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 I in the reply filed on 11/19/2025 is acknowledged.
Claim 26 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventive species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/19/2025.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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 1-4, 6-16, and 19-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kang et al. (USPGPub 2015/0080802).
Re Claim 1, Kang teaches a lithography method for fabricating a plurality of micro-sized structures with converging tips (Kang Abstract; ¶ 0001), the method comprising: providing a substrate having an upper surface and a backside surface (Kang Figs. 1B-1C), wherein said substrate comprises a pattern having open areas configured to permit transmission of radiation and solid areas configured to prevent transmission of radiation (Kang ¶ 0127); forming a layer of liquid-state photosensitive resin on said upper surface (Kang ¶ 0102); exposing said liquid state photosensitive resin to radiation through said substrate from the backside surface over a first period of time to yield light-exposed portions of said liquid-state photosensitive resin (Kang ¶ 0104), wherein said light-exposed portions are crosslinked and/or polymerized into respective initial solid-state resin structures on said upper surface in alignment with said open areas (Kang ¶ 0102, 0104-0105), said initial solid-state resin structures having an increased refractive index as compared to said liquid-state photosensitive resin, such that each initial solid-state resin structure acts as a waveguide directing said radiation passing through said open areas of said pattern to a converging point thereby forming solid-state resin structures with tapered sidewalls and converging tips (Kang ¶ 0105-0107); and contacting the coating layer with a solvent system so as to remove non-light exposed portions of said liquid-state photosensitive resin to leave behind a plurality of said micro-sized solid state resin structures with tapered sidewalls and converging tips across said upper surface of said substrate (Kang ¶ 0116).
Re Claim 2, Kang teaches wherein said open areas are apertures having a geometric shape selected from the group consisting of circular, rectangular, polygonal, and star (Kang ¶ 0106, 0112).
Re Claim 3, Kang teaches wherein said apertures have a size of from about 1 µm to about 1,000 µm (Kang ¶ 0135).
Re Claim 4, Kang teaches wherein said open areas have central portions that are opaque to prevent radiation from passing through the central portion of each aperture (Kang ¶ 0104 - partially transmissive).
Re Claim 6, Kang teaches wherein said pattern is a photomask adjacent said upper surface and/or said backside surface of said substrate (Kang ¶ 0033, 0051).
Re Claim 7, Kang teaches wherein said pattern is integrally formed with said substrate (Kang ¶ 0001).
Re Claim 8, Kang teaches wherein the pattern comprises an array of a plurality of spaced-apart apertures distributed across the substrate (Kang ¶ 0112, 0136).
Re Claim 9, Kang teaches wherein the pattern comprises an array of a plurality of spaced-apart apertures distributed across the substrate (Kang ¶ 0112, 0136).
Re Claim 10, Kang teaches wherein said layer of liquid-state photosensitive resin has a thickness that is taller than the height of said micro-sized solid-state resin structures (Kang ¶ 0137).
Re Claim 11, Kang teaches wherein said layer of liquid-state photosensitive resin has a thickness ranging from about 50 µm to about 9 mm (Kang ¶ 0137).
Re Claim 12, Kang teaches wherein said radiation is light at a wavelength of from about 300 nm to about 450 nm (Kang ¶ 0200).
Re Claim 13, Kang teaches wherein said radiation is exposed through a collimating lens such that the direction of propagation of energy flow from the source of radiation is parallel and enters the substrate at an incident angle perpendicular to the backside surface of the substrate (Kang ¶ 0112-0114, 0135).
Re Claim 14, Kang teaches wherein said exposing step is carried out for a time period of from about 1 second to about 1 hour (Kang ¶ 0129).
Re Claim 15, Kang teaches wherein said micro-structures are formed with a single exposing step, wherein said method does not include more than one exposing step (Kang ¶ 0029, 0114).
Re Claim 16, Kang teaches wherein said exposing step comprises said first period of time and further comprises at least a second period of time continuous with said first period of time (Kang ¶ 0028, 0114), wherein said micro-sized solid-state resin structures with tapered sidewalls and converging tips have a first height after said first period of time, and wherein said micro-sized solid-state resin structures with tapered sidewalls and converging tips have a second height after said second period of time that is greater than said first height (Kang ¶ 0145).
Re Claim 19, Kang teaches wherein micro-sized solid-state resin structures comprise respective shafts having cross-sectional geometries selected from the group consisting of circular, rectangular, polygonal, and oblong, and wherein a combination of any of the foregoing
geometries may be provided in a single micro-structure array across said substrate (Kang ¶ 0106, 0112).
Re Claim 20, Kang teaches wherein micro-sized solid-state resin structures each have a base size ranging from about 5 µm to about 1,000 µm, and a height ranging from about 30 µm to about 9 mm (Kang ¶ 0144-0145).
Re Claim 21, Kang teaches wherein said substrate is substantially planar, and wherein said substrate remains stationary during said exposing (Kang Fig. 1B-1C; ¶ 0055).
Re Claim 22, Kang teaches the method further comprising applying one or more intervening layers to said substrate before applying said photosensitive resin layer (Kang ¶ 0127).
Re Claim 23, Kang teaches the method further comprising using said plurality of said micro-sized solid-state resin structures as a template for micromolding (Kang Fig. 2; ¶ 0056, 0136).
Re Claim 24, Kang teaches a method for delivering of active agent across a biological barrier, the method comprising the steps of: puncturing the biological barrier with a plurality of microneedles (Kang ¶ 0141).
Re Claim 25, Kang teaches wherein said biological barrier is selected from the group consisting of stratum corneum, epidermis, dermis, and combinations thereof (Kang ¶ 0259-0260).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. (USPGPub 2015/0080802) in view of Kravitz et al. (USPGPub 2007/0023386).
Re Claim 5, Kang teaches all of the limitations of Claim 4. However, Kang fails to teach wherein said micro-sized structures with converging tips have a hollow shaft. Kravitz teaches a method of fabricating micro-sized structures with converging tips have a hollow shaft (Kravitz Abstract), wherein hollow tips are configured for transdermal drug delivery and the withdrawal of body fluids for biomedical and other applications (Kravitz ¶ 0004). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the method of Kang to fabricate said micro-sized structures with converging tips have a hollow shaft as disclosed by Kravitz, wherein hollow tips are configured for transdermal drug delivery and the withdrawal of body fluids for biomedical and other applications (Kravitz ¶ 0004).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. (USPGPub 2015/0080802) in view of Delmore et al. (USPGPub 2003/0045837).
Re Claims 17-18, Kang teaches all of the limitations of Claim 16. Kang fails to teach wherein exposure to radiation during said second period of time induces further crosslinking and/or photopolymerizing in regions of the resin layer adjacent to the converging tips of said initial micro-sized solid-state resin structures of the first height, thereby forming one or more additional harmonic structures on said initial micro-sized solid state resin structures; and wherein said one or more additional harmonic structures have sidewalls with alternating inclining and declining angles ultimately converging at respective tips. Delmore teaches a lithography method for fabricating a plurality of micro-sized structures with converging tips comprising a first exposure time and a second exposure time (Delmore ¶ 0033, 0080), wherein exposure to radiation during said second period of time induces further crosslinking and/or photopolymerizing in regions of the resin layer adjacent to the converging tips of said initial micro-sized solid-state resin structures of the first height (Delmore ¶ 0086), thereby forming one or more additional harmonic structures on said initial micro-sized solid state resin structures (Delmore Figs. 2-2E); and wherein said one or more additional harmonic structures have sidewalls with alternating inclining and declining angles ultimately converging at respective tips (as seen in Delmore Figs. 2-2E), the method for ablating additional substrate for desired needle depth (Delmore ¶ 0086).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the method of Kang wherein exposure to radiation during said second period of time induces further crosslinking and/or photopolymerizing in regions of the resin layer adjacent to the converging tips of said initial micro-sized solid-state resin structures of the first height, thereby forming one or more additional harmonic structures on said initial micro-sized solid state resin structures; and wherein said one or more additional harmonic structures have sidewalls with alternating inclining and declining angles ultimately converging at respective tips as disclosed by Delmore for ablating additional substrate for desired needle depth (Delmore ¶ 0086).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783