DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 1, 2, 5-11, and 20, as well as claims 3, 4, and 12-19 based on their dependencies to the former claims, 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.
5. Claims 1, 2, 9, 11, and 20 all recite the limitation “the functional device". There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which the claims depend, recites “a distal functional device”. It is assumed that “the functional device” is meant to recite “the distal functional device”. Proper correction is required.
6. Claims 5-11 all recite the limitation “the transducer device". There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which the claims depend, recites “an acoustic-electrical transducer device”. It is assumed that “the transducer device” is meant to recite “the acoustic-electrical transducer device”. Proper correction is required.
Claim Rejections - 35 USC § 102
7. 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.
8. Claims 1-3, 5, 7, 8, 12-14, 16-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Timm U.S. 2014/0005702 (herein referred to as “Timm”).
9. Regarding Claim 1, Timm teaches an endoscopic instrument system (Fig. 1) for minimally invasive surgery on a human body (para 0072), comprising:
a. an endoscopic instrument (Fig. 1, ref num 10) comprising at least:
a.1 a distal functional device (Fig. 1, ref num 26) comprising an electrode arrangement (Fig. 1, ref num 18, Fig. 2, ref num 64) which is designed to couple a radiofrequency electrical current, RF current, into organic tissue within the human body (para 0098, “the clamp arm assembly 64 may comprise electrodes electrically coupled to the electrosurgical/RF generator module 23 to receive therapeutic and/or sub-therapeutic energy, where the electrosurgical/RF energy may be applied to the electrodes either simultaneously or non simultaneously with the ultrasonic energy being applied to the blade 66”) and further comprising a structure-borne sound recording element for recording a structure-borne response of the organic tissue to the coupled RF current (Fig. 2, ref num 66; para 0097, “The blade 66 may be an ultrasonically actuatable blade acoustically coupled to the ultrasonic transducer 16”);
a.2 a proximal actuating device for handling the instrument system (Fig. 1, ref num 12), in particular the instrument, and for actuating the functional device from outside the human body (para 0072); and
a.3 an elongate connecting device which mechanically and functionally connects the functional device to the actuating device (Fig. 1, ref num 14), wherein the connecting device comprises a structure-borne sound transmission element which is designed to acoustically transmit the structure-borne sound response recorded by the structure-borne sound recording element in the direction of the actuating device (para 0100, “The distal end 52 of the ultrasonic transmission waveguide 78 is acoustically coupled (e.g., directly or indirectly mechanically coupled) to the blade 66 and the proximal end 50 of the ultrasonic transmission waveguide 78 is received within the handle assembly 12”); and
b. an acoustic-electrical transducer device (Fig. 1, ref num 16) which is designed to be arranged outside the human body when the instrument system is used (para 0072) and which is also designed to detect the structure-borne sound response at the transmission element and to convert it into an electrical response signal (para 0100, 0104-0105).
10. Regarding Claim 2, Timm teaches the functional device has a first jaw part (Fig. 2, ref num 64) and a second jaw part (Fig. 2, ref num 66), which are designed to grip the organic tissue by relative movement in relation to one another (para 0093, “The jaws of the clamping mechanism of the end effector assembly 26 are formed by clamp arm assembly 64 and the blade 66… wherein the clamp arm assembly 64 and the blade 66 cooperate to grasp tissue therebetween”), wherein the first jaw part is arranged rigidly with respect to the connecting device (para 0097, “The distal end of the tubular reciprocating tubular actuating member 58 is mechanically engaged to the end effector assembly 26. In the illustrated embodiment, the distal end of the tubular reciprocating tubular actuating member 58 is mechanically engaged to the clamp arm assembly 64, which is pivotable about the pivot point 70, to open and close the clamp arm assembly 64”) and the structure-borne sound recording element is arranged on the first and/or second jaw part (Fig. 3, ref num 66 is the structure-borne sound recording element).
11. Regarding Claim 3, Timm teaches the electrode arranged is arranged on the first jaw part and/or the second jaw part, in particular on a corresponding inner side of the first jaw part and/or the second jaw part (Fig. 3 and 4, ref num 64; para 0098, “the clamp arm assembly 64 may comprise electrodes electrically coupled to the electrosurgical/RF generator module 23 to receive therapeutic and/or sub-therapeutic energy, where the electrosurgical/RF energy may be applied to the electrodes”).
12. Regarding Claim 5, Timm teaches the transducer device comprises at least one piezoelectric element (para 0106, 0108, 0156).
13. Regarding Claim 7, Timm teaches the transducer device is designed to detect structure-borne sound transverse waves and/or to detect structure-born longitudinal waves on the structure-borne sound transmission element (para 0107, 0108).
14. Regarding Claim 8, Timm teaches the transducer device is integrated into the endoscopic instrument (Fig. 1, ref num 16).
15. Regarding Claim 12, Timm teaches the structure-borne sound transmission element comprises a rigid solid body, a hollow waveguide and/or a prestressed wire (para 0112).
16. Regarding Claim 13, Timm teaches a computing device which is designed to receive the electrical response signal and to generate an output signal at least based thereon (para 0080, “A phase-locked loop in the control system of the generator 20 may monitor feedback from the acoustic assembly. The phase lock loop adjusts the frequency of the electrical energy sent by the generator 20 to match the resonant frequency of the selected longitudinal mode of vibration of the acoustic assembly”).
17. Regarding Claim 14, Timm teaches the computing device is configured to generate an output signal in real time or qusai-real time (para 0080).
18. Regarding Claim 16, Timm teaches the computing device and/or the transducer device are configured such that the output signal is based only on those electrical response signals which are based on a structure-borne sound response which was recorded while non electrical RF current was coupled in (para 0080).
19. Regarding Claim 17, Timm teaches the functional device comprises at least one further sensor which is designed to generate at least one sensor signal, and wherein the computing device is designed to additionally generate the output signal based on the at least one sensor signal (para 0080, “a second feedback loop in the control system 25 maintains the electrical current supplied to the acoustic assembly at a pre-selected constant level in order to achieve substantially constant excursion at the end effector 18 of the acoustic assembly. In yet another embodiment, a third feedback loop in the control system 25 monitors impedance between electrodes located in the end effector assembly 26. Although FIGS. 1-9 show a manually operated ultrasonic surgical instrument, it will be appreciated that ultrasonic surgical instruments may also be used in robotic applications, for example, as described herein as well as combinations of manual and robotic applications”).
20. Regarding Claim 18, Timm teaches the at least one further sensor comprises a temperature sensor, an electrical impedance sensor, a tissue thickness sensor and/or pressure force sensor (para 0080, “a third feedback loop in the control system 25 monitors impedance between electrodes located in the end effector assembly 26”).
21. Regarding Claim 20, Timm teaches the output signal comprises a control signal which is designed to control a function of the functional device (para 0080).
Claim Rejections - 35 USC § 103
22. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
23. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Timm and in view of Aldridge U.S. 2015/0164538 (herein referred to as “Aldridge”).
24. Regarding Claim 4, Timm fails to teach the structure-borne sound recording element is spatially arranged between a first electrode of the electrode arrangement and a second electrode of the electrode arrangement.
Aldridge teaches a system of analogous art (Fig. 116A), wherein the device comprises a structure-borne sound recording element (Fig. 114A, 115A-D, ref num 6366) that is spatially arranged between a first electrode and a second electrode (Fig. 115A-D, ref nums 6370a-d, 6372a-d). This produces the same expected result of clamping the tissue (para 0319). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Timm to configured the structure-borne sound recording element is arranged between the first and second electrode, as this produces the same expected result of clamping the tissue.
25. Claims 6 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Timm and in view of Ben Oren U.S. 2020/0397312 (herein referred to as “Ben Oren”).
26. Regarding Claim 6, Timm fails to teach the transducer device comprises an optical detection system and/or a MEMS sensor, in particular a MEMS accelerometer.
Ben Oren teaches a system of analogous art (Fig. 1 and 15), wherein the system comprises a MEMS sensor, in particular a MEMS accelerometer (para 0134, 0188). This collects data about the motion of the device (para 0188), such that it may execute instructions based on the data (0183). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Timm to include a MEMS sensor to collect data about the motion of the device and apply instructions to the target tissue based on the feedback of the data.
27. Regarding Claim 19, Timm fails to teach the computing device is configured to generate the output signal at least partially based on an artificial intelligence entity, AIE.
Ben Oren teaches a computing device that is configured to generate the output signal at least partially based on an artificial intelligence entity, AIE (para 0065, “the processor(s) 11 may be circuitry arranged to perform particular computations, such as, related to artificial intelligence (AI), graphics and machine learning. Such circuitry may be referred to as an accelerator. Processor(s) 11 can include multiple processors, such as, for example, a central processing unit (CPU) and a graphics processing unit (GPU)”). It would have been obvious to one of ordinary skill in the art to use any type of machine learning, such as AI, to generate the output signal, as these are used interchangeably within the art (para 0065).
28. Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Timm and in view of Houser U.S. 2009/0036914 (herein referred to as “Houser”).
29. Regarding Claim 9, Timm fails to teach a trocar sleeve through which at least the functional device can be passed and introduced into the human body during minimally invasive surgery, wherein the transducer device is integrated into the trocar sleeve.
Houser teaches a system of analogous art (Figs. 1, 8, 10, 12, and 14), wherein the system comprises a trocar sleeve (Fig. 10, ref num 342) through which at least a functional device can be passed and introduced into the human body during minimally invasive surgery (Fig. 14, ref num 340 passes through 342; para 0002, “such instruments may be used for open procedures or minimally invasive procedures, such as endoscopic or laparoscopic procedures, wherein the end effector is passed through a trocar to reach the surgical site”), wherein a transducer device is integrated into the trocar sleeve (Fig. 14, ref num 336 is integrated with ref num 342). Using a trocar to introduce an end effector to the target tissue is well known within the art (para 0002), as well as integrating two structures together (It has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893)). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Timm to have a trocar sleeve and integrated transducer device with the trocar sleeve, as this is routine to one of ordinary skill.
30. Regarding Claim 10, Timm fails to teach the transducer device is attached to a sealing device of the trocar sleeve, which seals a distal space within the trocar sleeve from a proximal space within the trocar sleeve.
Houser teaches the transducer device is attached to a sealing device of the trocar sleeve, which seals a distal space within the trocar sleeve from a proximal space within the trocar sleeve (para 0117, “The full length sealed inner lumen 352 extends from a proximal end of the instrument 300 to a distal end of the end effector 324 through the transducer 316 and the end effector 354. The sealed inner lumen 352 extends longitudinally through several sections of the instrument 300. The sealed inner lumen 352 extends through a bore 312 formed through piezoelectric elements 310 and a bore 314 formed through an ultrasonic transducer 316. The sealed inner lumen 352 further extends through a bore 318 formed within an ultrasonic waveguide 320 and further extends through a bore 322 formed within the end effector 354. The distal end 326 of the end effector 354 is sealed. The bores 312, 314, 318, and 322 are substantially coaxially aligned”). This aids with the temperature control of the device (para 0118). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Timm to include a sealing device with the transducer in order to improve the temperature control of the device when applying the treatment.
31. Regarding Claim 11, Timm teaches the transducer device is mounted on the trocar sleeve such that it is pressed against the structure-borne sound transmission element, while the functional device is guided through the trocar sleeve (Fig. 5, ref num 78 which is part of the transducer is pressed against ref num 66).
32. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Timm and in view of Stulen U.S. 2020/0222135 (herein referred to as “Stulen”).
33. Regarding Claim 15, Timm fails to teach the output signal comprises an audible acoustic output signal indicating various conditions of the organic tissue into which the electrical RF current was coupled, and/or processes thereon.
Stulen teaches a computing device that generates an output signal, such that the output signal comprises an audible acoustic output signal indicating various conditions of the organic tissue into which the electrical RF current was coupled, and/or processes thereon (para 0199). This produces the same expected result of treating the target tissue (para 0199). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Timm to have the output signal comprise of an audible acoustic output as this produces the same expected result of treating the target tissue.
Conclusion
34. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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