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 .
Response to Amendment
Examiner acknowledges the amendments to claims 1, 16, and 20 with claims 17 and 18 canceled and claims 1-16, and 19-22 pending in the present application.
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) 1-9, 12-16, 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable by Orszulak (US Patent No 2012/0310241) in view of Nau R1 (US Patent No 2013/0253489) further in view of Nau R2 (US Patent No 20150238260).
Regarding claims 1, 16, and 20 Orszulak teaches A surgical system (electrosurgical system 105, para [0025]), comprising: (a) a surgical instrument (instrument 10, para [0025]), comprising: (I) a shaft assembly having a distal end (shaft 13, para [0027]), and (ii) an end effector at the distal end of the shaft assembly (end effector assembly 100, para [0027]), the end effector including:(A) a first jaw, (B) a second jaw movably coupled relative to the first jaw for clamping tissue therebetween (jaw members 110 and 120 movable from first position to closed position, para [0027]), and (C) at least one optical sensor for detecting the tissue (one optical sensor disposed in the jaw members, para [0012]); (b) a generator configured to supply a therapeutic energy to at least one of the first jaw or the second jaw (connecting the forceps 12 to a source of electrosurgical energy from a generator 200, para [0029]); and (c) a pass-through device configured to removably couple to the surgical instrument, removably couple to the generator (see [0029]-[0030] in which it is explained how the cable 21 is removably coupled to the generator via the connections 250-262 as well as removably coupled to the surgical system via the active and return terminals 230 and 232), and operatively couple the surgical instrument and the generator (cable 21, see fig. 3 for connection from instrument to generator 200), the pass-through device comprising: (I) a pass-through device body comprising a proximal end configured to removably couple to the generator, and a pass-through device housing connecting the proximal end and the distal end (see [0029]-[0030] in which it is explained how the cable 21 is removably coupled to the generator via the connections 250-262 as well as removably coupled to the surgical system via the active and return terminals 230 and 232), (ii) at least one therapeutic energy connector configured to operatively couple the generator to the surgical instrument for transmitting the therapeutic energy from the generator to the at least one of the first jaw or the second jaw (includes a plug 23 that connects the forceps 12 to a source of electrosurgical energy, e.g., generator 200, para [0029]), and (iii) at least one optical component configured to transmit light to the at least one optical sensor and to receive light from the at least one optical sensor (optical sensors 350a, 350b and 352a, 352b and optical transmitters 351 and 353 may be configured for transmissive, reflective, spectral and visual analysis of tissue, para [0056]); and(d) at least one optoelectronic component operatively coupled to the at least one optical fiber connector(optical transmission lines 356 include optical fibers as described above with respect to optical sensors which is in connection with the optical array, para [0057]), wherein the at least one optoelectronic component includes:(I) a light source configured to transmit light to the at least one optical sensor, or (ii) a light reader configured to receive light from the at least one optical sensor (see [0054] – [0058] which describes the optical array 350 is coupled to an illumination source 354 in which the optical array has sensors 350a and optical transmitters 351 and 353 configured to receive and transmit the optical data).
Orszulak does not teach a battery configured to power at least one of the light sources or the light reader.
However, using a battery to power the light source is very common and well known in the art and would have been obvious for one skilled in the art to change the power source to be a battery source. For example, the analogous light energy cutting and sensing surgical device disclosed by Nau R1 does teach the light energy generating source 50 is operatively coupled to a battery compartment 52 as a power source [0067].
Therefore, it would have been obvious for one skilled in the art to combine the passthrough surgical system structure disclosed by Orszulak to have a battery power source to power the light source as taught by Nau R1 as it is another common method to provide a power source that is more portable than a traditional hard-wired system as disclosed by Nau R1, [0067].
Furthermore, neither Orszulak nor Nau R1 go on to teach a pass-through device body comprising a distal end configured to removably couple to the surgical instrument, nor do they teach wherein the at least one therapeutic energy connector and the at least one optical component are housed within the pass-through device and wherein the light source and the light reader are housed within the distal cable plug.
However, the analogous light energy directing and sensing device taught by Nau R2 does teach all of wherein a pass-through device body comprising a distal end configured to removably couple to the surgical instrument (see the connector 17 which removably connects to the forceps 10 via the cable 15, [0043]), as well as wherein the at least one therapeutic energy connector and the at least one optical component are housed within the pass-through device and wherein the light source and the light reader are housed within the distal cable plug (see [0043] wherein the connector 17 operably couples to the forceps device 10 and connects or houses the power generating source 28 for energy treatment, the optical fiber component 32, and the laser light source and sensor 46 all found within the connector 17 or pass-through device).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the surgical system previously taught by Orszulak and Nau R1, with the specific pass-through connection housing taught by Nau R2 to allow for effective removability and operability while housing all of the critical components present for the forceps device, as shown by Nau R2, [0043].
Regarding claims 2, Orszulak teaches the surgical system of claim 1, wherein the at least one optical component includes at least one optical fiber connector (optical transmission lines 356 include optical fibers as described above with respect to optical sensors, para [0057].
Regarding claim 3, Orszulak teaches the surgical system of claim 1, wherein the at least one optical component includes at least one optoelectronic component (optical transmitters 351 and 353, para [0055], in being able to transmit, reflect, and do spectral and visual analysis of light the optical transmitters 351 and 353 are optoelectronic components).
Regarding claim 4, Orszulak teaches the surgical system of claim 3, wherein the at least one optoelectronic component includes a light source configured to transmit light to the at least one optical sensor (see para [0054], optical transmitters 351 and 353 provide a light source via LED and provide optical information as a dual function transmitter to the optical sensors 350 and 352).
Regarding claim 5, Orszulak teaches the surgical system of claim 4, wherein the at least one optoelectronic component further includes a light reader configured to receive light from the at least one optical sensor (the optical transmitters 351 and 353 are coupled to an illumination source 354 and an illumination sense processor 358 which receives light, para [0057]).
Regarding claim 6, Orszulak teaches the surgical system of claim 3, wherein the pass-through device further comprises at least one power connector configured to supply power from the generator to the at least one optoelectronic component (see fig. 7 for optical transmission lines 356 and electrical lines 344 within the cable 321 which is connected to the generator 200 via the terminal 230, see also para [0049] for further detail).
Regarding claim 7, Orszulak teaches the surgical system of claim 3, wherein the pass-through device further comprises a power source configured to supply power to the at least one optoelectronic component (see fig. 7 for optical transmission lines 356 and electrical lines 344 within the cable 321 which is connected to the generator 200 or power supply, see also para [0049] for further detail).
Regarding claim 8, Orszulak teaches the surgical system of claim 1, wherein the pass-through device further comprises at least one data connector configured to operatively couple the generator to the surgical instrument for transmitting data signals therebetween (The controller 224 then signals the power supply 227 and/or output stage 228, which then adjusts the DC and/or power supply, respectively. The controller 224 also receives input signals from the input controls of the generator 200 or forceps 12, para [0036]).
Regarding claim 9, Orszulak teaches the surgical system of claim 8, wherein the pass-through device further comprises a processor operatively coupled to the at least one optical component and to the at least one data connector (The system 300 includes optical and electrical sensors for detecting tissue and energy properties directly at the tissue site and transmitting the sensor measurements along electrical and/or optical cables to the generator 200, para [0049]), wherein the processor is configured to transmit control signals to the generator for adjusting the therapeutic energy based on data signals received by the processor from the at least one optical component (The controller 224 then signals the power supply 227 and/or output stage 228, which then adjusts the DC and/or power supply, respectively. The controller 224 also receives input signals from the input controls of the generator 200 or forceps 12, para [0036]).
Regarding claim 12, Orszulak teaches the surgical system of claim 1, wherein the pass-through device includes a pass- through box configured to be removably coupled to the surgical instrument and to the generator (the cable 321 has sheath 39 or in this case a pass-through box, as well as plug 23 which connects instrument to the generator, para [0029] and by definition of a plug is removably coupled).
Regarding claim 13, Orszulak teaches the surgical system of claim 1, further comprising a cable removably coupled to the surgical instrument and to the generator (the cable has plug 23 which connects instrument to the generator, para [0029] and by definition of a plug is removably coupled), wherein the pass-through device is presented by the cable (cable 321, para [0051]).
Regarding claim 14, Orszulak teaches the surgical system of claim 13, wherein the cable includes a distal cable plug removably coupled to the surgical instrument, wherein the pass-through device is presented by the distal cable plug (see lead 19 which is removably connected to the surgical instrument housing 20 on the distal cable 231, para [0043]- [0045]).
Regarding claim 15, Orszulak teaches the surgical system of claim 1, wherein the surgical instrument includes a proximal body (proximal housing 20, see fig. 3) and a distal body removably coupled to each other (removably coupled via the rotating assembly piece 80, para [0027]), wherein the shaft assembly extends distally from the distal body (see fig. 3 for shaft 13 extending distally), wherein the pass-through device is presented by the proximal body (see fig 3 for cable 21 or pass through device connected via the lead 19 to the proximal housing 20).
Regarding claim 19, the teachings of Orszulak from claims 8 and 9 teach the pass-through device of claim 16, further comprising a processor operatively coupled to the light source and to the light reader, wherein the processor is configured to receive data signals from the light reader, wherein the processor is configured to send control signals to the light source.
Regarding claim 21, Nau teaches the pass-through device of claim 16, further comprising a battery configured to power the at least one optoelectronic component (the light energy generating source 50 is operatively coupled to a battery compartment 52 as a power source [0067]).
Regarding claim 22, Orszulak teaches the pass-through device of claim 16, wherein the pass-through device is configured to removably couple a surgical instrument to a generator (see [0029]- [0030] in which it is explained how the cable 21 is removably coupled to the generator via the connections 250-262 as well as removably coupled to the surgical system via the active and return terminals 230 and 232).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orszulak (US Patent No 2012/0310241) in view of Nau R1 (US Patent No 2013/0253489) further in view of Nau R2 (US Patent No 20150238260) further in view of Hoarau (US Patent No 2011/0251605).
Regarding claim 10, Orszulak teaches the surgical system of claim 1,
Orszulak does not teach where further comprising a spectrometer, wherein the at least one optical component is configured to operatively couple the spectrometer to the surgical instrument for transmitting light between the spectrometer and the at least one optical sensor.
However, the analogous optical array system disclosed by Hoarau does teach comprising a spectrometer (spectrometer 716, para [0177]), wherein the at least one optical component is configured to operatively couple the spectrometer to the surgical instrument for transmitting light between the spectrometer and the at least one optical sensor (the spectrometer 720 may include a light source 732 for transmitting light to expose the tissue 2 to light; and a light detector 734. The light detector 734 is configured to sense changes in light through the tissue 2, para [0177], where the light detector is the light sensor).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date of the application to combine the surgical system disclosed by Orszulak with the spectrometer array taught by Hoarou so as to effectively measure the tissue response during treatment as defined by Hoarou.
Regarding claim 11, the combination teaches the surgical system of claim 10, wherein the spectrometer includes a light source configured to transmit light to the at least one optical sensor and a light reader configured to receive light from the at least one optical sensor (from Hoarau the spectrometer includes a light source for exposing tissue to light and a light sensor. The light sensor is configured to sense changes in light through tissue in response to tissue treatment and communicate such changes to the processor, para [0010]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 02/19/2025, with respect to the rejection(s) of claim(s) 1, 16, 20 under Orszulak and Nau R1 have been fully considered and are persuasive as per agreed upon in the prior interview. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the new prior art of reference of Nau R2.
Applicant’s arguments with respect to claim(s) 1, 16, 20 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. Based on the further search and consideration necessitated by the amendment, the examiner has found that the new prior art of record of Nau R2 teaches the amended claimed limitations of claims 1, 6, 20 and is therefore rejected under the new prior art of record rejection presented in this office action.
Specifically Nau R2 does teach all of wherein a pass-through device body comprising a distal end configured to removably couple to the surgical instrument (see the connector 17 which removably connects to the forceps 10 via the cable 15, [0043]), as well as wherein the at least one therapeutic energy connector and the at least one optical component are housed within the pass-through device and wherein the light source and the light reader are housed within the distal cable plug (see [0043] wherein the connector 17 operably couples to the forceps device 10 and connects or houses the power generating source 28 for energy treatment, the optical fiber component 32, and the laser light source and sensor 46 all found within the connector 17 or pass-through device) as per the new amended limitations set forth in the present office action. Therefore, claims 1, 16, and 20 remain rejected under the new prior art of record rejection of Orszulak in view of Nau R1 further in view of Nau R2.
All of the dependent claims as being dependent on the independent claims 1, 16 and 20 remain rejected under the new prior art of record rejection set forth in the present office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/KYLE M. BROWN/Examiner, Art Unit 3794 /LINDA C DVORAK/ Primary Examiner, Art Unit 3794