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 .
Claim Objections
Claim 8 objected to because of the following informalities:
In claim 8 line 8, “metallsic” should read “metallic”.
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 1-20 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1, 8, and 15 recites “a maximum outer diameter of about 75 microns to about 150 microns” and “a diameter about 15 microns to about 50 microns”. The term “about” describes a range and the phrase “74 microns to 150 microns” and “15 microns to 50 microns” describe a range. Thus it is unclear which range is being claimed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirk et al. (WO 2022219432 A1) in view of Prausnitz et al. (US Pub No. 20210393436 A1).
Regarding claim 1, Kirk in view of Prausnitz discloses a method for injecting a therapeutic into the inner ear of a subject (Kirk, method 980, Fig. 9) comprising:
providing a microneedle (Kirk, protrusion 546, Fig. 5) having a sharpened distal tip (Kirk, distal end 561, Fig. 5) and a shaft (Kirk, See annotated Fig. 5)
advancing the microneedle into the middle ear space of the subject (Kirk, Positioning a self-sealing delivery device adjacent the tissue barrier …", Fig. 9) and perforating the round window membrane (RWM) of the subject with the sharpened distal tip (Kirk, "… the protrusions 146 will penetrate the round window 121 …" - Para [0034]);
extending the microneedle such that the inner lumen is disposed in the inner ear space of the subject (Kirk, "As a result, the protrusions 146 are located inside the cochlea 130." - Para [0034]);
injecting a volume of therapeutic into the inner ear space (Kirk, "… one or more therapeutic substances are integrated into the protrusions 146 and are released into the cochlea 130 …" - Para [0037]); and
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the RWM (Kirk, round window 121).
Kirk does not expressly disclose a microneedle … with a maximum outer diameter of about 75 microns to about 150 microns, the microneedle defining an inner lumen with a diameter about 15 microns to about 50 microns, the inner lumen having a curvature near the sharpened distal tip such that the inner lumen opens at a side of the microneedle proximal to the sharpened distal tip, the microneedle mounted on a blunt metallic syringe needle, and the blunt metallic syringe needle attached to a syringe secured to a micropump; and retracting the microneedle.
Prausnitz teaches a microneedle … with a maximum outer diameter of about 75 microns to about 150 microns ("… the microneedle has a … diameter that does not exceed 500 microns." - Para [0060]), the microneedle defining an inner lumen with a diameter about 15 microns to about 50 microns ("… aperture diameter of about 5µm to about 400µm." - Para [0061]), the inner lumen having a curvature near the sharpened distal tip (See annotated Fig. 2) such that the inner lumen opens at a side of the microneedle proximal to the sharpened distal tip (See annotated Fig. 2), the microneedle mounted on a blunt metallic syringe needle ("The microneedle 114 may extend from a base comprising, for example, an elongated body 112 …" - Para [0070]), and the blunt metallic syringe needle attached to a syringe (actuator 120, Fig. 4) ("… the base portion 115 of the elongated body may be operably connected to an actuator 120." - Para [0070]) secured to a micropump ("… the microneedle device may include a micropump …" - Para [0090]); and retracting the microneedle (Retracting of microneedle from the eye, Fig. 18).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include a microneedle … with a maximum outer diameter of about 75 microns to about 150 microns, the microneedle defining an inner lumen with a diameter about 15 microns to about 50 microns, the inner lumen having a curvature near the sharpened distal tip such that the inner lumen opens at a side of the microneedle proximal to the sharpened distal tip, the microneedle mounted on a blunt metallic syringe needle, and the blunt metallic syringe needle attached to a syringe secured to a micropump; and retracting the microneedle as taught by Prausnitz for targeted administration of a drug (Prausnitz, Abstract).
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Regarding claim 2, Kirk in view of Prausnitz discloses a method for injecting a therapeutic into the inner ear of a subject (Kirk, method 980, Fig. 9) wherein:
Kirk does not expressly disclose that the microneedle has a maximum outer diameter less than about 100 microns along a portion of the shaft.
Prausnitz teaches that the microneedle has a maximum outer diameter less than about 100 microns along a portion of the shaft ("… the microneedle has a … diameter that does not exceed 500 microns." - Para [0060]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include that the microneedle has a maximum outer diameter less than about 100 microns along a portion of the shaft as taught by Prausnitz for targeted administration of a drug (Prausnitz, Abstract).
Regarding claim 3, Kirk in view of Prausnitz discloses a method for injecting a therapeutic into the inner ear of a subject (Kirk, method 980, Fig. 9) wherein:
Kirk does not expressly disclose that the microneedle is fabricated from a biocompatible polymer, stainless steel, or titanium.
Prausnitz teaches that the microneedle is fabricated from a biocompatible polymer, stainless steel, or titanium ("The microneedle can be formed/constructed of … stainless steel …" - Para [0073]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include that the microneedle is fabricated from a biocompatible polymer, stainless steel, or titanium as taught by Prausnitz for targeted administration of a drug (Prausnitz, Abstract).
Regarding claim 5, Kirk in view of Prausnitz discloses a method for injecting a therapeutic into the inner ear of a subject (Kirk, method 980, Fig. 9) wherein:
Kirk does not expressly disclose that the inner lumen has a diameter of 35 µm or less.
Prausnitz teaches that the inner lumen has a diameter of 35 µm or less ("… aperture diameter of about 5µm to about 400µm." - Para [0061]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include that the inner lumen has a diameter of 35 µm or less as taught by Prausnitz for targeted administration of a drug (Prausnitz, Abstract).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirk et al. (WO 2022219432 A1) in view of Prausnitz et al. (US Pub No. 20210393436 A1) and in further view of Chen et al. (WO 2023003518 A2).
Regarding claim 4, Kirk in view of Prausnitz and Chen discloses a method for injecting a therapeutic into the inner ear of a subject (Kirk, method 980, Fig. 9) wherein:
Kirk in view of Prausnitz does not expressly disclose that the blunt metallic syringe needle is a 30 gauge syringe needle.
Chen teaches that the blunt metallic syringe needle is a 30 gauge syringe needle ("… a single or an array of hollow injectors, such as a syringe of gauge between 25 to 34." - Para [0121]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include that the blunt metallic syringe needle is a 30 gauge syringe needle as taught by Chen so the composition is subcutaneously injected (Chen, Para [016]).
Claim(s) 6, 7, 15-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirk et al. (WO 2022219432 A1) in view of Prausnitz et al. (US Pub No. 20210393436 A1) and in further view of Ross et al. (WO 2022159736 A1).
Regarding claim 6, Kirk in view of Prausnitz and Ross discloses a method for injecting a therapeutic into the inner ear of a subject (Kirk, method 980, Fig. 9) wherein:
injecting into the inner ear space. (Kirk, "… one or more therapeutic substances are integrated into the protrusions 146 and are released into the cochlea 130 …" - Para [0037]).
Kirk in view of Prausnitz does not expressly disclose that a volume of therapeutic comprises injecting 1.0 µL or less of therapeutic.
Ross teaches that a volume of therapeutic comprises injecting 1.0 µL or less of therapeutic ("A total volume of the fluidic composition delivered may be from 1µL to 500µL." - Para [0036]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include that a volume of therapeutic comprises injecting 1.0 µL or less of therapeutic as taught by Ross for transporting the fluidic composition (Ross, Para [0038]).
Regarding claim 7, Kirk in view of Prausnitz and Ross discloses a method for injecting a therapeutic into the inner ear of a subject (Kirk, method 980, Fig. 9) wherein:
injecting into the inner ear space (Kirk, "… one or more therapeutic substances are integrated into the protrusions 146 and are released into the cochlea 130 …" - Para [0037]).
Kirk in view of Prausnitz does not expressly disclose injecting a volume of therapeutic comprises injecting 1.0 µL or less of therapeutic with a rate of 1 µL/min or less.
Ross teaches injecting a volume of therapeutic comprises injecting 1.0 µL or less of therapeutic ("A total volume of the fluidic composition delivered may be from 1µL to 500µL." - Para [0036]) with a rate of 1 µL/min or less ("The fluidic composition may be delivered to the patient at a rate of up to … .01 µL … per second per microneedle." - Para [0037]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include injecting a volume of therapeutic comprises injecting 1.0 µL or less of therapeutic with a rate of 1 µL/min or less as taught by Ross for transporting the fluidic composition (Ross, Para [0038]).
Examiner interprets .01 microliters per second to be equivalent to .6 microliters per minute which is less than microliter/min.
Regarding claim 15, Kirk in view of Prausnitz and Ross disclose a system for injecting a therapeutic into the inner ear of a subject (Kirk, device 140, Fig. 2A), comprising:
a microneedle (Kirk, protrusion 546, Fig. 5) having a sharpened distal tip (Kirk, distal end 561, Fig. 5) and a shaft (Kirk, See annotated Fig. 5 above),
and to inject into the inner ear (Kirk, "… one or more therapeutic substances are integrated into the protrusions 146 and are released into the cochlea 130 …" - Para [0037]). .
Kirk does not expressly disclose a microneedle … with a maximum outer diameter of about 75 microns to about 150 microns, the microneedle defining an inner lumen with a diameter about 15 microns to about 50 microns, the inner lumen having a curvature near the sharpened distal tip such that the inner lumen opens at a side of the microneedle proximal to the sharpened distal tip, the microneedle mounted on a blunt metallic syringe needle, the blunt metallic syringe needle being attached to a syringe secured to a micropump configured to inject 1.0 µL or less of therapeutic into the inner ear at a rate of 1 µL/min or less.
Prausnitz teaches a microneedle … with a maximum outer diameter of about 75 microns to about 150 microns ("… the microneedle has a … diameter that does not exceed 500 microns." - Para [0060]), the microneedle defining an inner lumen with a diameter about 15 microns to about 50 microns ("… aperture diameter of about 5µm to about 400µm." - Para [0061]), the inner lumen having a curvature near the sharpened distal tip (See annotated Fig. 2 above) such that the inner lumen opens at a side of the microneedle proximal to the sharpened distal tip (See annotated Fig. 2 above), the microneedle mounted on a blunt metallic syringe needle ("The microneedle 114 may extend from a base comprising, for example, an elongated body 112 …" - Para [0070]), the blunt metallic syringe needle being attached to a syringe (actuator 120, Fig. 4) ("… the base portion 115 of the elongated body may be operably connected to an actuator 120." - Para [0070]) secured to a micropump ("… the microneedle device may include a micropump …" - Para [0090]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kirk to include a microneedle … with a maximum outer diameter of about 75 microns to about 150 microns, the microneedle defining an inner lumen with a diameter about 15 microns to about 50 microns, the inner lumen having a curvature near the sharpened distal tip such that the inner lumen opens at a side of the microneedle proximal to the sharpened distal tip, the microneedle mounted on a blunt metallic syringe needle, the blunt metallic syringe needle being attached to a syringe secured to a micropump as taught by Prausnitz for targeted administration of a drug (Prausnitz, Abstract).
Prausnitz does not expressly disclose a micropump configured to inject 1.0 µL or less of therapeutic at a rate of 1 µL/min or less.
Ross teaches a micropump configured to inject 1.0 µL or less of therapeutic ("A total volume of the fluidic composition delivered may be from 1µL to 500µL." - Para [0036]) at a rate of 1 µL/min or less ("The fluidic composition may be delivered to the patient at a rate of up to … .01 µL … per second per microneedle." - Para [0037]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kirk to include a micropump configured to inject 1.0 µL or less of therapeutic at a rate of 1 µL/min or less as taught by Ross for transporting the fluidic composition (Ross, Para [0038]).
Regarding claim 16, Kirk in view of Prausnitz and Ross disclose the system (Kirk, device 140, Fig. 2A), as recited above, wherein
Kirk does not expressly disclose that the microneedle has a maximum outer diameter less than about 100 microns along a portion of the shaft.
Prausnitz teaches that the microneedle has a maximum outer diameter less than about 100 microns along a portion of the shaft ("… the microneedle has a … diameter that does not exceed 500 microns." - Para [0060]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include that the microneedle has a maximum outer diameter less than about 100 microns along a portion of the shaft as taught by Prausnitz for targeted administration of a drug (Prausnitz, Abstract).
Regarding claim 17, Kirk in view of Prausnitz and Ross disclose the system (Kirk, device 140, Fig. 2A), as recited above, wherein
Kirk does not expressly disclose that the microneedle is fabricated from a biocompatible polymer, stainless steel, or titanium.
Prausnitz teaches that the microneedle is fabricated from a biocompatible polymer, stainless steel, or titanium ("The microneedle can be formed/constructed of … stainless steel …" - Para [0073]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include that the microneedle is fabricated from a biocompatible polymer, stainless steel, or titanium as taught by Prausnitz for targeted administration of a drug (Prausnitz, Abstract).
Regarding claim 18, Kirk in view of Prausnitz and Ross disclose the system (Kirk, device 140, Fig. 2A), as recited above, wherein
Kirk does not expressly disclose that the microneedle is fabricated from stainless steel or titanium.
Prausnitz teaches that the microneedle is fabricated from stainless steel or titanium ("The microneedle can be formed/constructed of … stainless steel …" - Para [0073]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include that the microneedle is fabricated from stainless steel or titanium as taught by Prausnitz for targeted administration of a drug (Prausnitz, Abstract).
Regarding claim 20, Kirk in view of Prausnitz and Ross disclose the system (Kirk, device 140, Fig. 2A), as recited above, wherein
Kirk does not expressly disclose that the inner lumen has a diameter of 35 µm or less.
Prausnitz teaches that the inner lumen has a diameter of 35 µm or less ("… aperture diameter of about 5µm to about 400µm." - Para [0061]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include that the inner lumen has a diameter of 35 µm or less as taught by Prausnitz for targeted administration of a drug (Prausnitz, Abstract).
Claim(s) 8-10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirk et al. (WO 2022219432 A1) in view of Prausnitz et al. (US Pub No. 20210393436 A1) and Feinstein et al. (WO 2009116037 A2).
Regarding claim 8, Kirk in view of Prausnitz and Feinstein disclose a method for injecting a therapeutic into the cochlea of a subject (Kirk, method 980, Fig. 9), comprising:
providing a microneedle (Kirk, protrusion 546, Fig. 5) having a sharpened distal tip (Kirk, distal end 561, Fig. 5) and a shaft (Kirk, See annotated Fig. 5 above),
advancing the microneedle into the middle ear space of the subject (Kirk, Positioning a self-sealing delivery device adjacent the tissue barrier …", Fig. 9) and perforating the round window membrane (RWM) of the subject with the sharpened distal tip (Kirk, "… the protrusions 146 will penetrate the round window 121 …" - Para [0034]);
extending the micro needle through the RWM such that the inner lumen is disposed in the inner ear of the subject (Kirk, "As a result, the protrusions 146 are located inside the cochlea 130." - Para [0034]);
injecting a volume of therapeutic into the cochlea to distribute the therapeutic the cochlea (Kirk, "… one or more therapeutic substances are integrated into the protrusions 146 and are released into the cochlea 130 …" - Para [0037]); and the RWM (Kirk, round window 121).
Kirk does not expressly disclose a microneedle … with a maximum outer diameter of about 75 microns to about 150 microns, the microneedle defining an inner lumen with a diameter about 15 microns to about 50 microns, the inner lumen having a curvature near the sharpened distal tip such that the inner lumen opens at a side of the microneedle proximal to the sharpened distal tip, and the microneedle mounted on a blunt metallic syringe needle; the blunt metallic syringe needle attached to a syringe secured to a micropump; injecting … the therapeutic into the basal, middle, and apical turns of the cochlea, and retracting of the microneedle.
Prausnitz teaches a microneedle … with a maximum outer diameter of about 75 microns to about 150 microns ("… the microneedle has a … diameter that does not exceed 500 microns." - Para [0060]), the microneedle defining an inner lumen with a diameter about 15 microns to about 50 microns ("… aperture diameter of about 5µm to about 400µm." - Para [0061]), the inner lumen having a curvature near the sharpened distal tip (See annotated Fig. 2 above) such that the inner lumen opens at a side of the microneedle proximal to the sharpened distal tip (See annotated Fig. 2 above), and the microneedle mounted on a blunt metallic syringe needle ("The microneedle 114 may extend from a base comprising, for example, an elongated body 112 …" - Para [0070]); the blunt metallic syringe needle attached to a syringe (actuator 120, Fig. 4) ("… the base portion 115 of the elongated body may be operably connected to an actuator 120." - Para [0070]) secured to a micropump ("… the microneedle device may include a micropump …" - Para [0090]); and retracting of the microneedle (Retracting of microneedle from the eye, Fig. 18).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include a microneedle … with a maximum outer diameter of about 75 microns to about 150 microns, the microneedle defining an inner lumen with a diameter about 15 microns to about 50 microns, the inner lumen having a curvature near the sharpened distal tip such that the inner lumen opens at a side of the microneedle proximal to the sharpened distal tip, the microneedle mounted on a blunt metallic syringe needle, and the blunt metallic syringe needle attached to a syringe secured to a micropump; and retracting the microneedle as taught by Prausnitz for targeted administration of a drug (Prausnitz, Abstract).
Prausnitz does not expressly disclose injecting … the therapeutic into the basal, middle, and apical turns of the cochlea.
Feinstein teaches injecting … the therapeutic into the basal, middle, and apical turns of the cochlea ("… labeling in the basal turn of the cochlea, in the middle turn of the cochlea and in the apical turn of cochlea." - Page 116 Line 28).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include injecting … the therapeutic into the basal, middle, and apical turns of the cochlea as taught by Feinstein so these compounds may be used in the treatment of hearing loss (Feinstein, Page 116, Line 29).
Regarding claim 9, Kirk in view of Prausnitz and Feinstein disclose the method for (Kirk, method 980, Fig. 9), as recited above, wherein
Kirk does not expressly disclose that the microneedle has a maximum outer diameter less than about 100 microns along a portion of the shaft.
Prausnitz teaches that the microneedle has a maximum outer diameter less than about 100 microns along a portion of the shaft ("… the microneedle has a … diameter that does not exceed 500 microns." - Para [0060]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include that the microneedle has a maximum outer diameter less than about 100 microns along a portion of the shaft as taught by Prausnitz for targeted administration of a drug (Prausnitz, Abstract).
Regarding claim 10, Kirk in view of Prausnitz and Feinstein disclose the method for (Kirk, method 980, Fig. 9), as recited above, wherein
Kirk does not expressly disclose that the microneedle is fabricated from a biocompatible polymer, stainless steel, or titanium.
Prausnitz teaches that the microneedle is fabricated from a biocompatible polymer, stainless steel, or titanium ("The microneedle can be formed/constructed of … stainless steel …" - Para [0073]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include that the microneedle is fabricated from a biocompatible polymer, stainless steel, or titanium as taught by Prausnitz for targeted administration of a drug (Prausnitz, Abstract).
Regarding claim 12, Kirk in view of Prausnitz and Feinstein disclose the method for (Kirk, method 980, Fig. 9), as recited above, wherein
Kirk does not expressly disclose that the inner lumen has a diameter of 35 µm or less.
Prausnitz teaches that the inner lumen has a diameter of 35 µm or less ("… aperture diameter of about 5µm to about 400µm." - Para [0061]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include that the inner lumen has a diameter of 35 µm or less as taught by Prausnitz for targeted administration of a drug (Prausnitz, Abstract).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirk et al. (WO 2022219432 A1) in view of Prausnitz et al. (US Pub No. 20210393436 A1) and Feinstein et al. (WO 2009116037 A2) and in further view of Chen et al. (WO 2023003518 A2).
Regarding claim 11, Kirk in view of Prausnitz, Feinstein, and Chen disclose the method for (Kirk, method 980, Fig. 9), as recited above, wherein
Kirk in view of Prausnitz and Feinstein does not expressly disclose that the blunt metallic syringe needle is a 30 gauge syringe needle.
Chen teaches that the blunt metallic syringe needle is a 30 gauge syringe needle ("… a single or an array of hollow injectors, such as a syringe of gauge between 25 to 34." - Para [0121]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include that the blunt metallic syringe needle is a 30 gauge syringe needle as taught by Chen so the composition is subcutaneously injected (Chen, Para [016]).
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirk et al. (WO 2022219432 A1) in view of Prausnitz et al. (US Pub No. 20210393436 A1) and Feinstein et al. (WO 2009116037 A2) and in further view of Ross et al. (WO 2022159736 A1).
Regarding claim 13, Kirk in view of Prausnitz, Feinstein, and Ross disclose the method for (Kirk, method 980, Fig. 9), as recited above, wherein
injecting into the cochlea. (Kirk, "… one or more therapeutic substances are integrated into the protrusions 146 and are released into the cochlea 130 …" - Para [0037]).
Kirk does not expressly disclose that a volume of therapeutic comprises injecting 1.0 µL or less of therapeutic.
Ross teaches that a volume of therapeutic comprises injecting 1.0 µL or less of therapeutic ("A total volume of the fluidic composition delivered may be from 1µL to 500µL." - Para [0036]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include that a volume of therapeutic comprises injecting 1.0 µL or less of therapeutic as taught by Ross for transporting the fluidic composition (Ross, Para [0038]).
Regarding claim 14, Kirk in view of Prausnitz, Feinstein, and Ross disclose the method for (Kirk, method 980, Fig. 9), as recited above, wherein
injecting into the cochlea (Kirk, "… one or more therapeutic substances are integrated into the protrusions 146 and are released into the cochlea 130 …" - Para [0037]).
Kirk does not expressly disclose injecting a volume of therapeutic comprises injecting 1.0 µL or less of therapeutic with a rate of 1 µL/min or less.
Ross teaches injecting a volume of therapeutic comprises injecting 1.0 µL or less of therapeutic ("A total volume of the fluidic composition delivered may be from 1µL to 500µL." - Para [0036]) with a rate of 1 µL/min or less ("The fluidic composition may be delivered to the patient at a rate of up to … .01 µL … per second per microneedle." - Para [0037]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include injecting a volume of therapeutic comprises injecting 1.0 µL or less of therapeutic with a rate of 1 µL/min or less as taught by Ross for transporting the fluidic composition (Ross, Para [0038]).
Examiner interprets .01 microliters per second to be equivalent to .6 microliters per minute which is less than microliter/min.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirk et al. (WO 2022219432 A1) in view of Prausnitz et al. (US Pub No. 20210393436 A1) and Ross et al. (WO 2022159736 A1) and in further view of Chen et al. (WO 2023003518 A2).
Regarding claim 19, Kirk in view of Prausnitz and Ross disclose the system (device 140, Fig. 2A), as recited above, wherein
Kirk in view of Prausnitz does not expressly disclose that the blunt metallic syringe needle is a 30 gauge syringe needle.
Chen teaches that the blunt metallic syringe needle is a 30 gauge syringe needle ("… a single or an array of hollow injectors, such as a syringe of gauge between 25 to 34." - Para [0121]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kirk to include that the blunt metallic syringe needle is a 30 gauge syringe needle as taught by Chen so the composition is subcutaneously injected (Chen, Para [016]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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