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 .
Election/Restrictions
Applicant’s election without traverse of Species D (Figure 4A) in the reply filed on October 31, 2025 is acknowledged. Applicant asserted claims 1-6, 10-17, 21-22 encompass the elected species. However, examiner finds claims 6 and 17 to be related to Species E (Figure 4B), which was not elected. As such, examiner withdraws claims 6-9 and 17-20 as being directed towards a non-elected invention. Claims 1-5, 10-16, 21-22 are hereby examined on their merits as being directed towards the elected invention Species D (Figure 4A). This restriction requirement is made final.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) is acknowledged.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 10, 12, 14, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9770216 to Brown.
Regarding Claim 1, Brown teaches a method comprising:
receiving (i) a target location for performing a procedure in an organ of a patient (col. 6, lines 41-62 – selecting a treatment target location), and (ii) a mapping of a lumen located along a path to the target location (col. 6, lines 41-62 – selecting and mapping a target trajectory/path to the treatment target location);
producing an endoscopic view of at least the lumen (bronchoscope/endoscope views 470, local endoscope view 478, in Figure 8-9, show both the endoscope and lumen); and
displaying in the endoscopic view, on at least a wall of the lumen, one or more marks indicative of a progress of the procedure (pathway 476, virtual probe 479, target 452, Figure 8; virtual marks 512, Figure 10 are also displayed; all of these markings are displayed on the wall of the lumen, e.g. as shown in Figure 8 pathway 476 is overlaid on walls of the lumens, and guide the user to the treatment target. The markings in the displayed image are updated in real-time as the procedure progresses).
Regarding Claim 3, Brown further teaches wherein producing the endoscopic image comprises displaying the endoscopic view from a point of view of a distal-end assembly (DEA) of a probe performing the procedure (bronchoscope view 470, local view 478, Figure 8), and wherein displaying the marks comprises displaying one or both of a position and an orientation of the DEA being navigated along the path (path 476, Figure 8) and relative to the target location (target 452, Figure 8).
Regarding Claim 10, Brown further teaches displaying along the path a line having one or more first axes, which are parallel with one or more second axes of the path, respectively (a line representing the path is overlaid onto the display, path 476, Figure 8; the line is parallel to the path selected by the user since it overlays the selected path).
Regarding Claims 12, 14, and 21, they are rejected for the same reasoning as in Claims 1, 3, and 10 above, respectively. In addition, Brown teaches a memory (memory 202, Figure 2), display (206, Figure 2), and processor (processor 204, Figure 2) to carry out the method.
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.
Claims 2, 11, 13, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over US 9770216 to Brown in view of US 20060004286 to Chang.
Regarding Claim 2, Brown teaches path markers (476, Figure 8) but does not teaches wherein displaying the one or more marks comprises displaying: (i) a first mark indicative of a position in the path, and (ii) a second mark, different from the first mark, indicative of a position out of the path.
Chang teaches a guidance system for navigating an ENT device to a treatment target (Abstract). Markings are displayed to allow the physician to easily determine the relative distance by which the device is advanced or retracted (indicator marks 95, Figures 13A, 13B), including a planned path zone 92 (par. 0104, 0119) and deviations out of the planned path (94, Figure 13B) in order to keep out of zones 90 (par. 0119, Figures 13A-13B).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to utilize the markings of Chang in the system of Brown to further show deviations from the planned path, to aid the user in staying on the path and out of no-go zones.
Regarding Claim 11, Brown does not teach wherein the organ comprises an ear-nose-throat (ENT) system of the patient, wherein the target location comprises a sinus of the ENT system, and wherein the procedure comprises one or both of sensing and treatment in the sinus. Instead, Brown teaches a bronchoscope used to sense and treat in the lungs.
Chang teaches a guidance system for navigating an ENT device to a treatment target in the sinus (Abstract, Figure 9).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to utilize the system/method of Brown in an ENT sinus procedure so as to guide ENT instruments to the treatment target, as in Chang. Endoscopes used for a variety of procedures including lungs, sinuses, are well-known and established in the art.
Regarding Claims 13 and 22, the same reasons for rejection are utilized as for Claims 2 and 11 above, respectively.
Claims 4, 5, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over US 9770216 to Brown in view of US 20130197357 to Green.
Regarding Claim 4, Brown teaches path markers (476, Figure 8) but does not teach wherein displaying the one or more marks comprises displaying, on one or more annular sections of the wall of the lumen, one or more rings, respectively, which are indicative of one or both of the position and the orientation of the DEA relative to the target location.
Green teaches an image guidance system for guiding an invasive device to a target. Green further teaches displaying annular sections, i.e. rings, which are indicative of both the position and orientation of the device relative to the target location (virtual rings as shown in Figure 4, par. 0062). The spacing, i.e. frequency, of the rings indicates the distance to the target (par. 0063).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to include the ring marks of Green in the system of Brown in order to provide intuitive visual guidance cues regarding the distance from the medical device tip to the targeted anatomy, as taught by Green (par. 0063).
Regarding Claim 5, Brown in combination with Green, during navigation, the rings would be moved along the viewing area in the display, i.e. the wall of the lumen, at the movement speed along the path, i.e. the virtual display corresponds to the real movements and are continuously updated on the display.
Regarding Claims 15 and 16, the same reasoning is used as above for claims 4 and 5, respectively.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20240324870 to Wong teaches navigation rings that aid an operator to navigate a tool along an approach path to a target. For example, the rings increase in diameter moving away from the target and narrow when precisely on the path, like a video game (par. 0089).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
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, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799