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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 4, 2025 has been entered.
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(s) 1, 4-8, 12-23, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US 2004/0071761 A1) in view of Tachibana et al. (US 6,096,000).
With regard to claims 1, 4-8, 19, and 25, Miller et al. teach a method of delivering an agent to the conjunctiva and/or cornea of the eye, the method comprising: providing a solid agent carrier body comprising a plurality of channels integral with and extending at least partially through the agent carrier body (Fig. 2, [0075] rigid housing 20 may contain porous ceramic, [0073]), wherein the plurality of channels are each surrounded by rigid walls formed from the agent carrier body (each channel is within the rigid housing); holding the agent within the channels in the agent carrier body prior to delivering, wherein the channels retain the agent within the agent carrier body during the holding ([0072], [0073]); non-invasively applying the tissue contacting surface of the agent carrier body directly to a surface of the conjunctiva and/or cornea of the eye ([0032], [0048], [0067], [0084]); and non-invasively delivering the agent held in the channels of the agent carrier body to the conjunctiva and/or cornea of the eye by applying only ultrasonic waves through the agent carrier body to cause transportation of the agent through the channels into the conjunctiva and/or cornea of the eye, wherein the surface of the conjunctiva and/or cornea of the eye is not damaged by cavitation during the delivering ([0034], [0080], [0081], timing and cycling may cary). Miller et al. do not specifically disclose the channels terminate at a tissue contacting surface and have a pore size as recited. However, Tachibana et al. teach a housing for retaining a drug to be delivered using ultrasound which has a solid agent carrier body (Fig. 3 3B and 3C) comprising a plurality of channels integral with and extending at least partially through the agent carrier body (Figs. 2 and 3 channels 5), the plurality of channels terminating at a tissue contacting surface of the agent carrier body in a series of individual pores (Fig. 3) of up to 1000 pm in size (Col. 3 lines 7-8), wherein the plurality of channels are each surrounded by rigid walls formed from the agent carrier body (all channels 5 are surrounded by 3C which may be more rigid while 3B is softer or either of 3B or 3C may be a more rigid material, Col. 2 lines 52-66); holding the agent within the channels in the agent carrier body prior to delivering, herein the channels retain the agent within the agent carrier body during the holding (the agent is necessarily held in the channel prior to passing through, there is nothing separating the reservoir from the channel prior to delivery, the chamber and apertures are filled with fluid, Col. 4 lines 5-6, Col. 5 lines 20-40). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a reservoir and apertures in Miller et al. as in Tachinbana et al. as Miller et al. teach the device may include similar members for the releasable retention of a compound ([0074]) and the device of Tachibana et al. provides such a member which has the rigidity to contain the substance but still allow the device to conform to the contours of the tissue (Col. 2 lines 52-66) and would yield the same predictable result.
With regard to claim 12, the device is capable of a single use.
With regard to claims 13-18, 20, 22, 23, as combined Tachibana et al. teach the agent carrier has a plurality of geometric shapes including cylindrical, conical (star shapes would have conical tips), circular (Col. 3 lines 5-15). The apertures 5 connect to reservoir 4 (Fig. 3), the components of the reservoir between the apertures are taken as interlinking channels, the material of which is delivered.
With regard to claim 21, see Fig. 3 member 6, Col. 3 lines 18-32.
Claim(s) 2, 3, 9-11, 24, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US 2004/0071761 A1) and Tachibana et al. (US 6,096,000) as applied to claims 1 and 23 above, and further in view of Unger et al. (US 2009/0209899 A1).
With regard to claims 2, 3, and 26, Miller et al. teach using ultrasound to drive a substance into the eye but do not disclose a specific power. However, Unger et al. teach using a power as recited to drive a drug with ultrasound into the eye ([0081]) and being able to deliver desired doses to targeted areas ([0096], [0097]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a power level as recited in Miller et al. as Unger et al. teach this is effective for delivery to the eye and that a user would be able to select desired parameters to deliver a particular dosage to a particular tissue as needed for treatment.
With regard to claims 9-11 and 24, as combined Miller et al. teach delivering via ultrasound to the eye with a transducer (Fig. 3 member 6, Col. 3 lines 18-32) but do not explicitly disclose the means of ultrasonic delivery or a handle with a coupling rod as claimed. However, Unger et al. teach a device for ultrasonically delivering an agent to the eye via a handle which has a rod for transmitting ultrasonic waves (Figs. 4 and 9, rod 904 transducer 702, [0091]-[0096]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a handle and transducer arrangement in Miller et al. as in Unger et al. as Unger et al. teach this is an art effective arrangement for transporting ultrasonic waves into an agent for application through the tissue and would yield the same predictable result.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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 for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gibson et al. teach a rigid porous member for transdermal delivery.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783