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 .
Status of Claims
This office action is responsive to the application filed 24 August 2023.
Claims 1-12 are presently pending in this application.
Claim Objections
Claim 2 is objected to because of the following informalities:
“said at least said two sharp distal tips” - repeated use of the word “said”
Appropriate correction is required.
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)(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 1-4, 9, and 11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tobinaga et al. (US Patent Publication No. 20050065463 A1), hereinafter Tobinaga.
Regarding claim 1, Tobinaga teaches a drug delivery needle (Tobinaga: Fig. 2, microneedle 14) comprising: a body portion (Fig. 14d, microneedle 50) from which extends a penetration end (Fig. 14d, needle point 48) that comprises at least two sharp distal tips (Fig. 14d, sharp tips 52), said sharp distal tips (52) being separated from each other by an arcuate trough (Fig. 14d, U-shaped cut 49) that comprises a cutting edge (Fig. 14d, inclined surfaces 51) at least at a middle portion of said arcuate trough (Fig. 14d, surfaces 51 exist along the middle of the cut 49), wherein at least said two sharp distal tips (52) comprise a drug therein (microneedles 14 can carry a functional substance 15, which comprises insulin; para. 0036-0037), said drug being biodegradable (insulin is known to be biodegradable).
Regarding claim 2, Tobinaga teaches the drug delivery needle above, wherein the at least two sharp distal tips (52) are biodegradable (needles are made from a material capable of disintegration and dispersion into the dermis upon insertion such as sugar, which is biodegradable; para 0034).
Regarding claim 3, Tobinaga teaches the drug delivery needle above, wherein said cutting edge (51) extends completely between said sharp distal tips (Fig. 14d, inclined surfaces 51 are shown extend completely between both tips 52).
Regarding claim 4, Tobinaga teaches the drug delivery needle above, wherein said arcuate trough (49) is shaped as a conical section (Fig. 14d, U-shaped cut 49 is shown to be shaped as a conical section.
Regarding claim 9, Tobinaga teaches the drug delivery needle above, wherein a plurality of said drug delivery needles (14) are mounted on a substrate (Fig. 2, base 13).
Regarding claim 11, Tobinaga teaches the drug delivery needle above, wherein said sharp distal tips (52) have equal heights (Fig. 14d, tips 52 are shown to have equal heights).
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.
Claims 5-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Tobinaga in view of Ross et al. (US Patent No. 6702790 B1), hereinafter Ross.
Regarding claim 5, Tobinaga teaches the drug delivery needle above.
Tobinaga does not expressly disclose that said body portion is formed with a bevel that extends from said arcuate trough to a heel.
Ross teaches a body portion (Ross: Fig. 6A, needle 20) is formed with a bevel (Fig. 6A, needle 20 is beveled; col 3, ln 36-49) that extends from an arcuate trough (Fig. 6A, edge 24) to a heel (Fig. 7, tapered 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the body portion of Tobinaga such that said body portion is formed with a bevel that extends from said arcuate trough to a heel as taught by Ross in order to allow for a knife-like edge that allows for easier penetration by the needle (Ross: col 3, ln 36-49).
Regarding claim 6, Tobinaga teaches the drug delivery needle above.
Tobinaga does not expressly disclose that said bevel is concave, having an arcuate depression with respect to said arcuate trough and said heel.
Ross teaches a bevel (Ross: col 3, ln 36-49) that is concave (Fig. 6A-C, beveled edge 24 is shown to be concave), having an arcuate depression with respect to said arcuate trough (24) and said heel 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the needle of Tobinaga such that said bevel is concave, having an arcuate depression with respect to said arcuate trough and said heel as taught by Ross in order to allow for a knife-like edge that allows for easier penetration by the needle (Ross: col 3, ln 36-49).
Regarding claim 7, Tobinaga teaches the drug delivery needle above, wherein an outer perimeter of said body portion (50) has at least one rounded corner (Fig. 14d, needle 50 is rounded).
Tobinaga does not expressly disclose that an outer perimeter of said body portion has at least one non-rounded corner.
Ross teaches an outer perimeter of a body portion (Ross: 20) that has at least one non-rounded corner (Fig. 6A, edges of taper 28 are shown to be non-rounded).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the outer perimeter of Tobinaga such that it had at least one non-rounded corner as taught by Ross in order to provide a beveled tip and allow for easy penetration by the needle (Ross: col 3, ln 36-49).
Regarding claim 8, Tobinaga teaches the drug delivery needle above.
Tobinaga does not expressly disclose that an edge of said non-rounded corner extends up to one of said sharp distal tips.
Ross teaches an edge of said non-rounded corner (Fig. 6A, edges of taper 28) extends up to one of two sharp distal tips (Fig. 6A, edges of taper 28 extend up to the edges of tips 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the needle of Tobinaga such that an edge of said non-rounded corner extends up to one of said sharp distal tips as taught by Ross in order to create a sharp point towards the sharp distal tips (Ross: col 3, ln 36-54).
Regarding claim 10, Tobinaga teaches the drug delivery needle above.
Tobinaga does not expressly disclose that said body portion tapers towards said sharp distal tips.
Ross teaches a body portion (Ross: 20) tapers towards sharp distal tips (Fig. 6A, needle 20 tapers towards tips 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the body portion of Tobinaga such that said body portion tapers towards said sharp distal tips as taught by Ross in order to create a sharp point towards the sharp distal tips (Ross: col 3, ln 36-54).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Tobinaga.
Regarding claim 12, Tobinaga teaches the drug delivery needle above, wherein said sharp distal tips (52) have equal heights (Fig. 14d, tips 52 are shown to have equal heights).
It would have been an obvious matter of design choice to make the sharp distal tips of the drug delivery needle of Tobinaga to have unequal heights, as a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Conclusion
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783