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 .
Response to Amendment
The amendment filed on 7/1/2026 has been entered. Claims 1-3, 6-17, 19-21, and 23-24 remain pending in the application.
Response to Arguments
Applicant's arguments, see Page 10, filed on 7/1/2026, with respect to the rejection under 35 U.S.C. § 103 of Claim 1 as unpatentable over Truckai in view of Reever have been fully considered but they are not persuasive.
The applicant argues that the combination of Truckai and Reever would be inoperable. The applicant’s argument is on the grounds if one were to modify Truckai to include the fluidics tubing extending continuously from the handle body through to the shaft, the handle component would not be detachable in the manner disclosed by Truckai. Examiner respectfully disagrees. In response to applicant's argument that the combination of Truckai and Reever would be inoperable, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). As evidenced by U.S. Patent Appl. Publ. No. 2021/0068621 A1 to Shin et al. (“Shin”), fluidics tubing extending through the interior cavity, a connector portion, and into the shaft does not interfere with the shaft’s ability to detach from the handle (Figs. 1-2, paragraph 0041). It would have been obvious to one ordinary skill in the art to combine the teachings of Truckai and Reever while maintaining the detachable connection between the shaft and the handle of Truckai, thereby persevering the interchangeability and functionality of the endoscope components.
Accordingly, the 103 rejection of claim 1 stands. Please see section 35 USC § 103 below for further explanation.
Applicant’s arguments, see pages 10-11, filed 7/1/2026, with respect to claim 16 have been fully considered and are persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims, render the previous 103 rejection identified in the non-final dated 4/23/2026 moot, and require a new ground of rejection.
Therefore, the 103 rejection previously identified in the non-final action dated 4/23/2026 has been withdrawn.
However, upon further search and consideration, a new ground of rejection is made. Please see section 35 USC § 103 below for further explanation.
Applicant’s arguments, see page 11, filed 7/1/2026, with respect to claim 20 have been fully considered and are persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims, render the previous 103 rejection identified in the non-final dated 4/23/2026 moot, and require a new ground of rejection.
Therefore, the 103 rejection previously identified in the non-final action dated 4/23/2026 has been withdrawn.
However, upon further search and consideration, a new ground of rejection is made. Please see section 35 USC § 103 below for further explanation.
Claim Objections
Claim 21 is objected to because of the following informalities:
In claim 21, lines 2-3, “wherein the port is in communication with a working channel” should read “wherein the port is configured to be in communication with a working channel.” The amendment is suggested to clarify that the port is structurally configured to provide communication with the working channel, rather than merely reciting the result that the port is in communication with the working channel.
Appropriate correction is required.
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.
Claim 20 is 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 20 introduces new matter with the recitation of the limitation “inserting an instrument into a port on the first connector portion and advancing the instrument through a working channel in communication with the port.” The step of inserting an instrument into the port is not supported by the originally filed claims, specification, or drawings. In paragraphs 0028-0029 of the Applicant’s Specification, Applicant discloses a working channel port and a working channel tube. However, the Specification does not disclose or suggest an additional tool or instrument being inserted into the working channel port or that an instrument extended into the port passes into the working channel. Therefore, one skilled in the art would not be able to determine that the inventor at the time of filing had possession of the claimed invention.
Claim Rejections - 35 USC § 103
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.
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.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1-3, 7-9, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2018/0326144 A1 to Truckai et al. (“Truckai”) in view of U.S. Patent Appl. Publ. No. 2018/0132703 A1 to Reever et al. (“Reever”).
Regarding claim 1, Truckai discloses a medical device (endoscope 105 consisting of a reusable handle component 106; Fig. 1, paragraph 0026) comprising:
a handle body including a first central longitudinal axis (it can be seen that the handle component 106 is detachably coupled to the disposable endoscope shaft component 110; Fig. 2, paragraph 0028), wherein the handle body defines a first interior cavity (interior space 315 of the handle portion 106; Fig. 3);
a first connector portion coupled to a distal end of the handle body (the proximal hub 144 has an offset connector portion 160 that is angled relative to the axis 152 for connecting to handle component 106; Fig. 2, paragraph 0028), wherein the first connector portion defines a second interior cavity (interior space of the proximal hub 144; Fig. 7A), and wherein the first interior cavity opens into the second interior cavity (the inner cavity of the handle 106 can be seen in communication with the inner cavity of endoscope shaft component 110; Fig. 7B);
a shaft extending distally from the first connector portion (the endoscope component 110 has an elongate shaft 150 extending along longitudinal axis 152; Fig. 2, paragraph 0028), wherein a second central longitudinal axis of the shaft is offset from the first central longitudinal axis of the handle body (the proximal hub 144 has an offset connector portion 160 that is angled relative to the axis 152 for connecting to handle component 106; Fig. 3, paragraph 0028), and wherein the second interior cavity opens into the shaft (the interior cavity of the proximal hub portion 144 can be seen in communication with the interior cavity of the elongate shaft 150; Fig. 7A-B); and
fluidics tubing extending through the second interior cavity of the first connector portion and into the shaft (the fluid outflow channel 494 through the endoscope shaft 150 terminates in a fitting 490 in the hub 144; Fi. 7A-B, paragraph 0055).
However, Truckai does not explicitly disclose fluidics tubing extending through the first interior cavity of the handle body and into the second interior cavity of the first connector portion.
Reever teaches a handle assembly for a medical device (an exemplary insertion device 10 including a hollow handle 12; Fig. 1, paragraph 0023) comprising:
a handle body including a first interior cavity (hollow handle 12 includes … a pistol grip or extension 12B; Fig. 3, paragraph 0026);
a first connector portion coupled to a distal end of the handle body (hollow handle 12 includes an enlarged spherical, or substantially spherical ball-head 12A; Fig. 1), wherein the first connector portion defines a second interior cavity, and wherein the first interior cavity opens into the second interior cavity (hollow handle 12; Fig. 3);
a shaft extending distally from the first connector portion (hollow handle 12 includes an enlarged spherical, or substantially spherical ball-head 12A coupled to shaft 14; Fig. 1, paragraph 0026), wherein the second interior cavity opens into the shaft (the inner cavity of the ball-head 12A can be seen in communication with the inner cavity shaft 14; Fig. 3); and
fluidics tubing extending through the first interior cavity of the handle body, into the second interior cavity of the first connector portion, and into the shaft (each tube 44 extends from one of the ports 22, and 24, through shaft 14, and terminates in cap 16. Any one or both of tubes 44 may be fluidly coupled with a source of irrigation fluid, a source of aspiration fluid, (e.g. negative pressure), a source of medication for infusion, etc; Fig. 3, paragraph 0034). Reever teaches that this handle configuration allows the medical professional to grip the handle such that interference with the ports may be avoided (paragraph 0026).
Reever is considered to be analogous to the claimed invention because it is in the same field of medical devices with handles comprising fluidic tubing. It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the handle assembly of Truckai to incorporate the teachings of Reever by adding a channel in the handle for the outflow tubing to extend therethrough. Doing so would help to allow the medical professional to grip the handle such that interference with the ports may be avoided, as recognized by Reever.
Regarding claim 2, Truckai, as previously modified by Reever, discloses the medical device according to claim 1. Truckai further discloses comprising a second connector portion (hub 144; Fig. 1) coupled to (i) a proximal end of the shaft (elongated shaft; Fig. 1) and (ii) the first connector portion (offset connector portion 160; Fig. 1) (the endoscope shaft component 110 includes a proximal hub 144 that is adapted for coupling to the distal end 146 of the handle component 106 with a latch mechanism 148 carried by the hub 144 for locking the hub to the handle; Fig. 2, paragraph 0028), wherein the second connector portion is spaced from the first central longitudinal axis of the handle body (the proximal hub 144 has an offset connector portion 160 that is angled relative to the axis 152 for connecting to handle component 106; Fig. 3, paragraph 0028).
Regarding claim 3, Truckai, as previously modified by Reever, discloses the medical device according to claims 1 and 2. Truckai further discloses wherein the shaft further comprises:
a distal tip (the shaft 150 includes a substantially rigid portion or sleeve 154 that extends to a flexible, resilient distal shaft portion 155 described further below; Fig. 4, paragraph 0028); and
a camera positioned at the distal tip (the elongate shaft 150 extends to a distal flexing or deformable portion 155 that carries an electronic image sensor 200; Fig. 4, paragraph 0029).
Regarding claim 7, Truckai, as previously modified by Reever, discloses the medical device according to claim 1. Truckai further discloses wherein the first connector portion includes a working channel port (a biopsy device may have a flexible shaft (not shown) with a diameter ranging from 1mm to 3mm and can be introduced through port 232 in the proximal hub 144 which extends through channel 165 in the shaft 150 to the working end; Fig. 2, paragraph 0030).
Regarding claim 8, Truckai, as previously modified by Reever, discloses the medical device according to claim 1. Truckai further discloses wherein at least a portion of the first connector portion extends from a first side of the handle body to a second side of the handle body, and protrudes radially outward from the second side of the handle body (the first connector portion (endoscope component 110 extends from the first side of the handle body 106 to the second side of the handle body 106 and protrudes outward from the second side of the handle body 106 as seen in annotated Fig. 3 below; Fig. 3).
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Regarding claim 9, Truckai, as previously modified by Reever, discloses the medical device according to claim 1. Truckai further discloses wherein the first connector portion includes a proximal-facing planar surface (port 232 on the proximal hub 144 opens on a proximal-facing planar surface; Fig. 3).
Regarding claim 21, Truckai, as previously modified by Reever, discloses the medical device according to claim 1. Truckai further discloses further comprising a port positioned on the first connector portion, wherein the port is in communication with a working channel extending through the shaft such that an instrument extended into the port passes into the working channel (a biopsy device may have a flexible shaft (not shown) with a diameter ranging from 1mm to 3mm and can be introduced through port 232 in the proximal hub 144 which extends through channel 165 in the shaft 150 to the working end; Fig. 2, paragraph 0030), wherein the port is spaced from the shaft (the port 232 is spaced from the shaft 150; Fig. 2).
In addition, Truckai discloses that the port is aligned with the working channel (the proximal hub 144 of the endoscope component 110 as a tool-receiving portion 162 that is aligned with a working channel 165 extending through the elongated shaft 150; Fig. 2, paragraph 0028) and discloses a working channel that is offset from the second central longitudinal axis of the shaft (Fig. 4). However, Truckai does not explicitly disclose wherein the port has an axis that is offset from the second central longitudinal axis of the shaft.
Reever teaches a first connector portion (ball-head 12A; Fig. 1, paragraph 0026) coupled to a distal end of the handle body (hollow handle 12 includes an enlarges spherical, or substantially spherical ball-head 12A coupled to shaft 14 and a pistol grip or extension 12B depending therefrom; Fig. 1, paragraph 0026), wherein the first connector portion includes a port (ball-head 12A includes a single (i.e., only one) port 18 on a proximal side thereof; Fig. 1, paragraph 0026), and a shaft extending distally from the first connector portion (shaft 14; Fig. 1, paragraph 0026), wherein the shaft includes a working channel extending from the port to a distal tip of the shaft (working channel 30 extends from port 18 through shaft 14 and terminates in cap 16; Fig. 2, paragraph 0028), wherein the port has an axis that is offset from the second central longitudinal axis of the shaft (port 18 extends parallel or aligned with longitudinal axis S and communicated with working channel 30 extending through shaft 14 and tip 16 …. Working channel 30 extends along an axis offset and parallel with longitudinal axis S; Fig. 1, paragraph 0028).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the port of Truckai to incorporate the teachings of Reever by positioning the port such that the port has an axis that is offset from the central longitudinal axis of the shaft. Since Truckai already discloses a working channel extending through the shaft and the working channel has an axis that is offset from the central longitudinal axis of the shaft, modifying the position of the corresponding port to be offset from the central longitudinal axis of the shaft would have been obvious to correspond with the location of the working channel, as evidenced by Reever.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Truckai in view of Reever as applied to claim 1 above.
Regarding claim 15, Truckai, as previously modified by Reever, discloses the medical device according to claim 1. However, Truckai, as modified by Reever, does not explicitly disclose wherein the first central longitudinal axis of the handle body is approximately 68 mm from the second central longitudinal axis of the shaft.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the central longitudinal axis of the handle body of Truckai approximately 68 mm from the central longitudinal axis of the shaft since it has been held 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the endoscope would not operate differently with the claimed space between the central longitudinal axis of the handle body and the central longitudinal axis of the shaft. Further, Applicant places no criticality on the range claimed, indicating that “axis 341 may be spaced from axis 342 approximately 68 mm” (see paragraph 0014 of Applicant’s specification).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Truckai in view of Reever as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2017/0065151 A1 to Hatano (“Hatano”).
Regarding claim 6, Truckai, as previously modified by Reever, discloses the medical device according to claim 1. However, Truckai, as modified by Reever, does not explicitly disclose wherein the shaft includes a strain relief portion at a proximal portion of the shaft.
Hatano teaches wherein the shaft includes a strain relief portion at a proximal portion of the shaft (reference sign 12 indicates a first bend preventing member that covers the proximal end portion of the insertion portion 2 to prevent buckling of the insertion portion 2; Fig. 1, paragraph 0023). Hatano teaches that the strain relief portion helps to prevent buckling of the insertion portion (paragraph 0023).
Hatano is considered to be analogous to the claimed invention because it is in the same field of endoscopes a handle and insertion portion. It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the proximal portion of the shaft of Truckai, as modified by Reever, to incorporate the teachings of Hatano by adding a strain relief portion. Doing so would help to prevent buckling of the shaft, as recognized by Hatano.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Truckai in view of Reever as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2020/0323418 A1 to Narayana et al. (“Narayana”).
Regarding claim 10, Truckai, as previously modified by Reever, discloses the medical device according to claim 1. However, Truckai, as modified by Reever, does not explicitly disclose wherein the handle body includes (a) a suction actuator and (b) an air and water actuator coupled to the fluidics tubing.
Narayana teaches wherein the handle body includes (a) a suction actuator and (b) an air and water actuator coupled to the fluidics tubing (the handle assembly 106 may include … a suction button 116, an air/water button 118; Fig. 1B, paragraph 0030).
Narayana is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a handle. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a suction actuator and an air and water actuator in the handle of the endoscope of Truckai, as taught by Narayana, to increase the functionality of the endoscope of Truckai by allowing water and air to be introduced and evacuated from the distal end of the insertion portion of the endoscope.
Regarding claim 11, Truckai, as previously modified by Reever and Narayana, discloses the medical device according to claims 1 and 10. However, Truckai, as modified by Reever, does not explicitly disclose wherein the handle body includes a first control knob, a second control knob, a locking lever, and a locking knob.
Narayana teaches wherein the handle body includes a first control knob, a second control knob, a locking lever, and a locking knob (the handle assembly 106 may include … a locking lever 109, a second locking lever 110, a first control knob 112, a second control knob 114; Fig. 1A-B, paragraph 0030).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a first control knob, a second control knob, a locking lever, and a locking knob in the handle of the endoscope of Truckai, as taught by Narayana, to increase the functionality of the endoscope of Truckai by allowing the user to control the deflection of the distal end of the insertion section of the endoscope in the up, down, left, and right directions.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Truckai in view of Reever as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2019/0290435 A1 to Tah et al. (“Tah”).
Regarding claim 12, Truckai, as previously modified by Reever, discloses the medical device according to claim 1. However, Truckai, as modified by Reever, does not explicitly teach wherein the first central longitudinal axis of the handle body is substantially parallel to the second central longitudinal axis of the shaft.
Tah teaches wherein the first central longitudinal axis of the handle body is substantially parallel to the second central longitudinal axis of the shaft (the axis L3 of the handle 270 can be parallel with … the axis L1 of the elongate barrel 270; Fig. 2, paragraph 0057). Tah teaches a handle and shaft configuration with parallel offset axes for facilitating easier access to an implantation site for some patients, such as heavy-set patients (paragraph 0046).
Tah is considered to be analogous to the claimed invention because it is in the same field of medical device handles. It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the handle of Truckai, as modified by Reever, to incorporate the teachings of Tah by making the central longitudinal axis of the handle body substantially parallel to the central longitudinal axis of the shaft. Doing so would facilitate easier access to an implantation site for some patients, such as heavy-set patients, as recognized by Tah.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Truckai in view of Reever as applied to claims 1 and 2 above, and further in view of U.S. Patent Appl. Publ. No. 2022/0117470 A1 to Noyes (“Noyes”).
Regarding claim 13, Truckai, as previously modified by Reever, discloses the medical device according to claims 1 and 2. Specifically, Truckai discloses the second connector portion (proximal hub 144; Fig. 1) coupled to the first connector portion (offset connector portion 160; Fig. 1) and shaft (elongated shaft 150; Fig. 1). However, Truckai, as modified by Reever, does not explicitly teach wherein the second connector portion extends into (i) the first connector portion and (ii) the shaft. The connection mechanism for the second connector portion is not explicitly stated.
Noyes teaches an endoscope connector with a twist on male/female attachment mechanism that features an extension member (a small circumferential lip 145 on the proximal end of the circular extension 144 engages a wider circumferential lip 146 within the distal opening of the coupler housing in a manner that allows rotation movement of the joint; Fig. 1C-D, #144, paragraph 0128). Noyes teaches that the extension member for the twist on male/female attachment mechanism helps to allow rotation movement of the shaft (paragraph 0128).
Noyes is considered to be analogous to the claimed invention because it is in the same field of endoscope connectors for attaching the shaft to the handle. It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the connection mechanism of Truckai, as modified by Reever, to incorporate the teachings of Noyes by adding an extension member to the second connector portion for extending into the first connector portion and the shaft. Doing so would help to allow rotation of the shaft, as recognized by Noyes.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Truckai in view of Reever as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2020/0054194 A1 to Melsheimer (“Melsheimer”).
Regarding claim 14, Truckai, as previously modified by Reever, discloses the medical device according to claim 1. However, Truckai, as modified by Reever, does not explicitly disclose wherein the first connector portion is rectangular.
Melsheimer teaches wherein the connector is rectangular (the first connector portion of the handle is rectangular in shape as seen in Fig. 3; Fig. 3).
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Melsheimer is considered to be analogous to the claimed invention because it is in the same field of endoscope connectors for attaching the shaft to the handle. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the endoscope of Truckai, as modified by Reever, to have a rectangular first connector portion, as such modification would involve a mere change in configuration. It has been held that a change in configuration of shape of a device is obvious, absent persuasive evidence that a particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claims 16-17 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Truckai in view of Tah and Reever.
Regarding claim 16, Truckai discloses a medical device (endoscope 105 consisting of a reusable handle component 106; Fig. 1, paragraph 0026) comprising:
a handle body including a first central longitudinal axis (it can be seen that the handle component 106 is detachably coupled to the disposable endoscope shaft component 110; Fig. 2, paragraph 0028);
a first connector portion coupled to a distal end of the handle body (first connector portion of proximal hub 144 as seen in annotated Fig. 7A below; Figs. 1 and 7A), wherein the first connector portion includes a port (a biopsy device may have a flexible shaft (not shown) with a diameter ranging from 1mm to 3mm and can be introduced through port 232 in the proximal hub 144 which extends through channel 165 in the shaft 150 to the working end; Fig. 2, paragraph 0030);
a second connector portion coupled to a distal portion of the first connector portion, positioned entirely distal to the handle body (second connector portion of proximal hub 144 as seen in annotated Fig. 7A below; Figs. 1 and 7A), and spaced from the handle body (the proximal hub 144 has an offset connector portion 160 that is angled relative to the axis 152 for connecting to handle component 106; Fig. 3, paragraph 0028); and
a shaft extending distally from the second connector portion (the endoscope component 110 has an elongate shaft 150 extending along longitudinal axis 152; Fig. 2, paragraph 0028), wherein the shaft includes a working channel extending from the port to a distal tip of the shaft (a working channel 165 extending through the elongate shaft 150; Fig. 5A, paragraph 0028), wherein a second central longitudinal axis of the shaft is spaced from the first central longitudinal axis of the handle body (the proximal hub 144 has an offset connector portion 160 that is angled relative to the axis 152 for connecting to handle component 106; Fig. 3, paragraph 0028).
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However, Truckai does not explicitly disclose wherein the second central longitudinal axis of the shaft is substantially parallel to the first central longitudinal axis of the handle body.
Tah discloses a handle assembly for a medical device (a furlow insertion device (device) 200; Fig. 2, paragraph 0054) comprising:
a handle body including a central longitudinal axis (the handle 270 can be arranged along the axis L3; Fig. 2, paragraph 0057),
a first connector portion (the housing 250 also includes a straight portion 254; Fig. 2, paragraph 0056) coupled to a distal end of the handle body (the handle 270 being coupled with the housing 250; Fig. 2, paragraph 0057),
a second connector portion coupled to a distal portion of the first connector portion, positioned entirely distal to the handle body, and spaced from the handle body (the housing has a curved portion 252; Fig. 2, paragraph 0056); and
a shaft extending distally from the second connector portion (a housing 250 that is coupled with (or integrated monolithically with) the elongate barrel 210; Fig. 2, paragraphs 0054 and 0056), wherein a central longitudinal axis of the shaft is spaced from the central longitudinal axis of the handle body (the central longitudinal axis of the elongate barrel 210 is spaced from the central longitudinal axis of the handle 270; Fig. 2, paragraph 0056), and wherein the central longitudinal axis of the shaft is substantially parallel to the central longitudinal axis of the handle body (the axis L3 of the handle 270 can be parallel with … the axis L1 of the elongate barrel 270; Fig. 2, paragraph 0057). Tah teaches a handle and shaft configuration with parallel offset axes for facilitating easier access to an implantation site for some patients, such as heavy-set patients (paragraph 0046).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the handle of Truckai to incorporate the teachings of Tah by making the central longitudinal axis of the handle body substantially parallel to the central longitudinal axis of the shaft. Doing so would facilitate easier access to an implantation site for some patients, such as heavy-set patients, as recognized by Tah.
In addition, Truckai discloses that the port is aligned with the working channel (the proximal hub 144 of the endoscope component 110 as a tool-receiving portion 162 that is aligned with a working channel 165 extending through the elongated shaft 150; Fig. 2, paragraph 0028) and discloses a working channel that is offset from the second central longitudinal axis of the shaft (Fig. 4). However, Truckai does not explicitly disclose wherein the port has an axis that is offset from the second central longitudinal axis of the shaft.
Reever teaches a first connector portion (ball-head 12A; Fig. 1, paragraph 0026) coupled to a distal end of the handle body (hollow handle 12 includes an enlarges spherical, or substantially spherical ball-head 12A coupled to shaft 14 and a pistol grip or extension 12B depending therefrom; Fig. 1, paragraph 0026), wherein the first connector portion includes a port (ball-head 12A includes a single (i.e., only one) port 18 on a proximal side thereof; Fig. 1, paragraph 0026), and a shaft extending distally from the first connector portion (shaft 14; Fig. 1, paragraph 0026), wherein the shaft includes a working channel extending from the port to a distal tip of the shaft (working channel 30 extends from port 18 through shaft 14 and terminates in cap 16; Fig. 2, paragraph 0028), wherein the port has an axis that is offset from the second central longitudinal axis of the shaft (port 18 extends parallel or aligned with longitudinal axis S and communicated with working channel 30 extending through shaft 14 and tip 16 …. Working channel 30 extends along an axis offset and parallel with longitudinal axis S; Fig. 1, paragraph 0028).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the port of Truckai to incorporate the teachings of Reever by positioning the port such that the port has an axis that is offset from the central longitudinal axis of the shaft. Since Truckai already discloses a working channel extending through the shaft and the working channel has an axis that is offset from the central longitudinal axis of the shaft, modifying the position of the corresponding port to be offset from the central longitudinal axis of the shaft would have been obvious to correspond with the location of the working channel, as evidenced by Reever.
Regarding claim 17, Truckai, as previously modified by Tah and Reever, discloses the medical device according to claim 16. Truckai, as modified by Tah and Reever, further disclose wherein the medical device is configured to be held by a user such that a wrist of the user is aligned with the second central longitudinal axis of the shaft (the axis L3 of the handle 270 can be parallel with … the axis L1 of the elongate barrel 270; Fig. 2, paragraph 0046 and 0057). As disclosed by Tah, the user is intended to grip the handle. With the arrangement of the handle and the elongate barrel being on parallel axes, the user’s wrist when gripping the handle would be aligned with the central longitudinal axis of the elongate barrel.
Regarding claim 23, Truckai, as previously modified by Tah and Reever, discloses the medical device according to claim 16. Truckai further discloses wherein the handle body defines a first interior cavity (interior space 315 of the handle 106; Fig. 3), the first connector portion defines a second interior cavity (interior space of first connector portion of hub 144; Fig. 7A), the second connector portion defines a third interior cavity (interior space of the second connector portion of hub 144; Fig. 7A), and the second connector portion extends proximally into the first connector portion such that the second interior cavity opens into the third interior cavity (the interior spaces of the offset connector portion 160 and the interior space 315 of the handle 106 are open to each other; Fig. 7b), and wherein fluidics tubing extends through the third interior cavity and into the shaft (the fluid outflow channel 494 through the endoscope shaft 150 terminates in a fitting 490 in the hub 144; Fi. 7A-B, paragraph 0055), and wherein the axis of the port is offset from the central longitudinal axis of the handle body (the axis of the port 232 is offset from the central longitudinal axis of the handle component 106; Fig. 1).
However, Truckai, as modified by Tah and Reever, does not explicitly disclose wherein fluidics tubing extends through the first interior cavity, into the second interior cavity, into the third interior cavity, and into the shaft.
Reever teaches fluidics tubing extends through the first interior cavity, into the second interior cavity, into the third interior cavity, and into the shaft (each tube 44 extends from one of the ports 22, and 24, through shaft 14, and terminates in cap 16. Any one or both of tubes 44 may be fluidly coupled with a source of irrigation fluid, a source of aspiration fluid, (e.g. negative pressure), a source of medication for infusion, etc; Fig. 3, paragraph 0034). Reever teaches that this handle configuration allows the medical professional to grip the handle such that interference with the ports may be avoided (paragraph 0026).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the handle assembly of Truckai, as modified by Tah and Reever, to incorporate the teachings of Reever by adding a channel in the handle for the outflow tubing to extend therethrough. Doing so would help to allow the medical professional to grip the handle such that interference with the ports may be avoided, as recognized by Reever.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Truckai in view of Reever and U.S. Patent Appl. Publ. No. 2023/0020281 A1 to Ono et al. (“Ono”).
Regarding claim 20, Truckai discloses a method of operating an endoscope that includes a handle, the method comprising:
wherein the handle body is spaced from the central longitudinal axis of the shaft (the proximal hub 144 has an offset connector portion 160 that is angled relative to the axis 152 for connecting to handle component 106; Fig. 3, paragraph 0028), wherein a first connector portion is coupled to a distal end of the handle body (first connector portion of proximal hub 144 as seen in annotated Fig. 7A below; Figs. 1 and 7A) and a second connector portion is coupled to (a) a distal portion of the first connector portion and (b) the shaft (second connector portion of proximal hub 144 as seen in annotated Fig. 7A below; Figs. 1 and 7A); and
inserting an instrument into a port on the first connector portion and advancing the instrument through a working channel in communication with the port (it can be understood how the physician may … introduce a tool 128 through the working channel 165 and into a targeted working space 172 in the interior of a patient’s body; Fig. 1, paragraph 0028).
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However, Truckai does not explicitly disclose moving a handle body circumferentially about a central longitudinal axis of a shaft of the endoscope.
Ono teaches a method of operating an endoscope that includes a handle, the method comprising moving a handle body circumferentially about a central longitudinal axis of a shaft of the endoscope (when the operator performs the observation using the endoscope, the operator may perform the insertion or observation while changing the distal end portion of the insertion part or the bending direction thereof by bending the bendable portion and by rotating the insertion part around an axis with respect to the operation part; Fig. 1, paragraph 0004).
Ono is considered to be analogous to the claimed invention because it is in the same field of endoscopes comprising a handle and insertion portion. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a step of moving a handle body circumferentially about a longitudinal axis of the handle in the method of operating the endoscope of Truckai, as taught by Ono, to increase the functionality of the endoscope of Truckai by providing the user with additional control over the orientation and positioning of the endoscope shaft during use.
In addition, Truckai discloses that the port is aligned with the working channel (the proximal hub 144 of the endoscope component 110 as a tool-receiving portion 162 that is aligned with a working channel 165 extending through the elongated shaft 150; Fig. 2, paragraph 0028) and discloses a working channel that is offset from the second central longitudinal axis of the shaft (Fig. 4). However, Truckai does not explicitly disclose wherein the port has an axis that is offset from the second central longitudinal axis of the shaft.
Reever teaches a first connector portion (ball-head 12A; Fig. 1, paragraph 0026) coupled to a distal end of the handle body (hollow handle 12 includes an enlarges spherical, or substantially spherical ball-head 12A coupled to shaft 14 and a pistol grip or extension 12B depending therefrom; Fig. 1, paragraph 0026), wherein the first connector portion includes a port (ball-head 12A includes a single (i.e., only one) port 18 on a proximal side thereof; Fig. 1, paragraph 0026), and a shaft extending distally from the first connector portion (shaft 14; Fig. 1, paragraph 0026), wherein the shaft includes a working channel extending from the port to a distal tip of the shaft (working channel 30 extends from port 18 through shaft 14 and terminates in cap 16; Fig. 2, paragraph 0028), wherein the port has an axis that is offset from the second central longitudinal axis of the shaft (port 18 extends parallel or aligned with longitudinal axis S and communicated with working channel 30 extending through shaft 14 and tip 16 …. Working channel 30 extends along an axis offset and parallel with longitudinal axis S; Fig. 1, paragraph 0028).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the port of Truckai to incorporate the teachings of Reever by positioning the port such that the port has an axis that is offset from the central longitudinal axis of the shaft. Since Truckai already discloses a working channel extending through the shaft and the working channel has an axis that is offset from the central longitudinal axis of the shaft, modifying the position of the corresponding port to be offset from the central longitudinal axis of the shaft would have been obvious to correspond with the location of the working channel, as evidenced by Reever.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Truckai in view of Reever as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2021/0068621 A1 to Shin et al. (“Shin”).
Regarding claim 24, Truckai, as previously modified by Reever, discloses the medical device according to claim 1. However, Truckai, as modified by Reever, does not explicitly disclose an articulation wire extending through the handle body, the first connector portion, the second connector portion, and the shaft, wherein the articulation wire is configured to bend the shaft upon actuation of the articulation wire.
Shin teaches an articulation wire extending through the handle body (first, second, third, and fourth connecting wires 21, 22, 23, and 24; Fig. 3, paragraph 0045), the first connector portion (first, second, third, and fourth connecting wires 21, 22, 23, and 24; Fig. 3, paragraph 0045), the second connector portion (first and second operating wires 11 … third and fourth operating wires 13 and 14; Fig. 3, paragraph 0044), and the shaft (first and second operating wires 11 … third and fourth operating wires 13 and 14; Fig. 3, paragraph 0044), wherein the articulation wire is configured to bend the shaft upon actuation of the articulation wire (a detachable endoscope which can stably and precisely perform the quantitative motion of an operating wire of vertically and horizontal bending a front end of an insertion unit inserted into a body cavity; Fig. 1, paragraph 0011).
Shin is considered to be analogous to the claimed invention because it is in the same field of endoscopes comprising a handle and insertion portion. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated an articulation wire in the endoscope of Truckai, as taught by Shin, to increase the functionality of the endoscope of Truckai by facilitating bending of the endoscope, thereby improving maneuverability and enabling navigation through curved anatomical pathways.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Truckai in view of Tah and Reever as applied to claim 16 above, and further in view of Narayana.
Regarding claim 19, Truckai, as previously modified by Tah and Reever, discloses the medical device according to claim 16. However, Truckai, as modified by Tah and Reever, does not explicitly disclose wherein the handle body includes a first control knob, a second control knob, a locking lever, and a locking knob.
Narayana teaches wherein the handle body includes a first control knob, a second control knob, a locking lever, and a locking knob (the handle assembly 106 may include … a locking lever 109, a second locking lever 110, a first control knob 112, a second control knob 114; Fig. 1A-B, paragraph 0030).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a first control knob, a second control knob, a locking lever, and a locking knob in the handle of the endoscope of Truckai, as taught by Narayana, to increase the functionality of the endoscope of Truckai by allowing the user to control the deflection of the distal end of the insertion section of the endoscope in the up, down, left, and right directions.
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 OLIVIA G STARKEY whose telephone number is (571)272-3375. The examiner can normally be reached Monday-Friday 8:00-5:00 ET.
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/OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
