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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/03/2025 has been considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-14 in the reply filed on 08/20/2026 is acknowledged. The traversal is on the ground(s) that Groups I, II, and III inventions are sufficiently related to allow for examination of these inventions together. This is not found persuasive. Although there may be some overlap of the search for Groups I, II, and III, there is nothing to indicate that the search would be coextensive. Furthermore, the office action dated 07/16/2026 explains why Groups I, II, and III do not overlap the scope (See MPEP § 806.05 and CTRS dated 07/16/2026). Therefore, the extra search and/or examination burden for addressing Groups I, II, and III poses a serious burden to the examiner which makes the restriction requirement proper.
Therefore, the requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 1 is objected to because of the following informalities:
For claim 1, the examiner assumes “a medical device installed” should be “the medical device installed” for clarity.
Appropriate correction is required.
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.
Claims 1-14 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.
For claim 1, “medical device” and “instrument” is indefinite. It is unclear what is the difference between a medical device and an instrument. For the purpose of advancing prosecution, the examiner assumes the medical device and the instrument is the same.
For claim 1, “receive elongated shafts of medical devices having instruments” and “a medical device installed in the cylindrically shaped body” is indefinite. It is unclear if a medical device/instrument is configured to move through the cylindrically shaped body, then somehow lock in place (“installing” within the cylindrically shaped body, if a medical device/instrument is configured to move through the cylindrically shaped body, if a medical device/instrument is configured to be attached (“installed”) to the cylindrically shaped body, or something else. For the purpose of advancing prosecution, the examiner assumes the medical device/instrument is configured to move through the cylindrically shaped body.
Claims 2-14 are dependent of claim 1, and therefore rejected under these 112(b) rejections as well.
For claim 4, “wherein the cylindrically shaped body has a first diameter, the elongated shaft has a second diameter, and the first diameter corresponds to the second diameter” is indefinite. It is unclear how an elongated shaft of an instrument goes through the cylindrically shaped body if the elongated shaft and cylindrically shaped body have the same diameter. For the purpose of advancing prosecution, the examiner assumes the diameter of the instrument and the diameter of the channel is not the same.
For claim 5, “first diameter is agnostic to a second diameter” is indefinite. It is unclear what is meant by a diameter being “agnostic” to another diameter (i.e., cylindrically shaped body is next to the elongated shaft of the instrument, the diameter of the cylindrically shaped body and instrument is not the same, or something else). For the purpose of advancing prosecution, the examiner assumes the diameter of the instrument and the diameter of the channel is not the same.
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.
Claims 1 and 4-14 are rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (US 20170151027 A1, published June 1, 2017) in view of Greenburg et al. (US 20150327791 A1, published November 19, 2015) and Zhuang et al. (US 20120016316 A1, published January 19, 2012), hereinafter referred to as Walker, Greenburg, and Zhuang, respectively.
Regarding claim 1, Walker teaches an electromagnetic medical device instrument tracking apparatus, comprising:
an elongated hollow channel, including: a cylindrically shaped body configured to receive elongated shafts of medical devices having instruments at ends of the elongated shafts; a distal end; an inlet at the distal end; a proximal end; and an outlet at proximal end (Fig. 7, outer sheath catheter 710 as cylindrically shaped body, receiving guidewire 730 (medical device/instrument), having an inlet and an outlet at the distal and proximal ends of the outer sheath catheter 710);
at least one electromagnetic sensor disposed at the channel (Fig. 7, EM sensors 714 in outer sheath catheter 710; see para. 0064 – “The two EM sensors in each of the sheath...”); and
an electrical pathway in electrical communication with the at least one electromagnetic sensor and configured to route signals from the at least one electromagnetic sensor off the apparatus (Fig. 1, route signal from tracking subsystem 36 (includes EM sensor) to “off the apparatus” (processor, controller 34); see para. 0064 – “These pairs of 5-DOF sensors enable tracking of each of the leader 720 and the sheath 710 in 6-DOF so that complete orientation, location, and heading are known.”),
wherein the cylindrically shaped body positions the electromagnetic sensor by an instrument located at an end of an elongated shaft of a medical device installed in the cylindrically shaped body (Fig. 7, guidewire 730 (medical device/instrument) moves through outer sheath catheter 710 (cylindrically shaped body), so guidewire 730 (medical device/instrument) moves pass and can be “positioned by” (next to) the EM sensor 714 of outer sheath catheter 710 (cylindrically shaped body)).
Walker teaches at least one electromagnetic sensor disposed at the channel, but does not explicitly teach at least one electromagnetic sensor disposed at the proximal end of the channel.
Whereas, Greenburg, in an analogous field of endeavor, teaches at least one electromagnetic sensor disposed at the proximal end of the channel (see para. 0019 – “Another embodiment, shown in FIG. 1, utilizes multiple coils 22 [EM sensors]. The coils 22 are spaced apart along the length of the sheath 20. The coils 22 provide position data of various points along the length [including proximal] of the sheath 20...”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the EM sensors on the channel, as disclosed in Walker, by also having EM sensors on the proximate end of the channel, as disclosed in Franz. One of ordinary skill in the art would have been motivated to make this modification in order to patient a picture of the sheath, provide an indication of the location and orientation of the sheath, as disclosed in Greenburg (see para. 0019).
Walker in view of Greenburg teaches a distal end of an elongated hollow channel, and it would be inherent to have a fastener at the distal end of the channel to lock the medical device/instrument in place at a desired location, but does not explicitly teach a fastener coupled at the distal end.
Whereas, Zhuang, in an analogous field of endeavor, teaches a fastener coupled to the channel (see para. 0084 – “The needle may be inserted into sheath 40, causing position marker 32A to move further along the sheath 40. When position marker 32A is aligned with the tip 42A of sheath 40, the needle may be locked in place at connector base 36 by cam 38A, thereby fixing the location of position marker 32A at tip 42A.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a distal end of an elongated hollow channel, as disclosed in Walker in view of Greenburg, by having a fastener at the end of the channel, as disclosed in Zhuang. One of ordinary skill in the art would have been motivated to make this modification in order to maintain the position of the medical device/instrument.
Furthermore, regarding claim 4, Walker further teaches wherein the cylindrically shaped body has a first diameter, the elongated shaft has a second diameter, and the first diameter corresponds to the second diameter (112b, unclear how a shaft of an instrument goes through a tube if they have the same diameter; Fig. 7, diameter of the outer sheath catheter 710 (cylindrically shaped body) and the diameter of the elongated shaft of the instrument (guidewire 730) is different).
Furthermore, regarding claim 5, Walker further teaches wherein the cylindrically shaped body has a first diameter, the elongated shaft has a second diameter, and the first diameter is agnostic to a second diameter (112b, how is a diameter agnostic; Fig. 7, diameter of the outer sheath catheter 710 (cylindrically shaped body) and the diameter of the elongated shaft of the instrument (guidewire 730) is different).
Furthermore, regarding claim 6, Greenburg further teaches a second electromagnetic sensor disposed at the distal end (see para. 0019 – “Another embodiment, shown in FIG. 1, utilizes multiple coils 22 [EM sensors]. The coils 22 are spaced apart along the length of the sheath 20. The coils 22 provide position data of various points along the length [including proximal and distal] of the sheath 20...”).
Furthermore, regarding claim 7, Zhuang further teaches wherein the fastener fastens the cylindrically shaped body to the medical device (instrument is locked in place within cylindrical body; see para. 0084 – “The needle may be inserted into sheath 40, causing position marker 32A to move further along the sheath 40. When position marker 32A is aligned with the tip 42A of sheath 40, the needle may be locked in place at connector base 36 by cam 38A, thereby fixing the location of position marker 32A at tip 42A.”).
Furthermore, regarding claim 8, Greenburg further teaches wherein the cylindrically shaped body include an outer surface and the at least one electromagnetic sensor is disposed on the outer surface (see para. 0016 – “The sheath 20 includes one or more coils 22 [EM sensors] that are either embedded in its wall or are attached to an outside surface thereof.”).
Furthermore, regarding claim 9, Greenburg further teaches wherein the cylindrically shaped body include an inner surface and the at least one electromagnetic sensor is disposed on the inner surface (see para. 0016 – “The sheath 20 includes one or more coils 22 [EM sensors] that are either embedded in its wall or are attached to an outside surface thereof.”).
Furthermore, regarding claim 10, Walker further teaches wherein the instrument includes an ablation catheter (see para. 0043 – “In various embodiments, the medical instrument 18 is a flexible and/or elongate medical device or any other tool that may be inserted into a body lumen. As non-limiting examples, the instrument may be a catheter, sheath, leader, probe, biopsy needle, aspiration tool, endoscope, optical fiber, guidewire, tool for delivering or implanting a stent or valve, surgical tool, imaging tool, diagnostic tool, and/or therapeutic tool [ablation catheter].”).
Furthermore, regarding claim 11, Walker further teaches wherein the instrument includes a biopsy blade, needle or scissors (see para. 0043 – “In various embodiments, the medical instrument 18 is a flexible and/or elongate medical device or any other tool that may be inserted into a body lumen. As non-limiting examples, the instrument may be a catheter, sheath, leader, probe, biopsy needle, aspiration tool, endoscope, optical fiber, guidewire, tool for delivering or implanting a stent or valve, surgical tool, imaging tool, diagnostic tool, and/or therapeutic tool.”).
Furthermore, regarding claim 12, Walker further teaches wherein the apparatus is disposable (see para. 0043 – “In various embodiments, the medical instrument 18 is a flexible and/or elongate medical device or any other tool that may be inserted into a body lumen. As non-limiting examples, the instrument may be a catheter, sheath, leader, probe, biopsy needle, aspiration tool, endoscope, optical fiber, guidewire, tool for delivering or implanting a stent or valve, surgical tool, imaging tool, diagnostic tool, and/or therapeutic tool.” Where it is inherent and known in the art these tools (apparatus) can be disposed to prevent contamination).
Furthermore, regarding claim 13, Walker further teaches wherein the apparatus is reusable (see para. 0043 – “In various embodiments, the medical instrument 18 is a flexible and/or elongate medical device or any other tool that may be inserted into a body lumen. As non-limiting examples, the instrument may be a catheter, sheath, leader, probe, biopsy needle, aspiration tool, endoscope, optical fiber, guidewire, tool for delivering or implanting a stent or valve, surgical tool, imaging tool, diagnostic tool, and/or therapeutic tool.” Where it is inherent and known in the art these tools (apparatus) can be reused to reduce cost).
Furthermore, regarding claim 14, Walker further teaches wherein the apparatus is sanitizable and disinfectable (see para. 0043 – “In various embodiments, the medical instrument 18 is a flexible and/or elongate medical device or any other tool that may be inserted into a body lumen. As non-limiting examples, the instrument may be a catheter, sheath, leader, probe, biopsy needle, aspiration tool, endoscope, optical fiber, guidewire, tool for delivering or implanting a stent or valve, surgical tool, imaging tool, diagnostic tool, and/or therapeutic tool.” Where it is inherent and known in the art these tools (apparatus) can be sanitized and disinfected to prevent contamination in order to be reused).
The motivation for claims 6-9 was shown previously in claim 1.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Walker in view of Greenburg and Zhuang, as applied to claim 1 above, and in further view of S. Han et al, “Guidewires in GI endoscopy”, iGIE, vol. 2, no. 3, pp. 386-394, Sept. 2023, hereinafter referred to as Han.
Regarding claim 2, Walker in view of Greenburg and Zhuang teaches all of the elements disclosed in claim 1 above.
Walker in view of Greenburg and Zhuang inherently teaches the elongated shaft of an instrument and a cylindrically shaped body having a length, but does not explicitly teach where the cylindrically shaped body is shorter than the elongated shaft of an instrument.
Whereas, Han, in an analogous field of endeavor, teaches wherein the cylindrically shaped body (channel) has a first length, the elongated shaft (instrument) has a second length, and the first length is shorter than the second length (channel is shorter than instrument; see pg. 387, col. 2, para. 2 – “The long GW [guide wire] systems require exchange of accessories over the GW (for which the wire [instrument] must be at least twice the length [longer than] of the device [channel])...”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elongated shaft of an instrument and a cylindrically shaped body having a length, as disclosed in Walker in view of Greenburg and Zhuang, by having where the cylindrically shaped body is shorter than the elongated shaft of an instrument, as disclosed in Han. One of ordinary skill in the art would have been motivated to make this modification in order to allow countertension by the assistant while advancing devices over the GW (guidewire, instrument), as taught in Han (see pg. 387, col. 2, para. 2).
Furthermore, regarding claim 3, Han further teaches wherein the first length (channel) is on an order of one centimeter or less than the second length (instrument) (see pg. 387, col. 1, para. 2 – “GWs [guidewires, instrument] range in length from 260 to 270 cm for “short” GWs and from 450 to 500 cm for “long” GWs.” So the guidewire can have a length that is a centimeter or less longer than the channel).
One of ordinary skill in the art would have been motivated to make this modification in order to prevent accidental contact of the GW (guidewire, instrument) with the floor, which can lead to its contamination, as taught in Han (see pg. 387, col. 2, para. 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Barasofsky et al. (US 20250040995 A1, published February 6, 2025 with a priority date of August 4, 2023) discloses the sEWC (smart extended working channel) 14 may include one or more EM sensors 14 a disposed in or on the sEWC 14 at a predetermined distance from the distal end 14 b of the sEWC 14. A catheter 70, including one or more EM sensors 72, is inserted into the sEWC and selectively locked into position relative to the sEWC 14 such that the sensor 72 extends a predetermined distance beyond a distal tip of the sEWC 14 (Fig. 1).
Dickhans (US 20160058507 A1, published March 3, 2016) discloses engaging a mechanical interface of the ablation catheter with at least one mechanical interface defined along a slot provided on the extended working channel to lock the radiator of the ablation catheter in a position that is distal of the distal end of the extended working channel (Fig. 4).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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/N.C./Examiner, Art Unit 3798
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