CTNF 18/700,816 CTNF 91789 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Drawings 06-22-07 AIA The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 200, 210, 220, 230, 240 in Figure 2 . Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification 06-16 AIA Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. The abstract of the disclosure is objected to because it contains language which can be implied (“is provided” in line 1). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Claim Objections Claim 1 is objected to because there is a lack of antecedent basis for “the skin of a patient” in line 3 and “the skin surface” in line 6. Appropriate correction is required. Claim 2 is objected to because there is a lack of antecedent basis for “the inserted length of the at least one microneedle” in line 2 and “the viable epidermis of the skin” in line 2. Appropriate correction is required. Claim 7 is objected to because there is a lack of antecedent basis for “the exterior of the at least one microneedle” in line 1. Appropriate correction is required. Claim 13 is objected to because there is a lack of antecedent basis for “the viable epidermis” in line 4. Appropriate correction is required. Claim 14 is objected to because there is a lack of antecedent basis for “the skin of a patient” in line 5. Appropriate correction is required. Claim 20 is objected to because there is a lack of antecedent basis for “the guide member” in line 2. Appropriate correction is required. Claim 22 is objected to because there is a lack of antecedent basis for “the angle of insertion” in line 4 and “the viable epidermis of the skin” in line 5. Appropriate correction is required. Claim 27 is objected to because there is a lack of antecedent basis for “the skin of a patient” in line 2, “the microneedle” in line 3, “the inserted length of the microneedles” in line 4, and “the viable epidermis of the skin” in line 4. Appropriate correction is required. Claim 28 is objected to because there is a lack of antecedent basis for “the viable epidermis” in line 2, “the skin of a patient” in line 2, “the microneedle” in line 3, and “the inserted length of the microneedles” in line 4. Appropriate correction is required. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1-2, 6-12, and 28 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Samant et al. (US 20200315502) . Regarding claim 1, Samant discloses a method for targeting epidermal delivery of an agent of interest (“application of a bioactive agent to the patient's skin at or about the insertion site…A bioactive agent may be disposed on one or more outer surfaces of an array of microneedles, so that the bioactive agent is applied to the patient's skin at or about the insertion site when the array of microneedles contacts and/or is inserted into a patient's skin. For example, the bioactive agent may be delivered into the skin using a microneedle, such as by coating the bioactive agent on the microneedle's outer surface, by encasing the bioactive agent with the microneedle or in porosities of the microneedles or by increasing skin permeability using microneedles, which permits the bioactive agent to enter the skin more effectively.” [0075]; Figure 1A showing application to the viable epidermis 111), the method comprising: inserting at least one microneedle (microneedles 201 or 1001, for example) into the skin of a patient (Figure 1B), the at least one microneedle comprising the agent of interest (“the bioactive agent may be delivered into the skin using a microneedle, such as by coating the bioactive agent on the microneedle's outer surface, by encasing the bioactive agent with the microneedle or in porosities of the microneedles” [0075]), wherein the at least one microneedle is inserted at an angle that is non-perpendicular to the skin surface (“the microneedles are inserted into the skin at an angle less than 90° relative to the skin surface. For example, the microneedles may be inserted into the skin at an angle of about 10° to about 45° relative to the skin surface” [0054]; Figure 9, for example). Regarding claim 2, Samant discloses the method of claim 1, wherein a majority of the inserted length of the at least one microneedle (microneedles 201) is located within the viable epidermis of the skin (Figure 2, wherein the majority of the length of microneedles 201 is located within viable epidermis 111). Regarding claim 6, Samant discloses the method of claim 1, wherein the agent of interest is a vaccine or a drug (“bioactive agent” [0075]) which has biological activity in the viable epidermis for a dermatological treatment (“inducing local edema is effected by application of a bioactive agent to the patient's skin at or about the insertion site, to increase the local vasodilation, to increase local vascular permeability, to increase interstitial oncotic pressure, to decrease plasma oncotic pressure, or a combination thereof…A bioactive agent may be disposed on one or more outer surfaces of an array of microneedles, so that the bioactive agent is applied to the patient's skin at or about the insertion site when the array of microneedles contacts and/or is inserted into a patient's skin.” [0075]). Regarding claim 7, Samant discloses the method of claim 1, wherein the agent of interest is part of a coating on the exterior of the at least one microneedle (“the bioactive agent may be delivered into the skin using a microneedle, such as by coating the bioactive agent on the microneedle's outer surface” [0075]). Regarding claim 8, Samant discloses the method of claim 1, wherein the agent of interest is dispersed within a dissolvable matrix material forming the at least one microneedle (“using the microneedles to deliver the osmolyte into the skin, for example, by coating the microneedles with osmolyte and allowing the osmolyte to dissolve off the microneedles in the skin. This can be effected by using the apertures created by the microneedles as a pathway for transport of osmolytes into the skin, for example, from a reservoir on the surface of the skin. The osmolytes may result in a higher molar concentration of solutes at or near the skin apertures than at locations in the skin distant from the skin apertures. Osmolytes may include water-soluble molecules such as sugars, salts, and/or other molecules that will dissolve in the skin.” [0101]; Figure 24 for example showing the dissolvable osmolyte coating as forming part of each microneedle 2401 [0116]). Regarding claim 9, Samant discloses the method of claim 1, wherein the at least one microneedle has a length from 200 to 300 microns (“The length of a microneedle (L.sub.MN) may be between about 50 μm and about 2 mm. In most cases, L.sub.MN is between about 200 μm and about 1200 and ideally between about 200 μm and about 500 μm, or between about 200 μm and about 250 μm.” [0113]). Regarding claim 10, Samant discloses the method of claim 1, wherein the at least one microneedle is a linear array of a plurality of microneedles (Figure 1A, showing a linear array of microneedles 201). Regarding claim 11, Samant discloses the method of claim 10, wherein the at least one microneedle is inserted at an angle between 5 degrees and 45 degrees (“the microneedles are inserted into the skin at an angle less than 90° relative to the skin surface. For example, the microneedles may be inserted into the skin at an angle of about 10° to about 45° relative to the skin surface” [0054]). Regarding claim 12, Samant discloses the method of claim 11, wherein the at least one microneedle is inserted at an angle from 10 degrees to 30 degrees (“the microneedles are inserted into the skin at an angle less than 90° relative to the skin surface. For example, the microneedles may be inserted into the skin at an angle of about 10° to about 45° relative to the skin surface, about 10° to about 30° relative to the skin surface” [0054]). Regarding claim 28, Samant disclose a method for dermatological treatment (“inducing local edema is effected by application of a bioactive agent to the patient's skin at or about the insertion site, to increase the local vasodilation, to increase local vascular permeability, to increase interstitial oncotic pressure, to decrease plasma oncotic pressure, or a combination thereof…A bioactive agent may be disposed on one or more outer surfaces of an array of microneedles, so that the bioactive agent is applied to the patient's skin at or about the insertion site when the array of microneedles contacts and/or is inserted into a patient's skin.” [0075]), the method comprising: inserting an array of microneedles (microneedles 201) comprising a drug (“bioactive agent” [0075]), which has biological activity in the viable epidermis, into the skin of a patient (“A bioactive agent may be disposed on one or more outer surfaces of an array of microneedles, so that the bioactive agent is applied to the patient's skin at or about the insertion site when the array of microneedles contacts and/or is inserted into a patient's skin.” [0075]), wherein the microneedle has a length and is in inserted at a non-perpendicular angle (“the microneedles are inserted into the skin at an angle less than 90° relative to the skin surface. For example, the microneedles may be inserted into the skin at an angle of about 10° to about 45° relative to the skin surface” [0054]; Figure 9, for example) effective to locate a majority of the inserted length of the microneedles within the viable epidermis of the skin (Figure 2, wherein the majority of the length of microneedles 201 is located within viable epidermis 111); and releasing the drug from the inserted microneedle into the viable epidermis (“the bioactive agent is applied to the patient's skin at or about the insertion site when the array of microneedles contacts and/or is inserted into a patient's skin.” [0075]; for example: “using the microneedles to deliver the osmolyte into the skin, for example, by coating the microneedles with osmolyte and allowing the osmolyte to dissolve off the microneedles in the skin. This can be effected by using the apertures created by the microneedles as a pathway for transport of osmolytes into the skin, for example, from a reservoir on the surface of the skin. The osmolytes may result in a higher molar concentration of solutes at or near the skin apertures than at locations in the skin distant from the skin apertures. Osmolytes may include water-soluble molecules such as sugars, salts, and/or other molecules that will dissolve in the skin.” [0101]) . 07-15 AIA Claim s 14-19, 21, and 25 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Yeshurun et al. (USPN 8007466) . Regarding claim 14, Yeshurun discloses a system (Figures 10-13) comprising: at least one microneedle (on leading end of delivery interface 44; Figures 10-13) which comprises an antigen, drug or other agent of interest (“The device may adapted for any desired type of fluid supply (not shown) including attachment to a flexible tube and luer connector, direct connection to a syringe, or addition of a self-contained fluid supply reservoir, as will be clear to one ordinarily skilled in the art.” [Col 12, lines 22-26]; “delivering a fluid through the at least one hollow microneedle towards the non-stretched portion.” [Col 2, lines 61-63]); and an insertion apparatus (guide housing 42, delivery interface 44, arm 46) configured to guide the at least one microneedle into the skin of a patient at a non-perpendicular angle (Figures 10 and 12), wherein the at least one microneedle is configured to release the antigen, drug or other agent of interest into the skin following insertion into the skin (“causing at least one hollow microneedle to penetrate into the flexible biological barrier such that, at the end of the moving, the at least one hollow microneedle extends into the flexible biological barrier from the boundary region in a direction towards the non-stretched portion; and (c) delivering a fluid through the at least one hollow microneedle towards the non-stretched portion.” [Col 2, lines 57-63]). Regarding claim 15, Yeshurun discloses the system of claim 14, wherein the insertion apparatus comprises: a first member (guide housing 42) having a surface that is configured to rest against a skin surface (“a guide housing 42 is either held against or temporarily fixed to the skin surface” [Col 12, lines 11-12]); and a guide member (delivery interface 44) having an insertion end from which the at least one microneedle extends (Figures 10-13), wherein the guide member is configured to translate relative to the first member to insert the at least one microneedle into the skin surface at a selected non-perpendicular angle (Figures 10-13; “the delivery interface 44 is pivotally mounted on an arm 46 which is in turn pivotally mounted to housing 42. Lateral pins projecting from the delivery interface slide within corresponding slots in the housing to further define the path of motion.” [Col 12, lines 16-20]). Regarding claim 16, Yeshurun discloses the system of claim 15, wherein the insertion apparatus further comprises a second member (arm 46) connected to the first member, and the guide member (delivery interface 44 is configured to translate along a surface of the second member (“the delivery interface 44 is pivotally mounted on an arm 46 which is in turn pivotally mounted to housing 42. Lateral pins projecting from the delivery interface slide within corresponding slots in the housing to further define the path of motion.” [Col 12, lines 16-20]; Figures 10-13 showing that the end of delivery interface 44 translates along the arm 46 as they pivot). Regarding claim 17, Yeshurun discloses the system of claim 16, wherein the first member (guide housing 42) and the second member (arm 46) are connected at an end of each member by a hinge which is configured to permit the second member to rotate and adjust the selected non-perpendicular angle at which the at least one microneedle is inserted (Figures 10-13; “the delivery interface 44 is pivotally mounted on an arm 46 which is in turn pivotally mounted to housing 42. Lateral pins projecting from the delivery interface slide within corresponding slots in the housing to further define the path of motion.” [Col 12, lines 16-20]). Regarding claim 18, Yeshurun discloses the system of claim 14, wherein the at least one microneedle is a linear array of two or more microneedles (Figures 10-11 showing a linear array of at least 4 microneedles). Regarding claim 19, Yeshurun discloses the system of claim 14, wherein the at least one microneedle has a length from 200 to 300 microns (“The term "microneedle" is used herein in the description and claims to refer to a structure projecting from an underlying surface to a height of no more than 1 mm, and preferably having a height in the range of 50 to 500 microns.” [Col 7, lines 30-35]). Regarding claim 21, Yeshurun discloses the system of claim 14, wherein the insertion apparatus is designed to insert the at least one microneedle into the skin surface at only a single selected non-perpendicular angle (“This structure also provides a mechanical locking effect in its deployed state of FIGS. 11 and 13.” [Col 12, lines 20-22]). Regarding claim 25, Yeshurun discloses the system of claim 14, wherein the insertion apparatus is configured to guide the at least one microneedle into the skin of a patient at an angle between 5 degrees and 45 degrees (“Where reference is made to a direction of motion having a component parallel to the surface of the biological barrier, this includes any motion which is not perpendicular to the skin surface. Preferably, the motion has a majority component parallel to the skin surface, i.e., at an angle shallower than 45 degrees. Most preferably, the part of the motion performed in contact with the skin is performed substantially parallel to the skin's surface, i.e., with a motion vector not more than about .+-.15 degrees above or below the plane of the skin surface at rest.” [Col 6, lines 52-61]) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 3-5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Samant et al. (US 20200315502) in view of Gill et al. (US 20200138941) . Regarding claims 3-5, Samant discloses the method of claim 1. Samant fails to explicitly disclose wherein the agent of interest is an antigen, as required by claim 3; wherein the antigen is one selected for allergy immunotherapy, as required by claim 4; and wherein the antigen comprises a protein associated with peanut-induced allergic reactions, as required by claim 5. Gill teaches a method for targeting epidermal delivery of an agent of interest using at least one microneedle (“The one or more microneedles (e.g., present as a microneedle array) provided herein can be used to delivery one or more food allergens to a subject in need thereof in order to desensitize the subject to the allergen, and/or to obtain a sustained unresponsiveness to the allergen.” [0071]; “the microneedle tips of the one or more microneedles extend into the epidermis layer of the subject's skin once inserted” [0057]), wherein the agent of interest is an antigen selected for allergy immunotherapy and comprises a protein associated with peanut-induced allergic reactions (“the allergen is a peanut allergen or a combination of peanut allergens. The peanut allergen in one embodiment is in the form of a peanut protein extract.” [0074]) . Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the agent of interest in the method of Samant to be an antigen selected for allergy immunotherapy and comprising a protein associated with peanut-induced allergic reactions based on the teachings of Gill to treat peanut allergies by desensitizing the patient to a peanut protein (Gill [0071]). Regarding claim 13, Samant discloses the method of claim 1, wherein: the at least one microneedle comprises an agent of interest (“application of a bioactive agent to the patient's skin at or about the insertion site…A bioactive agent may be disposed on one or more outer surfaces of an array of microneedles, so that the bioactive agent is applied to the patient's skin at or about the insertion site when the array of microneedles contacts and/or is inserted into a patient's skin. For example, the bioactive agent may be delivered into the skin using a microneedle, such as by coating the bioactive agent on the microneedle's outer surface, by encasing the bioactive agent with the microneedle or in porosities of the microneedles” [0075]), and the at least one microneedle is inserted at an angle that is non-perpendicular to the skin surface (“the microneedles are inserted into the skin at an angle less than 90° relative to the skin surface. For example, the microneedles may be inserted into the skin at an angle of about 10° to about 45° relative to the skin surface” [0054]) and effective to localize at least 50% of the agent of interest in the viable epidermis (Figure 2, wherein the majority of the length of microneedles 201 is located within viable epidermis 111). Samant fails to explicitly disclose the agent of interest comprises an antigen. Gill teaches a method for targeting epidermal delivery of an agent of interest using at least one microneedle (“The one or more microneedles (e.g., present as a microneedle array) provided herein can be used to delivery one or more food allergens to a subject in need thereof in order to desensitize the subject to the allergen, and/or to obtain a sustained unresponsiveness to the allergen.” [0071]), the at least one microneedle comprising an antigen (“solid microneedles coated with a peanut allergen.” [0025]) and the at least one microneedle is inserted in the skin surface and effective to localize the antigen in the viable epidermis (“the microneedle tips of the one or more microneedles extend into the epidermis layer of the subject's skin once inserted” [0057]) Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the agent of interest in the method of Samant to be an antigen based on the teachings of Gill to treat peanut allergies by desensitizing the patient to a peanut protein (Gill [0071]) . 07-21-aia AIA Claim s 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Yeshurun et al. (USPN 8007466) in view of Gill et al. (US 20200138941) . Regarding claim 22, Yeshurun discloses the system of claim 14, wherein: the at least one microneedle delivers an antigen or a drug , and the angle of insertion and the at least one microneedle are configured to localize at least 50% of the antigen or drug in the viable epidermis of the skin (“the invention is primarily intended for delivery of fluids into layers of the skin of a living creature, and in particular, for intradermal or intraepidermal delivery of fluids into the skin of a human subject. The fluids delivered may be any fluids. Preferred examples include, but are not limited to, dermatological treatments, vaccines, and other fluids used for cosmetic, therapeutic or diagnostic purposes.” [Col 6, lines 28-34]). Yeshurun fails to explicitly disclose the at least one microneedle comprises a coating comprising the antigen or the drug, as required by claim 22; and wherein the antigen comprises a protein associated with peanut-induced allergic reactions, as required by claim 23. Gill teaches a system comprising at least one microneedle (“The one or more microneedles (e.g., present as a microneedle array) provided herein can be used to delivery one or more food allergens to a subject in need thereof in order to desensitize the subject to the allergen, and/or to obtain a sustained unresponsiveness to the allergen.” [0071]) inserted to the viable epidermis (“the microneedle tips of the one or more microneedles extend into the epidermis layer of the subject's skin once inserted” [0057]), wherein the at least one microneedle comprises a coating comprising an antigen (“solid microneedles coated with a peanut allergen.” [0025]) which comprises a protein associated with peanut-induced allergic reactions (“the allergen is a peanut allergen or a combination of peanut allergens. The peanut allergen in one embodiment is in the form of a peanut protein extract.” [0074]) . Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the microneedles of the system of Yeshurun to comprise a coating comprising the antigen which comprises a protein associated with peanut-induced allergic reactions based on the teachings of Gill to treat peanut allergies by desensitizing the patient to a peanut protein (Gill [0071]) . 07-21-aia AIA Claim s 20, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Yeshurun et al. (USPN 8007466) in view of Kobayashi et al. (US 20160354589) . Regarding claim 20, Yeshurun discloses the system of claim 14. Yeshurun fails to explicitly disclose the at least one microneedle is removably attached to the guide member. Kobayashi teaches a system comprising at least one microneedle (patch 1002 having needles 1027) which comprises a drug (“distal end portions of the needles 1027 are coated with a target drug such as vaccine, protein, or peptide.” [0264]); and an insertion apparatus (applicator 1001) including a guide member (first element 1003) configured to guide the at least one microneedle into the skin of a patient, wherein the at least one microneedle is removably attached to the guide member (“the patch 1002 applied to the skin by the pressure-sensitive adhesive layer 1024 is not removed from the skin by an adhesive force between the skin double-sided adhesive tape 1028 and the first element 1003 when the applicator 1001 is removed from the patch 1002 after application to the skin” [0266]). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the system of Yeshurun to include the at least one microneedle is removably attached to the guide member based on the teachings of Kobayashi to enhance transdermal absorption of the drug and liming pain and side effects (Kobayashi [0002]). Regarding claim 22, Yeshurun discloses the system of claim 14, wherein: the at least one microneedle delivers an antigen or a drug , and the angle of insertion and the at least one microneedle are configured to localize at least 50% of the antigen or drug in the viable epidermis of the skin (“the invention is primarily intended for delivery of fluids into layers of the skin of a living creature, and in particular, for intradermal or intraepidermal delivery of fluids into the skin of a human subject. The fluids delivered may be any fluids. Preferred examples include, but are not limited to, dermatological treatments, vaccines, and other fluids used for cosmetic, therapeutic or diagnostic purposes.” [Col 6, lines 28-34]). Yeshurun fails to explicitly disclose the at least one microneedle comprises a coating comprising the antigen or the drug. Kobayashi teaches a system comprising at least one microneedle (needles 1027) which comprises a coating comprising a drug (“distal end portions of the needles 1027 are coated with a target drug such as vaccine, protein, or peptide.” [0264]). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the microneedles of Yeshurun to comprise a coating comprising the antigen or drug based on the teachings of Kobayashi to enhance transdermal absorption of the drug and liming pain and side effects (Kobayashi [0002]). Regarding claim 24, modified Yeshurun discloses the system of claim 22, wherein the drug has biological activity in the viable epidermis for a dermatological treatment (“the invention is primarily intended for delivery of fluids into layers of the skin of a living creature, and in particular, for intradermal or intraepidermal delivery of fluids into the skin of a human subject. The fluids delivered may be any fluids. Preferred examples include, but are not limited to, dermatological treatments, vaccines, and other fluids used for cosmetic, therapeutic or diagnostic purposes” [Col 6, lines 27-32]) 07-21-aia AIA Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Gill et al. (US 20200138941) in view of Yeshurun et al. (USPN 8007466) . Regarding claim 27, Gill discloses a method for allergen immunotherapy (“The one or more microneedles (e.g., present as a microneedle array) provided herein can be used to delivery one or more food allergens to a subject in need thereof in order to desensitize the subject to the allergen, and/or to obtain a sustained unresponsiveness to the allergen.” [0071]), the method comprising: inserting an array of microneedles comprising an antigen into the skin of a patient (“The device comprises a microneedle array comprising a plurality of solid microneedles extending from a common substrate. Each microneedle of the plurality has a base, shaft and tip, and at least one microneedle of the array is coated with a food allergen.” [0021]), wherein the microneedle has a length and is in inserted effective to locate a majority of the inserted length of the microneedles within the viable epidermis of the skin (“the microneedle tips of the one or more microneedles extend into the epidermis layer of the subject's skin once inserted. In a further embodiment, the microneedle tips extend into the epidermis layer of the skin and do not extend into the dermis layer once inserted into the subject.” [0057]); and releasing the antigen from the inserted microneedle into the viable epidermis (“a subject is treated for a food allergy via delivering an effective amount of an allergen associated with the food allergy into the subject's cutis for an administration period. The delivering is carried out via inserting one or more solid microneedles into the subject's cutis, wherein the one or more solid microneedles each comprises a base, shaft and tip. At least one microneedle of the one or more solid microneedles is coated with allergen associated with the food allergy” [0016]). Gill fails to explicitly disclose the microneedle is in inserted at a non-perpendicular angle effective to locate a majority of the inserted length of the microneedles within the viable epidermis of the skin. Samant discloses a method for targeting epidermal delivery of an agent of interest (“application of a bioactive agent to the patient's skin at or about the insertion site” [0075]; Figure 1A showing application to the viable epidermis 111), the method comprising: inserting an array of microneedles (microneedles 201) comprising an agent of interest into the skin of a patient (Figure 1B; “the bioactive agent may be delivered into the skin using a microneedle, such as by coating the bioactive agent on the microneedle's outer surface, by encasing the bioactive agent with the microneedle or in porosities of the microneedles” [0075]), wherein the microneedle has a length and is inserted at an angle that is non-perpendicular to the skin surface effective to locate a majority of the inserted length of the microneedles within the viable epidermis of the skin (“the microneedles are inserted into the skin at an angle less than 90° relative to the skin surface. For example, the microneedles may be inserted into the skin at an angle of about 10° to about 45° relative to the skin surface” [0054]; Figure 2, wherein the majority of the length of microneedles 201 is located within viable epidermis 111). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method for allergen immunotherapy of Gill to include the microneedle is in inserted at a non-perpendicular angle effective to locate a majority of the inserted length of the microneedles within the viable epidermis of the skin based on the teaching of Samant to facilitate ease of insertion of the microneedles into the skin and reduce the likelihood of puncturing blood vessels (Samant [0054]). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LEAH J SWANSON/ Examiner, Art Unit 3783 /KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783 Application/Control Number: 18/700,816 Page 2 Art Unit: 3783 Application/Control Number: 18/700,816 Page 3 Art Unit: 3783 Application/Control Number: 18/700,816 Page 4 Art Unit: 3783 Application/Control Number: 18/700,816 Page 5 Art Unit: 3783 Application/Control Number: 18/700,816 Page 6 Art Unit: 3783 Application/Control Number: 18/700,816 Page 7 Art Unit: 3783 Application/Control Number: 18/700,816 Page 8 Art Unit: 3783 Application/Control Number: 18/700,816 Page 9 Art Unit: 3783 Application/Control Number: 18/700,816 Page 10 Art Unit: 3783 Application/Control Number: 18/700,816 Page 11 Art Unit: 3783 Application/Control Number: 18/700,816 Page 12 Art Unit: 3783 Application/Control Number: 18/700,816 Page 13 Art Unit: 3783 Application/Control Number: 18/700,816 Page 14 Art Unit: 3783 Application/Control Number: 18/700,816 Page 15 Art Unit: 3783 Application/Control Number: 18/700,816 Page 16 Art Unit: 3783 Application/Control Number: 18/700,816 Page 17 Art Unit: 3783 Application/Control Number: 18/700,816 Page 18 Art Unit: 3783 Application/Control Number: 18/700,816 Page 19 Art Unit: 3783 Application/Control Number: 18/700,816 Page 20 Art Unit: 3783
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