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 ,
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 and 15-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 is rejected because the specification, as originally filed, fails to support the limitation of “…the optical shape sensing system can automatically derive from an optical shape sensing signal obtained by optical interrogation of the optical fiber where a hub to connect a proximal part of the longitudinal device is in space to establish a corresponding recognizable longitudinal offset along the optical fiber” as now claimed. While Paragraph [0024] discloses
“…an operating procedure may comprise mounting the guidewire with the optical fiber inside in a hub serving to provide a known curvature of the optical fiber at a known position. This allows an automated way for the optical console system to identify a reference position, e.g. if the guidewire is attached to the associated longitudinal device, such that the proximal end of the associated longitudinal device is positioned at a longitudinal position of the optical fiber immediately after the hub.
it fails to disclose how the optical shape sensing system “automatically derives from an optical shape sensing system signal obtained by optical interrogation of the optical fiber where a hub to connect to a proximal part of the longitudinal device is in space” especially when the hub is not yet connected (e.g. to connect) to the longitudinal device. The only “automatic” step referenced in Paragraph [0024] is automatically identifying if the guidewire is attached to the longitudinal device. Moreover, the specification, as originally filed, fails to disclose where the processor automatically recognizes a recognizable longitudinal offset between the longitudinal device and the optical fiber based on an optical interrogation when the hub “to connect” is in space. Paragraphs [0025] and [0082] also fail to support the amended claim language in sufficient detail to show possession of the claimed invention. Claim 15 appears to have the same with respect to the processor automatically recognize a recognizable offset.
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.
Claims 1-13 and 21 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. Claim 1 is rejected because it is unclear if a longitudinal offset encoding system arranged with a lumen having a recognizable curvature is the same as “a hub” as now claimed. Claim 1 is also rejected because the limitation of “…the optical shape sensing system can automatically derive from an optical shape sensing signal obtained by optical interrogation of the optical fiber where a hub to connect a proximal part of the longitudinal device is in space to establish a corresponding recognizable longitudinal offset along the optical fiber” (emphasis added) is indefinite. The phase “to connect” implies the hub is not yet connected to the guidewire comprising an optical fiber so it is unclear how the recognizable offset is automatically derived. Claim 1 is rejected because it is unclear if “an optical shape sensing signal” (line 16) is the same optical shape sensing signal previously set forth. Likewise, it is unclear if “a recognizable longitudinal offset…” (lines 16-17) is the same recognizable longitudinal offset previously set forth. Claim 15 is rejected because “the signal” (line 4) lacks proper antecedent basis and it is unclear if it’s the data received from an optical interrogation.
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.
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.
Claims 1-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2012/029013 to Gutierrez et al. “Gutierrez” in view of U.S. Publication No. 2007/0282305 to Goldfarb or alternatively U.S. Publication No. 2007/0078437 to Borden et al. “Borden”, either Gutierrez and Goldfarb or Gutierrez and Borden in further view of U.S. Publication No. 2011/0202069 to Prisco et al. “Prisco”, WO 2013/019518 to Wong et al. “Wong” and U.S. Publication No. 2009/0292171 to Ito et al. “Ito”.
As for Claims 1, 5, 10 and 14-16, Gutierrez discloses an optical shape sensing system for use during minimally invasive catheter navigation procedures (Abstract). The system includes an optical guidewire for advancing a catheter to a target region (Abstract) by overlaying 3D shape information onto an image (Pages 1 and 7). Gutierrez explains that the optical guidewire includes multiple fiber-Bragg-gratings (FBG) integrated into along a length of the fiber to provide the 3D shape information (Pages 1 and 4) via a processing arrangement for processing the encoded optical signals to periodically reconstruct a portion or an entire shape of the optical guidewire (Pages 5-6; Figs. 3A, 3B, 3C and corresponding descriptions). Examiner notes that such descriptions are considered to read on “optically interrogating” the optical fiber in its broadest reasonable interpretation given that Appellant’s specification describes “optical interrogation” as using optical shape sensing elements by means of Fiber Bragg Gratings or Rayleigh based elements (Specification, Page 1). In addition, Applicant’s specification explains “It is to be understood that the OSS properties of the optical fiber can be obtained in various ways, as known by the skilled persons. E.g. the optical interrogation may make use of Rayleigh scattering, or make use of Fiber Bragg Gratings written into the fiber. The method for optical interrogation of the optical shape sensing properties may be performed in several ways, such as also known by the skilled person” (Specification, Page 5). Thus, according to the specification, optically interrogating an optical fiber is 1) well known and 2) accomplished, for example, using Fiber Bragg Gratings. While not specifically referenced, Figs. 3B and 3C appear to depict a hub at the proximal end of the catheter where multiple devices can be inserted into catheter at various angles.
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However, Gutierrez does not expressly disclose where hub provides a known and trackable curvature of the guidewire and optical fiber therein at a proximal end of the catheter allowing automatic registration of the proximal end of the catheter to a longitudinal position of the fiber inside the guidewire as now claimed.
Goldfarb teaches from within a similar field of endeavor with respect to medical devices to facilitate insertion and positioning of guidewires and various other apparatus within the body (Paragraph [0003]) wherein the device includes a handle (e.g. hub) with separate channels having a known curvature (Paragraph [0104]; see Figs. 3i, 5a and 5b and corresponding descriptions). Goldfarb explains that proximal portions of devices can be routed through the separate channels with the known curvature in order to make it easier to insert tools without interference (Paragraph [0104]).
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Alternatively, Borden teaches from within a similar field of endeavor with respect to catheter devices including a hub where one lumen of the catheter tube can include a deliberate bend (e.g. known curvature) so that connections to the hub can be spaced apart (Paragraphs [0019]-[0020]). Examiner notes that because the hub is molded over the catheter tubes, the hub would also include the deliberate bend. Borden also explains that a plurality of bends may be used for additional lumen configurations (Fig. 6 and corresponding descriptions).
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Prisco teaches from within a similar field of endeavor with respect to an optical shape sensing system and method for use during minimally invasive surgical procedures (Abstract; Paragraphs [0004]-[0011] and [0021]) where a pre-set perturbation allows an optical interrogator to determine pose information (Abstract; Paragraphs [0007], [0040]-[0042] Fig. 2E and corresponding descriptions). Prisco explains that the pre-set geometrical feature may be formed in a lumen through which the shape sensing segment passes (Paragraph [0010]) and may take the form of various shapes including an S-curve, a loop, a cusp, a semi-circle, etc. (Paragraph [0060]).
Accordingly, one skilled in the art would have been motivated to have modified the hub described by Gutierrez to include channel with a known, predetermined curvature in order to induce strain on the optical fiber to be recognized by the interrogator to determine a relative pose as described by Goldfarb/Borden and Prisco in order to enhance the accuracy of tracking the proximal portion of the optically interrogated guidewire. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Examiner notes the determined pose (e.g. position and orientation) would read on the steps to automatically derive where the modified hub is in space to establish a recognizable offset between the longitudinal device and the optical fiber in its broadest reasonable interpretation. For example, Prisco explains that the processor computes the position and orientation of the reference frame (e.g. hub) at location L_0 (Paragraph [0038]) which is considered to read on automatically determining where the hub is in space in its broadest reasonable interpretation.
Nonetheless, Wong teaches from within a similar field of endeavor with respect to shape sensing systems and methods (Abstract) where an elongate instrument may include a registration fixture configured to hold the elongate instrument in known positions and orientations such that the data regarding the position or orientation of the fiber may be collected to calculate a transform between the coordinate system of the fiber and the coordinate system of the elongate instrument (Paragraphs [0020]-[0021]). Wong explains that shape algorithms are used to process shape, strain, etc. data for registration of the aforementioned coordinate systems (Paragraphs [0058], [0118]-[0119] and [0142]).
Accordingly, one skilled in the art would have been motivated to have implemented Wong’s registration algorithms (e.g. automatic recognition) in the modified device in order to automatically derive device locations in space to enhance the accuracy of the registration. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for a “recognizable longitudinal offset”, Examiner notes that the modified hub and registration algorithms as described above would appear to provide the claimed offset given that Applicant’s specification discloses
“There are generally several ways other ways to implement the longitudinal offset encoding system. Especially, the longitudinal offset encoding system may comprise at least one of: 1) a device arranged to induce strain at the optical fiber at a known position (e.g. as explained by mounting a hub with known curvature), ... 5) a system comprising an electronic device (e.g. comprising a mechanical potentiometer or an optical sensor, e.g., gradient sensor, discrete sensor...” (Paragraph [0021]).
In other words, a hub configured to induce strain at a known position would implement the longitudinal offset encoding system. However, the modified device does not appear to also include an encoder (e.g. electronic device, optical device) configured to calculate an offset.
Nonetheless, Ito teaches from within a similar field of endeavor with respect to navigating medical devices within the body where lumen distances (e.g. channel 2F1) are known in order be used with advancement/retraction mechanisms configured with an encoder or optical detector to help determine the relative position of an inserted device within the lumen (Paragraph [0093]-[0094]).
Accordingly, at the time of the invention, it would have been obvious to a person skilled in the art to have used pre-calculated lumen distances and encoders or optical sensors as described by Ito in order to calculate the inserted distance of the optical fiber within the catheter relative to the curved hub section. Such a calculation would provide a longitudinal offset between the catheter and the optical fiber in its broadest reasonable interpretation and would to enhance the navigation and requires nothing more than combining prior art techniques to yield predictable results (MPEP 2143).
As for Claim 2, Examiner notes that the catheter as described above has a lumen for the guidewire to be inserted therein. Thus, the guidewire will follow a 3D shape of the catheter in its broadest reasonable interpretation.
As for Claim 3, Examiner notes the preset curve or angle would be provided to the system in order to automatically recognize the known curve/angle and used to visualize the shape of the device to the user in its broadest reasonable interpretation.
With respect to Claim 4, Examiner notes that absent any criticality or unexpected result, the particular size of the guidewire and catheter are considered to be an obvious design choice depending on the particular target within the body. In other words, any modification to the size or shape of the guidewire is considered to be obvious in the absence of showing any criticality or unexpected result (MPEP 2144.04).
As for Claims 6-7 and 17-18, Gutierrez discloses steps to acquire an image and to overlay the 3D shape of the optical guidewire on the image as described above. Examiner notes the shape of the fiber would be displayed as a graphical line where the pictured device appears to be.
With respect to Claim 8, Examiner notes that the modified system and method as described above uses a known distance of the catheter’s lumen in order to facilitate guidewire location. The known distance is may be considered a “model of a default shape” in its broadest reasonable interpretation.
Regarding Claim 9, Examiner notes that the modified system including the hub would induce strain at multiple points of the fiber (e.g. at predetermined curve) given that the optical fiber would follow the shape of the structure (e.g. hub) it was inserted into.
As for Claim 11, Examiner notes that the portion of the guidewire comprising the optical fiber extending through the hub with the pre-set curvature and catheter lumen following the pre-set curvature is considered to have a “predetermined curvature” in its broadest reasonable interpretation.
Regarding Claim 12, Examiner notes that the system as described above allows the system to recognize a position of the proximal end of the longitudinal device with respect to the aforementioned fixed point(s) in the hub (e.g. entrance or exit of hub with respect to curved lumen).
With respect to Claim 13, Examiner notes that one skilled in the art would appreciate that various sized catheters are available to a user of the systems described by Gutierrez and Ito. Accordingly, it would have been obvious to make such plurality of catheters available to the user for the navigation as described above as such a modification merely involves a duplication of parts and changes in shape/size according to conventional techniques.
Claim(s) 3 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez, Goldfarb/Borden, Prisco, Wong and Ito as applied to claims 1 and 15 above, and further in view of U.S. Patent No. 8,048,063 to Aeby et al. “Aeby”.
As for Claims 19-21, Gutierrez, Goldfarb/Borden, Prisco, Wong and Ito disclose an optical shape sensing system and method as described above. However, the art of record does not appear to disclose where the computer automatically receives device information based on an identification code (e.g. barcode/RFID).
Aeby teaches from within a similar field of endeavor with respect to catheter systems and methods where catheter manufacture information may be stored on an RFID tag to be read by the system controller (Column 7, Lines 45-55).
Accordingly, one skilled in the art would have been motivated to have modified the optical shape sensing system and method, particularly the catheter to include an RFID tag with manufacture specific information as described by Aeby in order to automatically identify device specific parameters. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Alternatively, regarding Claim 3, Examiner notes that the modified catheter with an RFID tag would provide type information to the processing means which may be used to visualize the shape of the device to the user in its broadest reasonable interpretation.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-21 have been considered but are moot in view of the updated grounds of rejection necessitated by amendment. Drawing objections have been withdrawn and new 35 U.S.C. 112(a) and (b) rejections also necessitated by amendment. However, Examiner will address Applicant’s remarks which may still pertain to the current rejection. For example, with respect to the prior art rejections, Applicant individually argues each reference (REMARKS, Pages 4-6) and in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In addition, Applicant argues “Goldman’s endoscope simply ‘has a distal end portion that…and does not have “a recognizable curvature such that an algorithm in the optical shape sensing system can automatically derive…” (REMARKS, Page 4). Examiner respectfully submits the claims fail to disclose an algorithm.
Accordingly, the rejections have been maintained.
Conclusion
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 CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L COOK/ Primary Examiner, Art Unit 3797
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