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 11/17/2025 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the Drawings, Specification, and Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 8/22/2025.
Response to Arguments
Applicant’s arguments, see pages 2-5, filed 11/17/2025, with respect to the rejection under 35 USC § 103 of Claim 1, 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 rejections identified in the non-final dated 8/22/2025 moot, and require a new ground of rejection.
Therefore, the 103 rejections previously identified in the non-final action dated 8/22/2025 have been withdrawn.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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations are:
“an insertion portion configured for insertion into a subject” in claim 1 as described in Para. [0008] of Applicant’s specification.
“the moving member translatable between a proximal position and a distal position in response to an operation force from the operating lever” in claim 1 as described in Paras. [0016-0017] of Applicant’s specification.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-2, 11-12, 14-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2017/0215704 A1 to Tsumaru (“Tsumaru”) in view of U.S. Patent Appl. Publ. No. 2020/0069153 A1 to Sueyasu (“Sueyasu ‘153”).
Regarding claim 1, Tsumaru discloses an endoscope (endoscope main body 1; Fig. 1, paragraph 0033), comprising:
an insertion portion configured for insertion into a subject (an insertion portion (flexible tube) 4 to be inserted into a lumen such as a body cavity as an observation target; Fig. 1, paragraph 0033), the insertion portion including an actuating mechanism (the raising base 21 is provided in the channel opening portion 6a opened at the distal end portion 6; Fig. 2, paragraph 0041);
an operation portion disposed proximally relative to the insertion portion (an endoscope manipulation unit 3 that is provided on the proximal end side; Fig. 1, paragraph 0033), the operation portion including an operating lever movable between a first position and a second position (the manipulation lever 31 pivotally supported in the endoscope manipulation unit 3 and having a knob exposed to the outside; Fig. 2, paragraph 0044);
a moving member (mobile member as seen in annotated Fig. 2 below; Fig. 2) operatively connected to the operating lever (the link member 28 connects the manipulation lever 31 to the link member 27 to form a link mechanism; Fig. 2, paragraph 0046), the moving member translatable between a proximal position and a distal position in response to an operation force from the operating lever (the mobile member moves in the reciprocal moving (back and forth) direction in the longitudinal axial direction of the insertion portion as indicated by m; Fig. 2);
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a rod having a proximal end and a distal end (rod-shaped link member (traction member) 27; Fig. 4, paragraph 0043), the proximal end of the rod connected to the moving member (proximal end of the link member 27 is connected to the mobile member; Fig. 2) and the rod translatable in conjunction with the moving member (the link member 27 moves in the reciprocal moving (back and forth) direction in the longitudinal axial direction of the insertion portion in accordance with a manipulation of the manipulation lever 31; Fig. 2, paragraph 0046);
a wire attached to the distal end of the rod (a rod-shaped link member (traction member) 27 made of a metal material of the like to which the other end of the raising wire 24 is connected; Fig. 4, paragraph 0043), extending into the insertion portion and attached to the actuating mechanism (one end of the raising wire 24 is connected to a middle point of the raising base 21; Fig. 2, paragraph 0042), the wire movable in conjunction with the rod to operate the actuating mechanism (when the link member 27 is moved, the raising wire 24 integrally moves, and the raising base 21 pivots; Fig. 2, paragraph 0046); and
a bearing (a guide member 38 is fitted in the opening of the outer member 26 on the proximal end side; Fig. 4, paragraph 0061) including an opening having a contact surface (a through hole 38c configured to movably insert the link member 27 is formed at the center of the guide member 38; Fig. 4, paragraph 0061),
wherein the rod extends through the opening and is in slidable contact with the contact surface (a point contact member with small projections distributed on the entire surface may be adhered to the surface of the through hole provided in the guide member 38, which is in contact with an outer surface of the link member 27, thereby reducing the contact area between the link member 27 and the surface of the through hole and reducing the sliding resistance generated upon a movement in the axial direction; paragraph 0062).
Tsumaru does not explicitly disclose wherein the contact surface is made of resin. However, Tsumaru does disclose the use of resin to construct components of the traction channel portion (these members may be made of …. a hard resin; paragraph 0050). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the guide member of resin, since the benefits of resin having a high mechanical strength and self-lubricating properties are known in the medical device field. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07.
In addition, Tsumaru does not explicitly disclose a detent located distally relative to the moving member, wherein, when the moving member is at the distal position, the moving member contacts the detent and wherein the bearing is located distally relative to the detent.
Sueyasu ‘153 teaches a moving member (the piston 31 has a flanged portion 32; Fig. 3-4, paragraph 0054) operatively connected to an operating lever (to the flanged portion 32, the rod 14 for causing the connection portion 21 to advance and retreat is connected; Fig. 3-4, paragraph 0055) and a detent (butting portion Cb; Fig. 3-4, paragraph 0074) located distally relative to the moving member, wherein, when the moving member is at the distal position, the moving member contacts the detent (the flanged portion 32 is butted against a butting portion Cb that is provided at a peripheral rim of the opening of the cylinder C; Fig. 4, paragraph 0074).
Sueyasu ‘153 teaches that the use of a detent and flange is equivalent in the art to the use of a stopper for stopping the movement of the lever main body (paragraph 0074). Furthermore, U.S. Patent Appl. Publ. No. 2016/0089125 A1 to Morimoto (“Morimoto”) teaches that the use of a stopper for stopping the movement of the lever main body is equivalent to restricting the motion range of a moving member (paragraph 0109). Morimoto further teaches the use of a stopper helps to restrict the range of the forceps elevator (paragraph 0111), thereby allowing the treatment tool to exit the distal tip of the endoscope in a favorable image range.
Sueyasu ‘153 and Morimoto are considered to be analogous to the claimed invention because they are in the same field of endoscopes with a treatment instrument raising drive mechanism comprising an operating lever and a moving member. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the moving member of Tsumaru to incorporate the teachings of Sueyasu ‘153 by adding at least one flange portion to the moving member for contacting a detent located on the peripheral rim of the outer member. Doing so would help restrict the range of motion of the raising base, thereby allowing the treatment tool to exit the distal tip of the endoscope in a favorable image range, as recognized by Sueyasu ‘153 and Morimoto. With such modification of Tsumaru, the detent is located proximally relative to the bearing.
Regarding claim 2, Tsumaru, as previously modified by Sueyasu ‘153, discloses the endoscope according to claim 1. Tsumaru further discloses a wire pipe containing a part of the wire (an end portion of a pipe (channel member) 36 is configured to insert the raising wire 24; Fig. 4, paragraph 0054) and
a tubular member including a conduit having an interior surface defining a first interior volume (distal end side outer member (channel member) 33; Fig. 4, paragraph 0052),
wherein at least a portion of the tubular member is located between the bearing and the wire pipe (the distal end side outer member 33 is located between the guide member 38 and the pipe 36; Fig. 4), and
wherein the wire extends through the first interior volume of the tubular member (note that the traction members 24 and 27 are inserted in the channel members 26, 33, and 36 so as to be movable in the longitudinal axial direction of the traction members 24 and 27; Fig. 4, paragraph 0055).
Regarding claim 11, Tsumaru, as previously modified by Sueyasu ‘153, discloses the endoscope according to claims 1-2. Tsumaru further discloses wherein the tubular member has a first section with a first inner diameter and a second section with a second inner diameter, wherein the first inner diameter is larger than the second inner diameter, and wherein the first section is located distally relative to the second section (a step is formed inside the distal end side outer member 33 on the distal end side, and the channel distal end portion 35 is fitted; Fig. 4, paragraph 0054).
Regarding claim 12, Tsumaru, as previously modified by Sueyasu ‘153, discloses the endoscope according to claims 1-2. Tsumaru does not explicitly disclose a nut fixing the bearing to the tubular member in the first embodiment of the traction mechanism. However, Tsumaru, in the second embodiment of the traction mechanism, discloses a nut fixing the bearing to the tubular member (by the fixing member 53, the guide member 54 is fixed to the outer member 26; Fig. 6, paragraph 0073). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the guide member fixing mechanism by exchanging the screw of the first embodiment with the nut of the second embodiment.
Regarding claim 14, Tsumaru, as previously modified by Sueyasu ‘153, discloses the endoscope according to claims 1-2. Tsumaru further discloses wherein the bearing is integrated with the tubular member (a guide member 38 is fitted in the opening of the outer member 26 on the proximal end side and fixed by a screw; Fig. 4, paragraph 0061).
Regarding claim 15, Tsumaru, as previously modified by Sueyasu ‘153, discloses the endoscope according to claim 1. Tsumaru further discloses wherein the actuating mechanism is one of a forceps raising base, a zoom mechanism of an image pickup optical system, and a rigidity changing mechanism of the insertion portion (the raising base 21 is provided in the channel opening portion 6a opened at the distal end portion 6; Fig. 2, paragraph 0041).
Regarding claim 18, Tsumaru, as previously modified by Sueyasu ‘153, discloses the endoscope according to claim 1. Tsumaru further discloses wherein the opening of the bearing has a first shape, wherein a cross-section of the rod has a second shape, and wherein the first shape is different from the second shape (a point contact member with small projections distributed on the entire surface may be adhered to the surface of the through hole provided in the guide member 38, which is in contact with an outer surface of the link member 27, thereby reducing the contact area between the link member 27 and the surface of the through hole and reducing the sliding resistance generated upon a movement in the axial direction; paragraph 0062). The small projections on the surface of the through hole of the guide member change the shape of the opening to be different than the shape of the link member. By doing so, the link member makes less contact with opening of the guide member.
Regarding claim 19, Tsumaru, as previously modified by Sueyasu ‘153, discloses the endoscope according to claims 1 and 18. Tsumaru further discloses a gap between the opening and the rod (gap between through hole 38c and guide member 38; Fig. 4); and
a resin ring located in the gap (the seal member 37 is made of an elastic material such as… resin to be deformable … the seal member 37 has a hollow tubular shape, preferably, a cylindrical shape; Fig. 4, paragraph 0060),
wherein the resin ring forms a seal between the bearing and the rod (the traction channel portion (channel member 25) has sealing properties by watertightness (or airtightness) by a seal member 37; Fig. 4, paragraph 0043).
Regarding claim 20, Tsumaru, as previously modified by Sueyasu ‘153, discloses the endoscope according to claim 1. Tsumaru further discloses wherein the bearing is integrated with the detent (the guide member 38 is connected to the traction channel portion which includes the tapered surface 33b; Fig. 4).
Claims 3-7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Tsumaru in view of Sueyasu ‘153, as applied to claims 1-2 above, and further in view of Japanese Patent Publ. No. H09238898A to Hamazaki et al. (“Hamazaki”).
Regarding claim 3, Tsumaru, as previously modified by Sueyasu ‘153, discloses the endoscope according to claims 1-2. However, Tsumaru, as modified by Sueyasu ‘153, does not explicitly disclose a first sealing ring provided around the wire pipe and contacting the interior surface of the conduit to form a first seal at a distal end of the conduit.
Hamazaki teaches a first sealing ring provided around the wire pipe and contacting the interior surface of the conduit to form a first seal at a distal end of the conduit (the tip member 47 and the rear end member 48 be provided O-ring 49 for sealing between the member to fittingly inserted thereto; Fig. 1, paragraph 0018). Hamazaki teaches the use of a seal for preventing water from leaking into surrounding sections of the operation portion (paragraph 0018).
Hamazaki is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a treatment instrument raising drive mechanism. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal end side outer member and pipe connection of Tsumaru, as modified by Sueyasu ‘153, to incorporate the teachings of Hamazaki by adding a first sealing ring around the wire pipe. Doing so would help to prevent water from leaking into surrounding sections of the operation portion, as recognized by Hamazaki.
Regarding claim 4, Tsumaru, as previously modified by Sueyasu ‘153 and Hamazaki, discloses the endoscope according to claims 1-3. Tsumaru further discloses a housing (outer member 26; Fig. 4) connected to a proximal end of the tubular member (on the proximal end side (the side connected to the outer member 26), a flange portion 33a that comes into contact with the waterproof packing 50 is formed; Fig. 4, paragraph 0053) and having a second interior volume (the outer member 26 forms a channel; Fig. 4, paragraph 0050). However, Tsumaru, as modified by Sueyasu ‘153, does not explicitly disclose a second sealing ring provided around the rod and contacting an interior surface of the housing to form a second seal.
Hamazaki teaches a second sealing ring provided around the rod and contacting an interior surface of the housing to form a second seal (the tip member 47 and the rear member 48 be provided O-ring 49 for sealing between the member to be fittingly inserted thereto; Fig. 1, paragraph 0018). Hamazaki teaches the use of a seal for preventing water from leaking into surrounding sections of the operation portion (paragraph 0018).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer member and link member connection of Tsumaru, as modified by Sueyasu ‘153, to incorporate the teachings of Hamazaki by adding a first sealing ring around the link member. Doing so would help to prevent water from leaking into surrounding sections of the operation portion, as recognized by Hamazaki.
Regarding claim 5, Tsumaru, as previously modified by Sueyasu ‘153 and Hamazaki, discloses the endoscope according to claims 1-4. Tsumaru, as modified by Hamazaki, discloses wherein the first sealing ring is formed of a first resin and the second sealing ring is formed of a second resin (the seal member 37 is made of an elastic material such as rubber, synthetic rubber, or resin to be deformable; paragraph 0060). Tsumaru discloses the use of resin for a deformable sealing member and Hamazaki teaches the use of sealing rings as a sealing member.
Regarding claim 6, Tsumaru, as previously modified by Sueyasu ‘153 and Hamazaki, discloses the endoscope according to claims 1-4. Tsumaru further discloses wherein the housing includes an opening between the second interior volume and an exterior surface of the housing (a cleaning opening portion 26a is opened on the proximal end side of the outer member 26; Fig. 2 and 4, paragraph 0045),
wherein the second interior volume is in fluid communication with the first interior volume (a tapered surface 33b configured to smoothen the flow of the cleaning solution in a portion 26b where the cleaning solution flows is formed on the inner surface side of the flange portion 33a; Fig. 4, paragraph 0053), and
wherein the opening is configured for injection of a sterilizing gas into the first interior volume and the second interior volume (a cleaning opening portion 26a is opened on the proximal end side of the outer member 26 to pour a cleaning solution from an oblique direction; Fig. 2 and 4, paragraph 0045).
Regarding claim 7, Tsumaru, as previously modified by Sueyasu ‘153 and Hamazaki, discloses the endoscope according to claims 1-4. Tsumaru further discloses wherein the housing is integrated with the tubular member (the traction channel portion 25 is formed to have sealing properties mainly by the outer member 26 [and] a distal end side outer member 33… not that these members need to be made of materials capable of connection and working by welding, deposition, soldering, or an adhesive; Fig. 4, paragraph 0050).
Regarding claim 10, Tsumaru, as previously modified by Sueyasu ‘153 and Hamazaki, discloses the endoscope according to claims 1-4. Hamazaki further teaches wherein the first sealing ring and the second sealing ring are O-shaped rings (the tip member 47 and the rear member 48 be provided O-ring 49 for sealing between the member to be fittingly inserted thereto, respectively so that the water in the operation portion 2 does not leak there; Fig. 1, paragraph 0018).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Tsumaru in view of Sueyasu ‘153, as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2017/0000316 A1 to Sueyasu (“Sueyasu ‘316”).
Regarding claim 8, Tsumaru, as previously modified by Sueyasu ‘153, discloses the endoscope according to claim 1. However, Tsumaru, as modified by Sueyasu ‘153, does not explicitly disclose a guide member located adjacent to the moving member; wherein a surface of the moving member includes a protrusion having opposite side surfaces separated by a distance defining an outer width, wherein the guide member includes two surfaces separated by a distance defining an inner width, and wherein the inner width is less than the outer width.
Sueyasu ‘316 teaches a guide member located adjacent to the moving member (the support portion 95 is attached to the mobile member 81; Fig. 5D-E, paragraph 0146);
wherein a surface of the moving member includes a protrusion having opposite side surfaces separated by a distance defining an outer width (the protruding portion 81b is provided on the outer circumferential surface of the mobile member 81; Fig. 5D, paragraph 0146),
wherein the guide member includes two surfaces separated by a distance defining an inner width (the extensions portions 95d are provided apart from each other by the width of the mobile member 81; Fig. 5D, paragraph 0143), and
wherein the inner width is less than the outer width (the inner width of the extension portions 95d is less than the outer width of the protruding portion 81b; Fig. 5D).
Sueyasu ‘316 teaches that the support portion helps to easily and securely attach the regulation portion to the moving member (paragraph 0155), thereby facilitating control of the range of movement of the moving member.
Sueyasu ‘316 is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a treatment instrument raising drive mechanism. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the raising base unit of Tsumaru, as modified by Sueyasu ‘153 to incorporate the teachings of Sueyasu ‘316 by adding a guide member adjacent to the mobile member. Doing so would help to facilitate control of the range of movement of the moving member, as recognized by Sueyasu ‘316.
Regarding claim 9, Tsumaru, as previously modified by Sueyasu ‘153 and Sueyasu ‘316, discloses the endoscope according to claims 1 and 8. Sueyasu ‘316 further discloses wherein the guide member includes a space in which a portion of the protrusion is located (the space inside the support portion 95 defined by the walls of the support portion 95c-d; Fig. 5B), and wherein edges surfaces of the space are located to prevent the moving member from separating from the guide member during translation of the moving member (the extension portions 95d catch the mobile member 81 therebetween, and the support portion 95 including the regulation portion 93 moves forward and backward together with the mobile member 81 by catching; Fig. 5B., paragraph 0143).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tsumaru in view of Sueyasu ‘153, as applied to claims 1 and 2 above, and further in view of U.S. Patent Appl. Publ. No. 2016/0150946 A1 to Tsumaru et al. (“Tsumaru ’946”).
Regarding claim 13, Tsumaru, as previously modified by Sueyasu ‘153, discloses the endoscope according to claims 1-2. However, Tsumaru, as modified by Sueyasu ‘153, does not explicitly disclose wherein the operation portion includes a base housing, and wherein the tubular member is connected to the base housing to prevent a movement of the tubular member relative to the base housing.
Tsumaru ’946 teaches wherein the operation portion includes a base housing (fixing member 37; Fig. 4A, paragraph 0057), and wherein the tubular member is connected to the base housing to prevent a movement of the tubular member relative to the base member (the raising tube path is fixed to the inside of the endoscope operating section 3 by a fixing member 37 fitted into a concave portion disposed in the tube path distal end portion 35; Fig. 4A, paragraph 0057). Tsumaru ’946 teaches that the fixing member helps to fix the raising tube path to the operation section housing (paragraph 0057), thereby preventing unwanted movement of the raising tube path.
Tsumaru ’946 is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a treatment instrument raising drive mechanism. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the raising base unit of Tsumaru, as modified by Sueyasu ‘153, to incorporate the teachings of Tsumaru ’946 by adding a base housing connected to the distal end side outer member. Doing so would help to prevent unwanted movement of the raising base unit, as recognized by Tsumaru ’946.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Tsumaru in view of Sueyasu ‘153, as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2018/0249895 A1 to Calabrese et al. (“Calabrese”).
Regarding claim 16, Tsumaru, as previously modified by Sueyasu ‘153, discloses the endoscope according to claim 1. However, Tsumaru, as modified by Sueyasu ‘153, does not explicitly disclose wherein the endoscope is a single-use endoscope.
Calabrese teaches wherein the endoscope is a single-use endoscope (it may be more practical for the endoscope to be used as a single-use endoscope; paragraph 0003) Calabrese teaches by using the endoscope only once before discarding it, cost and time burdens associated with maintaining the endoscope may be eliminated, and the risk of exposing a subject to infection through inadequate cleaning of the endoscope also may be eliminated, leading to improved outcomes (paragraph 0003).
Calabrese is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a treatment instrument raising drive mechanism. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscope of Tsumaru, as modified by Sueyasu ‘153, to incorporate the teachings of Calabrese by using a single-use endoscope. Doing so would help eliminate cost and time burdens associated with maintaining the endoscope and the risk of exposing a subject to infection through inadequate cleaning of the endoscope, as recognized by Calabrese.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Tsumaru as applied to claims 1-2 above, and further in view of U.S. Patent Appl. Publ. No. 2023/0380674 A1 to Harada et al. (“Harada”).
Regarding claim 17, Tsumaru, as previously modified by Sueyasu ‘153, discloses the endoscope according to claims 1-2. However, Tsumaru, as modified by Sueyasu ‘153, does not explicitly disclose wherein the bearing includes a feature engaging with the tubular member, wherein the feature is a protrusion, a recess, or a thread of a threaded connection.
Harada teaches wherein the feature is a protrusion, a recess, or a thread of a threaded connection (the fixing member 72 includes a male screw portion 72A that is formed in a substantially annular shape and is formed on an outer peripheral surface and a pair of slits 72B that is cut over an area from a distal end surface to a proximal end surface in the X-axis; Fig. 22, paragraph 0116). Harada teaches that the screw portion and the slits on the bearing help to maintain the connection between the fixing member and the distal end portion body (paragraph 0120).
Harada is considered to be analogous to the claimed invention because it is in the same field of endoscopes with bearings. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the guide member fixing mechanism of Tsumaru, as modified by Sueyasu ‘153, to incorporate the teachings of Harada by adding a thread of a threaded connection and recesses to the guide member. Doing so would help to maintain the connection between the guide member and the outer member, as recognized by Harada.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA GRACE STARKEY/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795