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 .
DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. “the adhesive” is indefinite because the “adhesive” and the “additional adhesive” are not clearly distinguished. Examiner suggests making the “adhesive” a “first adhesive”.
Claim Rejections - 35 USC § 103
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) 1, 3, 9, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0145564 (Khademhosseini) in view of WO 2019/221559 (Cha).
Regarding claim 1, 3, 9, 15-16, Khademhosseini teaches an apparatus (Fig 1A-1C), comprising: a primary layer comprising a first surface configured to be positioned abutting a tissue barrier associated with a fluidically-sealed chamber within a body of a recipient (primary layer comprising a first surface, construed as the tissue facing surface of 12 and 22; tissue barrier 100 associated with a fluidically sealed chamber inside the skin tissue; the chamber is within a body of a recipient; furthermore, “configured to be positioned” is a statement of intended use and does not differentiate the claimed apparatus from the prior art); a plurality of bioresorbable protrusions extending from the first surface and configured to form openings in the tissue barrier and deliver one or more therapeutic substances to the fluidically-sealed chamber (bioresorbable protrusions 14 pierce the tissue, thereby forming openings, and are degradable/dissolve in the body; para 31-38); and an adhesive disposed on at least a portion of the first surface configured to adhere the first surface to the tissue barrier and fluidically-seal the openings formed by the plurality of bioresorbable protrusions (adhesive layer 22 adheres the first surface to the tissue 100 and surrounds the protrusions, which would seal the openings from outside the patch), wherein the adhesive comprises at least one of an adhesive gel disposed on the first surface, an adhesive film disposed on the first surface, or an adhesive integrated into the first surface (Fig 1A; adhesive layer 22 is a layer/film disposed on the first surface, or integrated into the first surface by defining the contact surface with the tissue), the one or more of the plurality of bioresorbable protrusions comprise a bioresorbable scaffold structure loaded with the at least one of the one or more therapeutic substances (Fig 1B; para 35-38; protrusions 14 comprise a bioresorbable scaffold/support structure loaded with therapeutic substance 26), one or more of the adhesive or the primary later includes at least one therapeutic substance (para 35; primary layer including 12 includes therapeutic substance 26).
Khademhosseini fails to teach the adhesive includes at least one therapeutic substance. However, Cha teaches that a microneedle adhesive patch may comprise at least one therapeutic substance in order to heal the wound (see pages 2-7; adhesive comprises hydrogel; on page 7: “a bioadhesive material of the present invention excellent in wound closure and regeneration effect”, and “ a microneedle patch type bioadhesive material of a hydrogel formulation including a mussel adhesive protein for wound closure and regeneration”; on page 8: “the microneedle patch may be one containing a mussel adhesive protein and hyaluronic acid in a ‘therapeutically effective amount’”). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the adhesive including at least one therapeutic substance in order to heal the wound and regenerate tissue, as taught by Cha.
Regarding claims 15-16, Khademhosseini teaches that microneedles may deliver a number of different therapeutic substances, including insulin delivery, immunotherapy, cancer vaccine, sampling, and contraceptive delivery (para 4, 35). Cha teaches the adhesive may comprise a therapeutic agent in order to heal the wound/regenerate tissue (page 2-8). Therefore, one of ordinary skill in the art would recognize that the one or more therapeutic substances configured to be delivered by the plurality of bioresorbable protrusions may be different from the at least one therapeutic substance of the adhesive and wherein the one or more therapeutic substances configured to be delivered by the plurality of bioresorbable protrusions treat a biological symptom (e.g. insulin delivery, immunotherapy, cancer vaccine, etc), and the at least one therapeutic substance of the adhesive promotes healing of the openings (wound healing, tissue generation) in the tissue barrier in order to treat different conditions, as taught by Khademhosseini and Cha. In this case, making the one or more therapeutic substances configured to be delivered by the plurality of bioresorbable protrusions different from the at least one therapeutic substance of the adhesive and wherein the one or more therapeutic substances configured to be delivered by the plurality of bioresorbable protrusions treat a biological symptom (e.g. antibiotics, antiviral agents, analgesics, anesthetics, anorexics, antiarthritics, antidepressants, antihistamines, anti-inflammatory agents, antineoplastic agents, vaccines, including DNA vaccines, adjuvants, biologics, etc), and the at least one therapeutic substance of the adhesive promotes healing of the openings (wound healing, tissue generation) in the tissue barrier, yields predictable results (treating different conditions with different therapeutic substances). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the one or more therapeutic substances configured to be delivered by the plurality of bioresorbable protrusions different from the at least one therapeutic substance of the adhesive and wherein the one or more therapeutic substances configured to be delivered by the plurality of bioresorbable protrusions treat a biological symptom, and the at least one therapeutic substance of the adhesive promotes healing of the openings in the tissue barrier, as taught by Khademhosseini and Cha.
Claim(s) 1, 3, 9, 15-16, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0118672 (Gonnelli) in view of WO 2019/221559 (Cha).
Regarding claim 1, 3, 9, 15-16, 27, Gonnelli teaches an apparatus (Fig 3, 4A-4B), comprising: a primary layer comprising a first surface configured to be positioned abutting a tissue barrier associated with a fluidically-sealed chamber within a body of a recipient (para 28-31; primary layer comprising a first surface 110, construed as the tissue facing surface; tissue barrier is the skin associated with a fluidically sealed chamber inside the skin tissue; the chamber is within a body of a recipient; furthermore, “configured to be positioned” is a statement of intended use and does not differentiate the claimed apparatus from the prior art); a plurality of bioresorbable protrusions extending from the first surface and configured to form openings in the tissue barrier and deliver one or more therapeutic substances to the fluidically-sealed chamber (bioresorbable protrusions 120, 130 pierce the tissue, thereby forming openings, and are degradable/dissolve in the body; para 31); and an adhesive disposed on at least a portion of the first surface configured to adhere the first surface to the tissue barrier and fluidically-seal the openings formed by the plurality of bioresorbable protrusions (adhesive layer 112 adheres the first surface to the tissue and surrounds the protrusions, which would seal the openings from outside the patch), wherein the adhesive comprises at least one of an adhesive gel disposed on the first surface, an adhesive film disposed on the first surface, or an adhesive integrated into the first surface (Fig 4A; adhesive layer 112 is a layer/film disposed on the first surface), the primary layer is resiliently flexible to conform to a shape of a proximal surface of the tissue barrier (para 63), the one or more of the plurality of bioresorbable protrusions comprise a bioresorbable scaffold structure loaded with the at least one of the one or more therapeutic substances (para 31; protrusions comprise a bioresorbable scaffold/support structure loaded with therapeutic substance), a reservoir, wherein the reservoir contains at least one of the one or more therapeutic substances, and wherein one or more plurality of bioresorbable protrusions include one or more outlets that are fluidically-coupled to the reservoir (para 29-31; reservoir 170, outlets 121).
Gonnelli fails to teach the adhesive includes at least one therapeutic substance. However, Cha teaches that a microneedle adhesive patch may comprise at least one therapeutic substance in order to heal the wound (see pages 2-7; adhesive comprises hydrogel; on page 7: “a bioadhesive material of the present invention excellent in wound closure and regeneration effect”, and “ a microneedle patch type bioadhesive material of a hydrogel formulation including a mussel adhesive protein for wound closure and regeneration”; on page 8: “the microneedle patch may be one containing a mussel adhesive protein and hyaluronic acid in a ‘therapeutically effective amount’”). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the adhesive including at least one therapeutic substance in order to heal the wound and regenerate tissue, as taught by Cha.
Regarding claims 15-16, Gonnelli teaches that microneedles may deliver a number of different therapeutic substances, including antibiotics, antiviral agents, analgesics, anesthetics, anorexics, antiarthritics, antidepressants, antihistamines, anti-inflammatory agents, antineoplastic agents, vaccines, including DNA vaccines, adjuvants, biologics, and the like (para 18-22). Cha teaches the adhesive may comprise a therapeutic agent in order to heal the wound/regenerate tissue (page 2-8). Therefore, one of ordinary skill in the art would recognize that the one or more therapeutic substances configured to be delivered by the plurality of bioresorbable protrusions may be different from the at least one therapeutic substance of the adhesive and wherein the one or more therapeutic substances configured to be delivered by the plurality of bioresorbable protrusions treat a biological symptom (e.g. antibiotics, antiviral agents, analgesics, anesthetics, anorexics, antiarthritics, antidepressants, antihistamines, anti-inflammatory agents, antineoplastic agents, vaccines, including DNA vaccines, adjuvants, biologics, etc), and the at least one therapeutic substance of the adhesive promotes healing of the openings (wound healing, tissue generation) in the tissue barrier in order to treat different conditions, as taught by Gonnelli and Cha. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, making the one or more therapeutic substances configured to be delivered by the plurality of bioresorbable protrusions different from the at least one therapeutic substance of the adhesive and wherein the one or more therapeutic substances configured to be delivered by the plurality of bioresorbable protrusions treat a biological symptom (e.g. antibiotics, antiviral agents, analgesics, anesthetics, anorexics, antiarthritics, antidepressants, antihistamines, anti-inflammatory agents, antineoplastic agents, vaccines, including DNA vaccines, adjuvants, biologics, etc), and the at least one therapeutic substance of the adhesive promotes healing of the openings (wound healing, tissue generation) in the tissue barrier, yields predictable results (treating different conditions with different therapeutic substances). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the one or more therapeutic substances configured to be delivered by the plurality of bioresorbable protrusions different from the at least one therapeutic substance of the adhesive and wherein the one or more therapeutic substances configured to be delivered by the plurality of bioresorbable protrusions treat a biological symptom, and the at least one therapeutic substance of the adhesive promotes healing of the openings in the tissue barrier, as taught by Gonnelli and Cha.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0289616 (Chen) in view of US 2009/0131905 (Allen) and WO 2019/221559 (Cha).
Regarding claim 1, Chen teaches an apparatus (Fig 1-2), comprising: a primary layer comprising a first surface configured to be positioned abutting a tissue barrier associated with a fluidically-sealed chamber within a body of a recipient (para 68; primary layer 11 comprising a first surface, construed as the tissue facing surface; tissue barrier is associated with a fluidically sealed chamber inside the tissue; the chamber is within a body of a recipient; furthermore, “configured to be positioned” is a statement of intended use and does not differentiate the claimed apparatus from the prior art); a plurality of bioresorbable protrusions extending from the first surface and configured to form openings in the tissue barrier and deliver one or more therapeutic substances to the fluidically-sealed chamber (bioresorbable protrusions 12, 13 pierce the tissue, thereby forming openings, and are degradable/dissolve in the body; para 66-67; para 57-58: elements 12 are dissolvable/bioresorbable in tissue or body fluid; primary layer 11 is integral with and made of the same material as 12).
Chen fails to teach an adhesive disposed on at least a portion of the first surface configured to adhere the first surface to the tissue barrier and fluidically-seal the openings formed by the plurality of bioresorbable protrusions. However, Allen teaches that an adhesive may be applied on at least a portion of the first surface configured to adhere the first surface to the tissue barrier and fluidically-seal the openings formed by the plurality of bioresorbable protrusions (para 62, 110; adhering the substrate to the tissue/barrier would create a fluidic seal). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide an adhesive disposed on at least a portion of the first surface configured to adhere the first surface to the tissue barrier and fluidically-seal the openings formed by the plurality of bioresorbable protrusions in order to facilitate contact with the tissue/barrier, as taught by Allen. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, an adhesive disposed on at least a portion of the first surface configured to adhere the first surface to the tissue barrier and fluidically-seal the openings formed by the plurality of bioresorbable protrusions yields predictable results (coupling the microneedle device to tissue).
Chen in view of Allen fails to teach the adhesive includes at least one therapeutic substance. However, Cha teaches that a microneedle adhesive patch may comprise at least one therapeutic substance in order to heal the wound (see pages 2-7; adhesive comprises hydrogel; on page 7: “a bioadhesive material of the present invention excellent in wound closure and regeneration effect”, and “ a microneedle patch type bioadhesive material of a hydrogel formulation including a mussel adhesive protein for wound closure and regeneration”; on page 8: “the microneedle patch may be one containing a mussel adhesive protein and hyaluronic acid in a ‘therapeutically effective amount’”). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the adhesive including at least one therapeutic substance in order to heal the wound and regenerate tissue, as taught by Cha.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0289616 (Chen) in view of US 2009/0131905 (Allen) and WO 2019/221559 (Cha), and further in view of US 2016/0066789 (Rogers).
Regarding claim 2, Chen in view of Allen and Cha teaches the primary layer being bioresorbable (Chen; para 57-58; primary layer 11 is integral with and made of the same material as 12, which is bioresorbable) but fails to teach the adhesive being bioresorbable. However, Rogers teaches that the primary layer and adhesives may also be bioresorbable (para 165; adhesive layers and substrates bioresorbable). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the primary layer and adhesive bioresorbable, as taught by Rogers. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, making the primary layer and adhesive bioresorbable yields predictable results (bioresorbing of various devices and elements).
Claim(s) 1, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0265824 (Lalwani) in view of US 2009/0131905 (Allen) and WO 2019/221559 (Cha).
Regarding claim 1, 11, Lalwani teaches an apparatus (Fig 6) comprising: a primary layer comprising a first surface configured to be positioned abutting a tissue barrier associated with a fluidically-sealed chamber within a body of a recipient (para 66-67; primary layer is the circular base comprising a first surface from which the microneedles extend, construed as the RWM facing surface; RWM is associated with a fluidically sealed chamber inside the cochlea – para 8; the chamber is within a body of a recipient; furthermore, “configured to be positioned” is a statement of intended use and does not differentiate the claimed apparatus from the prior art); a plurality of bioresorbable protrusions extending from the first surface and configured to form openings in the tissue barrier and deliver one or more therapeutic substances to the fluidically-sealed chamber (para 62-66; micro-needles may comprise a coating with therapeutic substance), one or more of the plurality of bioresorbable protrusions are coated with at least one of the one or more therapeutic substances (para 66).
Lalwani fails to teach an adhesive disposed on at least a portion of the first surface configured to adhere the first surface to the tissue barrier and fluidically-seal the openings formed by the plurality of bioresorbable protrusions. However, Allen teaches that an adhesive may be applied on at least a portion of the first surface configured to adhere the first surface to the tissue barrier and fluidically-seal the openings formed by the plurality of bioresorbable protrusions (para 62, 110; adhering the substrate to the tissue/barrier would create a fluidic seal). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide an adhesive disposed on at least a portion of the first surface configured to adhere the first surface to the tissue barrier and fluidically-seal the openings formed by the plurality of bioresorbable protrusions in order to facilitate contact with the tissue/barrier, as taught by Allen. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, an adhesive disposed on at least a portion of the first surface configured to adhere the first surface to the tissue barrier and fluidically-seal the openings formed by the plurality of bioresorbable protrusions yields predictable results (coupling the microneedle device to tissue).
Lalwani in view of Allen fails to teach the adhesive includes at least one therapeutic substance. However, Cha teaches that a microneedle adhesive patch may comprise at least one therapeutic substance in order to heal the wound (see pages 2-7; adhesive comprises hydrogel; on page 7: “a bioadhesive material of the present invention excellent in wound closure and regeneration effect”, and “ a microneedle patch type bioadhesive material of a hydrogel formulation including a mussel adhesive protein for wound closure and regeneration”; on page 8: “the microneedle patch may be one containing a mussel adhesive protein and hyaluronic acid in a ‘therapeutically effective amount’”). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the adhesive including at least one therapeutic substance in order to heal the wound and regenerate tissue, as taught by Cha.
Claim(s) 32-33, 40, 57-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0265824 (Lalwani) in view of US 2009/0131905 (Allen) and US 2003/0073979 (Naimark).
Regarding claim 32-33, 40, 57-60, Lalwani teaches a method, comprising: accessing a tissue barrier associated with a fluidically-sealed chamber in a body of a recipient (para 56-66; tissue barrier is the round window membrane RWM); positioning a self-sealing delivery device adjacent the tissue barrier via an insertion instrument (para 64-67; instrument is the “surgical instrument for introduction into the ear, such as a driver, introducer, catheter, or other device”), wherein the self- sealing delivery device comprises a primary layer and a plurality of bioresorbable protrusions extending from a first surface of the primary layer (the primary layer is the surface of the base comprising a first surface from which the microneedles extend; bioresorbable protrusions are the micro-needles comprising a coating having the therapeutic substance; para 62-66, Fig 6); inserting the plurality of bioresorbable protrusions through the tissue barrier (para 62-66) and the insertion instrument is attached to a second surface of the primary layer via a first adhesive configured to weaken upon positioning the self-sealing delivery device adjacent the tissue barrier (Fig 4; second surface is the surface opposite to the protrusions; instrument is attached to the second surface); fluidically-sealing the tissue barrier with the primary layer (apertures formed in the RWM by the micro-needles conform to the size and shape of the micro-needles, and then self-close/self-seal); and delivering one or more therapeutic substances to the fluidically-sealed chamber via the self-sealing delivery device (para 64-66), the tissue barrier is a round window of a cochlea of the recipient, and wherein inserting the plurality of bioresorbable protrusions through the tissue barrier comprises: inserting the plurality of bioresorbable protrusions through the round window (para 56-66), wherein delivering the one or more therapeutic substances to the fluidically-sealed chamber via the self-sealing delivery device comprises: delivering the one or more therapeutic substances from a reservoir that is fluidically coupled to one or more outlets within the primary layer (para 65-67; “the array of micro-needles can be connected to an osmotic pump (or syringe) which is in fluid communication with a reservoir housing the therapeutic agent”; the micro-needles extend from the primary layer; therefore the primary layer comprises one or more outlets), the insertion instrument comprises a syringe configured to hold the one or more therapeutic substances, and the method comprises delivering the one or more therapeutic substances from the syringe to the self-sealing delivery device (para 65; “the array of micro-needles can be connected to an osmotic pump (or syringe) which is in fluid communication with a reservoir housing the therapeutic agent …”), wherein detaching the insertion instrument from the second surface comprises detaching the second surface from a tip of the syringe, the syringe being configured to deliver the one or more therapeutic substances to the self-sealing delivery device via the tip (see combination with Naimark below; the “tip of the syringe” is construed as the end of the syringe, implicitly configured to deliver the therapeutic substance – e.g. therapeutic substance flows from the reservoir of the syringe, through the tip, and either directly or indirectly to the protrusions; the combination with Naimark will allow for detachment of the second surface from the tip of the syringe).
Lalwani teaches fluidically sealing the tissue barrier as discussed above. However, to the extent that the fluidic-seal is formed by contact between the primary layer and the tissue barrier, Allen teaches that an adhesive may be applied on at least a portion of the first surface configured to adhere the first surface to the tissue barrier and fluidically-seal the openings formed by the plurality of bioresorbable protrusions (para 62, 110; adhering the substrate to the tissue/barrier would create a fluidic seal). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a second adhesive disposed on at least a portion of the first surface configured to adhere the first surface to the tissue barrier and fluidically-seal the openings formed by the plurality of bioresorbable protrusions via the second adhesive in order to facilitate contact with the tissue/barrier, and thereby fluidically seal the tissue barrier with the primary layer via the second adhesive, as taught by Allen. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, fluidically sealing the tissue barrier with the primary layer yields predictable results (coupling the primary layer to the tissue barrier and sealing). Regarding claims 34-35, when the combination is made, the steps will include positioning the primary layer abutting a proximal surface of the tissue barrier; and adhering the primary layer to the proximal surface of the tissue barrier (Allen para 62, 110; the adhesive is on the primary layer; adhering includes positioning the primary layer abutting a proximal surface of the tissue barrier; and adhering the primary layer to the proximal surface of the tissue barrier), wherein adhering the primary layer to the proximal surface of the tissue barrier comprises: adhering the primary layer to the proximal surface via at least one of an adhesive gel disposed on a first surface of the primary layer or an adhesive film disposed on a first surface of the primary layer (Allen para 62, 110; proximal surface of the tissue barrier is construed as the surface facing the primary layer; the layer of adhesive applied to the substrate/primary layer is a film – a thin covering or coating).
Lalwani in view of Allen fails to teach the insertion instrument is attached to a second surface of the primary layer via a first adhesive configured to weaken upon positioning the self-sealing delivery device adjacent the tissue barrier and detaching the insertion instrument from the second surface of the primary layer after weakening of the first adhesive while the first surface remains adhered to the tissue barrier via the second adhesive, wherein the second adhesive is configured to dissolve to weaken upon positioning the self-sealing delivery device adjacent the tissue barrier, wherein the second adhesive is configured to dissolve in response to at least one of contact with body fluid or exposure to a threshold temperature. However, Naimark teaches that an insertion instrument may be attached to a second surface of the primary layer via a first adhesive configured to weaken upon positioning the self-sealing delivery device adjacent the tissue barrier and detaching the insertion instrument from the second surface of the primary layer after weakening of the first adhesive while the first surface remains adhered to the tissue barrier via the second adhesive (para 30, 64-68, 81-85, 96, 101, 105: “the patch is disposed upon he wire element using adhesive material such as a bioadhesive glue that dissolves when in contact with body fluid”; when the adhesive is dissolved it is weakened and the instrument is detached), wherein the second adhesive is configured to dissolve to weaken upon positioning the self-sealing delivery device adjacent the tissue barrier, wherein the second adhesive is configured to dissolve in response to at least one of contact with body fluid or exposure to a threshold temperature (para 30, 64-68, 81-85, 96, 101, 105; second adhesive dissolves on body fluid contact). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide an insertion instrument attached to a second surface of the primary layer via a first adhesive configured to weaken upon positioning the self-sealing delivery device adjacent the tissue barrier and detaching the insertion instrument from the second surface of the primary layer after weakening of the first adhesive while the first surface remains adhered to the tissue barrier via the second adhesive, wherein the second adhesive is configured to dissolve to weaken upon positioning the self-sealing delivery device adjacent the tissue barrier, wherein the second adhesive is configured to dissolve in response to at least one of contact with body fluid or exposure to a threshold temperature, in order to release the insertion instrument and leave the microneedle patch adhered to the tissue, as taught by Naimark. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, an insertion instrument attached to a second surface of the primary layer via a first adhesive configured to weaken upon positioning the self-sealing delivery device adjacent the tissue barrier and detaching the insertion instrument from the second surface of the primary layer after weakening of the first adhesive while the first surface remains adhered to the tissue barrier via the second adhesive, wherein the second adhesive is configured to dissolve to weaken upon positioning the self-sealing delivery device adjacent the tissue barrier, wherein the second adhesive is configured to dissolve in response to at least one of contact with body fluid or exposure to a threshold temperature, yields predictable results (detaching the insertion instrument from the primary layer).
Claim(s) 40-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0265824 (Lalwani) in view of US 2009/0131905 (Allen) and US 2003/0073979 (Naimark) and further in view of US 2009/0118672 (Gonnelli).
Regarding claim 40-41, Lalwani in view of Allen and Naimark teaches wherein delivering one or more therapeutic substances to the fluidically-sealed chamber via the self-sealing delivery device comprises: delivering one or more therapeutic substances from a reservoir that is fluidically coupled to one or more outlets within the primary layer, as discussed above, but fails to teach the reservoir is integrated in the primary layer. However, Gonnelli teaches delivering one or more therapeutic substances to the fluidically-sealed chamber via the self-sealing delivery device comprises: delivering one or more therapeutic substances from a reservoir that is fluidically coupled to one or more outlets within the primary layer, wherein the reservoir is integrated in the primary layer (Fig 4A-4B para 29-30; primary layer 101 with integrated reservoir 170; therapeutic substance delivered through outlets coupled to openings 121 in the microneedles). It would have been obvious to one of ordinary skill in the art at the time of the invention to make delivering one or more therapeutic substances to the fluidically-sealed chamber via the self-sealing delivery device comprises: delivering one or more therapeutic substances from a reservoir that is fluidically coupled to one or more outlets within the primary layer, wherein the reservoir is integrated in the primary layer, as taught by Gonnelli. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, delivering one or more therapeutic substances to the fluidically-sealed chamber via the self-sealing delivery device comprises: delivering one or more therapeutic substances from a reservoir that is fluidically coupled to one or more outlets within the primary layer, wherein the reservoir is integrated in the primary layer yields predictable results (therapeutic substance delivery).
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0265824 (Lalwani) in view of US 2009/0131905 (Allen) and US 2003/0073979 (Naimark) and US 2009/0118672 (Gonnelli), and further in view of US 2015/0374964 (Verhoeven).
Regarding claim 42, Lalwani in view of Allen, Naimark, and Gonnelli fails to teach the reservoir is physically separate from the primary layer and is fluidically-coupled to the one or more outlets via a delivery tube and the primary layer. However, Verhoeven teaches that it was known to make a reservoir physically separate from the primary layer and is fluidically-coupled to the one or more outlets via a delivery tube and the primary layer (Fig 2A, para 37-41; reservoir 202, delivery tube 206 delivers therapeutic substance to a primary layer of a delivery device 214, 208). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the reservoir physically separate from the primary layer and is fluidically-coupled to the one or more outlets via a delivery tube and the primary layer. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, making the reservoir physically separate from the primary layer and fluidically-coupled to the one or more outlets via a delivery tube and the primary layer yields predictable results (therapeutic substance delivery).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0145564 (Khademhosseini) in view of WO 2019/221559 (Cha) and further in view of US 2015/0290444 (Wirtanen).
Regarding claim 11, Khademhosseini in view of Cha fails to teach one or more of the plurality of bioresorbable protrusions are coated with at least one of the one or more therapeutic substances. However, Wirtanen teaches that bioresorbable protrusions may be coated with a therapeutic substance (para 105). It would have been obvious to one of ordinary skill in the art at the time of the invention to make one or more of the plurality of bioresorbable protrusions are coated with at least one of the one or more therapeutic substances in order to deliver the therapeutic substance, as taught by Wirtanen. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, making one or more of the plurality of bioresorbable protrusions are coated with at least one of the one or more therapeutic substances yields predictable results (therapeutic substance delivery).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0145564 (Khademhosseini) in view of WO 2019/221559 (Cha) and further in view of US 2017/0281919 (Asai).
Regarding claim 22, Khademhosseini in view of Cha teaches the primary layer comprises a second surface that is generally opposite the first surface (in Khademhosseini, second surface is the surface opposite the skin/tissue facing surface) but fails to teach an additional adhesive disposed at the second surface, wherein the additional adhesive is configured to mechanically couple the primary layer to an insertion instrument, and the additional adhesive is configured to weaken while the primary layer is positioned to abut the tissue barrier to enable the insertion instrument to detach from the primary layer while the first surface adheres to the tissue barrier via the adhesive. However, Asai teaches an additional adhesive disposed at the second surface, wherein the additional adhesive is configured to mechanically couple the primary layer to an insertion instrument, and the additional adhesive is configured to weaken while the primary layer is positioned to abut the tissue barrier to enable the insertion instrument to detach from the primary layer while the first surface adheres to the tissue barrier via the adhesive (Fig 5-6, para 76; additional adhesive 52 at second surface of 16 and mechanically couples the primary layer 16 to an insertion instrument 45 or 20; instrument 45 is removed while the primary layer 16 is still adhered to the tissue; therefore, the additional adhesive is configured to weaken – e.g. releases adhesion – before the primary adhesive). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide an additional adhesive disposed at the second surface, wherein the additional adhesive is configured to mechanically couple the primary layer to an insertion instrument, and the additional adhesive is configured to weaken while the primary layer is positioned to abut the tissue barrier to enable the insertion instrument to detach from the primary layer while the first surface adheres to the tissue barrier via the adhesive in order to apply the needle body, as taught by Asai. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, providing an additional adhesive disposed at the second surface, wherein the additional adhesive is configured to mechanically couple the primary layer to an insertion instrument, and the additional adhesive is configured to weaken while the primary layer is positioned to abut the tissue barrier to enable the insertion instrument to detach from the primary layer while the first surface adheres to the tissue barrier via the adhesive yields predictable results (application of the needle body).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0145564 (Khademhosseini) in view of WO 2019/221559 (Cha) and further in view of US 2012/0296280 (Eum).
Regarding claim 30, Khademhosseini in view of Cha fails to teach one or more of the plurality of bioresorbable protrusions comprise a threaded body configured be screwed through the tissue barrier. However, Eum teaches protrusions comprise a threaded body configured be screwed through the tissue barrier (para 66, Fig 6). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the protrusions comprise a threaded body configured be screwed through the tissue barrier, as taught by Eum. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case making the protrusions comprise a threaded body configured be screwed through the tissue barrier yields predictable results (penetrating the tissue).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0118672 (Gonnelli) in view of WO 2019/221559 (Cha) and further in view of US 2012/0296280 (Eum).
Regarding claim 30, Gonnelli in view of Cha fails to teach one or more of the plurality of bioresorbable protrusions comprise a threaded body configured be screwed through the tissue barrier. However, Eum teaches protrusions comprise a threaded body configured be screwed through the tissue barrier (para 66, Fig 6). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the protrusions comprise a threaded body configured be screwed through the tissue barrier, as taught by Eum. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case making the protrusions comprise a threaded body configured be screwed through the tissue barrier yields predictable results (penetrating the tissue).
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/ANDREW H NGUYEN/Primary Examiner, Art Unit 3741
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