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 Arguments
Applicant's arguments filed 6/19/25 have been fully considered but they are not persuasive. Applicant argues that Sonnenschein does not teach a distal tip with a diameter less than 1.55mm. However, page 35, line 14 of Sonnenschein (WO 2011/033513) teaches that the diameter of the distal tip is 1.75mm, and line 19 teaches that with a smaller sensor the tip diameter can be reduced by an additional 0.3mm. Thus, 1.75 - 0.3mm = 1.45mm.
Also, on page 27 of Sonnenschein the working channel is described as a channel ‘through which tools can be introduced or liquids or gases can be supplied or withdrawn’. Thus, such working channel is considered to be for an irrigation tool.
Claim Rejections - 35 USC § 103
Claim(s) 1-4,7-10,12,13,14,15,17,18,21,22,24,25,26,30-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sonnenschein et al (WO 2011/033513), submitted by applicant and Colvin et al (6,498,884).
(Currently Amended) A miniature precision medical endoscopic device for ocular procedures (such phrase is considered to be intended use, not a structural limitation) comprising:
at least one camera; (see at least page 28:1-5 which teaches a camera in socket 43)
one or more illumination sources; (see at least page 27:29-31 which teaches illumination fibers, LEDs etc.)
an irrigation tool, (see at least page 27:21-27 which teaches liquids and gases can be supplied or withdrawn)
wherein at least one sensor of the at least one camera is distally located at a tip of a shaft of said endoscopic device, wherein the shaft has a substantially circular cross section and the sensor has a substantially rectangular cross section at said tip, (Sonnenschein teaches a circular shaft, see at least figure 24A, however is silent as to a rectangular sensor. Colvin teaches a rectangular sensor lens 14, see figure 6 and col. 5:1-15, where it is also taught that the rectangular lens, when in the endoscope body, ‘will form gaps through which the illuminating conduits will be placed’. It would have been obvious to use a rectangular shaped sensor for the sensor 90 of figure 24a of Sonnenschein since they are well known in the art and would allow for the gaps between the sensor and body to be filed with other conduits.
also, see at least page 28:5 and page 34:19-30 which teaches a camera in distal tip)
characterized with that one or more unaccommodated areas within said shaft, next to said at least one sensor, in a free region between the rectangular sensor and the circular shaft. (see at least figure 6 of Colvin which shows illumination conduits 18 in the gaps between the shaft 12 and the lens 14. It would have been obvious to use a similar arrangement with the device of Sonnenschein since it would yield a more compact design that efficiently utilizes space)
is utilized for simultaneously (the channel for the irrigation tool still exists whether or not an irrigation tool is located inside. It is considered to have been obvious to simultaneously accommodate the irrigation tool with the LEDs and camera since they all have their allotted location at the distal tip of the device and when irrigation is needed the user simply inserts the tool into the channel designated for it) accommodating one or more of said illumination sources and [[an]] said irrigation tool, wherein said irrigation tool is configured to deliver fluid through at least one irrigation port located at said tip in said annular region, and, (as seen in figure 24A of Sonnenschein, channel 94 is a working channel, and thus could be used for irrigation purposes along with the illumination channel 92. It would have been obvious have been obvious to use the working channel for irrigation since such is need during surgical procedures to make the procedure more effective.
Additionally, the shaft is considered to be the whole inside of the distal tip. Further, see at least page 34:24-30 which teaches an irrigation channel and a working channel. It is considered to have been obvious to use an irrigation tool in the irrigation channel since that is what the channel is used for. Page 34, lines 25+ teaches that a working channel can be used to advance tools. Further, page 28:8-14 teaches that the Microleds can fit in the empty spaces around the camera. Moreover, to use the working channel of Sonnenschein for irrigation is considered to have been obvious since it would yield predictable results, such as a more compact design. Further, as mentioned supra, at least page 27, lines 20-25 teach that a working channel can be used to supply liquids of gases.)
and,
wherein the diameter of said tip is less than 1.5mm, said tip is configured to be inserted through an incision made around the cornea. (Regarding ‘insertion through an incision’, Sonnenschein is capable of being inserted through an incision in the skin or cornea. There is no structural limitation in Sonnenschein that prevents the device from being inserted into the cornea.
Further, see at least page 35 1-15 which teaches a diameter of 1.75mm which includes a camera, optical fibers and a working channel. Further, page 35, lines 16-20 teaches that, when a smaller sensor is used, as well as Microleds, then the diameter of the distal tip will be reduced by an additional 0.3mm. Thus, the tip will then have a diameter of 1.45mm. (1.75 – 0.3).
Alternativley, page 34:19-30 teaches a distal tip of 1.99mm. It would have been obvious to reduce the distal tip to less than 1.5mm since it would yield predictable results such as a more compact design and would cause less tissue damage due to its smaller size and be able to enter smaller incisions of the patient.
2. (Original) The device of claim 1, wherein the at least one camera is adapted to provide high resolution images of at least 30K pixels. (see at least page 24:6-15)
3. (Original) The device of claim 1, wherein the incision made around the cornea is performed during cataract surgery and/or minimal invasive glaucoma surgeries (MIGS). (such is considered to be intended use that the tip of Sonnenschein can accomplish)
4. (Previously Presented) The device of claim 1, wherein the tip is configured to be inserted through trocars used in vitrectomy surgery. (such is considered to be intended use that the tip of Sonnenschein can accomplish)
7. (Original) The device of claim 1, wherein one or more illumination sources are incorporated in to said device via at least one of the unaccommodated area. (see at least page 27:29- to page 28:14 which teaches that microleds can fit into empty spaces around camera)
8. (Previously Presented) The device of claim 7, wherein the illumination source is located distally at the tip or proximally in a hand-piece of the device, or at a connector, or at a video controller. (see at least page 27:29- to page 28:14 which teaches that microleds can fit into empty spaces around camera)
9. (Original) The device of claim 8, wherein the distal illumination source is one or more LEDs. (see at least page 27:29- to page 28:14 which teaches that microleds can fit into empty spaces around camera)
10. (Original) The device of claim 8, wherein light reaches the distal end of the endoscope via optic fibres and/or light guides. (see at least page 27:29- to page 28:14 which teaches that microleds can fit into empty spaces around camera)
12. (Original) The device of claim 1, further comprising a tool for removing particles of lenses under direct vision. (as mentioned supra, Sonnenschein teaches an irrigation tool which is considered to be put into the irrigation channel; page 34:24-30)
13. (Previously Presented) The device of claim 12, wherein the tool for removing particles of lenses under direct vision is the irrigation tool, an aspiration tool, the camera or combination thereof. (as mentioned supra, Sonnenschein teaches an irrigation tool which is considered to be put into the irrigation channel; page 34:24-30)
14. (Original) The device of claim 13, wherein the irrigation and aspiration are integrated together in concentric circles, wherein one in the inner circle and one in the outer circle, or they are located adjacently. (see at least figures 4b,4c,22,24a where one of the channels can be an irrigation channel and the other can be used for aspiration)
15. (Previously Presented) The device of claim 1, wherein the irrigation tool having irrigation port that is shaped to control pressure or direction by fluidics passing through the tip. (the port of the irrigation channel is considered to be shaped to control direction so that the fluid does not spray everywhere but rather in a forward direction as desired.)
17. (Previously Presented) The device of claim 1, wherein the camera is attached to forceps or scissor tools. (see at least figure 5a and page 11:22)
18. (Original) The device of claim 1, wherein the camera is a video camera. (see at least page 6:24 to 7:25)
21. (Original) The device of claim 1, wherein an external illumination source is adapted to provide illumination in accordance with the orientation of the device/camera. (the illumination source can be external and sent thru fibers to the distal end of the tip; see at least page 27:29 to 28:5).
22. (Original) The device of claim 1, wherein a tube or the tip of the endoscope is made of a transparent material, thus it can be used as light guiding generated by an illumination source. (see at least page 13:11-14)
24. (Original) The device of claim 1, wherein the endoscope comprises an imager for converting an optical image viewed by the endoscope into digital image data. (see at least page 6:25)
25. (Original) The device of claim 24, further comprising a processor for processing the digital image data. (see at least page 22:11)
26. (Original) The device of claim 25, further comprising a communication module configured for transmitting the processed digital image data to a remote receiver in a wireless or wired manner. (figure 25 teaches a digital video transmitter)
30. (Original) The device of claim 1, wherein the tip is detachably attachable to a hand-piece of the device. (see page 27:14-20 which teaches tip connected to handle portion)
31. (Original) The device of claim 1, further comprising a hand-piece that has a straight tip designed for the back of the eye surgeries. (see at least figure 3a which shows handle which is attached a straight tip)
32. (Original) The device of claim 1, further comprising a hand-piece that has a curved tip designed for the front of the eye surgeries. (see at least figure 3E which shows a curved tip which is attached to handle of figure 3B)
33. (Original) The device of claim 1, a hand-piece of said device has a bendable and articulated tip. (see page 27:18-19 and figure 3E)
34. (Previously Presented) The device of claim 1, wherein the shaft has a round shape and the sensor has a rectangular shape. (see at least page 17, lines 16-25 of Sonnenschein, which teach that the probe has a circular shape, in spite of the fact that the SSI typically has a square or rectangular configuration.)
35. (Previously Presented) The device of claim 1 wherein the camera has a diameter of 1mm or less. (at least page 35:11 teaches a 1.1mm diameter camera head. To make the diameter less than 1mm would have been obvious since it would allow for smaller overall diameter of the device, resulting in less invasive surgery and a smaller incision for the patient)
Claim(s) 11,15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sonnenschein et al (WO 2011/033513) and Colvin et al (6,498,884) and Nun (6,217,584).
11. (Original) The device of claim 1, wherein a phaco-emulsifier tool is integrated in to said device. (Nun teaches a phaco-emulsifier; see at least col 1:44-55. It would have been obvious to use such with the device of Sonnenschein since it is common in the art of eye surgery, would provide a small compact design, and would yield no unpredictable results)
15. The device of claim 13, wherein the irrigation tool having irrigation port that is shaped to control pressure or direction by fluidics passing through the tip. (Although the ports of Sonnenschein are considered to control the fluid, Nun is used by the examiner to more explicitly teach ports that are tapered, se at least figure 10B of Nunn shows ports 250 that are shaped and considered to control the direction of fluid, and col. 12:62+ teaches tapered fluid conduits. It would have been obvious to have such taper in order to better control the direction of fluid flow more precisely)
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sonnenschein et al (WO 2011/033513) and Colvin et al (6,498,884) and Lewicky (4,340,037).
16. The device of claim 1, wherein the camera is integrated in to an olive tip irrigation cannula for allowing scarping the lens of the eye. (Lewicky teaches a olive shape cannula for irrigation; see at least col. 7:37-60. To use an olive tipped irrigation cannula would have been obvious since they are common in the art and would allow for more precise location of the irrigation fluid, in a predictable manner)
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sonnenschein et al (WO 2011/033513) and Colvin et al (6,498,884) and Thompson (2009/0259097).
19. The device of claim 1, wherein the camera is attached to a cannula. (Sonnenschein is silent as to this feature. Thompson teaches a camera 40 attached to a cannula 10, see at least figure 3. It would have been obvious to have such feature with the device of Wood since it would yield predictable results, and allow for a more compact design).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sonnenschein (WO 2011/033513) and Colvin et al (6,498,884) and Buttermore (5,716,320).
20. The device of claim 1, wherein a laser device is incorporated in to said multi- purpose eye surgery device. (Buttermore teaches use of laser in an intraocular surgical instrument, see at least col. 4:20-49. It would have been obvious to use laser since it is common in the art in order to perform eye surgery in an efficient and effective manner)
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sonnenschein (WO 2011/033513) and Colvin et al (6,498,884) and Viellerobe et al (2009/0097806).
23. The device of claim 7, wherein the wavelength of the light can be varied. (Viellerobe teaches an adjustable wavelength, see at least ¶123. It would have been obvious to use such with the device of Sonnenschein since it would yield predictable results, and allow for more varied therapy for the patient)
Claim(s) 26,27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sonnenschein (WO 2011/033513) and Colvin et al (6,498,884) and Williams (11,771,303).
26. The device of claim 25, further comprising a communication module configured for transmitting the processed digital image data to a remote receiver in a wireless or wired manner. (Williams is used to teach wireless transmission, see at least abstract. It would have been obvious to use such with the device of Sonnenschein since it would allow remote physicians to be aware of the results in a predictable manner)
27. The device of claim 26, wherein the communication module comprises one or more antennas for directing wireless signals relative to said digital image data to the remote receiver. (see at least figure 11 of Williams)
Claim(s) 28,29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sonnenschein (WO 2011/033513) and Colvin et al (6,498,884) and Wood (5,331,950).
28. The device of claim 1, further comprising a body cavity or an insertion socket through which the endoscope is detachably attachable to the device. (see at least figure 1 of Wood that shows a socket 18. It would have been obvious to use such with the device of Sonnenschein since it would provide a convenient and well known manner in which to connect to an external device)
29. (Original) The device of claim 25, wherein the processer is part of a control module that is detachably attachable to the device. (Woods shows a processor unit 20 that is detachably attachable to the device; see figure 1. It would have been obvious to use such with the device of Sonnenschein since it would provide a convenient manner in which to connect to the endoscope)
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 Scott M. Getzow whose telephone number is (571)272-4946. The examiner can normally be reached M-F 9-5.
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/Scott M. Getzow/Primary Examiner, Art Unit 3792