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 .
Claims 21, 28, 30, and 33 are currently amended.
Claims 35-39 are new.
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, 32, and 37-39 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 21, 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]), the second layer defining a channel (Fig. 4) extending between the first layer and the bandage matrix,
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]).
Examiner interprets that it would have been obvious to one of ordinary skill in the art that the second channel of Chen would extend between the first layer and the bandage matrix since the second layer itself extends between the first layer the bandage matrix.
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 in view of McAllister 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 than the first tissue depth (See Fig. 6A below).
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Regarding claim 25, Chen in view of McAllister 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 in view of McAllister 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 in view of McAllister 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 ("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 in view of McAllister 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), the second layer defining a channel extending between the first layer and the bandage matrix (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]).
Examiner interprets that it would have been obvious to one of ordinary skill in the art that the second channel of Chen would extend between the first layer and the bandage matrix since the second layer itself extends between the first layer the bandage matrix.
Regarding claim 32, Chen in view of McAllister 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]).
Regarding claim 37, Chen in view of McAllister discloses the therapeutic bandage (substance delivery device 3, “The forms of TDD (transdermal drug delivery) include… patch… “ – Para [0005]) recited above, wherein
release of the first therapeutic agent (substance S2, fig. 4) is configured to cause the channel in the second layer (carriers 13, Fig. 2) to open ("After the substance delivery device 1 is attached onto the tissue, steps S53, the tissue fluid, water or other solutions in the tissue is able to dissolve the dissolvable supporting structures 12, further separating the carriers 13 … the substances S1 are therefore released …" - Para [0076]) to open.
Regarding claim 38, Chen in view of McAllister 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 39, Chen in view of McAllister discloses the therapeutic bandage (substance delivery device 3, “The forms of TDD (transdermal drug delivery) include… patch… “ – Para [0005]) recited above, wherein
release of the first therapeutic agent (substance S2, fig. 4) is configured to cause the channel in the second layer (carriers 13, Fig. 2) to open ("After the substance delivery device 1 is attached onto the tissue, steps S53, the tissue fluid, water or other solutions in the tissue is able to dissolve the dissolvable supporting structures 12, further separating the carriers 13 … the substances S1 are therefore released …" - Para [0076]).
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, and 33-35 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 in view of McAllister discloses the therapeutic bandage (Chen, 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 in view of McAllister discloses the method for fabricating a therapeutic bandage (Chen, “…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 in view of McAllister discloses a therapeutic bandage substance delivery device 3, “The forms of TDD (transdermal drug delivery) include… patch… “ – Para [0005]) comprising:
each of the microneedles (Chen, dissolvable supporting structures 32 and carriers 33, Fig. 4) including a first layer (Chen, dissolvable supporting structures 32, Fig. 4) that encapsulates a first therapeutic agent (Chen, substances S2, "The substances S2 encapsulated in the dissolvable supporting structures 32…" - Para [0071], Fig. 4) and a second layer (Chen, carriers 33, Fig. 4) that encapsulates a second therapeutic agent (Chen, substances S1, "… the substance S1 encapsulated in the carriers…" - Para [0071], Fig. 4), the second layer defining a channel extending between the first layer and the bandage matrix (Chen, 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 (Chen, substrate 31, Fig. 4) into the skin of a patient (Chen, "… 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]).
Examiner interprets that it would have been obvious to one of ordinary skill in the art that the second channel of Chen would extend between the first layer and the bandage matrix since the second layer itself extends between the first layer the bandage matrix.
Regarding claim 34 Chen in view of McAllister discloses the therapeutic bandage (Chen, 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 (Chen, "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 35, Chen in view of McAllister discloses the therapeutic bandage (Chen, substance delivery device 3, “The forms of TDD (transdermal drug delivery) include… patch… “ – Para [0005]) recited above, wherein
the second bandage layer (Chen, carriers 13, Fig. 4) includes one or more antibodies (Chen, substances S1, Fig. 4) (Chen, "The biological active substance include but not limited to .. antibody …" - 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 in view of McAllister and Ginggen discloses the therapeutic bandage (Chen, 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 in view of McAllister and Soo discloses the therapeutic bandage (Chen, 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).
Claim(s) 36 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) and in further view of Kam et al. (US Patent No. 10098574 B1).
Regarding claim 36, Chen in view of McAllister and Kam disclose the therapeutic bandage (Chen, substance delivery device 3, “The forms of TDD (transdermal drug delivery) include… patch… “ – Para [0005]) as recited above, wherein
the second bandage layer (Chen, carriers 13, Fig. 4).
Chen does not expressly disclose a dye bound to the one or more antibodies.
Kam teaches a dye bound ("… the nanosensor can be a sensor comprised of … dye …" - Col. 10 Line 15) to the one or more antibodies ("… the nanosensor may include … an antibody …" - Col. 14 Line 65).
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 dye bound to the one or more antibodies as taught by Kam to act as a signa source that fluoresces (Kam, Co. 13 Line 16).
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 6/15/2026, with respect to the rejection(s) of claim(s) 21, 30, and 33 under 35 USC 102 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 Chen in view of McAllister.
Applicant argues that Chen does not disclose a therapeutic bandage including an array of microneedles, each including a first layer that encapsulates a first therapeutic agent and a second layer that encapsulates a second therapeutic agent, where the second layer defines a channel extending between the first layer and the bandage matrix.
Examiner interprets that McAllister teaches that the second layer defines a channel extending between the first layer and the bandage matrix of claims 21, 30, and 33 as recited in the rejection above.
Applicant’s arguments with respect to claim(s) 36 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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