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 amendment filed 30 March 2026.
Claims 1, 2, 5, and 6 are amended.
Claim 13 is added.
Claims 1-13 are presently pending in this application.
Claim Objections
Claim 5 is objected to because of the following informalities:
“wherein said beveled surfaces that extend from said arcuate trough” – improper grammar. It will be interpreted as –wherein said beveled surfaces extend from said arcuate trough--.
Appropriate correction is required.
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 1-5 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tobinaga et al. (US Patent Publication No. 20050065463 A1), hereinafter Tobinaga, in view of McWeeney et al. (US Patent No. 10159470 B2), hereinafter McWeeney.
Regarding claim 1, Tobinaga discloses 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), 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).
Tobinaga does not expressly disclose opposing beveled surfaces of the body portion intersect within the arcuate trough to form a blade-like cutting edge, the cutting edge extending along at least a middle portion of said arcuate trough.
McWeeney teaches a needle comprising opposing beveled surfaces (McWeeney: Fig. 4, comprising bevel grinds 214 and 216, which are present on both sides of the needle body; col 5, ln 59 – col 6, ln 18) of a body portion (Fig. 4, tubular body 202) intersect within an arcuate trough (Fig. 4, distal end 204 defines an arcuate trough; col 6, ln 19-28) to form a blade-like cutting edge (Fig. 5, bevel grinds 214 and 216 intersect on both sides of the needle, forming a cutting edge present on from the back-cut grinds 218 and 220 to the tips 208 and point 212), the cutting edge (218, 220 to 208, 212) extending along at least a middle portion of said arcuate trough (the cutting edge extends from the tip 208 and point 212 to the cutting edge 222, which is present along a middle portion of the arcuate trough; col 5, ln 59 – col 6, ln 18).
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 opposing beveled surfaces of the body portion intersect within the arcuate trough to form a blade-like cutting edge, the cutting edge extending along at least a middle portion of said arcuate trough as taught by McWeeney in order to allow for excising of tissue (McWeeney: col 6, ln 19-28) and provide smooth needle passage during needle insertion (col 6, ln 12-18).
Regarding claim 2, Tobinaga in view of McWeeney discloses 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 in view of McWeeney discloses 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 in view of McWeeney discloses 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 5, Tobinaga in view of McWeeney discloses the drug delivery needle above.
Tobinaga does not expressly disclose said beveled surfaces extend from said arcuate trough to a heel.
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McWeeney teaches beveled surfaces (McWeeney: 214 and 216) extend from an arcuate trough (col 6, ln 19-28) to a heel (Fig. 4 above, grinds 214 and 216 are shown extending from the trough defined by the cutting edge 222 to heel A).
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 beveled surfaces extend from said arcuate trough to a heel as taught by McWeeney in order to allow for excising of tissue (McWeeney: col 6, ln 19-28) and provide smooth needle passage during needle insertion (col 6, ln 12-18).
Regarding claim 9, Tobinaga in view of McWeeney discloses 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 10, Tobinaga in view of McWeeney discloses the drug delivery needle above.
Tobinaga does not expressly disclose that said body portion tapers towards said sharp distal tips.
McWeeney teaches a body portion (McWeeney: 202) tapers towards sharp distal tips (Fig. 4 and 6, body 202 is shown tapering towards the tip 208 and point 212).
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 body portion tapers towards said sharp distal tips as taught by McWeeney in order to allow for excising of tissue (McWeeney: col 6, ln 19-28) and provide smooth needle passage during needle insertion (col 6, ln 12-18)..
Regarding claim 11, Tobinaga in view of McWeeney discloses the drug delivery needle above, wherein said sharp distal tips (52) have equal heights (Fig. 14d, tips 52 are shown to have equal heights).
Regarding claim 12, Tobinaga in view of McWeeney discloses the drug delivery needle above, wherein said sharp distal tips (52) have equal heights (Fig. 14d, tips 52 are shown to have equal heights).
Tobinaga does not expressly disclose said sharp tips have unequal heights.
McWeeney teaches sharp distal tips (Fig. 6, tip 208 and point 212) have unequal heights (Fig. 6, tip 208 and point 212 are staggered; col 5, ln 59 – col 6, ln 18).
It would have been an obvious matter of design choice to make the sharp distal tips of the drug delivery needle of Tobinaga in view McWeeney 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. Furthermore, applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the sharp distal tips have unequal heights, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 13, Tobinaga in view of McWeeney discloses the drug delivery needle above, wherein the body portion (50) comprises an asymmetric outer perimeter (Fig. 14d, the outer perimeter of the needle 50 is asymmetric from a rotated point of view. Applicant has not provided a frame of reference).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Tobinaga in view of McWeeney, in further view of Ross et al. (US Patent No. 6702790 B1), hereinafter Ross.
Regarding claim 6, Tobinaga in view of McWeeney discloses the drug delivery needle above.
Tobinaga does not expressly disclose that each of said beveled surfaces is concave, having an arcuate depression with respect to said arcuate trough and said heel.
Ross teaches beveled surfaces (Ross: col 3, ln 36-49) that are 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 each of said beveled surfaces 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 in view of McWeeney discloses 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 in view of McWeeney discloses 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).
Response to Arguments
Applicant’s arguments, see page 5, filed 30 March 2026, with respect to the objection to claim 2 have been fully considered and are persuasive. The objection of claim 2 has been withdrawn.
Applicant’s arguments, see 5-8, filed 30 March 2026, with respect to the rejections of claims 1-12 under 35 USC 102(a)(2) and 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Tobinaga in view of McWeeney.
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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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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