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 .
Election/Restrictions
Applicant’s election without traverse of Species of Fig. 13 (claims 1-4 & 6-7) in the reply filed on 12/18/25 is acknowledged.
Claim 5 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species 1-12 & 14 -22 (Figs. 1-12, 14-22), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/18/25.
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karp et al. (US 2013/0331792).
Regarding claim 1, Karp discloses a microneedle patch in Fig. 1 (see marked-up Fig. 1 below) comprising:
a plurality of microneedles, i.e., protrusions, each having an upper end portion and a base portion and which are individualized from each other; and
a base layer that is formed of a water-soluble material (e.g., para [0062], the device body can degrade/erode more slowly than the tips or protrusions; para [0063], the device is made of one or more polymers; para [0065], wherein the polymers include polyvinyl alcohols, polylactic acid, polyethers, e.g., poly-ethylene glycol, copolymers of PEG; para [0071], poly(vinyl alcohols, polyacrylates, polyacrylamides…);
and includes linear portions that pass the base portions of the microneedles neighboring each other among the plurality of microneedles and are joined to the base portions of the microneedles neighboring each other.
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Regarding claim 2, wherein: the upper end portions of the plurality of microneedles each include a sharp end portion; and a maximum diameter of the base portion is larger than a diameter of the upper end portion (at tip portion).
Regarding claim 3, wherein the plurality of microneedles is fixed to a region where at least two or more linear portions among the linear portions intersect.
Regarding claim 4, wherein the base layer has a mesh structure or a nonwoven structure.
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 3 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Karp et al. (US 2013/0331792) in view of Marin et al. (US 5,397,355).
Note: It appears to Examiner that the plurality of microneedles in Karp being fixed (in directly fixed) to a region where at least two or other liner portions among the linear portions intersect; however, in case that Applicant disagrees with the Examiner’s statement above. The claim 3 is alternatively being rejected as a combination of Karp and Marin as below.
Regarding claim 3, Karp discloses all the claimed subject matter as required. Assuming that Karp does not disclose the plurality of microneedles is fixed to a region where at least two or more linear portions among the linear portion intersect. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the microneedle being located at corner of the liner portions intersect, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Marin discloses a microneedle patch comprising: a plurality of microneedles 18; a base layer 16; wherein the plurality of microneedles is fixed to a region 20 & 22 wherein at least two or more linear portions 16 among the linear portion intersect, see Figs. 2-3.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify a location of the microneedle in the device of Karp with obtaining the microneedle being fixed to a region where at least two or other liner portions among the linear portions intersect, as taught by Marin, in order to less exert radial force to prevent less injurious to a target tissue during the insertion into a patient.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Karp et al. (US 2013/0331792) in view of Cormier et al. (US 7,963,935).
Regarding claim 6, Karp discloses all the claimed subject matter as required except for wherein: the plurality of microneedles further includes, in at least a portion thereof, a plurality of kinds of effective materials; a first group of microneedles among the plurality of microneedles includes a first effective material among the plurality of kinds of effective materials; and a second group of microneedles different from the first group includes a second effective material among the plurality of kinds of effective materials.
Cormier discloses a microneedle patch 5, in Figs. 1-5 comprising: a plurality of microneedle 10; a base layer 12; the plurality of microneedles 10 further includes, in at least a portion thereof, a plurality of kinds of effective materials A, B, C & D; a first group 60 of microneedles 10 among the plurality of microneedles includes a first effective material among the plurality of kinds of effective materials; and a second group 61 of microneedles different from the first group includes a second effective material among the plurality of kinds of effective materials. Note: Cormier discloses that the microprojection array divided into portions 60-63; wherein a different coating of effective material (or drug) is applied to each portion, thereby allowing a single microprojection array to be utilized to deliver more than one beneficial agent during use…, col. 9, line 55-col. 10, line 57.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Karp with dividing into different multiple portions, wherein different coating of drugs being applied in each of the multiple portions, as taught by Cormier, in order to be utilized to deliver more than one beneficial agent during use…, col. 9, line 55-col. 10, line 57.
Regarding claim 7, Karp discloses all the claimed subject matter as required. Karp also discloses that the base layer degrades (e.g., device body can degrade/erode more slowly than the tips or protrusions, para [0062] or claim 55 in Karp, and is removed (Examiner interprets that the limitation “is removed” is considered as intended use purpose), and the microneedles remain in a region below the target region.
Karp does not disclose that in a case in which the microneedle patch is attached to a target region and moisture is provided to the microneedle patch.
Cormier discloses the microneedle patch is attached to a target region via (adhesive layer16) and moisture (from the adhesive layer) is provided to the microneedle patch.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the microneedle patch device of Karp with providing adhesive layer, as taught by Cormier, in order to secure the microneedle patch device to the skin of a patient during use.
Claims 1-2 & 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Cormier et al. (US 7,963,935) in view of Quan et al. (US 8,167,852).
Regarding claim 1, Cormier discloses a microneedle patch 5 comprising:
a plurality of microneedles 10 each having an upper end portion 18 and a base portion (opposite the upper end portion 18) and which are individualized from each other; and
a base layer 12 and includes linear portions (form in the rectangular aperture at the base layer 12, Figs. 1-2) that pass the base portions of the microneedles neighboring each other among the plurality of microneedles and are joined to the base portions of the microneedles neighboring each other.
Cormier does not disclose that the base layer is formed of a water-soluble material.
Quan discloses a microneedle patch 10 comprising:
a plurality of microneedles 1 each having an upper end portion and a base portion and which are individualized from each other; and a base layer 2 that is formed of a water-soluble material (e.g., the substrate 2 formed of polyvinyl alcohol; the substrate 2 can dissolve or swell in the body when the microneedles 1 inserted into skin, see col. 5, lines 28-36).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the base layer of the device of Cormier with providing a water-soluble material in the base layer, as taught by Quan, in order to dissolve in the skin of patient to avoid remove the base layer after use.
Regarding claim 2, Cormier in view of Quan discloses all claim subject matter as required. Cormier discloses that wherein: the upper end portions 18 of the plurality of microneedles each include a sharp end portion; and a maximum diameter of the base portion is larger than a diameter of the upper end portion, see Figs. 1-2.
Regarding claim 4, Cormier in view of Quan discloses all claim subject matter as required. It appears to Examiner that wherein the base layer has a mesh structure or a nonwoven structure. In addition, it is well-known in the art would recognize that providing mesh structure in the base layer to provide flexibility in the microneedle patch.
Regarding claim 6, Cormier in view of Quan discloses all claim subject matter as required. Cormier discloses the plurality of microneedles 10 further includes, in at least a portion thereof, a plurality of kinds of effective materials A, B, C & D; a first group 60 of microneedles 10 among the plurality of microneedles includes a first effective material among the plurality of kinds of effective materials; and a second group 61 of microneedles different from the first group includes a second effective material among the plurality of kinds of effective materials. Note: Cormier discloses that the microprojection array divided into portions 60-63; wherein a different coating of effective material (or drug) is applied to each portion, thereby allowing a single microprojection array to be utilized to deliver more than one beneficial agent during use…, col. 9, line 55-col. 10, line 57.
Regarding claim 7, Cormier in view of Quan discloses all claim subject matter as required. Quan also discloses that wherein, in a case in which the microneedle patch 2 is attached to a target region (on skin surface) and moisture is provided to the microneedle patch, the base layer degrades (because formed of water-soluble) and is removed, and the microneedles remain in a region below the target region.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Cormier et al. (US 7,963,935) in view of Quan et al. (US 8,167,852) and further in view of Marin et al. (US 5,397,355).
Regarding claim 3, Cormier in view of Quan discloses all the claimed subject matter as required. Assuming that Cormier in view of Quan does not disclose the plurality of microneedles is fixed to a region where at least two or more linear portions among the linear portion intersect. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the microneedle being located at corner of the liner portions intersect, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Marin discloses a microneedle patch comprising: a plurality of microneedles 18; a base layer 16; wherein the plurality of microneedles is fixed to a region 20 & 22 wherein at least two or more linear portions 16 among the linear portion intersect, see Figs. 2-3.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify a location of the microneedle in the device of Cormier in view of Quan with obtaining the microneedle being fixed to a region where at least two or other liner portions among the linear portions intersect, as taught by Marin, in order to less exert radial force to prevent less injurious to a target tissue during the insertion into a patient.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783