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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/1/26 has been entered.
Acknowledgments
This office action is in response to the reply filed on 6/1/26.
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 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Orr (US 2011/0166516). Orr discloses:
A microneedle balloon catheter (Fig. 8)(230), comprising: a balloon (250) fluidically coupled to a first fluidic channel (232); a plurality of microneedles (280a-c) fluidically coupled to a second fluidic channel (262a-c), wherein the plurality of microneedles are on an exterior surface of the balloon (Fig.8,[0061-0062]); 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 ([0039]), wherein the first and second fluidic channels are fluidically isolated from each other [0061], wherein the second fluidic channel is affixed directly to an exterior surface of the balloon such that the plurality of microneedles are longitudinally fixed relative to the balloon [0061-0062] Fig. 8, and wherein an expansion of the balloon to an inflated state moves the plurality of the microneedles radially outward [0064].
a fluid drive fluidically coupled to the first and second fluidic channels; the fluid drive comprises a first fluid drive and a second fluid drive (inflation source and [0059-multiple different therapeutic agents may be delivered; [0064-0065])
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. [0059-0065]
the fluid drive is a manually operated fluid drive. [0031—inflation source is commonly a syringe, for example]
the plurality of microneedles are arranged in a line along a length of the balloon. Fig.8
the plurality of microneedles are arranged in a two-dimensional array. Fig.8
at least some of the plurality of microneedles have different dimensions. [0059]
a distal end of the plurality of microneedles is tapered. Fig.8
in the first position the balloon is folded, and the plurality of microneedles are arranged within a fold of the balloon. [0039,0048] (no inadvertent piercing tissue upon delivery)
The claims of 11-18 are similarly rejected as above
Claim 19: the first fluid is air (inflation fluid—fluid is a gas or liquid) and the second fluid is a drug [0059,0061,0064-0065]
Claim 20: the first fluid is a liquid (saline) and the second fluid is a drug [0059,0061,0064-0065]
Response to Arguments
Applicant’s arguments with respect to the claims and amendments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783
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