]; wherein the layer 54 (in the base portion) does not contain any microprojections, i.e., bioactive material. Therefore, the layer 52 has higher concentration of the bioactive material than the base portion. Alternatively, layer 72 has a higher concentration of drug substance than layer 74; layer 78 encompasses the portion of the microprojections not contained in layers 72 or 74, para [0064]. Therefore, the bioactive material at the layer 72 has higher concentration than the base portion 78. In addition, Singh discloses in para [0069] that the microneedle array is fabricated by applying a first solution comprising the active is cast so that it fills the cavities of a mold partially or fills no more than cavities, then applying a second solution with a lower or zero concentration of active and drying the first and second solutions. In other words, the bioactive agent is located on/in the microneedles 76/88 and the base portion being formed without including any agent or bioactive material therein. Singh also discloses that layer 84 contains active agent; wherein layer 82 serves to control the rate at which the active agent is released from the deposit layer 84, the layer 86 formed of material eroding more rapidly to separate the microneedle in use, para [0065]. In other words, there is no bioactive material being formed at the base portion. Therefore, the one or more bioactive materials are present in a higher concentration in the plurality of microneedles than in the base portion);
wherein the two or more bioactive materials comprise one or more viral vectors (antiviral agent, para [0082], vaccines listed in para [0086]).
Singh does not disclose that the one or more bioactive materials comprise a therapeutically effective amount of 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], ... where the substance to be administered is a protein or a fragment thereof, any recombinant DNA technology known to one skilled in the art may be used to produce the protein. ... bacteriophage DNA, plasmid DNA or cosmid DNA expression vectors containing nucleic acid coding sequence encoding a protein, ... a recombinant virus expression vector (e.g., baculovirus) containing the protein of interest coding sequence; plant cells infected with a recombinant virus expression vector (e.g., cauliflower mosaic virus, CaMV; tobacco mosaic virus, TMV) or transformed with a recombinant plasmid expression vector (e.g., Ti plasmid) containing the protein of interest coding sequence; or mammalian cells (e.g., COS, CHO, BHK, 293, 3T3) harboring recombinant expression constructs containing promoters derived from the genome of mammalian cells (e.g., metallothionein promoter) or from mammalian viruses (e.g., the adenovirus late promoter; the vaccinia virus 7.5K promoter) 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 (formulation for treatment and/or prevent of cancer or metastasis) 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, paras [0159, 0117, 0177]. Therefore, a person skilled in the art would recognize that the viral vectors and the effective amount of doxorubicin can be combined together for delivering into a patient for treating certain diseases.
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 Singh 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 is relied on the material, i.e. doxorubicin for treating skin cancer, but does not use or rely on using any device in Oh to modify Singh nor Mikszta’s device for delivering the doxorubicin.
Sing in view of Mikszta does not disclose that the one or more viral vectors and the therapeutically effective amount of doxorubicin are delivered simultaneously, as required in the claimed invention.
Falo discloses a method of delivering one or more bioactive materials via transdermal insertion into a subject comprising:
inserting a dissolvable microneedle array at a target skin area of the subject,
one or more bioactive materials;
a base portion; and
a plurality of microneedles extending from the base portion,
wherein the one or more bioactive materials comprise one or more viral vectors (vaccines, paras [0021,0052] or proteins, para [0072]) and a therapeutically effective amount of chemotherapeutic for treating cutaneous tumor, paras [0104, 0101, 0109];
wherein the one or more viral vectors and the therapeutically effective amount of chemotherapeutic for treating cutaneous tumor are delivered simultaneously (e.g., multiple bioactive agents can be delivered in a single microneedle array (path), para [0103]).
Giving such a teaching by Falo, a person having ordinary skill in the art would have easily recognizes that modifying the method and device of Sing in view of Mikszta with providing a method of delivering one or more viral vector and a therapeutically effective amount of chemotherapeutic (e.g., doxorubicin, as disclosed by Mikszta), as taught by Falo, would provide the benefit of delivering more than one therapeutic drugs at same time for enhancing the treatment in certain diseases.
Regarding claim 17, Singh in view of Mikszta and Falo 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.
Regarding claim 18, Singh in view of Mikszta and Falo discloses the invention substantially as claimed invention. Singh also discloses that wherein the dissolvable microneedle array has a moisture content of 5% or less, (para [0097], moisture contents of about 2-5%).
Response to Arguments
Applicant's arguments filed 01/16/26 have been fully considered but they are not persuasive.
1) Applicant argues that: Neither Singh, Mikszat nor Falo does teach the use of doxorubicin or the combination doxorubicin with viral vectors.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Singh discloses that the microneedle arrays are suitable for a wide variety of drug substances, e.g., viral vector, para [0086], anti-cancer agent, para [0082], or peptides and proteins for treating cutaneous tumor, paras [0084-0085]. Although Singh does not each or suggest the use of any such agent in combination with a viral vector; however, as discussed in the rejections in claims 1 & 16 above; however,
Mikszta discloses method and device for intradermal delivery of substances by targeting the subsnce to the intradermal compartment of a subject’s skin, see abstract. By the use of "direct intradermal (ID) administration" refers to as "dermal-access means", for example, using microneedle-based injection in multiple needle arrays, paras [0014, 0079]. Mikszta further states that methods and formulations for treatment and/or prevention of cancer or metastasis comprising delivering a therapeutically or prophylactically effective amount of a therapeutic substance to the intradermal compartment of subject’s skin. The substances are administered in combination with a therapeutically or prophylactically effective amount of one or additional therapeutics agents known to those skilled in the art for the treatment and/or prevention of caner, para [0159]; wherein the one or more bioactive materials comprises one or more viral vectors, paras [0136-0139, 0173] and a therapeutically effective amount of chemo agent including doxorubicin, para [0164].
For the reasons above, Mikszta clearly disclose method and device for treatment and/or prevention of cancer that can be used of doxorubicin or the combination doxorubicin with viral vectors.
Singh and Mkiszta does not disclose a method of delivering the one or more viral vectors and therapeutically effective amount to doxorubicin at same time; however, this limitation has been discussed in Falo, e.g., multiple bioactive agents can be delivered in a single microneedle array, para [0103]. Giving teaching by Falo, a person skilled in the art would recognize that the combination of one or more viral vector and the amount of doxorubicin (as suggested in Mikszta) can be delivered at the same time.
2) Applicant states that Mikszta teaches where to inject liquid formulations intradermally, not how to co-formulate a live viral vector with doxorubicin into a single dissolving tip layer.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a live viral vector) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is noted that the viral vectors do not have to be “alive”. In this case, the claim invention only requires “one or more viral vectors” with combination doxorubicin. This method has been taught by Mikszat as discussed in the rejection in claims 1 & 16 above.
3) Applicant argues that Mikszta’s intradermal needle teachings are not applicable to the stability and co-formulation challenges unique to dissolvable microneedle arrays.
In response, as discussed above, Mikszta teaches that the combination therapeutic agents (e.g., one or more viral vector combine(s) with other cancer agent, i.e., doxorubicin) by microneedle arrays, paras [0102, 0112]. The claimed feature “dissolvable” of microneedle arrays has been disclosed by Singh. It is noted that Examiner relies on the teaching from Mikszta by using the microneedle array for delivering more than one substance, i.e., one or more viral vectors with combination doxorubicin for treating and/or preventing cancer. Therefore, a person skilled in the art would recognize that the dissolvable microneedle arrays in Singh can be delivered more than one substance, i.e., one or more viral vectors with combination doxorubicin, as taught by Mikszta, for purpose of treating and/or preventing cancer.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783