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 Objections
Claim 28 is objected to because of the following informalities: Claim 28 repeats "organism specific monoclonal antibody". Appropriate correction is required.
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.
Claim(s) 21, 23-26, 28, 30 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Chen et al. (US Pub No. 2018/0289616 A1, herein Chen).
Regarding claim 1, Chen discloses a therapeutic bandage (substance delivery device 3, “The forms of TDD (transdermal drug delivery) include… patch… “ – Para [0005]) comprising:
a bandage matrix (substrate 31, Fig. 4); and
an array of microneedles (dissolvable supporting structures 32 and carriers 33, Fig. 4) extending from the bandage matrix (“The dissolvable supporting structures are disposed on the substrate.” – Abstract, Fig. 4), each of the microneedles including a first layer (dissolvable supporting structures 32, Fig. 4) that encapsulates a first therapeutic agent (substances S2, Fig. 4) (“The substances S2 encapsulated in the dissolvable supporting structures 32…" - Para [0071]) and a second layer (carriers 33, Fig. 4) that encapsulates a second therapeutic agent (substances S1, Fig. 4) ("… the substance S1 encapsulated in the carriers…" - Para [0071]),
wherein the array of microneedles is configured to deliver at least one of the first therapeutic agent or the second therapeutic agent from the bandage matrix (substrate 31, Fig. 4) into the skin of a patient (“…a delivery system capable of delivering substances through tissues, especially through skin…” – Para [0028]).
Regarding claim 23, Chen discloses the therapeutic bandage (substance delivery device 3, “The forms of TDD (transdermal drug delivery) include… patch… “ – Para [0005]) recited above, wherein
the first layer (dissolvable supporting structures 32, Fig. 4) is configured to release the first therapeutic agent at a first rate ("… the dissolvable supporting structures 32 is able to release the substances S2 rapidly…" - Para [0072]), and the second layer (carriers 33, Fig. 4) is configured to release the second therapeutic agent at a second rate that is less than the first rate ("… the carriers 33 is able to provide the substances S1 in a sustained-release manner…" - Para [0072]).
Examiner interprets S2 being released rapidly and S1 being released in a sustained-release manner as S1 being released at a different and slower rate than S2.
Regarding claim 24, Chen discloses the therapeutic bandage (substance delivery device 3, “The forms of TDD (transdermal drug delivery) include… patch… “ – Para [0005]) recited above, wherein
the first layer (dissolvable supporting structures 32, Fig. 4) defines a first length ("…a height of the dissolving supporting structures ranges from 600 µm to 900 µm…" - Para [0026]) and the second layer (carriers 33, Fig. 4) defines a second length ("…a height of the dissolving supporting structures ranges from 600 µm to 900 µm…" - Para [0026]), the first layer being configured to release the first therapeutic agent at a first tissue depth (epidermis T1, Fig. 6A), the second layer being configured to release the second therapeutic agent at a second tissue depth (dermis T2, Fig. 6A) ("… the carriers 13 are able to penetrate the stratum corneum and reach the dermal layer of the skin…" - Para [0064]) that is different
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than the first tissue depth (See Fig. 6A).
Regarding claim 25, Chen discloses the therapeutic bandage (substance delivery device 3, “The forms of TDD (transdermal drug delivery) include… patch… “ – Para [0005]) recited above, wherein
the first layer is formed from a mixture of polyvinylpyrrolidone (PVP) and polyvinyl alcohol (PVA) ("… the supporting structures were made by different materials: PVP/PVA supporting structures…" - Para [0051]) and the second layer is formed from poly(lactic-co-glycolic acid) (PLGA) (“… the degradable carriers include… poly(lactic-co-glycolic acid)…" - Para [0015])
Regarding claim 26, Chen discloses the therapeutic bandage (substance delivery device 3, “The forms of TDD (transdermal drug delivery) include… patch… “ – Para [0005]) recited above, wherein
at least one of the first therapeutic agent and the second therapeutic agent comprise at least one of an immunomodulatory compound, a biological agent or an antimicrobial agent ("The substances delivered by the substance delivery device 1 of the present invention are not limited. Preferably, the substances may include a drug or biological active substances." - Para [0066])
Regarding claim 28, Chen discloses the therapeutic bandage (substance delivery device 3, “The forms of TDD (transdermal drug delivery) include… patch… “ – Para [0005]) recited above, wherein
the biological agent comprises at least one of an organism specific monoclonal antibody, anti-MecA anti-alpha toxin, or an organism-specific monoclonal antibody ("The biological active substances include but not limited to… antibody…" - Para [0066])
Examiner interprets antibody to include organism specific monoclonal antibody.
Regarding claim 30, Chen discloses a method for fabricating a therapeutic bandage (“…the manufacturing method of the substance delivery device…” – Para [0078]), the method comprising
forming a bandage matrix (substrate 31, Fig. 4) (“Manufacture of Dissolvable Supporting Structure… including the substrate of the present invention…” – Para [0083]-[0084]); and
disposing an array of microneedles (dissolvable supporting structures 32 and carriers 33, Fig. 4) extending from the bandage matrix ("The dissolvable supporting structures are disposed on the substrate." - Abstract, Fig. 4), each of the microneedles including a first layer (dissolvable supporting structures 32, Fig. 4) that encapsulates a first therapeutic agent (substances S2, "The substances S2 encapsulated in the dissolvable supporting structures 32…" - Para [0071], Fig. 4) and a second layer (carriers 33, Fig. 4) that encapsulates a second therapeutic agent (substances S1, "… the substance S1 encapsulated in the carriers…" - Para [0071], Fig. 4), wherein the array of microneedles is configured to deliver at least one of the first agent or the second agent from the bandage matrix (substrate 31, Fig. 4) into the skin of a patient ("… a delivery system capable of delivering substances through tissues, especially through skin…" - Para [0028]).
Regarding claim 32, Chen discloses the method for fabricating a therapeutic bandage (“…the manufacturing method of the substance delivery device…” – Para [0078]) as recited above, further comprising
disposing within at least some of the microneedles at least one of an immunomodulatory compound, a biological agent, or an antimicrobial agent ("The substances delivered by the substance delivery device 1 of the present invention are not limited. Preferably, the substances may include a drug or biological active substances." - Para [0066]).
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.
Claim(s) 22, 31, 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US Pub No. 2018/0289616 A1, herein Chen) in view of McAllister et al. (US Pub No. 2017/0050010 A1).
Regarding claim 22, Chen discloses the therapeutic bandage (substance delivery device 3, “The forms of TDD (transdermal drug delivery) include… patch… “ – Para [0005]) recited above, wherein
Chen does not expressly disclose that the bandage matrix comprises a first bandage layer disposed on a film layer, a second bandage layer disposed on the first bandage layer, and a cellulose layer disposed on the second bandage layer, the array of microneedles protruding from the cellulose layer.
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McAllister teaches that the bandage matrix (microneedle array 105, Fig. 2) comprises a first bandage layer (mechanical force indicator 155, Fig. 2) disposed on a film layer (handling layer 140, Fig. 2) ("…mechanical force indicator 155 is disposed between the adhesive layer 135 and the handling layer 140." - Para [0034]), a second bandage layer (adhesive layer 135, Fig. 2) disposed on the first bandage layer, and a cellulose layer (base substrate 110, Fig. 2) disposed on the second bandage layer, the array of microneedles protruding from the cellulose layer (“a base substrate 110 having a microneedle side 115” – Para [0033]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the therapeutic bandage of Chen to include that the bandage matrix comprises a first bandage layer disposed on a film layer, a second bandage layer disposed on the first bandage layer, and a cellulose layer disposed on the second bandage layer, the array of microneedles protruding from the cellulose layer as taught by McAllister for application to a patient's skin (McAllister, Para [0019]).
Regarding claim 31, Chen discloses the method for fabricating a therapeutic bandage (“…the manufacturing method of the substance delivery device…” – Para [0078]) as recited above, wherein the forming comprises:
Chen does not expressly disclose disposing a first bandage layer on a film layer; disposing a second bandage layer on an opposing side of the first bandage layer; disposing a cellulose layer on an opposing side of the second bandage layer; and, configuring the microneedles to protrude from the cellulose layer.
McAllister teaches disposing a first bandage layer (mechanical force indicator 155, Fig. 2) on a film layer (handling layer 140, Fig. 2) ("…mechanical force indicator 155 is disposed between the adhesive layer 135 and the handling layer 140." - Para [0034], Fig. 2); disposing a second bandage layer (adhesive layer 135, Fig. 2) on an opposing side of the first bandage layer ("…mechanical force indicator 155 is disposed between the adhesive layer 135 and the handling layer 140." - Para [0034], Fig. 2); disposing a cellulose layer (base substrate 110, Fig. 2) on an opposing side of the second bandage layer (Fig. 2); and, configuring the microneedles to protrude from the cellulose layer (“…step (e) may further form a base substrate connected to the primary funnel portion distal to the at least one microneedle.” – Para [0075]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Chen to include disposing a first bandage layer on a film layer; disposing a second bandage layer on an opposing side of the first bandage layer; disposing a cellulose layer on an opposing side of the second bandage layer; and, configuring the microneedles to protrude from the cellulose layer as taught by McAllister for application to a patient's skin (McAllister, Para [0019]).
Regarding claim 33, Chen discloses a therapeutic bandage comprising:
each of the microneedles (dissolvable supporting structures 32 and carriers 33, Fig. 4) including a first layer (dissolvable supporting structures 32, Fig. 4) that encapsulates a first therapeutic agent (substances S2, "The substances S2 encapsulated in the dissolvable supporting structures 32…" - Para [0071], Fig. 4) and a second layer (carriers 33, Fig. 4) that encapsulates a second therapeutic agent (substances S1, "… the substance S1 encapsulated in the carriers…" - Para [0071], Fig. 4), wherein the array of microneedles is configured to deliver at least one of the first therapeutic agent or the second therapeutic agent from the bandage matrix (substrate 31, Fig. 4) into the skin of a patient ("… a delivery system capable of delivering substances through tissues, especially through skin…" - Para [0028]).
Chen does not expressly disclose a bandage matrix comprising a first bandage layer disposed on a film layer, a second bandage layer disposed on the first bandage layer and a cellulose layer disposed on the second bandage layer; and an array of microneedles extending from the cellulose layer of the bandage matrix
McAllister teaches that a bandage matrix (microneedle array 105, Fig. 2) comprising a first bandage layer (mechanical force indicator 155, Fig. 2) disposed on a film layer (handling layer 140, Fig. 2) (handling layer 140, "…mechanical force indicator 155 is disposed between the adhesive layer 135 and the handling layer 140." - Para [0034]), a second bandage layer (adhesive layer 135, Fig. 2) disposed on the first bandage layer and a cellulose layer (base substrate 110, Fig. 2) disposed on the second bandage layer; and an array of microneedles extending from the cellulose layer of the bandage matrix ("a base substrate 110 having a microneedle side 115" - Para [0033]).
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Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the therapeutic bandage of Chen to include a bandage matrix comprising a first bandage layer disposed on a film layer, a second bandage layer disposed on the first bandage layer and a cellulose layer disposed on the second bandage layer; and an array of microneedles extending from the cellulose layer of the bandage matrix as taught by McAllister for application to a patient's skin (McAllister, Para [0019]).
Regarding claim 34, Chen discloses the therapeutic bandage (substance delivery device 3, “The forms of TDD (transdermal drug delivery) include… patch… “ – Para [0005]) recited above, wherein
at least one of the first therapeutic agent and the second therapeutic agent comprise at least one of an immunomodulatory compound, a biological agent or an antimicrobial agent ("The substances delivered by the substance delivery device 1 of the present invention are not limited. Preferably, the substances may include a drug or biological active substances." - Para [0066]).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US Pub No. 2018/0289616 A1, herein Chen) in view of Ginggen et al. (CA 3037490 A1, herein Ginggen).
Regarding claim 27, , Chen discloses the therapeutic bandage (substance delivery device 3, “The forms of TDD (transdermal drug delivery) include… patch… “ – Para [0005]) recited above, wherein
Chen does not expressly disclose that the immunomodulatory compound comprises at least one of: chemokines, lipids, N-formylated peptides, eicosinoids, leukotrienes, cytokines, or methylated BSA
Ginggen teaches that the immunomodulatory compound ("… one or more immune modulators…" - Para [0327]) comprises at least one of: chemokines, lipids, N-formylated peptides, eicosinoids, leukotrienes, cytokines, or methylated BSA ("Examples of useful therapeutic agents include… cytokine…" - Para [0327]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the therapeutic bandage of Chen to include that the immunomodulatory compound comprises at least one of: chemokines, lipids, N-formylated peptides, eicosinoids, leukotrienes, cytokines, or methylated BSA as taught by Ginggen to deliver one or more useful therapeutic agents (Ginggen, Para [0326])
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US Pub No. 2018/0289616 A1, herein Chen) in view of Soo et al. (WO 2012/103257 A2, herein Soo).
Regarding claim 29, , Chen discloses the therapeutic bandage (substance delivery device 3, “The forms of TDD (transdermal drug delivery) include… patch… “ – Para [0005]) recited above, wherein
Chen does not expressly disclose that the antimicrobial agent comprises at least one of vancomycin, daptomycin, sitafloxicin, apicidin, savarin, ambuic acid, hydroxyketones, oxacillin, peptide-conjugated locked nucleic acids, tetrapeptide derivatives, o- hydroxyemodin, or a combination thereof.
Soo teaches that the antimicrobial agent comprises at least one of vancomycin, daptomycin, sitafloxicin, apicidin, savarin, ambuic acid, hydroxyketones, oxacillin, peptide-conjugated locked nucleic acids, tetrapeptide derivatives, o- hydroxyemodin, or a combination thereof ("… antimicrobial agents can be … vancomycin…" - Pg. 12, Para 2 ).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the therapeutic bandage of Chen to include that the antimicrobial agent comprises at least one of vancomycin, daptomycin, sitafloxicin, apicidin, savarin, ambuic acid, hydroxyketones, oxacillin, peptide-conjugated locked nucleic acids, tetrapeptide derivatives, o- hydroxyemodin, or a combination thereof as taught by Soo to provide controlled delivery of at least one active agent (Soo, Pg. 12, Para 2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783