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 .
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, 5-7, 19, 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Driller et al. (US 5,016,615) in view of Mitragotri (US 6,589,173 B1).
With regard to claim 1, Driller discloses A system (Fig. 3) for ultrasound-enhanced delivery of at least one substance to a target site (20) in a subject using ultrasound, the system comprising: a delivery unit (Fig. 3, element 9) comprising a drug applicator (14 and 15) and an ultrasound transducer (12); and a signal generating unit (10) operationally connected to the delivery unit (Col 3, line 37 to Col 4, line 19), wherein the drug applicator comprises at least one space (see at 32, Fig. 3) configured to hold the at least one drug and at least one opening (porous membrane 15) at a surface directed towards the target site (20), and wherein the signal generating unit and/or the ultrasound transducer are configured to emit an ultrasound waveform in an ultrasound application cycle for delivery of the at least one drug to the target site (Col 3, line 37 to Col 4, line 19).
However, Driller does not disclose the explicit time duration of the ultrasound emitting event.
Mitragotri teaches an ultrasound system that can apply pulsed ultrasound (pulsed ultrasound as compared to continuous ultrasound alternate between ultrasound emission states and a paused state in which no ultrasound emission occurs) with a TA between a microsecond and 300 milliseconds (Col 5, lines 31-44). While Mitragotri does not explicitly teach a TA of 1 to 30 seconds and a TW of less than 0.001 second it would be prima facie obvious to optimize the times of each of these durations because Mitragotri teaches the use of pulsed ultrasound over continuous ultrasound in order to reduce the severity of adverse side effects of ultrasound such as thermal effects (Col 5, lines 31-44). Further, the claimed language uses the term “configure to” which implies a functional limitation such that only the structure must be taught and the prior art reads on the claims as long as the structure would be capable of performing the recited function. Because Driller teaches the structure and further Mitragotri teaches the used pulsed ultrasound the structure of the signal generating unit and/or ultrasound transducer would be capable to optimize the specific time durations as claimed.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Driller to have the time durations as taught by Mitragotri for the purpose of reducing the severity of adverse side effects of ultrasound such as thermal effects (Col 5, lines 31-44).
With regard to claim 5, Driller discloses wherein the drug applicator (14/15) is configured to be exchangeable and/or designed for a single use application (any device can be configured as a single use as it can be disposed of after a single use).
With regard to claim 6, Driller discloses wherein the drug applicator (14/15) is configured to be filled (chamber 32 of the drug applicator is filled with garamicin, Col 4, lines 20-55) and/or refilling of at least one space with a drug (this last limitation is not required to be taught by the prior art because it follows an “or” clause.).
With regard to claim 7, Driller discloses wherein the drug applicator (14/15) comprise a port structure to allow filling of the at least one space with a drug (any opening in the drug applicator chamber 32 could that is used to fill it with garamicin can be considered a port. Thus because Driller teaches filling the chamber 32 with a drug in Col 4, lines 20-55, a port would necessarily exist to accommodate the filling. Further definition of the port structure or location of the port structure is needed to overcome the current rejection).
With regard to claim 19, Driller discloses wherein the substance comprises a pharmaceutical formulation containing at least one pharmaceutically active compound (garamicin, Col 4, lines 20-55).
With regard to claim 20, Driller discloses wherein the target site is in an intraocular space (20, Fig. 3) or under a skin of the subject (this last limitation is not required to be taught by the prior art because it follows an “or” clause).
With regard to claim 21, Driller discloses the claimed invention except for the system not operating during the waiting TW of the system.
Mitragotri teaches the use of pulsed ultrasound as compared to continuous ultrasound (Col 5, lines 31-44). Pulsed ultrasound by definition includes periods of ultrasound emission and then a period were no ultra sound is emitted.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Driller to use pulsed ultrasound as taught by Mitragotri for the purpose of reducing the severity of adverse side effects of ultrasound such as thermal effects (Col 5, lines 31-44).
With regard to claim 22, Driller discloses the time duration of the ultrasound emitting event are controlled by the signal generating unit and/or the ultrasound transducer (Col 3, line 37 to Col 4, line 19).
Claim(s) 3-4, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Driller et al. (US 5,016,615) in view of Mitragotri (US 6,589,173 B1) and in further view of Slayton (US 2015/0174388 A1).
With regard to claim 3, Driller/Mitragotri teach the claimed invention except for sealing the opeing at the surface.
Slayton teaches and ultrasound and drug delivery system and further teaches the use of packaging to enclose the drug portion of the system ([0107]). Thus if a packaging was also used to enclose the delivery unit of Driller this would seal the opening prior to use.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Driller/Mitragotriwith sealing of the opening as taught by Slayton for the purpose of protecting the device prior to use ([0107]).
With regard to claim 4, Driller/Mitragotri teach the claimed invention except for a seal.
Slayton teaches and ultrasound and drug delivery system and further teaches the use of packaging to enclose the drug portion of the system ([0107]). Thus if a packaging was also used to enclose the delivery unit of Driller this would seal the opening prior to use. The packaging is removed prior to use ([0107]) which would reveal the opening (as taught in Driller).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Driller/Mitragotri with sealing of the opening as taught by Slayton for the purpose of protecting the device prior to use ([0107]).
With regard to claim 10, Driller/Mitragotri teach the claimed invention except for a specific depth.
Slayton teaches the use of ultrasound wherein the at least one drug penetrates to a depth of at least 1.5mm ([0173]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Driller/Mitragotri with penetration depth of at least 1.5mm as taught by Slayton for the purpose of enhancing transdermal transport of the drug ([0173]).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Driller et al. (US 5,016,615) in view of Mitragotri (US 6,589,173 B1) and in further view of Liu et al. (US 2017/0043149 A1).
With regard to claim 8 and 9, Driller/Mitragotri teach the claimed invention except for a specific drug molecule size.
Liu teaches the use of ultrasound to enhance drug delivery and further teaches the molecules being delivered with a size greater than 70kDa ([0012]) and greater than 150kDa ([0012]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Driller/Mitragotri with the specific sized molecules as the substation of one drug type for another is well known in the art and does not alter the overall function of the device ([0012]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Driller et al. (US 5,016,615) in view of Mitragotri (US 6,589,173 B1) and in further view of Slayton (US 2015/0174388 A1) and Bujak et al. (US 2015/0148711 A1).
With regard to claim 11, Driller/Mitragotri/Slyton teach the claimed invention except for the frequency.
Bujak teaches the use of ultrasound for drug delivery and further teaches the frequency is greater than 35kHz ([0034], can be up to 50 MHz which is greater than 35kHz).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Driller/Mitragotri/Slayton with the frequency as taught by Bujak for optimization of eye treatment ([0034]).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Driller et al. (US 5,016,615) in view of Mitragotri (US 6,589,173 B1) and in further view of Slayton (US 2015/0174388 A1) and Brisken et al. (WO 00/48518).
With regard to claim 12, Driller/Mitragotri/Slayton teach the claimed invention except for a mechanical index.
Brisken teaches the use of ultrasound for drug delivery and further teaches wherein a mechanical index of the ultrasound application cycle is greater than 0.2 (p. 24, line 3-8, index is 1.8).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Driller/Mitragotri/Slayton with the mechanical index as taught by Brisken for the purpose of yielding best results for enhancing drug delivery (p. 24, line 3-8).
With regard to claim 13, Driller/Mitragotri/Slayton teach the claimed invention except for an intensity.
Brisken teaches the use of ultrasound for drug delivery and further teaches wherein an intensity is greater than 1.5 W/cm2 (p.27 table 3, shows the intensity to be between 0.1 and 20 in an preferred condition and 0.5 to 5 in the example condition).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Driller/Mitragotri/Slayton with the intensity as taught by Brisken for the purpose of optimizing the conditions for drug delivery to the target site (p. 24, line 3-8 and as described in Table 3 on p. 27).
Claim(s) 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Driller et al. (US 5,016,615) in view of Mitragotri (US 6,589,173 B1) and in further view of Humayun (US 2013/0046179 A1).
With regard to claim 14-16, Driller/Mitragotri disclose the claimed invention except for a send and/or receiving unit.
Claim 14: Humayun teaches and ultrasound and drug delivery system that further includes a send and/or receiving unit (short range wireless device for wireless communication to the ultrasound machine for power and data, [0063]).
Claim 15, Humayun teaches wherein the information receiving and/or sending unit ([0063]) is operationally connected to the signal generating unit which comprises a controller ([0064], controller component of the ultrasound probe which is equivalent to the signal generating unit as taught in Driller), wherein the controller is configured to control at least one of a plurality of parameters of the application cycle based on the information related to the drug ([0064]).
Claim 16: Humayun teaches wherein the information receiving and/or sending unit ([0063]) is arranged and configured such that the information receiving and/or sending unit retrieves information related to the drug when the drug applicator is coupled to the system (receives data as taught in [0063], limitation uses the term “configured to” indicating that the receiving and/or sending unit must only be capable of retrieving information regarding the drug. Because Humayun teaches that the transducer probe can receive data information it would be capable such that some of this information is related to the drug).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Driller/Mitragotri with the receiving and/or sending unit as taught by Humuyan for the purpose of retrieving information and controlling the delivery of the ultrasound to the eye ([0063], [0064]).
With regard to claim 17, Diller discloses wherein the controller is configured to control at least one of a plurality of parameters of the application cycle, the plurality parameters of the application cycle are selected from the following (only one of the parameters needs to be taught by the prior art, citations will be made where Driller teaches the following):
(a) the time duration TA of the ultrasound emitting event (col 3, lines 28-36),
(b) the time duration TW of the wait period after the ultrasound emitting event,
(c) the number of application cycles,
(d) the intensity of the ultrasound emitting event (col 3, lines 28-36),
(e) the central frequency of the ultrasound emitting event,
(f) the mechanical index of the ultrasound emitting system, and in case of a pulsed ultrasound emitting event:
(g) the repetition rate of the ultrasound emitting event and
(h) the duty cycle of the ultrasound emitting event.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Driller et al. (US 5,016,615) in view of Mitragotri (US 6,589,173 B1) and in further view of Humayun (US 2013/0046179 A1) and Lipkovker (US 5,421,816).
With regard to claim 18, Driller/Mitragotri/Humayun teach the claimed invention except for a temperature sensor.
Lipkovker teaches an ultrasound device (Fig. 6) that includes the use of a temperature sensor (71) configured to sense the temperature of the surface of the sclera or cornea (for use on the body and would be capable of being used on the sclera or cornea), or a thermocouple and/or an infrared thermometer, and wherein the controller is configured to control the ultrasound emitting event such that during the time TA the temperature of the surface of the sclera or cornea does not increase by more than 1C (col 11, line 32-37, teaches that when a threshold temperature is exceeded the controller can stop emitting ultrasound. The language of the claims “configured to” indicates a functional imitation in which the controller must only be capable of performing the recited function. Because the temperature sensor is used to detect a change in temperature and adjust ultrasound delivery based on the temperature reading, it would be capable such that the ultrasound delivery may be stopped if the temperature increases by more than 1C).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Driller/Mitragotri/Humayun with the temperature sensor as taught by Lipkovker for the purpose of being used as a safety device to prevent damage if a temperature threshold is exceeded (Col 11, lines 32-37).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-22 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.
Mitragotri is being used to teach the use of pulsed ultrasound which, by definition, include a period of ultrasound emission and a period of rest where no ultrasound is emitted. While the specific time durations are not explicitly taught it would be prima facie obvious to optimize the time durations as doing so does not alter the overall function of the device. Further the claim limitations are considered functional and therefore only the structure must taught and must simply be capable of performing the recited function. Because Mitragotri teaches the use of pulsed ultrasound with both an emission and a waiting period the controller would be capable of working at the claimed time durations. Further no significance has been placed on the claimed range and thus appears to be within the skill of one or ordinary skill in the art to optimize.
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 LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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