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 § 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.
Claim 7 is 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 7 recites “a distal end”. It is unclear whether this refers to the distal end recited in claim 1, or an entirely different distal end. Thus, the claim is rendered indefinite. For the purposes of examination, it will be assumed that this is the same distal end.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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, 3-4, 6-9, 12-13, 16, & 19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Ouyang (US 9,895,048).
Regarding claim 1, Ouyang discloses a handheld medical device 100 having a disposable single-use tip 110. Ouyang, Abstract; 1:34-39. Ouyang discloses that tip assembly 110 of handheld medical device 100 is part of “single-use portion 104 and [is] made at a relatively low-cost and [is] intended to be disposed of after a single use.” id. at 7:35-38. Tip 110 comprises a proximal end 1110 and a distal end 1116 and a sensor (“simple low-cost fixtures that use an LED and light sensor” 1160; id. at 11:52-53) for transmitting and receiving light waves, sensor 1160 is positioned on the proximal end 1110 of tip 110, wherein sensor 1160 is configured to operatively couple to a receiver disposed outside of and separate from tip 110 (“[i]nsulated cable 810 includes a plurality of further insulated electrical conductors for sending power to the... LEDs [sensor] in the distal tip and signals back to electronics [receiver] in the handle” see id. at 9:60-63), and wherein tip 110 is a disposable component completely detachable from and selectively attachable to handheld medical device 100. See id. at 4:34-41; 6:4-7; 7:4-6; 7:52-58; 12:50-62; Figs. 3A, 11.
In the alternative, although Ouyang’s disclosure more generally “relates mainly to a medical device for use in tissue examination,” some aspects of Ouyang are directed to a handheld endoscope. See Ouyang, Title; Abstract; 1:34-35. Although endoscopy and ultrasonography use different methods (i.e., light waves versus sound waves) to visualize the body’s internal structures, they are both medical imaging techniques. As such, a skilled artisan would recognize that a handheld endoscopic imaging device having a reusable handle portion and a single-use/disposable tip portion, as described in Ouyang, would also be applicable to a handheld ultrasonic imaging device requiring similar features.
Regarding claim 3, Ouyang teaches the tip of claim 1, wherein the tip is selectively attachable to a handle (handle portion 140, Column 7, Line 23) of the handheld ultrasound device (Column 4, Lines 34-41; Column 7, Lines 52-58; Figure 3A).
Regarding claim 4, Ouyang teaches the tip of claim 3, wherein the receiver is disposed within the handle (electronics in the handle, Column 9, Lines 63-64).
Regarding claim 6, Ouyang teaches the tip of claim 3, wherein the tip is tethered to the handle via a cable (insulated cable 810, Column 9, Lines 61-64), and wherein the sensor is operatively coupled to the receiver via the cable such that the tip is operable when separated from the handle (Column 7, Lines 55-58).
Column 7, Lines 55-58 teach that there exist two different kinds of connection between the tip and the handle: mechanical connectors 320 & 322 that provide a physical connection and electrical connectors 310 & 312 that provide an electrical connection. In a case in which the tip is connected to the electrical connectors but not the mechanical connectors, then the tip is operable while being separated from the handle.
Regarding claim 7, Ouyang teaches the tip of claim 6, wherein the distal end of the tip defines a cavity (upper lumen 730, Column 12, Lines 24-25, Figure 11) for storing the cable when the tip is attached to the handle (Column 12, Lines 24-25, Figure 11).
Regarding claim 8, Ouyang teaches the tip of claim 6, wherein the tip comprises the cable (Column 9, Lines 61-64).
Regarding claim 9, Ouyang teaches the tip of claim 6, wherein the handle comprises the cable (Column 9, Lines 61-64).
Regarding claim 12, Ouyang teaches the tip of claim 1, wherein the tip is sterile (Column 7, Lines 42-44) and is configured for one-time use (Column 7, Lines 35-38).
Regarding claim 13, Ouyang teaches the tip of claim 1, wherein the tip incorporates a curvature along a length of the tip (Figure 1).
Regarding claim 16, Ouyang discloses a tip 104 for a handheld medical device 100, comprising: a sensor 1160 for transmitting and receiving light waves; a shaft having a proximal end (110, 112, 122) and a distal end 120, sensor 1160 is positioned on proximal end 110 of the shaft; and a connector 310 and/or 322 at distal end 120 of the shaft, the connector removably connecting tip 104 to handle 140 of handheld medical device 100, the connector providing an operative connection between tip 104 and handle 140 (at 320/322 mechanical connectors and/or at 310/312 electrical connectors), wherein the distal end 120 of the shaft is shaped complementary to an end of the handle (via the connector sites see Fig. 3A), and wherein tip 104 includes a first attachment element 310 and/or 320 and the handle includes a second attachment element 312 and/or 322, first attachment element 310 and/or 320 cooperating with second attachment element 312 and/or 322, respectively, to selectively attach tip 104 to handle 140 and to completely detach tip 104 from handle 140. Ouyang, 4:34-41; 6:4-7; 7:4-6; 7:52-58; 12:50-62; Figs. 3A, 11.
In the alternative, although Ouyang’s disclosure more generally “relates mainly to a medical device for use in tissue examination,” some aspects of Ouyang are directed to a handheld endoscope. See Ouyang, Title; Abstract; 1:34-35. Although endoscopy and ultrasonography use different methods (i.e., light waves versus sound waves) to visualize the body’s internal structures, they are both medical imaging techniques. As such, a skilled artisan would recognize that a handheld endoscopic imaging device having a reusable handle portion and a single- use/disposable tip portion as described in Ouyang, would also be applicable to a handheld ultrasonic imaging device requiring similar features.
Regarding claim 19, Ouyang teaches the tip of claim 16, wherein the tip is detachably received on the handle (Column 4, Lines 34-41; Column 7, Lines 52-58) such that the tip is operable separate from the handle (See rejection of claim 6).
Claim 20 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Dardel (US 5,490,522).
Regarding claim 20, Dardel discloses a tip 300 for a handheld ultrasound device 400, tip 300 is selectively attachable (via 310, 340, 610, 620) to handheld ultrasound device 400, tip 300 comprises a proximal end 320, a distal end 310, and a transducer 600 for ultrasound waves that is positioned on proximal end 320 of tip 300 (i.e., when assembled, transducer 600 is positioned on proximal end 320 of tip 300 see Dardel, Fig. 3b); and a sterile barrier 100 extending distally beyond tip 300 to enclose at least a portion of handheld ultrasound device 400, wherein sterile barrier 100 is secured to tip 300 between the proximal and distal ends of tip 300, i.e., along the body of tip 300 between ends 320 and 310, respectively, via frame 200. Dardel, 4:29-33; 4:51-55; Figs. 1, 2, 3a, 3b, 4.
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 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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ouyang, as applied to claim 3, above, in view of Dardel.
Regarding claim 5, Ouyang teaches the tip of claim 3, wherein the tip is sterile (Column 7, Lines 42-44).
However, Ouyang fails to disclose that the tip incorporates a sterile barrier for enclosing the handle.
Dardel teaches that the tip (cap 300 & ultrasonic probe 600, Column 3, Line 66-Column 4, Line 28) incorporates a sterile barrier (flexible tube 100, Column 3, Line 66-Column 4, Line 14) for enclosing the handle (electronics casing 400, Column 4, Lines 17-18) (Figure 3b).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the tip of Ouyang such that the tip incorporates a sterile barrier for enclosing the handle, as taught by Dardel. Because the handle portion of Ouyang is reusable, providing a sterile barrier that encloses the handle prevents the handle from needing to be manually sterilized after each use.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ouyang, as applied to claim 1, above, in view of Burnside (US 2010/0204569).
Regarding claim 10, Ouyang teaches the tip of claim 1, wherein the tip is operable when separated from the handle (Column 7, Lines 55-58).
However, Ouyang fails to disclose that the sensor is operatively coupled to the receiver via a wireless connection.
Burnside teaches that the sensor (wireless module 950, [0137]) is operatively coupled to the receiver (data-receiving component, [0137]) via a wireless connection.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the tip of Ouyang such that the sensor is operatively coupled to the receiver via a wireless connection, as taught by Burnside. This would allow the device to continue to be able to transmit data while in the separated configuration.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ouyang, as applied to claim 1, above, in view of Olson (WO 99/35968).
Regarding claim 11, Ouyang teaches the tip of claim 1, wherein the tip is sterile (Column 7, Lines 42-44).
However, Ouyang fails to disclose that the tip is configured for re-sterilization.
Olson teaches that the tip (probe 100, Figure 4) is configured for re-sterilization after use (Page 15, Lines 6-7 & Page 27, Lines 30-32).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the tip of Ouyang to be re-sterilizable, as taught by Olson. This ensures the device can be reused while being sterile for subsequent patients.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang, as applied to claim 1, above, in view of Palmer (WO 2010/096174).
Regarding claim 14, Ouyang teaches the tip of claim 1, further comprising: a shaft comprising the proximal end of the tip (Figure 1).
However, Ouyang fails to disclose that the shaft is permanently deformable.
Palmer teaches that the shaft is permanently deformable ([0091]).
Paragraph [0091] states that the angle the tip can be steered to can be fixed via a locking mechanism, thus making the shaft permanently deformable.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have included modified the tip of Ouyang such that the shaft is permanently deformable, as taught by Palmer. This would allow the operator to maintain a desired angle of the shaft.
Regarding claim 15, Ouyang teaches the tip of claim 1, further comprising: a shaft comprising the proximal end of the tip (Figure 1).
However, Ouyang fails to disclose that the shaft is temporarily deformable.
Palmer teaches that the shaft is temporarily deformable ([0091], Figure 1A).
Paragraph [0091] states that the tip includes a steerable joint, thus making it temporarily deformable.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have included modified the tip of Ouyang such that the shaft is temporarily deformable, as taught by Palmer. This would make it easier for the operator to adjust the angle of the shaft.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ouyang in view of Dardel, as applied to claim 5, above, in further view of Dykes (US 2018/0116630).
Regarding claim 21, Ouyang in view of Dardel teach the tip of claim 5.
However, Ouyang in view of Dardel fail to disclose that the sterile barrier is secured to an outer surface of the tip between the proximal end and the distal end, wherein the sterile barrier extends distally from the tip to enclose the handle, and wherein the proximal end of the tip is not enclosed within the sterile barrier.
Dykes teaches that the sterile barrier (disposable plastic sheath section 909 & sleeve lock 923, [0064]) is secured to an outer surface of the tip between the proximal end and the distal end ([0065], Figure 9F), wherein the sterile barrier extends distally from the tip to enclose the handle (Figure 9E), and wherein the proximal end of the tip is not enclosed within the sterile barrier (Figure 9E).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the tip of Ouyang and Dardel such that the sterile barrier is secured to an outer surface of the tip between the proximal end and the distal end, wherein the sterile barrier extends distally from the tip to enclose the handle, and wherein the proximal end of the tip is not enclosed within the sterile barrier as taught by Dykes. By keeping the proximal end of the tip exposed, the body of the device can remain sterile without attenuating the ultrasound waves.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ouyang, as applied to claim 16, above, in view of Dykes.
Regarding claim 22, Ouyang teaches the tip of claim 16.
However, Ouyang fails to disclose a sterile barrier that is secured to the outer surface of the tip between the proximal end and the distal end, wherein the sterile barrier extends distally from the tip to enclose the handle, and wherein the proximal end of the shaft is not enclosed within the sterile barrier.
Dykes teaches a sterile barrier (disposable plastic sheath section 909 & sleeve lock 923, [0064]) that is secured to an outer surface of the tip between the proximal end and the distal end ([0065], Figure 9F), wherein the sterile barrier extends distally from the tip to enclose the handle (Figure 9E), and wherein the proximal end of the shaft is not enclosed within a sterile barrier (Figure 9E).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the tip of Ouyang to include a sterile barrier that is secured to an outer surface of the tip between the proximal end and the distal end, wherein the sterile barrier extends distally from the tip to enclose the handle, and wherein the proximal end of the shaft is not enclosed within a sterile barrier as taught by Dykes. By keeping the proximal end of the tip exposed, the body of the device can remain sterile without attenuating the ultrasound waves.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798