DETAILED ACTION
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 .
Response to Amendment
The amendment filed January 29, 2026 has been entered. Claims 1-5 and 7-21 remain pending in the application. Claim 6 was previously cancelled. Applicant’s amendments to the claims have overcome the objections previously set forth in the Non-Final Rejection mailed July 31, 2025.
Claim Objections
Claim 16 is objected to because there is a lack of antecedent basis for “the actuating component core” as opposed to “the central core” in line 1. 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.
Claim 20 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.
Regarding claim 20, the limitation “further comprising a capsule” in line 1 renders the claim indefinite. It is unclear if “a capsule” introduced in claim 1 is the same structure as “a capsule” introduced in claim 5, line 7, from which claim 20 depends, or if the article comprises two separate capsules. For examination purposes, “a capsule” in claim 20, line 1 has been interpreted to be the same structure as “a capsule” introduced in claim 5, line 7.
It is suggested to amend claim 20 to: “An article as in claim 5, wherein the plurality of microneedles, at least in the pre-deployment configuration within the capsule, are oriented external to a geometric center of the capsule.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 7-9, 14-18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bellinger et al. (WO 2015/191920) in view of Imran (US 2016/0158516).
Regarding claim 1, Bellinger discloses an article (structure 102 within “a capsule” [Page 17, line 3]; Figure 4C, for example), comprising:
a capsule (“the folded/compressed residence structure may be inserted within a capsule or other containment structure in the second configuration such that the residence structure can be delivered orally.” [Page 17, lines 2-4]);
an actuating component (structure 102) disposed within and operably separate from the capsule (Figure 4C; “The capsule or other containment structure can be, in some cases, configured to dissolve such that the residence structure is released at a particular location internal to the subject (e.g., in the stomach) whereby upon release, it can reversibly revert to the first configuration (e.g.by. recoil)” [Page 17, lines 5-8]), the actuating component comprising a central core (first polymeric component 110) and three or more arms (second polymeric components 120) associated with and extending from the central core (Figure 1E), having a first, folded pre-deployment configuration (Figure 1F) when disposed within the capsule (“the structures illustrated in FIGs. 1E-1H may be delivered (e.g., orally administered) to a subject via a capsule (containing the structure in the second configuration)” [Page 60, lines 25-27]) and a second, deployed configuration (Figure 1E), upon complete release and complete separation from the capsule (“the structures illustrated in FIGs. 1E-1H may be delivered (e.g., orally administered) to a subject via a capsule (containing the structure in the second configuration) and released (obtaining the first configuration)” [Page 60, lines 25-28]); and
each arm having a proximal portion and a distal end (Figure 1E) and comprising an active pharmaceutical agent (“the structure (e.g., the loadable polymeric component) is pre-loaded with an active substance such as a therapeutic” [Page 36, lines 13-14]), wherein change between the pre-deployment configuration (Figure 1F) and the deployed configuration (Figure 1E) is mediated by the central core that undergoes elastic deformation when the actuating component is in the folded pre-deployment configuration and recoils when the actuating component assumes the deployed configuration (“The capsule or other containment structure can be, in some cases, configured to dissolve such that the residence structure is released at a particular location internal to the subject (e.g., in the stomach) whereby upon release, it can reversibly revert to the first configuration (e.g.by. recoil).” [Page 17, line 5-8]; “In some embodiments, the structure with projections comprises a flexible material configured for elastic (non-plastic) deformation. The projections themselves may be flexible or rigid with flexible connections to a core” [Page 58, lines 10-13]).
Bellinger fails to explicitly disclose each arm comprising an array comprising a plurality of microneedles disposed near the distal end, the plurality of microneedles comprising the active pharmaceutical agent.
Imran teaches an article (device 110; for deployment in the stomach “embodiments of the invention can be used for delivering drug in a number of locations in the GI tract including the stomach” [0081]) comprising a capsule (capsule 120); an actuating component comprising a central core (delivery member 172) and multiple arms (biodegradable advancement structure/platform 175) associated with and extending from the central core (Figures 20a-i) having a first pre-deployment configuration when disposed within the capsule (Figure 20a) and a second, deployed configuration (Figure 20h-i), upon complete relation and separation from the capsule (Figure 20I; “in step 407, balloon 172, (along with balloons 160 and 130) has deflated pulling back and leaving tissue penetrating members retained in the intestinal wall IW. Also, the body portion 120p″ of the capsule has completely degraded (due to degradation of coating 120c″) along with other biodegradable portions of device 110. Any portion not degraded is carried distally through the small intestine by peristaltic contraction from digestion and is ultimately excreted.” [0137]); and each arm comprising an array comprising a plurality of microneedles (tissue penetrating members 140) disposed near a distal end (Figure 19 and 20b-h), the plurality of microneedles comprising an active pharmaceutical agent (“Tissue penetrating member 140 can be fabricated from various drugs and other therapeutic agents 101” [0123]).
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 article of Bellinger to include that each arm comprising an array comprising a plurality of microneedles disposed near the distal end, the plurality of microneedles comprising the active pharmaceutical agent based on the teachings of Imran to allow for controlled release of the active pharmaceutical agent to ensure that a full dose of the active pharmaceutical agent is absorbed by the blood stream (Imran [0123]).
Regarding claim 2, modified Bellinger discloses an article as in claim 1.
Modified Bellinger fails to explicitly disclose wherein the plurality of microneedles, at least in the pre- deployment configuration, are oriented external to a geometric center of the capsule.
Imran teaches an article (device 110) comprising a capsule (capsule 120); an actuating component comprising a central core (delivery member 172) and multiple arms (biodegradable advancement structure/platform 175) associated with and extending from the central core (Figures 20a-i); each arm comprising a plurality of microneedles (tissue penetrating members 140), wherein the plurality of microneedles, at least in the pre- deployment configuration, are oriented external to a geometric center of the capsule (Figure 17a, for example, showing that the tissue penetrating members 140 are located radially outward from the geometric center of the capsule 120).
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 article of Bellinger to include the plurality of microneedles, at least in the pre- deployment configuration, are oriented external to a geometric center of the capsule based on the teachings of Imran to ensure that the plurality of microneedles are able to be fully deployed and allow for controlled release of the active pharmaceutical agent to ensure that a full dose of the active pharmaceutical agent is absorbed by the blood stream (Imran [0123]).
Regarding claims 3-4, Bellinger discloses an article (structure 102 within “a capsule” [Page 17, line 3]; Figure 4C, for example), comprising:
a capsule (“the folded/compressed residence structure may be inserted within a capsule or other containment structure in the second configuration such that the residence structure can be delivered orally.” [Page 17, lines 2-4]);
an actuating component (structure 102) disposed within and operably separate from the capsule (Figure 4C; “The capsule or other containment structure can be, in some cases, configured to dissolve such that the residence structure is released at a particular location internal to the subject (e.g., in the stomach) whereby upon release, it can reversibly revert to the first configuration (e.g.by. recoil)” [Page 17, lines 5-8]), the actuating component comprising a central core (first polymeric component 110) and three or more arms (second polymeric components 120) associated with and extending from the central core (Figure 1E), having a first, folded pre-deployment configuration (Figure 1F) and a deployed configuration (Figure 1E); and
at least one arm having a proximal portion and a distal end (Figure 1E), wherein
wherein the actuating component has the pre-deployment configuration within the capsule (Figure 1F; “the structures illustrated in FIGs. 1E-1H may be delivered (e.g., orally administered) to a subject via a capsule (containing the structure in the second configuration)” [Page 60, lines 25-27]) and the deployed configuration, different than the pre-deployment configuration and obtained upon complete release and complete separation of the actuating component from the capsule, external to the capsule (“the structures illustrated in FIGs. 1E-1H may be delivered (e.g., orally administered) to a subject via a capsule (containing the structure in the second configuration) and released (obtaining the first configuration)” [Page 60, lines 25-28]), wherein change between the pre-deployment configuration and the deployed configuration is mediated by the central core that undergoes elastic deformation when the actuating component is in the folded pre-deployment configuration and recoils when the actuating component assumes the deployed configuration (“The capsule or other containment structure can be, in some cases, configured to dissolve such that the residence structure is released at a particular location internal to the subject (e.g., in the stomach) whereby upon release, it can reversibly revert to the first configuration (e.g.by. recoil).” [Page 17, line 5-8]; “In some embodiments, the structure with projections comprises a flexible material configured for elastic (non-plastic) deformation. The projections themselves may be flexible or rigid with flexible connections to a core” [Page 58, lines 10-13]).
Bellinger fails to explicitly disclose at least one arm having an array of protrusions disposed near the distal end, as required by claim 3; and wherein the protrusion comprises a plurality of microneedles, as required by claim 4.
Imran teaches an article (device 110; for deployment in the stomach “embodiments of the invention can be used for delivering drug in a number of locations in the GI tract including the stomach” [0081]) comprising a capsule (capsule 120); an actuating component comprising a central core (delivery member 172) and multiple arms (biodegradable advancement structure/platform 175) associated with and extending from the central core (Figures 20a-i) having a first pre-deployment configuration (Figure 20a) and a deployed configuration (Figure 20h-i); and at least one arm comprising an array of protrusions comprising a plurality of microneedles (tissue penetrating members 140) disposed near a distal end (Figure 19 and 20b-h).
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 article of Bellinger to include at least one arm having an array of protrusions disposed near the distal end, wherein the protrusion comprises a plurality of microneedles based on the teachings of Imran to allow for controlled release of the active pharmaceutical agent to ensure that a full dose of the active pharmaceutical agent is absorbed by the blood stream (Imran [0123]).
Regarding claim 7, modified Bellinger discloses an article as in claim 1, wherein each arm has an unfolding force of greater than or equal to 0.2 N (“the residence structure has a folding force of at least about 0.2 N” [Page 3, line 4-5]).
Regarding claim 8, modified Bellinger discloses an article as in claim 1, wherein each arm is configured to disassociate in a location internal of a subject in less than 24 hours after obtaining the deployed configuration (“the linker comprises a material such that, under relatively neutral pH physiological conditions (e.g., such as those in the duodenum), the linker can be mechanically broken (i.e. mechanical failure) by a tensile force less than or equal to about 2 N… within less than or equal to about 24 hours under said neutral pH physiological conditions” [Page 47, lines 15-19], wherein the linkers 134,135 connect the second polymeric components 120 to the first polymeric component 110).
Regarding claim 9, modified Bellinger discloses an article as in claim 1, wherein the actuating component is configured for adopting a shape and/or size for gastric deployment after being stored in the pre- deployment configuration for durations of greater than or equal to 10 seconds and less than or equal to 24 hours (“the elastic polymeric component may have a strength of recoil sufficient to substantially return the elastic polymeric component to its pre-deformed shape within less than about 30 minutes, within less than about 10 minutes, within less than about 5 minutes, or within less than about 1 minute after release of the mechanical deformation.” [Col 22, lines 8-10]).
Regarding claim 13, modified Bellinger discloses an article as in claim 1.
Modified Bellinger fails to explicitly disclose wherein the pharmaceutical agent is present in the plurality of microneedles in an amount of greater than or equal to 10 wt% and less than or equal to 100 wt%.
Imran teaches an article (device 110) comprising a capsule (capsule 120); an actuating component comprising a central core (delivery member 172) and three or more arms (support platform), at least one arm comprising a plurality of microneedles (tissue penetrating members 140); wherein a pharmaceutical agent is present in the plurality of microneedles in an amount of greater than or equal to 10 wt% and less than or equal to 100 wt% (“depending upon the drug 101 and the desired delivered dose, the weight percent of drug in member 140 can range from about 0.1 to about 15%” [0129]).
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 article of Bellinger to include the pharmaceutical agent is present in the plurality of microneedles in an amount of greater than or equal to 10 wt% and less than or equal to 100 wt% based on the teachings of Imran to provide the desired dose and concentration profile of the drug in the body (Imran [0129]).
Regarding claim 14, modified Bellinger discloses an article as in claim 1, wherein the central core comprises a same or a different material as each arm of the three or more arms of the actuating component (“Structure 102 comprises elastic polymeric component 110 coupled with loadable polymeric components 120. For example, loadable polymeric component 120 may be coupled with elastic polymeric component 110 via optional first linkers 130. In certain embodiments, elastic polymeric component 110 comprises an enteric elastomer.” [Col 59, lines 3-6]).
Regarding claim 15, modified Bellinger discloses an article as in claim 1, wherein the core is configured for undergoing mechanical deformation such that the core does not permanently deform and/or break, and/or is configured to recoil after a particular amount of time such that the actuating component can be selectively retained at a location internally of a subject until delivery of the pharmaceutical agent and/or dissolution of the plurality of microneedles and/or arms (“the structure comprises one or more polymeric components configured for containing and/or releasing a therapeutic agent, and/or configured for undergoing mechanical deformation such that the component(s) does not permanently deform and/or break, and/or configured to recoil after a particular amount of time such that the structure can be selectively retained at a location internally of a subject.” [Page 18, lines 10-16]).
Regarding claim 16, modified Bellinger discloses an article as in claim 1, wherein the actuating component core comprises an elastic polymeric material (“Structure 102 comprises elastic polymeric component 110 coupled with loadable polymeric components 120. For example, loadable polymeric component 120 may be coupled with elastic polymeric component 110 via optional first linkers 130. In certain embodiments, elastic polymeric component 110 comprises an enteric elastomer.” [Col 59, lines 3-6]).
Regarding claim 17, modified Bellinger discloses an article as in claim 1, wherein each arm (second polymeric components 120) comprises a degradable material (“. A first degradable linker is present in each loadable polymeric component near or at the interface with the elastic polymeric component, by a first degradable linker. In certain embodiments, the loadable polymeric components further comprise a second degradable linker that may be the same as or different from the first degradable linker.” [Page 19, lines 19-23]; linkers 134, 135 in Figure 1E).
Regarding claim 18, modified Bellinger discloses an article as in claim 1, wherein each arm has a length of greater than or equal to 10 mm and less than or equal to 30 mm (“the loadable polymeric components have a length of between about 1.3 and about 2.7 cm.” [Page 11, lines 9-10], equivalent to 13 to 27 mm; and “the projections each may have a length of about 0.5 cm to about 2.5 cm” [Page 58, lines 18-19], equivalent to 5-25 mm).
Regarding claim 21, modified Bellinger discloses an article as in claim 1, wherein at least a portion of the capsule is configured to dissolve, degrade, mechanically weaken, and/or mechanically separate at a location internal to a subject such that the actuating component is completely released from the capsule (“The capsule or other containment structure can be, in some cases, configured to dissolve such that the residence structure is released at a particular location internal to the subject (e.g., in the stomach) whereby upon release, it can reversibly revert to the first configuration (e.g.by. recoil).” [Page 17, lines 5-8]).
Claims 5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bellinger et al. (WO 2015/191920) in view of Imran (US 2016/0158516) and further in view of Prausnitz et al. (USPN 6743211).
Regarding claim 5, Bellinger discloses an article (structure 102 within “a capsule” [Page 17, line 3]; Figure 4C, for example), comprising:
a central core (first polymeric component 110);
three or more arms (second polymeric components 120) associated with and extending from the central core (Figure 1E); and
a capsule (“the folded/compressed residence structure may be inserted within a capsule or other containment structure in the second configuration such that the residence structure can be delivered orally.” [Page 17, lines 2-4]) such that the arms have a pre-deployment configuration within the capsule (Figure 1F; “the structures illustrated in FIGs. 1E-1H may be delivered (e.g., orally administered) to a subject via a capsule (containing the structure in the second configuration)” [Page 60, lines 25-27]) and a deployed configuration (Figure 1E), different than the pre-deployment configuration and obtained upon complete release and complete separation of the arms from the capsule, external to the capsule (“the structures illustrated in FIGs. 1E-1H may be delivered (e.g., orally administered) to a subject via a capsule (containing the structure in the second configuration) and released (obtaining the first configuration)” [Page 60, lines 25-28]).
Bellinger fails to explicitly disclose an array of a plurality of microneedles disposed proximate a distal end of each arm, wherein an average spacing between adjacent microneedles of the plurality of microneedles is greater than or equal to 50 microns and less than or equal to 1500 microns; and the capsule such that the plurality of microneedles has a pre-deployment configuration within the capsule and a deployed configuration, different than the pre-deployment configuration and obtained upon complete release and complete separation of the plurality of microneedles from the capsule, external to the capsule.
Imran teaches an article (device 110; for deployment in the stomach “embodiments of the invention can be used for delivering drug in a number of locations in the GI tract including the stomach” [0081]) comprising a central core (delivery member 172) and multiple arms (biodegradable advancement structure/platform 175) associated with and extending from the central core (Figures 20a-i); an array comprising a plurality of microneedles (tissue penetrating members 140) disposed proximate a distal end of each arm (Figure 19 and 20b-h); and a capsule (capsule 120) such that the plurality of microneedles has a pre-deployment configuration within the capsule (Figure 20a) and a deployed configuration (Figure 20I), different than the pre-deployment configuration and obtained upon complete release and complete separation of the plurality of microneedles from the capsule, external to the capsule (“Then, in step 407, balloon 172, (along with balloons 160 and 130) has deflated pulling back and leaving tissue penetrating members retained in the intestinal wall IW. Also, the body portion 120p″ of the capsule has completely degraded (due to degradation of coating 120c″) along with other biodegradable portions of device 110. Any portion not degraded is carried distally through the small intestine by peristaltic contraction from digestion and is ultimately excreted.” [0137]).
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 article of Bellinger to include an array of a plurality of microneedles disposed proximate a distal end of each arm, and the capsule such that the plurality of microneedles has a pre-deployment configuration within the capsule and a deployed configuration, different than the pre-deployment configuration and obtained upon complete release and complete separation of the plurality of microneedles from the capsule, external to the capsule based on the teachings of Imran to allow for controlled release of the active pharmaceutical agent to ensure that a full dose of the active pharmaceutical agent is absorbed by the blood stream (Imran [0123]).
Modified Bellinger in view of Imran fails to explicitly disclose an average spacing between adjacent microneedles of the plurality of microneedles is greater than or equal to 50 microns and less than or equal to 1500 microns.
Prausnitz teaches an article (device 10) comprising a plurality of microneedles (plurality of microneedles 12), wherein an average spacing between adjacent microneedles of the plurality of microneedles is greater than or equal to 50 microns and less than or equal to 1500 microns (“the microtubes have a tube center-to-center spacing of about 150 µm” [Col 22, lines 23-24]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the microneedles of Bellinger in view of Imran to have an average spacing between adjacent microneedles of the plurality of microneedles greater than or equal to 50 microns and less than or equal to 1500 microns based on the teachings of Prausnitz to enhance the microneedles’ contact with the target penetration location by adapting to the target’s radius of curvature (Prausnitz [Col 11, line 5-12]).
Regarding claim 20, modified Bellinger discloses an article as in claim 5, further comprising a capsule (“the folded/compressed residence structure may be inserted within a capsule or other containment structure in the second configuration such that the residence structure can be delivered orally.” [Page 17, lines 2-4]).
Modified Bellinger fails to explicitly disclose wherein the plurality of microneedles, at least in the pre- deployment configuration, are oriented external to a geometric center of the capsule.
Imran teaches an article (device 110) comprising a capsule (capsule 120); a central core (delivery member 172), multiple arms (biodegradable advancement structure/platform 175) associated with and extending from the central core (Figures 20a-i); and an array of a plurality of microneedles disposed proximate a distal end of each arm (tissue penetrating members 140), wherein the plurality of microneedles, at least in the pre- deployment configuration, are oriented external to a geometric center of the capsule (Figure 17a, for example, showing that the tissue penetrating members 140 are located radially outward from the geometric center of the capsule 120).
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 article of Bellinger to include the plurality of microneedles, at least in the pre- deployment configuration, are oriented external to a geometric center of the capsule based on the teachings of Imran to ensure that the plurality of microneedles are able to be fully deployed and allow for controlled release of the active pharmaceutical agent to ensure that a full dose of the active pharmaceutical agent is absorbed by the blood stream (Imran [0123]).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Bellinger et al. (WO 2015/191920) in view of Imran (US 2016/0158516) as applied in claim 1 above, and further in view of Prausnitz et al. (USPN 6743211).
Regarding claim 10, modified Bellinger discloses an article as in claim 1.
Modified Bellinger fails to explicitly disclose an average diameter of a base of the plurality of microneedles is greater than or equal to 100 microns and less than or equal to 500 microns.
Prausnitz teaches an article (device 10) comprising a plurality of microneedles (plurality of microneedles 12), wherein an average diameter of a base of the plurality of microneedles is greater than or equal to 100 microns and less than or equal to 500 microns (“The diameter of each microneedle 12 generally is between about 10 nm and 1 mm” [Col 9, lines 65-66], equivalent to 0.01-1000 microns).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the microneedles of Bellinger in view of Imran to have an average diameter of a base of the plurality of microneedles is greater than or equal to 100 microns and less than or equal to 500 microns based on the teachings of Prausnitz to ensure the microneedles are able to penetrate the target tissue to deliver the pharmaceutical agent while excluding bacterial entry (Prausnitz [Col 10, line 6-12]).
Regarding claim 11, modified Bellinger discloses an article as in claim 1.
Modified Bellinger fails to explicitly disclose an average height of the plurality of microneedles is greater than or equal to 0.1 mm and less than or equal to 5 mm.
Prausnitz teaches an article (device 10) comprising a plurality of microneedles (plurality of microneedles 12), wherein an average height of the plurality of microneedles is greater than or equal to 0.1 mm and less than or equal to 5 mm (“The height (or length) of the microneedles 12 generally is between about 1 .mu.m and 1 mm.” [Col 9, lines 47-48], equivalent to 0.001-1 mm).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the microneedles of Bellinger in view of Imran to have an average height of the plurality of microneedles is greater than or equal to 0.1 mm and less than or equal to 5 mm based on the teachings of Prausnitz to ensure the microneedles have the length necessary to penetrate the target tissue to deliver the pharmaceutical agent without causing unnecessary pain (Prausnitz [Col 9, line 46-64]).
Regarding claim 12, modified Bellinger discloses an article as in any claim 1.
Modified Bellinger fails to explicitly disclose an average spacing between adjacent microneedles of the plurality of microneedles is greater than or equal to 50 microns and less than or equal to 1500 microns.
Prausnitz teaches an article (device 10) comprising a plurality of microneedles (plurality of microneedles 12), wherein an average spacing between adjacent microneedles of the plurality of microneedles is greater than or equal to 50 microns and less than or equal to 1500 microns (“the microtubes have a tube center-to-center spacing of about 150 µm” [Col 22, lines 23-24]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the microneedles of Bellinger in view of Imran to have an average spacing between adjacent microneedles of the plurality of microneedles greater than or equal to 50 microns and less than or equal to 1500 microns based on the teachings of Prausnitz to enhance the microneedles’ contact with the target penetration location by adapting to the target’s radius of curvature (Prausnitz [Col 11, line 5-12]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Bellinger et al. (WO 2015/191920) in view of Imran (US 2016/0158516) as applied in claim 1 above, and further in view of Berry et al. (US 2009/0156477).
Regarding claim 19, modified Bellinger discloses an article as in claim 1.
Modified Bellinger fails to explicitly disclose the actuating component is configured to deliver greater than or equal to 1 µg and less than or equal to 5000 µg of pharmaceutical agent per square centimeter of tissue of the subject proximate a penetration location of the actuating component.
Berry teaches delivering a pharmaceutical agent to a gastrointestinal tract (“the subject can be one with an ulcerating disease. Ulcerating diseases include regional ileitis of the gastrointestinal tract, ulcerative colitis and peptic ulcers (either duodenal or gastric).” [0073]; “The mode of administration may be any medically acceptable mode including oral, ocular, topical, transdermal, rectal, nasal, subcutaneous, intravenous, etc. or via administration to a mucous membrane.” [0090]), configured to deliver greater than or equal to 1 µg and less than or equal to 5000 µg of pharmaceutical agent per square centimeter of tissue of the subject (“the level of administration is between 5 nanograms to 14 milligrams per 4 square centimeter area of cells.” [0090], equivalent to 0.00125-3500 µg per square centimeter).
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 actuating component of the apparatus of Bellinger to be configured to deliver greater than or equal to 1 µg and less than or equal to 5000 µg of pharmaceutical agent per square centimeter of tissue of the subject proximate a penetration location of the actuating component based on the teachings of Berry to ensure that an effective dose of the pharmaceutical agent is delivered in order to reduce inflammatory response (Berry [0088]).
Response to Arguments
Applicant’s arguments with respect to claims 1-5 and 7-21 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.
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.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights