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 .
Acknowledgments
This office action is in response to the reply filed on 3/16/26.
In the reply, the applicant amended claims 1,11,16. Claims 1-20 are pending.
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)(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 1-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Orth et al. (US 11,071,847) (“Orth”). Orth discloses:
A microneedle balloon catheter (1300), comprising: a balloon (1350) fluidically coupled to a first fluidic channel (1333); a plurality of microneedles (1314) fluidically coupled to a second fluidic channel (1320), wherein the plurality of microneedles are on an exterior surface of the balloon (Fig. 13, C3L26-28); and a guiding sheath, wherein in a first position of the microneedle balloon catheter the balloon, the plurality of microneedles, and a portion of the first and second fluidic channels are housed within the guiding sheath and in a second position of the microneedle balloon catheter the balloon and the plurality of microneedles are arranged outside of the guiding sheath (C3L18-20,C22L6-28), wherein the first and second fluidic channels are fluidically isolated from each other. C2L50-51, C17L30-46, Fig.13, C18L12-28, Figs. 15a,b, and wherein a portion of the second fluidic channel 1320’,1320’’ is interposed between the plurality of microneedles 1314 and the balloon 1350 (Fig. 13) and is curved with a radius conforming to an outer dimension of the balloon in an inflated state, see Fig. 13.
a fluid drive (attached to the adapter 1339) fluidically coupled to the first and second fluidic channels.
the fluid drive comprises a first fluid drive and a second fluid drive respectively coupled to the first and second fluidic channels. See Fig.13, C17L30-46
the fluid drive is coupled to provide a first fluid to the first fluidic channel and a second fluid to the second fluidic channel, wherein the first and second fluids are different fluids. See Fig.13, C17L30-46
the fluid drive is a manually operated fluid drive. See Fig.13, C17L30-46
the plurality of microneedles are arranged in a line along a length of the balloon. Fig. 13
the plurality of microneedles are arranged in a two-dimensional array. Fig. 11d
at least some of the plurality of microneedles have different dimensions. C18L42-55
a distal end of the plurality of microneedles is tapered. Fig. 13
in the first position the balloon is folded, and the plurality of microneedles are arranged within a fold of the balloon. Fig. 11b
The claims of 11-18 are similarly rejected as above
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.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Orth.
With respect to claims 19-20 the first fluid is air and the second fluid is a drug, the first fluid is a liquid and the second fluid is a drug are inherently disclosed and/or obvious.
Response to Arguments
Applicant's arguments/amendments have been fully considered but they are not persuasive. Applicant argues that Orth does not disclose or teach the amended claim language because the amended claim language requires a specific geometry where the second fluidic channel itself—not merely a surrounding scaffold—is interposed directly between the needles and the balloon and is shaped with a radius of curvature that matches the balloon’s inflated state. This argument is not persuasive. Even with the spines (1312,,1312’,1312’’), a portion of the second fluidic channel 1320’,1320’’, is interposed between the plurality of microneedles 1314 and the balloon 1350 (as seen below) and the second fluidic channel is curved with a radius conforming to an outer dimension of the balloon in an inflated state, see Fig. 13, below.
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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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783