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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/30/2026 has been entered.
Disposition of Claims
Claims 1-20 are pending.
Response to Arguments
Applicant's arguments, see Pages 7-11, filed on 4/30/2026, with respect to the rejections under 35 U.S.C. § 102 of Claims 1, 9, and 15 have been fully considered but they are not persuasive.
The applicant’s arguments are on the grounds that the treatment instrument head is not mateably docked in the instrument insertion opening. Examiner respectfully disagrees. Okada discloses a treatment instrument head that is docked within the instrument insertion opening (Fig. 3). The Examiner interprets “docked” under its broadest reasonable interpretation as requiring only that the instrument be received within, engaged with, or coupled to the repository. Okada discloses the elongated distal portion of the at least one cartridge tool extends through the at least one working channel of the elongated shaft while the body of the at least one cartridge tool remains docked in the repository (the first sheath tube portion 3 is within the channel 7 while the second engagement mechanism 15 is docked within the instrument opening 16; the endoscope 12 has a channel 7 through which a treatment instrument head 6 can pass; Fig. 3, paragraph 0047).
The applicant further argues that the treatment instrument head does not have a body and an elongated distal portion. Examiner respectfully disagrees. Okada discloses at least one cartridge tool with an elongated distal portion (the treatment instrument head 6 includes the first flexible sheath tube portion 3; Fig. 1A, paragraph 0046) and a body (round flange 35 and first connecting member 31; Fig. 1A-2).
Additionally, the applicant argues that Okada does not disclose that the supporting shaft and the head of the projection 32 implement a functionality of the cartridge when the first control is actuated. Examiner respectfully disagrees. Okada discloses that the first engagement mechanism 13, including the projection 32, engages the first operating wire 5 with the second operating wire 10 (paragraph 0073). Okada further discloses that the second operating wire 10 is retractable within the second sheath tube 8 (paragraph 0048) and the first operating wire 5 implements the functionality of the treatment instrument head (paragraph 0046).
Applicant’s arguments, see Pages 11-12, filed on 4/30/2026, with respect to the rejections under 35 U.S.C. § 102 of Claims 1, 9, and 15 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 Objections
Claim 9 is objected to because of the following informalities:
In claim 9, line 10, “a sliding having protuberance” should read “a slider having a protuberance”
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 4-6 and 15-20 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.
Claims 4 and 17-18 recite the limitation “a distal end of the elongated shaft” in l. 2 of claim 4, l. 2 of claim 17, and l. 2 of claim 18. It is unclear if applicant is referring to distal end of the elongated shaft introduced previously in claims 1 and 15 or an additional distal end of the elongated shaft. For the purposes of examination, “a distal end of the elongated shaft” is being interpreted as “the distal end of the elongated shaft.”
Claim 6 recites the limitation "the cartridge tool" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, "the cartridge tool" is being interpreted as "the at least one cartridge tool."
Claim 6 recites the limitation "the one of the least one cartridge tool" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, "the one of the least one cartridge tool" is being interpreted as "the at least one cartridge tool."
Claim 15 recites the limitation “an elongated distal portion” in line 5. It is unclear if applicant is referring to the elongated distal portion introduced previously in claim 15 or an additional elongated distal portion. For the purposes of examination, “an elongated distal portion” is being interpreted as “the elongated distal portion.”
Claims 5, 16, and 19-20 are rejected as being dependent upon claims previously rejected under 35 USC § 112(b).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regards to claim 7, the claim reads “wherein the at least one cartridge tool has an elongated distal portion configured to extend into the at least one working channel and has a body that releasably attaches to the repository.”
Claim 1 reads “a repository configured to detachably dock a body of at least one cartridge tool having an elongated distal portion and provide access to the at least one working channel for the elongated distal portion of the at least one cartridge tool.” In addition, neither claim 1 nor claim 7 positively recites the “at least one cartridge tool”, thus claim 7 is not drawn to any element positively recited in claim 1. As such, claim 7 is improperly dependent as it fails to limit claim 1 from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 6-10, 12-13, 14, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2005/0209505 A1 to Okada (“Okada”) in view of U.S. Patent Appl. Publ. No. 2019/035648 A1 to Owens et al. (“Owens”).
Regarding claim 1, Okada discloses a cystoscope (endoscope 12; Fig. 1A, paragraph 0046) comprising:
a handle (operating portion 17; Fig. 1A, paragraph 0047);
an elongated shaft that defines at least one working channel (the endoscope 12 has a channel 7 through which a treatment instrument head 6 can pass; Fig. 1A, paragraph 0047), the elongated shaft having a distal end (distal end of endoscope 12; Fig. 1A);
a repository (space between the walls of the instrument opening 16 including the space within the instrument driving mechanism 11 for receiving the treatment instrument head 6; Figs. 2-3) configured to detachably dock a body of at least one cartridge tool having an elongated distal portion (the endoscope 12 is provided with an instrument opening 16 for use in attaching or detaching the treatment instrument head 6 to or from the treatment instrument driving mechanism 11 at a proximal end of the channel 7; Fig. 1A, paragraph 0051) and provide access to the at least one working channel for the elongated distal portion of the at least one cartridge tool such that the elongated distal portion of the at least one cartridge tool extends through the at least one working channel of the elongated shaft while the body of the at least one cartridge tool remains docked in the repository (the first sheath tube portion 3 is within the channel 7 while the second engagement mechanism 15 is docked within the instrument opening 16; the endoscope 12 has a channel 7 through which a treatment instrument head 6 can pass; Fig. 3, paragraph 0047); and
a first control (numerous switches such as switch 28 for operating the treatment instrument driving mechanism 11 can be seen on operating portion 17; Fig. 1A) for actuating a movable element of the repository (the second operating wire (the second operating member) 10 is retractable within the second sheath tube portion 8; Fig. 2, paragraph 0047), the movable element of the repository comprising a slider portion (the first engagement mechanism 13 has … the second connecting member 33 on the side of the treatment instrument driving mechanism 11; Fig. 2-3, paragraph 0056) having a protuberance extending therefrom (the head 41 is arranged at a distal end of supporting shaft 40; Fig. 2, paragraph 0057), wherein the protuberance is configured to engage the at least one cartridge tool when docked within the repository (the head 41 is able to protrude via the through hole 30 of the first connecting member 31 with the central axis C1 of the treatment instrument head 6 perpendicular to the central axis C2 of the treatment instrument driving mechanism 11; Fig. 2-3, paragraph 0057) and thereby implement a functionality of the at least one cartridge tool at the distal end of the elongated shaft when the first control is actuated (the first engagement mechanism 13 is used for engaging the first operating wire 5 of the treatment instrument head 6 with the second operating wire 10 of the treatment instrument driving mechanism 11; Fig. 2, paragraph 0048). Okada discloses the at least one cartridge tool with an elongated distal portion (the treatment instrument head 6 includes the first flexible sheath tube portion 3; Fig. 1A, paragraph 0046) and a body (round flange 35 and first connecting member 31; Fig. 1A-2).
However, Okada does not explicitly disclose implementing a functionality of the at least one cartridge tool at the distal end of the elongated shaft while the at least one cartridge tool remains docked in the repository.
Owens teaches a cystoscope (imaging component 100; Fig. 1A, paragraph 0086) comprising:
a handle (imaging component 100 may comprise a handle portion 101; Fig. 1A, paragraph 0086);
an elongated shaft that defines at least one working channel (the imaging shaft 103 may comprise a proximal end and a distal end with a cavity 105 extending across the length of the shaft from the proximal end towards the distal end; Fig. 1A, paragraph 0086), the elongated shaft having a distal end (distal end of imaging shaft 103; Fig. 1A, paragraph 0086);
a repository configured to detachably dock a body of at least one cartridge tool having an elongated distal portion (the handle portion 101 may be a part of a two-part handle such that when a first instrument or a second instrument is received the two handle portions may combine to form a single handle; Fig. 3A, paragraph 0087) and provide access to the at least one working channel for the elongated distal portion of the at least one cartridge tool such that the elongated distal portion of the at least one cartridge tool extends through the at least one working channel of the elongated shaft while the body of the at least one cartridge tool remains docked in the repository (the cavity 105 of the imaging shaft 103 may be configured to slidably received one or more of a plurality of instruments; Fig. 5A-C, paragraph 0090); and
a first control for implementing a functionality of the at least one cartridge tool at the distal end of the elongated shaft when the first control is actuated and while the at least one cartridge tool remains docked in the repository (the handle portion may additionally comprise one or a plurality of control elements 319; Fig. 5C, paragraph 0122). Owens teaches positioning and aligning elements on the body of the cartridge tool for limiting translation of the cartridge tool and providing a more secure attachment between the cartridge tool and the handle of the imaging device (paragraph 0087).
Owens is considered to be analogous to the claimed invention because it is in the same field of endoscopes with repositories configured to receive an instrument tool. 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 repository of Okada to incorporate the teachings of Owens by securing the body of the cartridge tool in the repository such that a functionality of the at least one cartridge tool can be implemented at the distal end of the elongated shaft while the at least one cartridge tool remains docked in the repository. Doing so would allow for a more secure attachment between the cartridge tool and the repository, thereby helping maintain proper positioning and alignment of the cartridge tool, as recognized by Owens.
Regarding claim 6, Okada, as previously modified by Owens, discloses the cystoscope according to claim 1. Okada further discloses wherein the repository comprises a recess (instrument opening 16; Fig. 3) such that at least a portion of the cartridge tool is within a profile of the handle when the cartridge tool is docked within the repository (the treatment instrument head 6 is within the profile of operating portion 17 when docked inside the instrument opening 16; Fig. 3).
Regarding claim 7, Okada, as previously modified by Owens, discloses the cystoscope according to claim 1. Okada further discloses wherein the at least one cartridge tool has an elongated distal portion configured to extend into the at least one working channel (the treatment instrument head 6 includes the first flexible sheath tube portion 3; Fig. 1A, paragraph 0046) and has a body that releasably attaches to the repository (round flange 35 and first connecting member 31; Fig. 1A-3, paragraph 0056 and 0069-0070).
Regarding claim 8, Okada, as previously modified by Owens, discloses the cystoscope according to claims 1 and 7. Okada further discloses wherein the at least one cartridge tool has a movable element that is engaged by the protuberance of the movable element of the repository when the at least one cartridge tool is docked within the repository (the head 41 is able to protrude via the through hole 30 of the first connecting member 31; Fig. 2-3, paragraph 0057) such that manipulation of the first control implements the functionality of the at least one cartridge tool (a first operating wire (the first operating member) 5 is retractably arranged within the first sheath tube portion 3 serves to drive the treatment portion 2; Fig. 1A-2, paragraph 0046).
Regarding claim 9, Okada discloses a cystoscope system (an endoscopic treatment instrument system 1; Fig, 1A, paragraph 0046) comprising:
at least one cartridge tool having a body (round flange 35 and first connecting member 31; Fig. 1A-2) and an elongated distal portion (the treatment instrument head 6 includes the first flexible sheath tube portion 3; Fig. 1A, paragraph 0046);
a cystoscope (endoscope 12; Fig. 1A, paragraph 0046) having:
i) a handle (operating portion 17; Fig. 1A, paragraph 0047),
ii) an elongated shaft that defines at least one working channel (the endoscope 12 has a channel 7 through which a treatment instrument head 6 can pass; Fig. 1A, paragraph 0047), the elongated shaft having a distal end (distal end of endoscope 12; Fig. 1A),
iii) a repository (space between the walls of the instrument opening 16 including the space within the instrument driving mechanism 11 for receiving the treatment instrument head 6; Figs. 2-3) configured to detachably dock the body of the at least one cartridge tool (the endoscope 12 is provided with an instrument opening 16 for use in attaching or detaching the treatment instrument head 6 to or from the treatment instrument driving mechanism 11 at a proximal end of the channel 7; Fig. 1A, paragraph 0051) and provide access to the at least one working channel for the elongated distal portion of the at least one cartridge tool such that the elongated distal portion of the at least one cartridge tool extends through the at least one working channel of the elongated shaft while the body of the at least one cartridge tool remains docked in the repository (the first sheath tube portion 3 is within the channel 7 while the second engagement mechanism 15 is docked within the instrument opening 16; the endoscope 12 has a channel 7 through which a treatment instrument head 6 can pass; Fig. 3, paragraph 0047) and,
iv) a first control (numerous switches such as switch 28 for operating the treatment instrument driving mechanism 11 can be seen on operating portion 17; Fig. 1A) for actuating a movable element of the repository (the second operating wire (the second operating member) 10 is retractable within the second sheath tube portion 8; Fig. 2, paragraph 0047), the movable element of the repository comprising a slider (the first engagement mechanism 13 has … the second connecting member 33 on the side of the treatment instrument driving mechanism 11; Fig. 2-3, paragraph 0056) having protuberance (the head 41 is arranged at a distal end of supporting shaft 40; Fig. 2, paragraph 0057), wherein the protuberance is configured to engage the at least one cartridge tool when docked within the repository (the head 41 is able to protrude via the through hole 30 of the first connecting member 31 with the central axis C1 of the treatment instrument head 6 perpendicular to the central axis C2 of the treatment instrument driving mechanism 11; Fig. 2-3, paragraph 0057) and thereby implement a functionality of the at least one cartridge tool at the distal end of the elongated shaft when the first control is actuated (the first engagement mechanism 13 is used for engaging the first operating wire 5 of the treatment instrument head 6 with the second operating wire 10 of the treatment instrument driving mechanism 11; Fig. 2, paragraph 0048).
However, Okada does not explicitly disclose implementing a functionality of the at least one cartridge tool at the distal end of the elongated shaft while the at least one cartridge tool remains docked in the repository.
Owens teaches a cystoscope (imaging component 100; Fig. 1A, paragraph 0086) comprising:
a handle (imaging component 100 may comprise a handle portion 101; Fig. 1A, paragraph 0086);
an elongated shaft that defines at least one working channel (the imaging shaft 103 may comprise a proximal end and a distal end with a cavity 105 extending across the length of the shaft from the proximal end towards the distal end; Fig. 1A, paragraph 0086), the elongated shaft having a distal end (distal end of imaging shaft 103; Fig. 1A, paragraph 0086);
a repository configured to detachably dock a body of at least one cartridge tool having an elongated distal portion (the handle portion 101 may be a part of a two-part handle such that when a first instrument or a second instrument is received the two handle portions may combine to form a single handle; Fig. 3A, paragraph 0087) and provide access to the at least one working channel for the elongated distal portion of the at least one cartridge tool such that the elongated distal portion of the at least one cartridge tool extends through the at least one working channel of the elongated shaft while the body of the at least one cartridge tool remains docked in the repository (the cavity 105 of the imaging shaft 103 may be configured to slidably received one or more of a plurality of instruments; Fig. 5A-C, paragraph 0090); and
a first control for implementing a functionality of the at least one cartridge tool at the distal end of the elongated shaft when the first control is actuated and while the at least one cartridge tool remains docked in the repository (the handle portion may additionally comprise one or a plurality of control elements 319; Fig. 5C, paragraph 0122). Owens teaches positioning and aligning elements on the body of the cartridge tool for limiting translation of the cartridge tool and providing a more secure attachment between the cartridge tool and the handle of the imaging device (paragraph 0087).
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 repository of Okada to incorporate the teachings of Owens by securing the body of the cartridge tool in the repository such that a functionality of the at least one cartridge tool can be implemented at the distal end of the elongated shaft while the at least one cartridge tool remains docked in the repository. Doing so would allow for a more secure attachment between the cartridge tool and the repository, thereby helping maintain proper positioning and alignment of the cartridge tool, as recognized by Owens.
Regarding claim 10, Okada, as previously modified by Owens, discloses the cystoscope system according to claim 9. Okada further discloses wherein the at least one cartridge tool has a movable element that is engaged by the protuberance of the movable element of the repository when the at least one cartridge tool is docked within the repository (the head 41 is able to protrude via the through hole 30 of the first connecting member 31; Fig. 2-3, paragraph 0057) such that manipulation of the first control implements the functionality of the at least one cartridge tool (a first operating wire (the first operating member) 5 is retractably arranged within the first sheath tube portion 3 serves to drive the treatment portion 2; Fig. 1A-2, paragraph 0046).
Regarding claim 12, Okada, as previously modified by Owens, discloses the cystoscope system according to claim 9. Okada further discloses wherein the at least one cartridge tool is selected from a plurality of cartridge tools (treatment instrument head 6; Fig. 1A, paragraph 0070), each of the plurality of cartridge tools having an elongated distal portion configured to extend into the at least one working channel (first flexible sheath tube portion 3; Fig. 1A and 3, paragraph 0046) and having a body that releasably attaches to the repository (round flange 35 and first connecting member 31; Fig. 1A-3, paragraph 0056 and 0069-0070).
Regarding claim 13, Okada, as previously modified by Owens, discloses the cystoscope system according to claims 9 and 12. Okada further discloses wherein at least two of the plurality of cartridge tools have different functionalities (an operator can handle a plurality of treatment instruments using a single treatment instrument driving mechanism by preparing a plurality of treatment instrument heads and replacing them one after another, thereby avoiding the burden of having to handle long treatment instruments for each step; paragraph 0021).
Regarding claim 15, Okada discloses a method of employing a cystoscope comprising:
providing a cystoscope (endoscope 12; Fig. 1A, paragraph 0046) having: i) a handle (operating portion 17; Fig. 1A, paragraph 0047), ii) an elongated shaft that defines at least one working channel (the endoscope 12 has a channel 7 through which a treatment instrument head 6 can pass; Fig. 1A, paragraph 0047), the elongated shaft having a distal end (distal end of endoscope 12; Fig. 1A), iii) a repository (space between the walls of the instrument opening 16 including the space within the instrument driving mechanism 11 for receiving the treatment instrument head 6; Figs. 2-3) configured to detachably dock a body of at least one cartridge tool having an elongated distal portion (the endoscope 12 is provided with an instrument opening 16 for use in attaching or detaching the treatment instrument head 6 to or from the treatment instrument driving mechanism 11 at a proximal end of the channel 7; Fig. 1A, paragraph 0051) and provide access to the at least one working channel for an elongated distal portion of the at least one cartridge tool such that the elongated distal portion of the at least one cartridge tool extends through the at least one working channel of the elongated shaft while the body of the at least one cartridge tool remains docked in the repository (the first sheath tube portion 3 is within the channel 7 while the second engagement mechanism 15 is docked within the instrument opening 16; the endoscope 12 has a channel 7 through which a treatment instrument head 6 can pass; Fig. 3, paragraph 0047) and, iv) a first control (numerous switches such as switch 28 for operating the treatment instrument driving mechanism 11 can be seen on operating portion 17; Fig. 1A) for actuating a movable element of the repository (the second operating wire (the second operating member) 10 is retractable within the second sheath tube portion 8; Fig. 2, paragraph 0047), the movable element comprising a slider (the first engagement mechanism 13 has … the second connecting member 33 on the side of the treatment instrument driving mechanism 11; Fig. 2-3, paragraph 0056) having protuberance (the head 41 is arranged at a distal end of supporting shaft 40; Fig. 2, paragraph 0057) that is configured to engage the at least one cartridge tool docked within the repository (the head 41 is able to protrude via the through hole 30 of the first connecting member 31 with the central axis C1 of the treatment instrument head 6 perpendicular to the central axis C2 of the treatment instrument driving mechanism 11; Fig. 2-3, paragraph 0057);
docking the at least one cartridge tool within the repository of the cystoscope such that the distal elongated portion of the at least one cartridge tool extends through the at least one working channel (the first sheath tube portion 3 is within the channel 7 while the second engagement mechanism 15 is docked within the instrument opening 16; the endoscope 12 has a channel 7 through which a treatment instrument head 6 can pass; Fig. 3, paragraph 0047) and the body of the at least one cartridge tool releasably attaches within the repository (round flange 35 and first connecting member 31; Fig. 1A-3, paragraph 0056 and 0069-0070), wherein docking the at least one cartridge tool causes the protuberance of the movable element of the repository to engage the cartridge tool (the first engagement mechanism 13 is used for engaging the first operating wire 5 of the treatment instrument head 6 with the second operating wire 10 of the treatment instrument driving mechanism 11; Fig. 2, paragraph 0048); and
actuating the first control to implement a functionality of the at least one cartridge tool at the distal end of the elongated shaft (a first operating wire (the first operating member) 5 is retractably arranged within the first sheath tube portion 3 serves to drive the treatment portion 2; Fig. 1A-2, paragraph 0046).
However, Okada does not explicitly disclose actuating the first control to implement a functionality of the at least one cartridge tool at the distal end of the elongated shaft while the at least one cartridge tool remains docked in the repository.
Owens teaches a cystoscope (imaging component 100; Fig. 1A, paragraph 0086) comprising:
a handle (imaging component 100 may comprise a handle portion 101; Fig. 1A, paragraph 0086);
an elongated shaft that defines at least one working channel (the imaging shaft 103 may comprise a proximal end and a distal end with a cavity 105 extending across the length of the shaft from the proximal end towards the distal end; Fig. 1A, paragraph 0086), the elongated shaft having a distal end (distal end of imaging shaft 103; Fig. 1A, paragraph 0086);
a repository configured to detachably dock a body of at least one cartridge tool having an elongated distal portion (the handle portion 101 may be a part of a two-part handle such that when a first instrument or a second instrument is received the two handle portions may combine to form a single handle; Fig. 3A, paragraph 0087) and provide access to the at least one working channel for the elongated distal portion of the at least one cartridge tool such that the elongated distal portion of the at least one cartridge tool extends through the at least one working channel of the elongated shaft while the body of the at least one cartridge tool remains docked in the repository (the cavity 105 of the imaging shaft 103 may be configured to slidably received one or more of a plurality of instruments; Fig. 5A-C, paragraph 0090); and
a first control for implementing a functionality of the at least one cartridge tool at the distal end of the elongated shaft when the first control is actuated and while the at least one cartridge tool remains docked in the repository (the handle portion may additionally comprise one or a plurality of control elements 319; Fig. 5C, paragraph 0122). Owens teaches positioning and aligning elements on the body of the cartridge tool for limiting translation of the cartridge tool and providing a more secure attachment between the cartridge tool and the handle of the imaging device (paragraph 0087).
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 repository of Okada to incorporate the teachings of Owens by securing the body of the cartridge tool in the repository such that a functionality of the at least one cartridge tool can be implemented at the distal end of the elongated shaft while the at least one cartridge tool remains docked in the repository. Doing so would allow for a more secure attachment between the cartridge tool and the repository, thereby helping maintain proper positioning and alignment of the cartridge tool, as recognized by Owens.
Regarding claim 19, Okada, as previously modified by Owens, discloses the method according to claim 15. Okada further discloses wherein the at least one cartridge tool has a movable element that is engaged by the protuberance movable element of the repository when the at least one cartridge tool is docked within the repository (the head 41 is able to protrude via the through hole 30 of the first connecting member 31; Fig. 2-3, paragraph 0057) such that manipulation of the first control implements the functionality of the at least one cartridge tool (a first operating wire (the first operating member) 5 is retractably arranged within the first sheath tube portion 3 serves to drive the treatment portion 2; Fig. 1A-2, paragraph 0046).
Regarding claim 20, Okada discloses the method according to claim 15. Okada further discloses comprising exchanging the at least one cartridge tool with a different cartridge tool (an operator can handle a plurality of treatment instruments using a single treatment instrument driving mechanism by preparing a plurality of treatment instrument heads and replacing them one after another, thereby avoiding the burden of having to handle long treatment instruments for each step; paragraph 0021).
Claims 2-3, 11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Okada in view of Owens as applied to claims 1, 9, and 15 above, and in view of U.S. Patent Appl. Publ. No. 2015/0065807 A1 to Greenberg et al. (“Greenberg”).
Regarding claim 2, Okada, as previously modified by Owens, discloses the cystoscope according to claim 1. However, Okada, as modified by Owens, does not explicitly disclose comprising an irrigation port in fluid communication with the at least one working channel, wherein the irrigation port is separate from the repository.
Greenberg teaches an irrigation port in fluid communication with the working channel (fluid inflow port 2108 [is] in fluid communication with a single central lumen 2105; Fig. 21A-D, #2108, paragraph 0072), wherein the irrigation port is separate from repository (the proximal portion 2170 of catheter 2100 comprises a central port 2102 for insertion therethrough of … a cystoscope and/or another instrument; Fig. 21A-C, #2102, paragraph 0072). Greenberg teaches that a 4-way cystoscopy catheter with an irrigation port separate from the repository allows for a procedure which requires both irrigation and treatment with a treatment tool to be performed without needing to remove the original Folley catheter (paragraph 0014).
Greenberg is considered to be analogous to the claimed invention because it is in the same field of endoscopes with repositories configured to receive an instrument tool. 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 Okada, as modified by Owens, to incorporate the teachings of Greenberg by adding an irrigation port in fluid communication with the working channel and separate from the repository. Doing so would allow for a procedure which requires both irrigation and treatment with a treatment tool to be performed without needing to remove the original Folley catheter, as recognized by Greenberg.
Regarding claim 3, Okada, as previously modified by Owens and Greenberg, teaches the cystoscope according to claims 1-2. Greenberg further teaches wherein the repository comprises a seal configured to restrict egress of irrigation fluid from the at least one working channel when the at least one cartridge tool is docked within the repository (the central port 2102 may comprised a seal or one-way valve … the seal may also be utilized to keep the central port 2102 from leaking when a cystoscope and/or another instrument is inserted therethrough; Fig. 21C, paragraph 0072). Greenberg teaches that the seal helps to prevent leaking when an instrument is inserted into the repository (paragraph 0072).
Regarding claim 11, Okada, as previously modified by Owens, discloses the cystoscope system according to claim 9. However, Okada, as modified by Owens, does not explicitly teach an irrigation port in fluid communication with the at least one working channel and wherein the repository further comprises a seal configured to restrict egress of irrigation fluid from the working channel when the cartridge tool is docked within the repository.
Greenberg teaches an irrigation port in fluid communication with the working channel (fluid inflow port 2108 [is] in fluid communication with a single central lumen 2105; Fig. 21A-D, #2108, paragraph 0072) and wherein the repository further comprises a seal configured to restrict egress of irrigation fluid from the working channel when the cartridge tool is docked within the repository (the central port 2102 may comprised a seal or one-way valve … the seal may also be utilized to keep the central port 2102 from leaking when a cystoscope and/or another instrument is inserted therethrough; Fig. 21C, paragraph 0072). Greenberg teaches that a 4-way cystoscopy catheter with an irrigation port separate from the repository allows for a procedure which requires both irrigation and treatment with a treatment tool to be performed without needing to remove the original Folley catheter (paragraph 0014), and Greenberg teaches that the seal helps to prevent leaking when an instrument is inserted into the repository (paragraph 0072).
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 endoscope of Okada, as modified by Owens, to incorporate the teachings of Greenberg by adding an irrigation port in fluid communication with the working channel to the handle and adding a seal to the repository. Doing so would allow for a procedure which requires both irrigation and treatment with a treatment tool to be performed without needing to remove the original Folley catheter and help to prevent leaking when an instrument is inserted into the repository, as recognized by Greenberg.
Regarding claim 16, Okada, as modified by Owens, discloses the method according to claim 15. However, Okada, as modified by Owens, does not explicitly teach further comprising supplying irrigation fluid to the at least one working channel through an irrigation port channel, wherein docking the cartridge tool engages a seal that restricts egress of irrigation fluid from the working channel into the repository.
Greenberg teaches supplying irrigation fluid to the working channel through an irrigation port channel (fluid inflow port 2108 [is] in fluid communication with a single central lumen 2105; Fig. 21A-D, #2108, paragraph 0072), wherein docking the cartridge tool engages a seal that restricts egress of irrigation fluid from the working channel into the repository (the central port 2102 may comprised a seal or one-way valve … the seal may also be utilized to keep the central port 2102 from leaking when a cystoscope and/or another instrument is inserted therethrough; Fig. 21C, paragraph 0072). Greenberg teaches that a 4-way cystoscopy catheter with an irrigation port separate from the repository allows for a procedure which requires both irrigation and treatment with a treatment tool to be performed without needing to remove the original Folley catheter (paragraph 0014), and Greenberg teaches that the seal helps to prevent leaking when an instrument is inserted into the repository (paragraph 0072).
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 endoscope of Okada, as modified by Owens, to incorporate the teachings of Greenberg by adding an irrigation port in fluid communication with the working channel to the handle and adding a seal to the repository. Doing so would allow for a procedure which requires both irrigation and treatment with a treatment tool to be performed without needing to remove the original Folley catheter and help to prevent leaking when an instrument is inserted into the repository, as recognized by Greenberg.
Claims 4-5 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Okada in view of Owens as applied to claims 1 and 15 above, and further in view of U.S. Patent Appl. Publ. No. 2020/0367723 A1 to Yoshinaga et al. (“Yoshinaga”).
Regarding claim 4, Okada, as previously modified by Ownes, discloses the cystoscope according to claim 1. Okada discloses knobs on the handle (Fig. 1A). However, Okada does not explicitly disclose wherein the handle further comprises a steering control configured to cause selective deflection of a distal end of the elongated shaft.
Yoshinaga teaches wherein the handle further comprises a steering control configured to cause selective deflection of a distal end of the elongated shaft (a bending operation knob 20 for leftward and rightward bending which bends the bending portion 4 in leftward and rightward directions … are mounted; Fig. 1, paragraph 0034).
Yoshinaga is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a movable elongated tube. 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 steering control in the endoscope of Okada, as taught by Yoshinaga, to increase the functionality of the endoscope of Okada by enabling defection of a distal end of the elongated shaft.
Regarding claim 5, Okada, as previously modified by Owens and Yoshinaga, discloses the cystoscope according to claims 1 and 4. Okada discloses a lever on the handle (Fig. 1A). However, Okada does not explicitly disclose wherein the handle further comprises a steering lock configured to maintain the distal end of the elongated shaft at a desired deflection.
Yoshinaga teaches wherein the handle further comprises a steering lock configured to maintain the distal end of the elongated shaft at a desired deflection (the operation section 6 includes a lock lever 30 which forms a lock mechanism 200 (see Fig. 2) described later which fixes rotary positions of the bending operation knobs 10, 20; Fig. 1, paragraph 0035).
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 steering lock in the endoscope of Okada, as taught by Yoshinaga, to increase the functionality of the endoscope of Okada by enabling locking of the defection of a distal end of the elongated shaft.
Regarding claim 17, Okada, as previously modified by Owens, discloses the method according to claim 15. Okada discloses knobs on the handle (Fig. 1A). However, Okada does not explicitly disclose operating a steering control of the handle of the cystoscope to cause selective deflection of a distal end of the elongated shaft.
Yoshinaga teaches operating a steering control of the handle of the cystoscope to cause selective deflection of a distal end of the elongated shaft (a bending operation knob 20 for leftward and rightward bending which bends the bending portion 4 in leftward and rightward directions … are mounted; Fig. 1, paragraph 0034).
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 steering control in the endoscope of Okada, as taught by Yoshinaga, to increase the functionality of the endoscope of Okada by enabling defection of a distal end of the elongated shaft.
Regarding claim 18, Okada, as previously modified by Owens, discloses the method according to claim 15. Okada discloses a lever on the handle (Fig. 1A). However, Okada does not explicitly disclose operating a steering lock of the handle of the cystoscope to maintain a distal end of the elongated shaft at a desired deflection.
Yoshinaga teaches operating a steering lock of the handle of the cystoscope to maintain a distal end of the elongated shaft at a desired deflection (the operation section 6 includes a lock lever 30 which forms a lock mechanism 200 (see Fig. 2) described later which fixes rotary positions of the bending operation knobs 10, 20; Fig. 1, paragraph 0035).
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 steering lock in the endoscope of Okada, as taught by Yoshinaga, to increase the functionality of the endoscope of Okada by enabling locking of the defection of a distal end of the elongated shaft.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Okada in view of Owens as applied to claim 9 above, and further in view of U.S. Patent No. 5,269,802 A to Garber (“Garber”).
Regarding claim 14, Okada, as previously modified by Owens, discloses the cystoscope system according to claims 9 and 12. Specifically, Okada discloses the use of different cartridge tools. However, Okada does not explicitly teach wherein at least two of the plurality of cartridge tools have expandable implants of different sizes.
Garber teaches expandable implants of different sizes (because prostates come in many different lengths and shapes, a family of stents could be constructed to accommodate different anatomical configurations; Fig. 1, col. 5, l. 40-46). Garber teaches the use of different sized expandable implants helps to accommodate different anatomical configurations (col. 5, l. 40-46).
Garber is considered to be analogous to the claimed invention because it is in the same field of medical instruments for treatment in cavities of the body. 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 instrument tool of Okada to incorporate the teachings of Garber by adding expandable implants of different sizes. Doing so would help to accommodate different anatomical configurations, as recognized by Garber.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Appl. Publ. No. 2023/0148842 A1 to Schroter teaches a repository in the handle of an endoscope for receiving a cartridge tool as described in the abstract and following descriptive text.
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/OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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