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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/17/2026 has been entered.
Disposition of Claims
Claims 1-3, 6-17, and 19-23 are pending.
Claims 4-5 and 18 are canceled.
Response to Arguments
Applicant’s arguments, see Page 8, filed on 3/17/2026, with respect to the rejection under 35 U.S.C. § 112(a) of Claim 20 have been fully considered and are persuasive in light of amendments to the claims.
The rejection under 35 U.S.C. § 112(a) of Claim 20 has been withdrawn.
Applicant’s arguments, see Pages 9-11, filed on 3/17/2026, with respect to the rejections under 35 U.S.C. § 103 of Claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see Page 11, filed on 3/17/2026, with respect to the rejections under 35 U.S.C. § 102 of Claim 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see Pages 11-12, filed on 3/17/2026, with respect to the rejections under 35 U.S.C. § 103 of Claim 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 and 7-9 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 handle assembly for 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 handle assembly 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 handle assembly 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 handle assembly 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 handle assembly 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 handle assembly 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).
Claims 16-17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Truckai in view of U.S. Patent Appl. Publ. No. 2019/0290435 A1 to Tah et al. (“Tah”).
Regarding claim 16, Truckai discloses a handle assembly for a medical device (endoscope 105 consisting of a reusable handle component 106; Fig. 1, paragraph 0026) comprising:
a handle body including a 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 (offset connector portion 160; Fig. 1, paragraph 0028),
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 (hub 144; Fig. 1); 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 a central longitudinal axis of the shaft is spaced from the 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 shaft includes an imaging device at a 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).
However, Truckai does not explicitly disclose wherein the central longitudinal axis of the shaft is substantially parallel to the 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).
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 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.
Regarding claim 17, Truckai, as previously modified by Tah, discloses the handle assembly according to claim 16. Truckai, as modified by Tah, further disclose wherein the handle assembly is configured to be held by a user such that a wrist of the user is aligned with the 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 22, Truckai, as previously modified by Tah, discloses the handle assembly according to claim 16. Truckai further discloses comprising electrical wiring extending through the handle body, the first connector portion, the second connector portion, and the shaft, to the imaging device (the image sensor 200 is further operatively connected by leads 208 in shaft 150 to an image processor 210 carried in a handle component 106; Figs. 3 and 5A, paragraph 0029).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. U.S. Patent Appl. Publ. No. 2023/0020281 A1 to Ono et al. (“Ono”) in view of Tah.
Regarding claim 20, Ono discloses 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).
However, Ono does not explicitly disclose a handle configuration wherein a user's radial-ulnar joint axis is substantially coaxial with central longitudinal axis of the shaft during use and wherein the handle body is spaced from the central longitudinal axis of the shaft.
Tah teaches a handle configuration wherein a user's radial-ulnar joint axis is substantially coaxial with central longitudinal axis of the shaft during use and wherein the handle body is spaced from the central longitudinal axis of the shaft (the handle 170 can be aligned along a third longitudinal axis L3. In some implementations, the axis L3 of the handle 170 can be parallel with the axis L1 of the elongate barrel 110. In other implementations, the axis L3 of the handle 170 can be … offset with respect to the axis L1 of the elongate barrel 110; Fig. 2, paragraph 0046). As disclosed in Fig. 3 and paragraph 0026 of Applicant’s specification, a handle on an offset parallel axis to the axis of the shaft can be gripped such that a user's radial-ulnar joint axis is substantially coaxial with the central longitudinal axis of the shaft during rotation about an axis.
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 Ono 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 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 handle assembly 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 handle assembly 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 handle assembly 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 handle assembly 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 Tah.
Regarding claim 12, Truckai, as previously modified by Reever, discloses the handle assembly 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).
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 handle assembly 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.
Claims 14 and 21 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. 2020/0054194 A1 to Melsheimer (“Melsheimer”).
Regarding claim 14, Truckai, as previously modified by Reever, discloses the handle assembly 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).
Regarding claim 21, Truckai, as previously modified by Reever, discloses the handle assembly according to claim 1. Truckai further discloses a working channel port positioned on the first connector portion, wherein the working channel port is spaced from the shaft (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, #232, paragraph 0030). However, Truckai does not explicitly disclose a working channel port having an axis that is offset from the second central longitudinal axis of the shaft.
Melsheimer teaches a working channel port positioned on the first connector portion, wherein the working channel port is spaced from the shaft and has an axis that is offset from the second central longitudinal axis of the shaft (an additional catheter 29, power cord, or other suitable tubing, is coupled at a proximal end to handle 24; Fig. 4, paragraph 0015).
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 additional working channel port in the handle of the endoscope of Truckai, as taught by Melsheimer, to increase the functionality of the endoscope of Truckai by allowing the user to insert additional tools or have additional fluid supply channels.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Truckai in view of Tah as applied to claim 16 above, and further in view of Narayana.
Regarding claim 19, Truckai, as previously modified by Tah, discloses the handle assembly according to claim 16. However, Truckai, as modified by Tah, 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 23 is rejected under 35 U.S.C. 103 as being unpatentable over Truckai in view of Tah as applied to claim 16 above, and further in view of Reever.
Regarding claim 23, Truckai, as previously modified by Tah, discloses the handle assembly 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 the offset connector portion 160; Fig. 7A), the second connector portion defines a third interior cavity (interior space of the proximal 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).
However, Truckai, as modified by Tah, 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, 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.
Conclusion
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
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