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 .
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/02/2024 was filed after the mailing date of the application on 07/02/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 19 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.
Regarding claim 19, the Examiner cannot determine what is meant by the "subtraction measuring data", and is unable to find support for what "subtraction measuring data" entails. The Examiner notes that the specification mentions subtraction of subtraction measuring data, but does not define what subtraction measuring data is, or how subtraction measuring data is collected, differentiated, or determined outside of a different type of measuring data. The Examiner is unable to determine how "measuring position measuring data by subtraction of subtraction measuring data, in particular measured in isolation during a smaller advance and/or derived by subtraction during a smaller advance, from the overall measuring data." (p.[0050]). The Examiner cannot search for this claimed limitation given that the Examiner is unable to determine what this limitation entails. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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)(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 1-8 and 12-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Holthuizen (US Patent Publication 2020/0085506).
Regarding claim 1 and 15, Holthuizen teaches “an elongated medical instrument for partial introduction into an intervention region of an examination object (Figures 3 and 5), wherein within the elongated medical instrument at least one optical waveguide is routed to at least one distal measuring position, in which the optical waveguide has an opening for transmitting and receiving light (p.[0022])”, “a measuring device (246, p.[0043]) external to the examination object, the measuring device being connected to a proximal end of the at least one optical waveguide (p.[0043]), the measuring device including a light source configured to create transmit light of a transmit spectrum to be guided through at least one of the at least one optical waveguides to the at least one measuring position (p.[0043]),” “a light detector configured to receive light guided from the at least one measuring position via at least one of the at least one optical waveguides to the measuring device (p.[0043])”, “an evaluation unit configured to evaluate measuring data describing a position a receive spectrum of the receive light based on of the transmit spectrum (p.[0043]) for determining position information describing the position of the elongated medical instrument in the examination object based on reflection characteristics of materials of the examination object (p.[0007, 0008, 0021])”, and “a display facility configured to output the position information (p.[0014])”.
Regarding claim 15 specifically, the computer method describes the same limitations as claim 1, and therefore is taught by the rejection of claim 1 above. The Examiner notes that Holthuizen does teach that a computer method is performed within the scope of the rejection above as stated in p.[0001], "The invention further relates to a computer program causing a system to perform steps of a method resulting in a detection of a position of a device within tissue based on a determination of tissue types."
Regarding claim 2, the limitations of claim 1 are taught as described above. Holthuizen teaches “wherein the evaluation unit configured to at least one use a course of the measuring data into the examination object to determine the position information, the transmit spectrum covering a number of wavelengths to determine the position information, or wavelength ranges to determine the position information” in p.[0007-0008], which describes how the device is able to determine the position information of the device via optical sensors and therefore teaches the limitation as described.
Regarding claim 3, the limitations of claim 1 are taught as described above. Holthuizen teaches “wherein the evaluation unit is configured to at least one of, determine at least one material class of a material at least one of the at least one measuring position reflecting the transmit light into the receive light, or determine a transition between material classes” in p.[0007-0008], see tissue type discussion which constitutes as a material class and therefore teaches the limitation as described.
Regarding claim 4, the limitations of claim 3 are taught as described above. Holthuizen teaches “wherein the position information describes an arrangement at least one of the at least one measuring position in a section of material of the examination object” in Fig. 6, which shows position information of the bone screw within a section of the material of the examination object (in cancellous bone versus cortical bone, p.[0046]) and therefore teaches the limitation as described.
Regarding claim 5, the limitations of claim 3 are taught as described above. Holthuizen teaches “wherein the evaluation unit is configured to use image data of the intervention region of the examination object to at least one of determine the at least one material class or assign at least one of the at least one measuring position to a section of material visible in the image data” in Fig. 6, and further in p.[0007] which states "The imaging system may be capable of generating an image of a region of interest, for example of a spine, and the planning and navigation system may be adapted for a planning of an insertion of a device into the region of interest, for example of an insertion of a pedicle screw in one of the vertebra of the spine. On the one hand, the tissue types that may be encountered during a device placement are stored in a table. On the other hand, a navigation system, which at least provides information assisting in guiding the device placement, may determine an actual position of the device based on a determination of the tissue at or in front of the device and based on the sequence of tissue types stored in the table. This may be done based on a real-time tissue sensing which may be performed by the device being inserted into the region of interest. Such a device may be a k-wire, an awl or a tap, or a screw. The system may thus compare a predicted tissue type determined by means of imaging and during planning with a real-time measured tissue type determined by means of sensing".
Regarding claim 6, the limitations of claim 5 are taught as described above. Holthuizen teaches “an output unit configured to output a display based on the image data showing the position information” in Fig. 6, which shows the output display image based on the image data showing the position information, and therefore teaches the limitation as described.
Regarding claim 7, the limitations of claim 3 are taught as described above. Holthuizen teaches “wherein the evaluation unit is configured to use a trained function to determine the at least one material class” in p.[0007, 0050, 0051], which describes that an algorithm is used to produce a table of tissue properties (i.e., material classes) and therefore teaches the limitation as described.
Regarding claim 8, the limitations of claim 1 are taught as described above. Holthuizen teaches “wherein at least one of the at least one measuring position is provided at a distal end of the elongated medical instrument” in Figure 5 shows the measuring position is provided at the end of the elongated medical instrument, and therefore teaches the limitation as described. See also, abstract ("to determine possible positions of the distal end of the optical guide on the path based on the comparison of tissue types, and to generate a signal indicative for the possible positions.").
Regarding claim 12, the limitations of claim 1 are taught as described above. Holthuizen teaches “wherein the at least one of the at least one optical waveguide for guidance of transmit light to at least one of the at least one measuring position has an interruption point for coupling out the transmit light at the at least one measuring position” in Claim 1, which states "comprising an optical sensing device including an optical guide with a distal end, the optical guide being arrangeable within the insertable device, and a processing unit, wherein the processing unit is configured (i) to receive tissue type information of a region of interest including different tissue types, (ii) to receive an input identifying a path through the region of interest, (iii) to determine a sequence of tissue types along the identified path, based on the received tissue type information (iv) to receive optical information from the optical sensing device (v) to determine a tissue type at the distal end of the optical guide based on the received optical information, (vi) to compare the determined tissue type with the sequence of tissue types along the path, (vii) to determine possible positions of the distal end of the optical guide on the path based on the comparison of the tissue types, and (viii) to generate a signal indicative for a mismatch between the determination tissue type based on the received optical information and the possible tissue types for the possible positions along the path through the region of interest."
Regarding claim 13, the limitations of claim 1 are taught as described above. Holthuizen teaches “wherein the elongated medical instrument includes a treatment means at a tip for treatment of a target tissue class” in Fig. 3, which shows a pedicle bone screw at the tip of the medical instrument, considered to be a treatment means, teaches the limitation as described.
Regarding claim 14, the limitations of claim 1 are taught as described above. Holthuizen teaches “an imaging facility including a patient couch for the examination object and an activation unit, the activation unit being configured to activate at least one of the patient couch or of a recording arrangement of the imaging facility for positioning for a recording of image data with the imaging facility using the position information” in Figure 1, which shows an examination table, couch, bed, or the like (112), inside a facility (implied, given that the patient is in a room), with recording arrangements via the camera (124, 130), which is activated responsive to the first range of wavelengths in the visible spectrum to image the position information. This is further described in p.[0039-0040].
Regarding claim 16, the limitations of claim 1 are taught as described above. Holthuizen teaches “wherein the reflection characteristics are reflection characteristics of tissues of the examination object” in the Abstract, which states "The optical sensing means may include an optical guide with a distal end, wherein the optical guide may be configured to be arranged in a device to be inserted into tissue in a region of interest. The processing unit may be configured to receive information of a region of interest including different tissue types as well as of a path through the tissues, to determine a sequence of tissue types along the path, to determine a tissue type at the distal end of the optical guide based on information received from the optical sensing means, to compare the determined tissue type with the tissue types on the path, ". Note that the optical sensing means is further described in p.[0044] and teaches a form of spectroscopy that operates using reflected light and therefore teaches the limitation as described.
Regarding claim 17, the limitations of claim 1 are taught as described above. Holthuizen teaches “wherein at least one of the at least one measuring position is at a tip of the instrument” in Figs. 5-6, which shows the measuring position is at the tip of the instrument and therefore teaches the limitation as described.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Holthuizen (US Patent Publication 2020/0085506).
Regarding claim 9, the limitations of claim 1 are taught as described above. While Holthuizen doesn’t describe a number of measuring positions, it is the Examiner's position that the device is capable of assuming a plurality of measuring positions under broadest reasonable interpretation. In claim 1 of Holthuizen, the application claims that possible positions (plural suggesting more than one) of the distal end can be determined, and is further elaborated upon in claim 2, which states that additional positions can be determined based on the tracked position, suggesting that a number of measuring positions can be achieved. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a number of measuring positions, as stated in Holthuizen. It is known in the art to use multiple positions of measurement to provide an accurate depiction of the desired subject, and such modifications produce predictable results.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Holthuizen (US Patent Publication 2020/0085506) in view of Vrba (US Patent Publication 2019/0069949).
Regarding claim 10, the limitations of claim 9 are taught as described above. Holthuizen does not teach that the measuring positions are spaced across in a longitudinal direction along a distal portion of the elongated medical device, but Vrba does in an analogous electrosurgical device. Vrba teaches in p.[0379] "FIGS. 42A and 42B, with marker bands 4210 (e.g., radiopaque marker bands) defining the proximal and distal extents of the tube structure", which shows measuring positions spaced across the elongated medical instrument and teaches the limitation as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use measuring positions spaced along the distal portion of the device, as taught in Vrba, in Holthuizen. The use of the marker bands allows for the monitoring of the position of the device external to the body, and produces predictable results (p.[0727]).
Regarding claim 11, the limitations of claim 10 are taught as described above. Holthuizen teaches “a common optical waveguide of the at least one optical waveguide is configured to guide the receive light from a number of measuring positions, and
the evaluation unit is configured to at least one of,
determine the position information as a function of an increasing intensity of the receive light as the number of measuring positions located in the examination object increases, or
for overall measuring data describing at least one measuring position for receive light from the number of measuring positions, determine measuring position measuring data by subtracting subtraction measuring data, from the overall measuring data” in p.[0025] which teaches "Furthermore, the device may be adapted to perform at least one out of the group consisting of diffuse reflectance spectroscopy, diffuse optical tomography, differential path length spectroscopy, and Raman spectroscopy. The console may comprise at least one spectrometer." Note that a diffuse reflectance spectroscopy operates using evaluations of light intensity, and therefore teaches the limitation as described.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Holthuizen (US Patent Publication 2020/0085506) in view of Vrba (US Patent Publication 2019/0069949) and Sudre (US Patent Publication 2024/0350208).
Regarding claim 18, the limitations of claim 10 are taught as described above. Holthuizen/Vrba does not teach that the measuring positions are spaced apart equidistantly, but Sudre does in Figure 6 and 7, which shows optical markers 23, 24, and 42 are markers that are used to measure position and are spaced apart equally from one another. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Sudre in Holthuizen. As taught in Sudre, the use of the optical markers allows for the position of the device to be known and produces predictable results (p.[0090-0091]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Holthuizen (US Patent Publication 2020/0085506) in view of Roh (US Patent No. 11,950,851).
Regarding claim 20, the limitations of claim 13 are taught as described above. Holthuizen does not teach the use of an ablation needle for tumor treatment, but Roh does in an analogous image analysis device for navigation in tissue. Roh teaches in col. 14, lines 19-23] that the treatment may be for tumor tissue, and further in col. 11, lines 26-29, ablation needles can be used to treat desired tissue, therefore teaching the limitation as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Roh in Holthuizen. As stated in Roh, the use of the imaging system in addition to a treatment means allows for more effective treatment to reduce surgical time and likelihood of injury and improve the chance of positive patient outcomes (col. 4, lines 9-27).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794