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
This office action is responsive to the amendment filed on 30 June 2025. As directed by the amendment: claims 8, 11, and 20 have been amended, the examiner notes the status identifier of claim 20 is incorrect and should be “CURRENTLY AMENDED”. Thus claims 1-21 are presently pending in this application. Applicant’s amendments to the Claims have overcome each 35 U.S.C. 112(b) rejection previously set forth in the Non-Final Office Action mailed 28 March 2025.
Response to Arguments
Applicant's arguments filed 30 June 2025 have been fully considered but they are not persuasive.
First Reason
1. The direct affixing is not claimed, instead the claim language allows for an interpretation where the affixing of the microneedle array patch is not directly on the plunger.
2. The holding structure of Kobayashi teaches the claimed limitation of being at a second end of the plunger as it is closer to the top of the plunger than to the bottom. The shape of the holding structure is not claimed, the pin shape is only recited in the specification. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Second Reason
1.The examiner notes the claim limitations recited in the argument are different from what claim 8 actually recites. It is the position of the examiner that all of the claimed limitations are met as outlined in the rejection of claim 8 below. All elements that are required by the claim to be internal are internal in Kobayashi as outlined in the rejection below.
2. The force applicator of Kobayashi is positioned to apply force along the length of the plunger as outlined in the rejection of claim 8. The specific calibration of the force applicator is not claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Third Reason
1. The position of the examiner is that all limitations required by the claims are taught by the art of record as outlined. Limitations from the specification are not read into the claims.
2. The position of the examiner is that all elements that are required by the claims to be internal are internal in Kobayashi as outlined in the rejection below.
Fourth Reason
1. The position of the examiner is that all elements that are required by the claims to be internal are internal in Kobayashi as outlined in the rejection below. The claims do not require the elements to be an integrated unit that can be modified, and it is unclear how this would differ from the elements of Kobayashi.
2. The force applicator of Kobayashi is positioned to apply force along the length of the plunger as outlined in the rejection of the claims. The specific calibration of the force applicator is not claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Fifth Reason
1. The position of the examiner is that all elements that are required by the claims are taught by the art. The claims do not require direct attachment of the microneedles to the plunger. The limitations from the specification are not read into the claims.
2. The position of the examiner is that all elements that are required by the claims are taught by the art. The claims do not require the recited loading limitations. The limitations from the specification are not read into the claims.
Arguments directed to the examiner’s response
The position of the examiner is that the teachings of the specification are limitations that are not imported into the claims. While the specification and drawings may indicate a construction that is different than that of Kobayashi, the differences are not claimed.
The limitation in the specification requiring the holding structure to be shaped as a pin structure is not imported into the claims. The differences between the holding structure of Kobayashi and that of the instant invention are not claimed.
The claims are afforded the broadest reasonable interpretation in light of the specification but it is improper to import claim limitations from the specification. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 8-14 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.
Claim 8 recites “the holding interface is attached to the plunger release bar, is adjacent to the second end of the plunger”. It is unclear what component is being referred to as being adjacent to the second end of the plunger. For the purpose of examination, this is being interpreted as the holding interface is adjacent to the second end of the plunger.
Claims 9-14 are rejected as being dependent on, and failing to cure the deficiencies of, rejected independent claim 8.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 5-6, 8, 12-13, 15-17 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kobayashi (JP 2018191702 A).
Regarding claim 1, Kobayashi discloses a microneedle array patch applicator (10 Fig 1), comprising: a shaft (made up of 106, 120, 122, and 124 Fig 8) having an opening (see the opening at the bottom of 106 Fig 8) at a first end (the bottom of the device as shown in Fig 8) for affixing a microneedle array patch (See the affixed microneedle patch 400 as shown in Fig 10); a plunger (130 Fig 8) positioned substantially within the shaft (As shown in Fig 8, a large portion of the plunger 130 is positioned within the shaft), the plunger having a first end (104 Fig 8) positioned adjacent to the opening (As shown in Fig 8), wherein the first end of the plunger is of a size and shape to transfer force against the microneedle array patch (See the force transfer as shown in Fig 13), and the plunger having a holding structure (136 Fig 8) at a second end of the plunger (See the sleeve 136 around the top end of the plunger in Fig 8); a loading mechanism (elements 108 and 134 Fig 8) operably associated with the plunger within the shaft, the loading mechanism having a plunger load (108 Fig 8) and a load spring (134 Fig 8), the plunger load positioned at a second end of the shaft (See 108 positioned at the top of the device in Fig 8), the load spring surrounding the plunger (See the spring 134 around the plunger 130 in Fig 8); and a force applicator (112 Fig 8) substantially within the shaft (while the button 112A of the mechanism is outside of the shaft, the other components form a large portion of the mechanism and are positioned within the shaft as shown in Fig 8, even more so when the button is pressed radially inward as shown in Fig 12) to provide force along the length of the plunger (See the edge of ring 112b biased against the shaft 130 by the spring 112C as shown in Fig 8), the force applicator having a holding interface (ring 112B Fig 8) adjacent to the second end of the plunger (the ring is positioned nearer the top of the plunger than the bottom as shown in Fig 8) and a button (112A Fig 8) on a sidewall of the shaft (See the button 112A protruding from the sidewall in Fig 8 and against the sidewall in Fig 12), wherein the holding structure is affixed to the holding interface (the top edge of the ring 112b is affixed to and supports the bottom edge of the sleeve 136 as shown in Fig 8) and the load spring (134 Fig 12) is compressed whereupon the plunger is at a loaded position ([0071] “In a state in which the sleeve 136 contacts the peripheral portion of the through hole 112 </ b> D, the first elastic member 134 is compressed and urges the plunger 130 toward the first end portion via the sleeve 132.”).
Regarding claim 5, Kobayashi discloses the applicator of Claim 1. Kobayashi further discloses further comprising a removable flange positioned at the first end of the shaft (200, see the position in Fig 9, this flange 200 is removable as described in [0082]).
Regarding claim 6, Kobayashi discloses the applicator of Claim 1. Kobayashi further discloses wherein the first end of the plunger is visible and protruding from the opening at a neutral position (See Fig 15, when the spring 134 is decompressed, the plunger protrudes visibly out of the opening).
Regarding claim 8, Kobayashi discloses a microneedle array patch applicator (10 Fig 1), comprising: a shaft (made up of 106, 120, 122, and 124 Fig 8) having an opening (see the opening at the bottom of 106 Fig 8) at a first end (the bottom of the device as shown in Fig 8) for affixing a microneedle array patch (See the affixed microneedle patch 400 as shown in Fig 10); a plunger (130 Fig 8) positioned substantially within the shaft (As shown in Fig 8, a large portion of the plunger 130 is positioned within the shaft), the plunger having a first end (104 Fig 8) positioned adjacent to the opening (As shown in Fig 8), wherein the first end of the plunger is of a size and shape to transfer force against the microneedle array patch (See the force transfer as shown in Fig 13), and the plunger having a holding structure (136 Fig 8) at a second end of the plunger (See the sleeve 136 around the top end of the plunger in Fig 8); a plunger load (108 Fig 8) operably associated with the plunger within the shaft, the plunger load positioned at a second end of the shaft (See 108 positioned at the top of the device in Fig 8); a load spring (134 Fig 8) associated with the plunger load (while not contacting each other directly the spring pushes the plunger down and pulls the plunger load 108 along with it as shown in Fig 13), the load spring surrounding the plunger (See the spring 134 around the plunger 130 in Fig 8); and a force applicator including a plunger release bar (112 Fig 8, the ring 112B can be interpreted as a short bar), a button (112A Fig 8), and a holding interface (the top surface of ring 112B Fig 8), where the plunger release bar is positioned completely within the shaft (the components of the plunger release bar 112 are all positioned completely within the shaft when the button is pushed in as shown in Fig 12) and extends elongationally along a length of the shaft (112 extends a short amount along a length of the shaft) and, the holding interface is attached to the plunger release bar (the top surface of ring 112B is attached to the rest of the ring 112B), is adjacent to the second end of the plunger (the ring is positioned nearer the top of the plunger than the bottom as shown in Fig 8) and the button protruding from the shaft (See the button 112A protruding from the sidewall in Fig 8 and against the sidewall in Fig 12), wherein the holding structure is affixed to the holding interface (the top edge of the ring 112b is affixed to and supports the bottom edge of the sleeve 136 as shown in Fig 8) and the load spring is compressed whereupon the plunger is at a loaded position ([0071] “In a state in which the sleeve 136 contacts the peripheral portion of the through hole 112 </ b> D, the first elastic member 134 is compressed and urges the plunger 130 toward the first end portion via the sleeve 132.”).
Regarding claim 12, Kobayashi discloses the applicator of Claim 8. Kobayashi further discloses further comprising a removable flange positioned at the first end of the shaft (200, see the position in Fig 9, this flange 200 is removable as described in [0082]).
Regarding claim 13, Kobayashi discloses the applicator of Claim 8. Kobayashi further discloses wherein the first end of the plunger is visible and protruding from the opening at a neutral position (See Fig 15, when the spring 134 is decompressed, the plunger protrudes visibly out of the opening).
Regarding claim 15, Kobayashi discloses a method of applying a microneedle array patch to a skin region of an individual ([0006] “an applicator capable of fixing a microneedle array on the skin”), comprising: affixing the microneedle array patch (400 Fig 8) to a first end of a plunger (130 Fig 8) of a microneedle array patch applicator (See the attaching in Figs 8-10), wherein the plunger is positioned within a shaft (the shaft is made up of 106, 120, 122, and 124 Fig 8, as shown in Fig 8, a large portion of the plunger 130 is positioned within the shaft) of the microneedle array patch applicator having an opening (see the opening at the bottom of 106 Fig 8), and wherein the first end of the plunger is visible protruding from the opening at a neutral position (See Fig 15, when the spring 134 is decompressed, the plunger protrudes visibly out of the opening); loading the plunger and the affixed microneedle array patch to a loaded position (See the loaded position in Fig 10, [0071] “In a state in which the sleeve 136 contacts the peripheral portion of the through hole 112 </ b> D, the first elastic member 134 is compressed and urges the plunger 130 toward the first end portion via the sleeve 132.”), wherein a holding structure (136 Fig 8) associated with a second end of the plunger (See the sleeve 136 around the top end of the plunger in Fig 8) is thereby affixed to a holding interface (ring 112B Fig 8) of a force applicator (112 Fig 8) positioned substantially within the shaft (while the button 112A of the mechanism is outside of the shaft, the other components forma a large portion of the mechanism and are positioned within the shaft as shown in Fig 8, even more so when the button is pressed radially inward as shown in Fig 12); positioning the opening against the skin region of the individual (As shown in Fig 11, the opening of the applicator is against the skin 500); operating the force applicator (As shown by the arrow in Fig 12 pushing in the button 112A) to release the plunger and thereby the holding structure being released from the holding interface and the microneedle array patch being inserted into the skin region of the individual (As shown in Fig 13, the holding structure and interface are released and the plunger moves down to push the microneedles into the skin).
Regarding claim 16, Kobayashi discloses the method of Claim 15. Kobayashi further discloses further comprising: pushing down a plunger load (108 Fig 8) into the shaft at the loaded position (when in the loaded position as shown in Fig 10, the spring 134 pushes the plunger 130 down and the plunger load is on the plunger, while the plunger load does not move during the loaded position, the biasing forces are pushing it down through the forces acting on the plunger), wherein the plunger load is positioned at a second end of the shaft (See 108 positioned at the top of the device in Fig 8) and associated with the plunger (As shown in Fig 8, 108 is arranged on the end of the plunger 130).
Regarding claim 17, Kobayashi discloses the method of Claim 15. Kobayashi further discloses further comprising a removable flange positioned at the first end of the shaft (200, see the position in Fig 9, this flange 200 is removable as described in [0082]).
Regarding claim 21, Kobayashi discloses the method of Claim 15. Kobayashi further discloses wherein the plunger is associated with a loading mechanism (elements 108 and 134 Fig 8), the loading mechanism having a plunger load (108 Fig 8) positioned at a second end of the shaft (See 108 positioned at the top of the device in Fig 8), a first load spring (134 Fig 8) surrounding the first end of the plunger (As shown in Fig 8, spring 134 is at the bottom end of the plunger), and a second load spring (138 Fig 8) surrounding the second end of the plunger (As shown in Fig 8, spring 138 is at the top end of the plunger).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-4, 7, 10, 14, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi (JP 2018191702 A).
Regarding claim 3, Kobayashi discloses the applicator of Claim 1. Kobayashi further discloses a constant pressure ([0079] “By using the applicator 10, the pressing member 104 always operates with a constant force, so that the microneedle array 400 can stably puncture the skin 500. “The urging force applied to the plunger 130 can be easily changed by changing the elasticity coefficient of the first elastic member 134 and the physical properties including the material.”).
However, Kobayashi fails to explicitly disclose that the force applicator is calibrated to release a constant pressure in a range between 0.25 MPa to 8 MPa.
Kobayashi discloses ([0079]) that the constant pressure can be easily changed and the force is “so that the microneedle array 400 can stably puncture the skin 500.” As such the constant pressure applied is disclosed to be a result effective variable in that changing the pressure changes the how the microneedle array punctures the skin. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Kobayashi device to have a constant pressure within the claimed range, as it involves only adjusting a parameter Kobayashi describes as being easily changed. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Kobayashi by making the constant pressure be in a range between 0.25 MPa to 8 MPa as matter of routine optimization since 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).
Regarding claim 4, Kobayashi discloses the applicator of Claim 1. Kobayashi further discloses wherein the force applicator (112 Fig 8) further comprises a spring (112 C Fig 8).
Kobayashi fails to disclose the spring is positioned between the holding interface and the button. However, shifting the position of the spring to be between the holding interface and the button, for example, the be positioned between the button and the exterior of the sidewall of the shaft would not modify the operation of the device, the button would still be biased radially outward and the holding interface biased into engagement with the holding structure. Therefore, such a modification would be an obvious matter of design choice and thus it would have been obvious to one of ordinary skill in the art at the time of effective filing to modify the applicator of Kobayashi so that the spring is positioned between the holding interface and button as claimed.
Regarding claim 7, Kobayashi discloses the applicator of Claim 1. Kobayashi further teaches further comprising a second load spring (138 Fig 8), and the holding interface (ring 112B Fig 8) extends further towards the second end of the shaft than the first load spring (As shown in Fig 8, the ring 112B is positioned above the spring 134).
Kobayashi fails to disclose the second load spring is positioned adjacent to the first end of the plunger and the holding interface extends further towards the second end of the shaft than the second load spring. However, shifting the position of the holding interface and its related mechanism components to be arranged above the second load spring would not modify the operation of the device and would be an obvious matter of design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of effective filing to modify the applicator of Kobayashi so that the holding interface and the load springs are positioned as claimed.
Regarding claim 10, Kobayashi discloses the applicator of Claim 8. Kobayashi further discloses a constant pressure ([0079] “By using the applicator 10, the pressing member 104 always operates with a constant force, so that the microneedle array 400 can stably puncture the skin 500. “The urging force applied to the plunger 130 can be easily changed by changing the elasticity coefficient of the first elastic member 134 and the physical properties including the material.”).
However, Kobayashi fails to explicitly disclose that the plunger release bar is calibrated to release a constant pressure in a range between 0.25 MPa to 8 MPa.
Kobayashi discloses ([0079]) that the constant pressure can be easily changed and the force is “so that the microneedle array 400 can stably puncture the skin 500.” As such the constant pressure applied is disclosed to be a result effective variable in that changing the pressure changes the how the microneedle array punctures the skin. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Kobayashi device to have a constant pressure within the claimed range, as it involves only adjusting a parameter Kobayashi describes as being easily changed. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Kobayashi by making the constant pressure be in a range between 0.25 MPa to 8 MPa as matter of routine optimization since 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).
Regarding claim 14, Kobayashi discloses the applicator of Claim 8. Kobayashi further teaches further comprising a second load spring (138 Fig 8).
Kobayashi fails to disclose the second load spring is positioned adjacent to the first end of the plunger. However, shifting the position of the second load spring and its related mechanism components to be arranged to be lower in the applicator, adjacent to the first end of the plunger would not modify the operation of the device and would be an obvious matter of design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of effective filing to modify the applicator of Kobayashi so that the second load spring is positioned as claimed.
Regarding claim 19, Kobayashi discloses the applicator of Claim 15. Kobayashi further discloses a constant pressure ([0079] “By using the applicator 10, the pressing member 104 always operates with a constant force, so that the microneedle array 400 can stably puncture the skin 500. “The urging force applied to the plunger 130 can be easily changed by changing the elasticity coefficient of the first elastic member 134 and the physical properties including the material.”).
However, Kobayashi fails to explicitly disclose that the plunger release bar is calibrated to release a constant pressure in a range between 0.25 MPa to 8 MPa.
Kobayashi discloses ([0079]) that the constant pressure can be easily changed and the force is “so that the microneedle array 400 can stably puncture the skin 500.” As such the constant pressure applied is disclosed to be a result effective variable in that changing the pressure changes the how the microneedle array punctures the skin. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Kobayashi device to have a constant pressure within the claimed range, as it involves only adjusting a parameter Kobayashi describes as being easily changed. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Kobayashi by making the constant pressure be in a range between 0.25 MPa to 8 MPa as matter of routine optimization since 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).
Regarding claim 20, Kobayashi discloses the method of Claim 15. Kobayashi further discloses wherein the plunger (130 Fig 8) is associated with a loading mechanism (elements 108 and 134 Fig 8), the loading mechanism having a plunger load (108 Fig 8) positioned at a second end of the shaft (See 108 positioned at the top of the device in Fig 8) and a load spring (134 Fig 8) surrounding the plunger (As shown in Fig 8, the spring 134 is around the plunger 130).
Kobayashi fails to disclose wherein when the plunger is in the neutral position, the holding interface extends further towards the second end of the shaft than does the second end of the plunger, however, shifting the position of the holding interface and its related mechanism components to be arranged to be higher in the applicator, above the second end of the plunger in the neutral position would not modify the operation of the device and would be an obvious matter of design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of effective filing to modify the applicator of Kobayashi so that the holding interface is positioned when in the neutral position as claimed.
Claims 2, 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi (JP 2018191702 A) in view of Frederick et al. (EP 1773444 B1).
Regarding claim 2, Kobayashi discloses the applicator of Claim 1. However, Kobayashi fails to disclose wherein the force applicator is calibrated to propel the plunger at an application velocity in a range between 100 cm/s to 2000 cm/s.
Frederick et al. teaches a force applicator (36 Fig 2) is calibrated to propel the plunger (42 Fig 2) at an application velocity in a range between 100 cm/s to 2000 cm/s ([0040] Desired velocities are described as having a minimum of 2 m/s and a maximum of 20 m/s, which is 200 cm/s to 2000 m/s). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the application velocity to be within the claimed range as taught by Frederick et al. to provide a velocity that is effective to pierce the microneedles through the stratum corneum layer of the skin while limited to prevent the sensation of pain, hematoma, or localized swelling. [0040]
Regarding claim 9, Kobayashi discloses the applicator of Claim 8. However, Kobayashi fails to disclose wherein the plunger release bar is calibrated to propel the plunger at an application velocity in a range between 100 cm/s to 2000 cm/s.
Frederick et al. teaches a plunger release bar (36 Fig 2) is calibrated to propel the plunger (42 Fig 2) at an application velocity in a range between 100 cm/s to 2000 cm/s ([0040] Desired velocities are described as having a minimum of 2 m/s and a maximum of 20 m/s, which is 200 cm/s to 2000 m/s). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the application velocity to be within the claimed range as taught by Frederick et al. to provide a velocity that is effective to pierce the microneedles through the stratum corneum layer of the skin while limited to prevent the sensation of pain, hematoma, or localized swelling. [0040]
Regarding claim 18, Kobayashi discloses the method of Claim 15. However, Kobayashi fails to disclose wherein the force applicator is calibrated to propel the plunger at an application velocity in a range between 100 cm/s to 2000 cm/s.
Frederick et al. teaches a force applicator (36 Fig 2) is calibrated to propel the plunger (42 Fig 2) at an application velocity in a range between 100 cm/s to 2000 cm/s ([0040] Desired velocities are described as having a minimum of 2 m/s and a maximum of 20 m/s, which is 200 cm/s to 2000 m/s). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the application velocity to be within the claimed range as taught by Frederick et al. to provide a velocity that is effective to pierce the microneedles through the stratum corneum layer of the skin while limited to prevent the sensation of pain, hematoma, or localized swelling. [0040]
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi (JP 2018191702 A) in view of Hagino et al. (US 2007/0233011 A1).
Regarding claim 11, Kobayashi discloses the applicator of Claim 8. Kobayashi further discloses the plunger defines a longitudinal direction and an axis.
However, Kobayashi fails to disclose the force applicator further comprises a spring, and the spring is positioned between the holding interface and the button to bias the holding interface towards the axis; the plunger release bar is mounted on a pivot, the pivot extending orthogonally to the axis, that causes the holding interface to be moved away from the axis when the button is pressed in towards the axis; and the holding interface is spaced from the button in the longitudinal direction by the plunger release bar.
Hagino et al. teaches a force applicator (60 Fig 24) further comprises a spring (90b Fig 24), and the spring is positioned between the holding interface (62 Fig 24) and the button (64 Fig 24) to bias the holding interface towards the axis (the spring 90b biases the holding interface 62 toward the axis of 40 Fig 24, G1 Fig 3, [0077] “rotation in the arrow G1 direction by the force exerted by the compressed spring 90b”); the plunger release bar (61 Fig 8) is mounted on a pivot (63 Fig 8), the pivot extending orthogonally to the axis (See the extension of pivot 63 in Fig 8), that causes the holding interface to be moved away from the axis when the button is pressed in towards the axis (See the movement depicted by the arrows in Fig 25, [0077] “the release button 60 rotates in the arrow G2 direction about the support shaft 63”); and the holding interface is spaced from the button in the longitudinal direction by the plunger release bar (See the spacing between 64 and 62 in Figs 8 and 24). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the force applicator of Kobayashi to have the limitations of Hagino et al. as such a modification is the result of a simple substitution of one known element (the pivoting release bar of Hagino et al.) for another (the lateral release bar of Kobayashi) to achieve a predictable result (a mechanism for a user to press a button to release the force in a spring). Additionally, one of ordinary skill would be able to select the appropriate force applicator system depending on space constraints within the device and where the user would prefer the button to be positioned.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783