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 § 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.
Claims 1, 6, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Uram et al. (US 2019/0216306) in view of Kienzle et al. (US 9,610,007), Amundson et al. (US 6,178,346), and Mirsepassi et al. (US 2018/0168768).
Regarding Claim 1, Uram discloses:
A method, comprising:
inserting a probe (30) into an ophthalmic incision (see Paragraphs 0068 and Paragraph 0075), the probe being coupled to a surgical handpiece (32; see Fig. 2);
supplying the illumination light to a surgical site via a plurality of illumination fibers disposed in the probe (see Paragraph 0026 discussing the illumination fibers);
transmitting a signal corresponding to an image of the surgical site from the image fibers to a processor associated with the surgical console (see Paragraph 0057); and
displaying the image on the surgical console (see Paragraph 0057).
Uram does not explicitly disclose selecting, via a surgical console, a wavelength of illumination light supplied by an illumination source between visible light and near-infrared light; receiving reflected illumination light at an active-pixel sensor disposed in the surgical handpiece via a plurality of imaging fibers disposed in the probe (although Uram does disclose a camera assembly attached to the handpiece, see 34 attached to 32 and uses fibers to transmit the image (see Paragraph 0026), no sensor is explicitly disclosed); transmitting via the active-pixel sensor (although transmitting to the surgical console is disclosed as referenced above).
Amundson teaches an endoscope for providing infrared illumination to a subject across wavelength regions ranging from 1.4-14 microns (Col 6, lines 43-63). Further, wavelengths in the range of 0.8-11 microns are used to visualize opaque body fluids (lines 3-20). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device disclosed by Uram with the emission wavelengths taught by Amundson for the benefit of visualizing body structures through opaque body fluids such as blood (Amundson Col 6, lines 21-24).
Mirsepassi teaches a surgical probe system in which the probe (10) is connected to a console (4) where a processor will adjust these parameters based on user input (Paragraphs 0024-0025) at the console (Paragraph 0024, based on commands entered at the console 4). Kienzle also teaches a controller with a mode switch button and brightness controls (Col 9 Lines 28-32). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the image processing interface taught by Uram in view of Amundson with the light emission control taught by Mirsepassi and Kienzle for the benefit of providing background and situational awareness during a procedure (Mirsepassi (0022)). Furthermore, giving the user manual control over various parameters (intensity, color balance, and wavelength) is obvious in that it allows the user to configure the device as desired given the particular situation.
Kienzle teaches placing an image sensor (1132) in the handpiece (see Fig. 2B). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Urum’s device to have a sensor in the handpiece. Such a modification is both the mere rearrangement of parts without a change in function with a reasonable expectation of success while providing the sensor in a self-contained handpiece. This eliminates the need to have a separate camera unit. Furthermore, sensors such as CCD and CMOS devices have become standard in the art because of their small size.
Regarding Claim 6, Uram as modified further discloses wherein the active-pixel sensor is a complementary metal-oxide semiconductor (CMOS) sensor (Kienzle – Col 8 Line 12).
Regarding Claim 17, Uram discloses:
A method, comprising:
inserting a probe (30) in an incision in an eye (see Paragraphs 0068 and Paragraph 0075), the probe being coupled to a surgical handpiece (32; see Fig. 2);
supplying the illumination light to a surgical site via a plurality of illumination fibers disposed in the probe (see Paragraph 0026 discussing the illumination fibers);
transmitting a signal corresponding to an image of the surgical site from the image fibers to a processor associated with the surgical console (see Paragraph 0057); and
displaying the image on the surgical console (see Paragraph 0057).
Uram does not explicitly disclose selecting, via a surgical console, a wavelength of illumination supplied by an illumination source between visible light and near infrared light, wherein the wavelengths of the visible light supplied by the illumination source range from 400 nanometers to 700 nanometers and the wavelengths of the near-infrared light supplied by the illumination source range from 1 micrometer to 10 micrometers; receiving reflected illumination light at an active-pixel sensor disposed in the surgical handpiece via a plurality of imaging fibers disposed in the probe (although Uram does disclose a camera assembly attached to the handpiece, see 34 attached to 32 and uses fibers to transmit the image (see Paragraph 0026), no sensor is explicitly disclosed); transmitting via the active-pixel sensor (although transmitting to the surgical console is disclosed as referenced above).
Amundson teaches an endoscope for providing infrared illumination to a subject across wavelength regions ranging from 1.4-14 microns (Col 6, lines 43-63). Further, wavelengths in the range of 0.8-11 microns are used to visualize opaque body fluids (lines 3-20). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device disclosed by Uram with the emission wavelengths taught by Amundson for the benefit of visualizing body structures through opaque body fluids such as blood (Amundson Col 6, lines 21-24).
Mirsepassi teaches a surgical probe system in which the probe (10) is connected to a console (4) where a processor will adjust these parameters based on user input (Paragraphs 0024-0025) at the console (Paragraph 0024, based on commands entered at the console 4). Kienzle also teaches a controller with a mode switch button and brightness controls (Col 9 Lines 28-32). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the image processing interface taught by Uram in view of Amundson with the light emission control taught by Mirsepassi and Kienzle for the benefit of providing background and situational awareness during a procedure (Mirsepassi (0022)). Furthermore, giving the user manual control over various parameters (intensity, color balance, and wavelength) is obvious in that it allows the user to configure the device as desired given the particular situation.
Kienzle teaches placing an image sensor (1132) in the handpiece (see Fig. 2B). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Urum’s device to have a sensor in the handpiece. Such a modification is both the mere rearrangement of parts without a change in function with a reasonable expectation of success while providing the sensor in a self-contained handpiece. This eliminates the need to have a separate camera unit. Furthermore, sensors such as CCD and CMOS devices have become standard in the art because of their small size.
Regarding Claim 18, Uram as modified further discloses wherein the plurality of imaging fibers comprise a first end coupled to the active pixel sensor in the surgical handpiece and a second end that receives reflected illumination light at a distal end of the probe, each of the plurality of imaging fibers having a first cross-sectional dimension (Kienzle – Fig. 2B showing the sensor in the hand piece with the fibers running to the proximal end; see also 1202 and Col 21 Lines 24-34).
Regarding Claim 19, Uram discloses wherein the plurality of illumination fibers comprise a first end configured to be coupled to an illumination source through a proximal end of the surgical handpiece and a second end that projects illumination light outwardly from the probe, each of the plurality of illumination fibers having a second cross-sectional dimension different than the first cross-sectional dimension (see Paragraph 0026 discussing 6000 fibers filling a 0.36 mm space and 21 fibers filling the remaining 0.54 mm space). Even if Uram did not explicitly disclose the relative sizes, changing the size without changing the function is obvious (see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) holding that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Here, Applicant has not provided a reason or placed any criticality on the relative sizes of the fibers, such that modifying the size of one to be different from the other is considered obvious.
Claims 2-3 and 7-13, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Uram et al. (US 2019/0216306) in view of Kienzle et al. (US 9,610,007), Amundson et al. (US 6,178,346), and Mirsepassi et al. (US 2018/0168768), as applied to claim 1, and Lobanoff (US 2020/0345449).
Uram, Kienzle, Amundson, and Mirsepassi disclose the invention substantially as claimed as stated above.
Regarding Claim 2, they do not explicitly disclose supplying near-infrared illumination light to the surgical site to visualize aqueous veins of an eye. However, near-infrared light is known to be used to visualize veins, and Lobanoff teaches using NIR to do so during eye surgery (see Paragraph 0036). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use Uram’s device with NIR to visualize aqueous veins as taught by Lobanoff. Such a modification uses the technology of NIR in a known way to visualize the veins during eye surgery as is known in the art.
Regarding Claim 3, they do not explicitly disclose placing a stent device in the surgical site while supplying the near-infrared illumination light. Lobanoff teaches placing stents during eye surgery (Paragraph 0010), and stents are known to be used in the eye. Placing the stent while using NIR allows the surgeon to see the veins while performing the procedure to ensure the stent is placed properly. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Uram’s method to use Lobanoff’s stent while supply NIR light. Such a modification allows the surgeon to see the veins while placing the stent into the eye.
Regarding Claim 7, they do not explicitly disclose wherein the incision is a cataract incision. Lobanoff teaches that imaging is used during cataract surgery (see Paragraph 0043). Also, Uram’s device is intended to be used in the eye and cataract surgeries are known in the art. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Uram’s method to be used in a cataract incision during cataract surgery to visualize the target area during the procedure.
Regarding Claim 8, Uram discloses:
A method for glaucoma treatment (Paragraph 0004), comprising:
inserting a probe (30) into an incision in an eye (see Paragraphs 0068 and Paragraph 0075), the probe being coupled to a surgical handpiece (32; see Fig. 2);
supplying the illumination light in the first wavelength to a surgical site in the eye via a plurality of illumination fibers disposed in the probe (see Paragraph 0026 discussing the illumination fibers);
transmitting a signal corresponding to an image of the surgical site from the surgical handpiece to the surgical console via a plurality of imaging fibers disposed in the probe (see Paragraph 0057).
Uram does not explicitly disclose selecting, via a surgical console, a first wavelength of an illumination light supplied by an illumination source, the first wavelength comprising visible wavelength; switching, via the surgical console, between the first wavelength of the illumination light to a second wavelength of the illumination light, the second wavelength comprising a near-infrared wavelength; supplying the illumination light in the second wavelength to the surgical site via the plurality of illumination fibers disposed in the probe; identifying, while supplying the illumination light in the second wavelength to the surgical site, aqueous veins at the surgical site; and implanting, into the surgical site, a drainage device.
Amundson teaches an endoscope for providing infrared illumination to a subject across wavelength regions ranging from 1.4-14 microns (Col 6, lines 43-63). Further, wavelengths in the range of 0.8-11 microns are used to visualize opaque body fluids (lines 3-20). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device disclosed by Uram with the emission wavelengths taught by Amundson for the benefit of visualizing body structures through opaque body fluids such as blood (Amundson Col 6, lines 21-24).
Mirsepassi teaches a surgical probe system in which the probe (10) is connected to a console (4) where a processor will adjust these parameters based on user input (Paragraphs 0024-0025) at the console (Paragraph 0024, based on commands entered at the console 4). Kienzle also teaches a controller with a mode switch button and brightness controls (Col 9 Lines 28-32). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the image processing interface taught by Uram in view of Amundson with the light emission control taught by Mirsepassi and Kienzle for the benefit of providing background and situational awareness lighting and vitreous lighting during a procedure (Mirsepassi (0022)). Furthermore, giving the user manual control over various parameters (intensity, color balance, and wavelength) is obvious in that it allows the user to configure the device as desired given the particular situation.
Lobanoff teaches using NIR to do image veins during eye surgery (see Paragraph 0036) and placing stents during eye surgery (Paragraph 0010). Placing the stent while using NIR allows the surgeon to see the veins while performing the procedure to ensure the stent is placed properly. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use Uram’s device with NIR to visualize aqueous veins while placing a stent as taught by Lobanoff. Such a modification uses the technology of NIR in a known way to visualize the veins during eye surgery as is known in the art.
Regarding Claim 9, Uram does not explicitly disclose wherein the illumination light is supplied to an active-pixel sensor disposed in the surgical handpiece via the plurality of imaging fibers disposed in the probe. Kienzle teaches placing an image sensor (1132) in the handpiece (see Fig. 2B). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Urum’s device to have a sensor in the handpiece. Such a modification is both the mere rearrangement of parts without a change in function with a reasonable expectation of success while providing the sensor in a self-contained handpiece. This eliminates the need to have a separate camera unit. Furthermore, sensors such as CCD and CMOS devices have become standard in the art because of their small size.
Regarding Claim 10, Uram as modified further discloses wherein the active-pixel sensor is a complementary metal-oxide semiconductor (CMOS) sensor (Kienzle – Col 8 Line 12).
Regarding Claim 11, Uram as modified further discloses wherein the transmitting the signal corresponding to an image of the surgical site comprises transmitting the signal from the active pixel sensor to a processor associated with the surgical console (see Uram – Paragraph 0057).
Regarding Claim 12, Uram as modified further discloses displaying the image on a surgical console (see Uram – Paragraph 0057).
Regarding Claim 13, Uram as modified further discloses wherein the drainage device comprises a microinvasive glaucoma surgery device or a stent (see Lobanoff – Paragraph 0010 mentioning both MIGS and stents).
Regarding Claim 16, Uram does not explicitly disclose wherein the incision is a cataract incision. Lobanoff teaches that imaging is used during cataract surgery (see Paragraph 0043). Also, Uram’s device is intended to be used in the eye and cataract surgeries are known in the art. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Uram’s method to be used in a cataract incision during cataract surgery to visualize the target area during the procedure.
Regarding Claim 20, Uram does not explicitly disclose supplying near-infrared illumination light to the surgical site to visualize aqueous veins of an eye; and placing a drainage device in the surgical site while supplying the near-infrared illumination light. Lobanoff teaches using NIR to do image veins during eye surgery (see Paragraph 0036) and placing stents during eye surgery (Paragraph 0010). Placing the stent while using NIR allows the surgeon to see the veins while performing the procedure to ensure the stent is placed properly. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use Uram’s device with NIR to visualize aqueous veins while placing a stent as taught by Lobanoff. Such a modification uses the technology of NIR in a known way to visualize the veins during eye surgery as is known in the art.
Claims 4-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Uram et al. (US 2019/0216306), Kienzle et al. (US 9,610,007), Amundson et al. (US 6,178,346), Mirsepassi et al. (US 2018/0168768), and Lobanoff (US 2020/0345449), as applied to claims 1-3 and 8 above, and further in view of Dunki-Jacobs et al. (US 2008/0159653).
Uram, Kienzle, Amundson, Mirsepassi, and Lobanoff disclose the invention substantially as claimed as stated above.
Regarding Claim 4, Uram as modified does not disclose stabilizing, via a gyroscopic chip, the image displayed on the surgical console against incidental movement of the surgical handpiece. Dunki-Jacobs teaches an image processing system in which a rotation sensor 144 is arranged in a scope tip 140’ to sense a position of the scope tip 140’ relative to a position of a control body 130’ ([0055-56, 61]; Fig. 1B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Uram’s device to include the rotation sensor taught by Dunki-Jacobs for the benefit of associating the scope tip with positional information such that the rotational position of the scope tip is known (Dunki-Jacobs [0041]). Including a gyroscope to stabilize a camera is well-known in imaging and can be found in all kinds of cameras to reduce image movement.
Regarding Claim 5, Uram as modified further discloses orienting, via the gyroscopic chip, the image displayed on the surgical console (see Dunki-Jacobs – Paragraph 0035).
Regarding Claim 14, Uram as modified does not disclose stabilizing, via a gyroscopic chip, the image displayed on the surgical console against incidental movement of the surgical handpiece. Dunki-Jacobs teaches an image processing system in which a rotation sensor 144 is arranged in a scope tip 140’ to sense a position of the scope tip 140’ relative to a position of a control body 130’ ([0055-56, 61]; Fig. 1B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Uram’s device to include the rotation sensor taught by Dunki-Jacobs for the benefit of associating the scope tip with positional information such that the rotational position of the scope tip is known (Dunki-Jacobs [0041]). Including a gyroscope to stabilize a camera is well-known in imaging and can be found in all kinds of cameras to reduce image movement.
Regarding Claim 15, Uram as modified further discloses orienting, via the gyroscopic chip, the image displayed on the surgical console (see Dunki-Jacobs – Paragraph 0035).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795