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 Objections
Claim 22 objected to because of the following informalities:
Claim 22 recites “formed in one transducer.” First appearance of the transducer should be “a transducer.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16, 20-21, 27 and 30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites “an ultrasonic wave” transmitted to a delivery site and then “an ultrasonic wave reflected by the delivery site.” The second “an ultrasonic wave” lacks a clear relationship to the wave already introduced. It is unclear whether the received wave is the same wave after reflection or a different wave. Amendment to “the ultrasonic wave reflected by the delivery site,” or to “a reflected ultrasonic wave,” would cure this.
Claim 20 recites “with conductive material coating on each of the plurality of stacked dielectric or piezoelectric layers.” There is no antecedent basis for “conductive material coating.”
Claim 30 recites “an adjustment signal received from the detector.” There is no antecedent basis for “the detector.” Claims 16 and 29 recite a “delivery site detector.”
Claim 20 recites that each stacked layer “is bonded to its adjacent dielectric or piezoelectric layers with conductive material coating on each of the plurality of stacked dielectric or piezoelectric layers.” The claim is unclear.
“Adjacent layers” is plural. An end layer of the stack has only one adjacent layer.
It is unclear whether “conductive material coating” is the bonding agent, a separate coating on each layer, or both, and whether every face of every layer must be coated.
See specification page 16 (“bonded.. with a conductive material 401b” that “is coated on each” layer). Claim 20 collapses those two statements into one phrase.
Claim 21 recites that the processor controls the indicator “based on a detection of the delivery site detector” and sends a signal “based on a detection of the delivery site detector.” That language reads as detecting the detector itself. It is unclear whether the indication or signal is based on a detection by the delivery site detector.
Claim 27 recites the same “detection of the delivery site detector” phrase and is rejected for the same reason.
Claim 27 further recites “The medicament delivery device according to claim 26, when comprising the delivery site detector according to claim 16.” Claim 26 already comprises the guard of claim 23 or the housing of claim 25, each of which includes the detector of claim 16. The “when comprising” clause is surplus and makes the scope of 27 look contingent on a condition that is always met. It is unclear whether claim 27 is limited to one branch of claim 26.
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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Randlov (US 7,722,535) in view of Zimmer (US 8,702,630).
Regarding claim 16, Randlov discloses a delivery site detector (apparatus for choosing a site for a skin-invasive action (drug injection) before the needle goes in; col. 3, lines 3-48) configured to be attached to a medicament delivery device (apparatus may be an injection device, e.g. doser pen equipped with measuring means; col. 7, lines 50-56), the delivery site detector comprising:
an ultrasonic transmitter (means for emitting acoustic waves; col. 6, line 55 – col. 7, line 6); and
an ultrasonic receiver (means for detecting an acoustic response signal; col. 6, line 55 – col. 7, line 6),
wherein the ultrasonic transmitter is configured to transmit an ultrasonic wave (transmitting acoustic waves; col. 6, line 55 – col. 7, line 6) to a delivery site (particular area part of the skin or subcutis of a mammal in figs. 1-3; col. 3, lines 24-35),
wherein the ultrasonic receiver is configured to receive an ultrasonic wave reflected by the delivery site (detecting an acoustic response signal in fig. 3; col. 6, line 55 – col. 7, line 6; col. 9, lines 20-25), and
wherein the ultrasonic transmitter comprises a frequency generator configured to generate and transmit ultrasonic waves (apparatus generates and emits ultrasonic signal; col. 6, line 55 – col. 7, line 6).
Randlov fails, however, to disclose waves transmitted with at least two different frequencies.
Zimmer teaches waves transmitted with at least two different ultrasound frequencies (Zimmer: ultrasound pulses are at different ultrasound frequencies; col. 3, lines 12-13; ultrasound pulses 0.8 MHz and 2.4 MHz; pulses P1 and P2 are injected alternately at frequencies f1 and f2 in fig. 4; col. 7, lines 25-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasonic transmitter / acoustic-wave generating means of Randlov to include a frequency generator that generates and transmits ultrasonic waves in at least two different ultrasound frequencies, as taught by Zimmer, in order to interrogate the delivery site at more than one penetration depth and thereby better characterize the skin and subcutis layers to choose the injection site.
Claims 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Randlov (US 7,722,535) in view of Zimmer (US 8,702,630), as applied to claim 16 above, and further in view of Bolorforosh (US 6,673,016).
Regarding claim 17, modified Randlov discloses the delivery site detector according to claim 16 comprising a frequency generator (apparatus generates and emits ultrasonic signal; col. 6, line 55 – col. 7, line 6; one frequency).
Modified Randlov fails, however, to disclose that the frequency generator comprises a plurality of stacked dielectric or piezoelectric layers.
Bolorforosh teaches a plurality of stacked dielectric or piezoelectric layers (Bolorforosh: top layer 12 and bottom layer 14 of piezoelectric material in fig. 1; col. 3, lines 16-35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the frequency generator of modified Randlov to comprise a plurality of stacked dielectric or piezoelectric layers, as taught by Bolorforosh, in order to generate the two ultrasound frequencies from one stacked element on the pen.
Regarding claim 18, modified Randlov discloses the delivery site detector according to claim 17, wherein at least two of the plurality of stacked dielectric or piezoelectric layers have different thicknesses (Bolorforosh: each of the layers 12, 14 has same or different geometry, including same thickness or thicknesses that vary in one or more dimensions; col. 3, lines 42-45; col. 14, lines 33-42).
Regarding claim 19, modified Randlov discloses the delivery site detector according to claim 17, wherein all layers of the plurality of stacked dielectric or piezoelectric layers have the same thickness (Bolorforosh: each of the layers 12, 14 has same or different geometry, including same thickness or thicknesses that vary in one or more dimensions; col. 3, lines 42-45; col. 14, lines 33-42).
Regarding claim 20, modified Randlov discloses the delivery site detector according to claim 17, wherein each of the plurality of stacked dielectric or piezoelectric layers is bonded to its adjacent dielectric or piezoelectric layers with conductive material coating on each of the plurality of stacked dielectric or piezoelectric layers (Bolorforosh: bond layers between transducer components are thin and uniform; col. 4, lines 28-29; middle electrode 62 between layers 12 and 14; col. 13:37-38; claims 10 and 21).
Regarding claim 21, modified Randlov discloses the delivery site detector according to claim 16.
Modified Randlov fails, however, to disclose:
an indicator operably connected to the delivery site detector;
a processor connected to the indicator and the delivery site detector; and
a battery connected to the delivery site detector, the indicator, and the processor,
wherein the processor is configured to control the indicator to provide at least a visual, audible, and/or tactile indication, and/or to send out a signal containing data based on a detection of the delivery site detector.
Zimmer teaches an indicator operably connected to the delivery site detector (Zimmer: display 7 which uses bar charts 8, 9 to display selected parameters and further uses displays 10, 11 to show penetration depth in fig. 1; col. 5, lines 11-17; connected to apparatus 1 in fig. 1);
a processor connected to the indicator and the delivery site detector (Zimmer: controller 3 has control device 4 in fig. 1; col. 5, lines 6-7; both connected to apparatus 1 in fig. 1); and
wherein the processor is configured to control the indicator to provide at least a visual, audible, and/or tactile indication, and/or to send out a signal containing data based on a detection of the delivery site detector (Zimmer: controller device 4 is coupled to input device 7 and display device 7 and provides visual indications to operator; col. 5, lines 6-27).
Bolorforosh teaches a battery connected to the delivery site detector, the indicator, and the processor (Bolorforosh: transducer is advantageously used with a battery powered ultrasound system, such as a handheld, carried or mobile ultrasound system; col. 14; lines 48-51).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery site detector of modified Randlov to include an indicator and a processor, as taught by Zimmer, and a battery, as taught by Bolorforosh, in order to power the detector as a handheld unit and to show the user whether the scanned site is suitable before the needle goes in.
Regarding claim 22, modified Randlov discloses the delivery site detector according to claim 16 comprising an ultrasonic transmitter (means for emitting acoustic waves; col. 6, line 55 – col. 7, line 6) and an ultrasonic receiver (means for detecting an acoustic response signal; col. 6, line 55 – col. 7, line 6).
Modified Randlov fails, however, to disclose that the ultrasonic transmitter and ultrasonic receiver are formed in one transducer.
Bolorforosh teaches that the ultrasonic transmitter and ultrasonic receiver are formed in one transducer (Bolorforosh: transducer system comprises a transducer element 10 connected with a transmitter 20 and a receiver 22 in fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the separate emitting and detecting means of modified Randlov to be formed in one transducer, as taught by Bolorforosh, in order to put the transmitter and receiver in a single element that fits on the pen face.
Claims 23, 25-26 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Randlov (US 7,722,535) in view of Zimmer (US 8,702,630), as applied to claim 16 above, and further in view of Baym (US 2016/0008556).
Regarding claim 23, modified Randlov discloses the delivery site detector according to claim 16.
Modified Randlov fails, however, to disclose a delivery member guard comprising the delivery site detector.
Baym teaches a delivery member guard comprising a delivery site detector (Baym: skin-facing portion of needle insertion system 300 comprising sensor 330 at a position in proximity to the distal tip 365 of needle 310 in fig. 3; para [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the doser pen arrangement of Randlov by placing the delivery site detector on the skin-facing insertion structure next to the needle, as taught by Baym, in order to characterize the delivery site at the point where the needle enters the skin.
Regarding claim 25, modified Randlov discloses a housing of a medicament delivery device (housing portion of doser pen injection device; col. 7, lines 50-56), the housing comprising the delivery site detector according to claim 16.
Modified Randlov fails, however, to disclose that the housing is configured to accommodate a medicament container of the medicament delivery device.
Baym teaches that the housing is configured to accommodate a medicament container of the medicament delivery device (Baym: insertion system includes a medicament reservoir; para [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the doser pen housing of modified Randlov to accommodate a medicament container, as taught by Baym, in order to dose in the same housing that bears the site detector.
Regarding claim 26, modified Randlov discloses a medicament delivery device (apparatus may be an injection device, e.g. doser pen equipped with measuring means; col. 7, lines 50-56) comprising either the delivery member guard according to claim 23 (Baym: skin-facing portion of needle insertion system 300 comprising sensor 330 at a position in proximity to the distal tip 365 of needle 310 in fig. 3; para [0035]), or the housing according to claim 25 (housing portion of doser pen injection device; col. 7, lines 50-56).
Regarding claim 29, modified Randlov discloses the medicament delivery device according to claim 26, comprising a medicament delivery member (injection needle of skin-invasive apparatus; col. 3, lines 3-48).
Modified Randlov fails, however, to disclose a depth adjuster configured to determine the furthest distance that a medicament delivery member can reach.
Baym teaches a depth adjuster (Baym: control circuitry 140; para [0036]) configured to determine the furthest distance that a medicament delivery member can reach (Baym: control circuitry 140 is operable to control movement 170 of the moveable hollow needle 110 including the distal tip 165 into the skin to an insertion depth 165 in response to one or more signals 150 from the at least one sensor 130 indicating the skin structure 132, 134, 136, 138, and indicating the depth of the skin structure; para [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medicament delivery device of modified Randlov to include a depth adjuster that sets how far the needle can reach, as taught by Baym, in order to match insertion depth to the skin structure the detector has measured.
Regarding claim 30, modified Randlov discloses the medicament delivery device according to claim 29 comprising a depth adjuster (Baym: control circuitry 140; para [0036]).
Modified Randlov fails, however, to disclose that the depth adjuster is automatically controlled and adjusted based on an adjustment signal received from the detector.
Baym teaches a depth adjuster that is automatically controlled and adjusted based on an adjustment signal received from the detector (Baym: control circuitry 140 is operable to control movement 170 of the moveable hollow needle 110 including the distal tip 165 into the skin to an insertion depth 165 in response to one or more signals 150 from the at least one sensor 130 indicating the skin structure 132, 134, 136, 138, and indicating the depth of the skin structure; para [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the depth adjuster of modified Randlov so that it is automatically controlled by a signal from the detector, as taught by Baym, in order to set insertion depth from the same site measurement without a separate manual step.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Randlov (US 7,722,535) in view of Zimmer (US 8,702,630) and Baym (US 2016/0008556), as applied to claim 23 above, and further in view of Allegretti (US 2022/0176045).
Regarding claim 24, modified Randlov discloses the delivery member guard according to claim 23 comprising a delivery member guard (Baym: skin-facing portion of needle insertion system 300 comprising sensor 330 at a position in proximity to the distal tip 365 of needle 310 in fig. 3; para [0035]) and a medicament delivery member (injection needle of skin-invasive apparatus; col. 3, lines 3-48) of the medicament delivery device for use of the medicament delivery device (apparatus may be an injection device, e.g. doser pen equipped with measuring means; col. 7, lines 50-56), an ultrasonic transmitter (means for emitting acoustic waves; col. 6, line 55 – col. 7, line 6) and an ultrasonic receiver (means for detecting an acoustic response signal; col. 6, line 55 – col. 7, line 6).
Modified Randlov fails, however, to disclose that the delivery member guard comprises a sleeve, wherein the sleeve comprises a proximal wall configured to contact the delivery site, wherein an aperture is arranged in the proximal wall of the sleeve and is configured to be passed through by a medicament delivery member.
Allegretti teaches a sleeve (Allegretti: sleeve 50 in figs. 9-10), wherein the sleeve comprises a proximal wall (Allegretti: distal face 54 in figs. 9-10) configured to contact the delivery site (Allegretti: end wall 52 has a distal face 54 forming a skin contact surface during use; para [0062]), wherein an aperture (Allegretti: end wall with an opening to allow the needle to extend from sleeve when retracted; para [0017]) is arranged in the proximal wall of the sleeve and is configured to be passed through (Allegretti: end wall with an opening to allow the needle to extend from sleeve when retracted; para [0017]) by a medicament delivery member.
Modified Randlov also fails to disclose that the ultrasonic transmitter and ultrasonic receiver are attached to the proximal wall of the sleeve (Baym: skin-facing portion of needle insertion system 300 comprising sensor 330 at a position in proximity to the distal tip 365 of needle 310 in fig. 3; para [0035]).
Baym teaches that the ultrasonic transmitter and ultrasonic receiver are attached to the proximal wall of the sleeve (Baym: skin-facing portion of needle insertion system 300 comprising sensor 330 at a position in proximity to the distal tip 365 of needle 310 in fig. 3; para [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the skin-facing insertion structure of modified Randlov to be a sleeve having a proximal wall that contacts the delivery site and an aperture for the needle, as taught by Allegretti, and to attach the ultrasonic transmitter and receiver to that wall, as taught by Baym, in order to cover the needle until use and to keep the site detector on the face that actually meets the skin.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Randlov (US 7,722,535) in view of Zimmer (US 8,702,630) and Baym (US 2016/0008556), as applied to claim 26 above, and further in view of Bolorforosh (US 6,673,016).
Regarding claim 27, modified Randlov discloses the medicament delivery device according to claim 26, when comprising the delivery site detector (apparatus for choosing a site for a skin-invasive action (drug injection) before the needle goes in; col. 3, lines 3-48) according to claim 16, the medicament delivery device comprising:
an indicator operably connected (Zimmer: display 7 which uses bar charts 8, 9 to display selected parameters and further uses displays 10, 11 to show penetration depth in fig. 1; col. 5, lines 11-17; display 7 is connected to apparatus 1 in fig. 1) to the delivery site detector (apparatus for choosing a site for a skin-invasive action (drug injection) before the needle goes in; col. 3, lines 3-48);
a processor connected to the indicator and the delivery site detector (Zimmer: controller 3 has control device 4 in fig. 1; col. 5, lines 6-7; both connected to apparatus 1 in fig. 1); and
wherein the processor is configured to control the indicator to provide at least a visual, audible, and/or tactile indication based on a detection of the delivery site detector, and/or to send out a signal containing data based on a detection of the delivery site detector (Zimmer: controller device 4 is coupled to input device 7 and display device 7 and provides visual indications to operator; col. 5, lines 6-27).
Modified Randlov fails, however, to disclose a battery connected to the delivery site detector (Bolorforosh: transducer is advantageously used with a battery powered ultrasound system, such as a handheld, carried or mobile ultrasound system; col. 14; lines 48-51).
Bolorforosh teaches a battery connected to the delivery site detector (Bolorforosh: transducer is advantageously used with a battery powered ultrasound system, such as a handheld, carried or mobile ultrasound system; col. 14; lines 48-51).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medicament delivery device of Randlov to include a battery, as taught by Bolorforosh, in order to power the device as a handheld unit.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Randlov (US 7,722,535) in view of Zimmer (US 8,702,630), Baym (US 2016/0008556) and Bolorforosh (US 6,673,016), as applied to claim 27 above, and further in view of Slate (US 2016/0271326).
Regarding claim 28, modified Randlov discloses the medicament delivery device according to claim 27 comprising a delivery site detector (apparatus for choosing a site for a skin-invasive action (drug injection) before the needle goes in; col. 3, lines 3-48).
Modified Randlov fails, however, to disclose a disposable cassette unit and a reusable drive unit releasably attached to the cassette unit, and wherein the delivery site detector is arranged in the cassette unit, and wherein the battery, the indicator and the processor are arranged in the drive unit.
Slate teaches a disposable cassette unit (Slate: disposable cassette 112 in figs. 1-2) and a reusable drive unit (Slate: re-usable drive mechanism or autoinjector 114 in fig. 1) releasably attached to the cassette unit (Slate: cassette 112, along with the expended syringe 128, can be removed from the cradle 116 of the autoinjector 114 and discarded), and wherein the delivery site detector is arranged in the cassette unit (delivery site detector of modified Randlov is already on the insertion face of Baym – that face is the cassette / needle-end part; combining them puts the detector in the cassette and the electronics in the drive), and wherein the battery (Slate: power supply 323 mounted in autoinjector 314 in fig. 10D; para [0082]), the indicator (Slate: indicator lights 321 for indicating status of system 300 in fig. 9, para [0077]) and the processor (Slate: button 220 and microcomputer or controller 218 are mounted inside the autoinjector 214 in fig. 6; para [066]) are arranged in the drive unit.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medicament delivery device of Randlov to comprise a disposable cassette unit releasably attached to a reusable drive unit, with the detector in the cassette and the battery, indicator, and processor in the drive, as taught by Slate, in order to throw away the needle-end part after use and keep the electronics.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
