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 Objections
Claim 16 is objected to because “the primary later” is apparently in error for “The primary layer”. Appropriate correction is required.
Claim 35 is objected to because “an adhesive film on a first surface” is apparently in error for “an adhesive film on the first surface”. Appropriate correction is required.
Claim 40 is objected to because “delivering one or more” (line 4) is apparently in error for “delivering the one or more”. Appropriate correction is required.
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.
Claims 9, 11 are 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 claims are dependent on canceled claims. Furthermore, in claim 9, “the one or more of the plurality of bioresorbable protrusions” and “the at least one of the one or more therapeutic substances” lack antecedent basis.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 and 11 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claims are dependent on canceled claims. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 9, 16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2023/0145564 (Khademhosseini).
Regarding claim 1, 3, 9, 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).
Claim(s) 1, 3, 6, 9, 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2009/0118672 (Gonnelli).
Regarding claim 1, 3, 6, 9, 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).
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0289616 (Chen) in view of US 2009/0131905 (Allen).
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).
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 further in view of US 2016/0066789 (Rogers).
Regarding claim 2, Chen in view of Allen 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, 21, 32-35, 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0265824 (Lalwani) in view of US 2009/0131905 (Allen).
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).
Regarding claim 21, Lalwani in view of Allen fails to explicitly teach the primary layer has an outer lateral dimension that is less than 1 mm. However, Lalwani teaches that the size of the base/ primary layer is a results-effective variable, affecting the dosage delivered (para 79). It has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 IIA. In this case, the general conditions of the claim are disclosed by Lalwani – an apparatus comprising a primary layer and protrusions, wherein the size of the primary layer (base) affects the dosage of therapeutic substance. Discovering the optimum or workable range of size (e.g. the outer lateral dimension) of the primary layer would have been obvious. It would have been obvious to one of ordinary skill in the art at the time of the invention to make the primary layer having an outer lateral dimension that is less than 1 mm in order to deliver a desired dosage, as taught by Lalwani.
Regarding claim 32-35, 40, 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 (para 64-67), wherein the self- sealing delivery device comprises a primary layer and a plurality of bioresorbable protrusions extending from the primary layer (primary layer is 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); 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 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 (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).
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 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, and thereby fluidically seal the tissue barrier with the primary layer, 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).
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 further in view of US 2009/0118672 (Gonnelli).
Regarding claim 40-41, Lalwani in view of Allen 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 2009/0118672 (Gonnelli), and further in view of US 2015/0374964 (Verhoeven).
Regarding claim 42, Lalwani in view of Allen 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 US 2015/0290444 (Wirtanen).
Regarding claim 11, Khademhosseini 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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0145564 (Khademhosseini) in view of US 2018/0289616 (Chen).
Regarding claim 15, Khademhosseini fails to teach the one or more therapeutic substances comprise a plurality of therapeutic substances, and wherein a first one of the plurality of therapeutic substances has a first release profile, a second one of the plurality of therapeutic substances has a second release profile, and wherein the second release profile is different from the first release profile. However, Chen teaches bioresorbable protrusions having a plurality of therapeutic substances, and wherein a first one of the plurality of therapeutic substances has a first release profile, a second one of the plurality of therapeutic substances has a second release profile, and wherein the second release profile is different from the first release profile (Fig 4, para 72; different therapeutic substances S1 and S2 with different release profiles – rapid or sustained). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the bioresorbable protrusions having a plurality of therapeutic substances, and wherein a first one of the plurality of therapeutic substances has a first release profile, a second one of the plurality of therapeutic substances has a second release profile, and wherein the second release profile is different from the first release profile in order to deliver two different substances, as taught by Chen. 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 bioresorbable protrusions having a plurality of therapeutic substances, and wherein a first one of the plurality of therapeutic substances has a first release profile, a second one of the plurality of therapeutic substances has a second release profile, and wherein the second release profile is different from the first release profile yields predictable results (multiple 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 US 2017/0281919 (Asai).
Regarding claim 22, Khademhosseini teaches the primary layer comprises a second surface that is generally opposite the first surface (second surface is the surface opposite the skin/tissue facing surface) but fails to teach at least one attachment mechanism disposed at the second surface, wherein the at least one attachment mechanism is configured to detachably mechanically couple the primary layer to an insertion instrument. However, Asai teaches at least one attachment mechanism disposed at the second surface, wherein the at least one attachment mechanism is configured to detachably mechanically couple the primary layer to an insertion instrument (Fig 5-6, para 76; attachment mechanism 52 at second surface of 16 and detachably mechanically couples the primary layer 16 to an insertion instrument 45 or 20). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide at least one attachment mechanism disposed at the second surface, wherein the at least one attachment mechanism is configured to detachably mechanically couple the primary layer to an insertion instrument 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 at least one attachment mechanism disposed at the second surface, wherein the at least one attachment mechanism is configured to detachably mechanically couple the primary layer to an insertion instrument 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 US 2012/0296280 (Eum).
Regarding claim 30, Khademhosseini 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 US 2012/0296280 (Eum).
Regarding claim 30, Gonnelli 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2003/0199812 teaches a primary layer with an integrated reservoir (Fig 1). US 9302903 teaches protrusions comprising multiple therapeutic substances having varying release profiles (Fig 3)
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/ANDREW H NGUYEN/Primary Examiner, Art Unit 3741