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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, drawn to an endoscope, in the reply filed on 1/6/2026 is acknowledged.
Claim 17 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, there being no allowable generic or linking claim.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, line 10, “the insertion members” should read “insertion members”. This suggested modification would eliminate a potential 112(b) rejection arising from a lack of antecedent basis.
In claim 1, line 14, “the four insertion members” should read “four insertion members.” This suggested modification would eliminate a potential 112(b) rejection arising from a lack of antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 and 18-19 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 1, 14, and 15 recite the limitation "the annular member" in l. 7-8 of claim 1, l. 3 of claim 14, and l. 3 of claim 15. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the annular member” is being interpreted as “an annular member of the plurality of annular members.”
Claim 1 recites the limitation "the annular members" in l. 10 and 14. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the annular members” is being interpreted as “the plurality of annular members.”
Claims 1, 4-5, and 12 recite the limitation "the second spaces" in l. 19 of claim 1, l. 4 of claim 4, l. 3 of claim 5, and l. 3 and 5 of claim 12. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the second spaces” is being interpreted as “the virtual second spaces.”
Claims 4, 12, 14, and 15 recite the limitation "the axial direction" in l. 2 of claim 4, l. 2 of claim 12, l. 2 of claim 14, and l. 2 of claim 15. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the axial direction” is being interpreted as “the axial direction of the insertion part.”
Claim 13 recites the limitation "the two insertion members" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the two insertion members” is being interpreted as “the pair of insertion members”
Claim 15 recites the limitation "the incorporated object other than the treatment tool pipe line" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the incorporated object other than the treatment tool pipe line” is being interpreted as “an incorporated object other than the treatment tool pipe line.”
Claim 18 recites the limitation "the inner diameter" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the inner diameter” is being interpreted as “the inner diameter of the treatment tool pipe line.”
Claims 2-3, 6-11, 16, and 18-19 are rejected as being dependent upon claims previously rejected under 35 USC § 112(b).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Appl. Publ. No. 2009/0198105 A1 to Sugisawa (“Sugisawa”).
Regarding claim 1, Sugisawa discloses an endoscope (an electronic endoscope 11; Fig. 1, paragraph 0033) comprising:
an insertion part (an electronic endoscope (hereinafter referred to as endoscope) 11 is provided with an insertion section 12; Fig. 1, paragraph 0033) including a bendable portion configured by connecting a plurality of annular members (the bending portion 18 is constituted of plural (for example, 16) joint rings 20 connected in series; Fig. 1, paragraph 0037),
wherein the bendable portion has a plurality of incorporated objects comprising a treatment tool pipe line into which a treatment tool is to be inserted (the forceps outlet is connected to the forceps channel 16 provided through the insertion section 12; Fig. 4, paragraph 0036) and a wire that is to perform a bending operation of the bendable portion (an up-and-down operation wire 37 or a right-and-left operation wire 38 … is threaded through the guide hole 36; Fig. 4, paragraph 0041),
a pair of insertion members into which the wire is inserted are provided in the annular member to face each other (a guide hole 36 is formed through the wire guide section 35 in the diameter direction of the wire guide section 35. An up-and-down operation wire 37 or a right-and-left operation wire 38 … is threaded through the guide hole 36; Fig. 2, paragraph 0040-0041), and
in a state of being viewed in an axial direction of the insertion part,
the insertion members included respectively in two of the annular members connected with each other are disposed at different positions along a circumferential direction of the annular member (the wire guide sections 35 are disposed at different positions along a circumferential direction of the joint ring 20; Fig. 4),
the treatment tool pipe line is disposed in a first space partitioned by a virtual inscribed circle inscribed in the four insertion members of the two of the annular members connected with each other (the forceps channel 16 having the largest outer diameter among the above-mentioned internal components is disposed at the center of the joint rings 20 in the diameter direction; Fig. 4, paragraph 0044), and
a first incorporated object, which is a non-hollow incorporated object and is one of the plurality of incorporated objects, and a second incorporated object, which is a non-hollow incorporated object and is other one of the plurality of incorporated objects, are disposed in one of virtual second spaces (two non-hollow signal lines 51 are located in a same space; Fig. 4), each of the second spaces being partitioned by adjacent two of the four insertion members, an inner peripheral surface of the annular member, and the first space (the air/water channel 41, the optical fibers 50 as the light guide, the signal line 51, and the like are arranged the forceps channel 16 and contact with internal circumferential surfaces of the joint rings 20 while they are kept away from the coupling pins 31; Fig. 4, paragraph 0044).
Regarding claim 14, Sugisawa discloses the endoscope according to claim 1. Sugisawa further discloses wherein, in a state of being viewed in the axial direction, a distance between a center of the annular member and a center of the treatment tool pipe line is equal to or less than half of an outer diameter of one of the plurality of incorporated objects having a smallest outer diameter among the plurality of incorporated objects included in the bendable portion (the forceps channel 16 having the largest outer diameter among the above-mentioned internal components is disposed at the center of the joint rings 20 in the diameter direction; Fig. 4, paragraph 0044). As disclosed by Sugisawa, the forceps channel and the joint ring share a center, thereby the distance between the centers is zero.
Regarding claim 15, Sugisawa discloses the endoscope according to claim 1. Sugisawa further discloses wherein, in a state of being viewed in the axial direction, a distance between a center of the annular member and a center of the incorporated object other than the treatment tool pipe line is larger than a distance between the center of the annular member and a center of the treatment tool pipe line (the air/water channel 41, the optical fibers 50 as the light guide, the signal line 51, and the like are arranged the forceps channel 16 and contact with internal circumferential surfaces of the joint rings 20 while they are kept away from the coupling pins 31; Fig. 4, paragraph 0044). As disclosed by Sugisawa, the forceps channel and the joint ring share a center (the forceps channel 16 having the largest outer diameter among the above-mentioned internal components is disposed at the center of the joint rings 20 in the diameter direction; Fig. 4, paragraph 0044), thereby the distance between the center of the forceps channel and the center of the joint ring is less than the distance between the center of the signal line and the center of the joint ring.
Regarding claim 16, Sugisawa discloses the endoscope according to claim 1. Sugisawa further discloses wherein the plurality of incorporated objects have a circular cross section in the bendable portion (the forceps channel 16, the operation wires 37 and 38, the optical fibers 50, the signal lines 51, and the branch channels 45 and 46 have a circular cross section; Fig. 4).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 2-4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sugisawa.
Regarding claim 2, Sugisawa discloses the endoscope according to claim 1. However, Sugisawa does not explicitly disclose wherein a difference between outer diameters of the first incorporated object and the second incorporated object is equal to or less than half of an outer diameter of one of the plurality of incorporated objects having a smallest outer diameter among the plurality of incorporated objects included in the bendable portion.
It would have been obvious to one of ordinary skill in the art at the time of the invention to change the diameters of the first and second incorporated objects, since such a modification would have involved a mere change in the size (or dimension) of a component. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). It is well known in the art that the smaller the diameter of the incorporated objects the bigger diameter of the treatment tool pipe line can be and that many design parameters are taken into consideration when determining the diameter of the incorporated objects.
Regarding claim 3, Sugisawa, as modified above, discloses the endoscope according to claims 1 and 2. Sugisawa further discloses wherein the first incorporated object is a cable (signal line 51; Fig. 4, paragraph 0035) that is connected to an imager disposed at a distal end of the insertion part (the rigid portion 17 incorporates … an imaging unit having an imaging element; Fig. 1, paragraph 0035), and a third incorporated object is a light guide (optical fibers 50 provided as a light guide to extend through the insertion section; Fig. 4, paragraph 0036). However, Sugisawa does not explicitly disclose the cable and the light guide in the same virtual second space.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to switch the positions of one of the signal lines and the light guide, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70.
Regarding claim 4, Sugisawa discloses the endoscope according to claim 1. Sugisawa further discloses wherein, in a state of being viewed in the axial direction, a third incorporated object, which is a hollow incorporated object and is one of the plurality of incorporated objects, is disposed in one of the second spaces (the endoscope 11 incorporates … two branch channels 45 and 46; Fig. 4, paragraph 0042). However, Sugisawa does not explicitly disclose the third incorporated object disposed in a virtual second space adjacent to the virtual second which in which the first incorporated object and the second incorporated object are disposed.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to switch the positions of the branch channels and the light guide, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70.
Regarding claim 13, Sugisawa discloses the endoscope according to claim 1. However, Sugisawa does not explicitly disclose wherein a difference between a distance between the two insertion members facing with each other and an outer diameter of the treatment tool pipe line is equal to or less than an outer diameter of one of the plurality of incorporated objects having a smallest outer diameter among the plurality of incorporated objects included in the bendable portion.
It would have been obvious to one of ordinary skill in the art at the time of the invention to change the diameter of the treatment tool pipe line, since such a modification would have involved a mere change in the size (or dimension) of a component. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). It is well known in the art that the larger the diameter of the treatment tool pipe line the larger variety of tools can be inserted into the treatment tool pipe line and that many design parameters are taken into consideration when determining the diameter of the treatment tool pipe line.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sugisawa in view of U.S. Patent Appl. Publ. No. 2019/0246884 A1 to Lu et al. (“Lu”).
Regarding claim 18, Sugisawa discloses the endoscope according to claim 1. However, Sugisawa does not explicitly disclose wherein a ratio of an inner diameter of the treatment tool pipe line to an outer diameter of a distal end portion of the insertion part is 35% or more, and the inner diameter is 3 mm or more.
Lu teaches wherein a ratio of an inner diameter of the treatment tool pipe line to an outer diameter of a distal end portion of the insertion part is 35% or more, and the inner diameter is 3 mm or more (working channel 2222 of 3.6mm … and overall diameter of about 6mm without any bump or protrusion; Fig. 4D, paragraph 0051). Lu discloses a ratio of an inner diameter of the treatment tool pipe line to an outer diameter of a distal end portion of the insertion part to be 60% (Fig. 4D). Lu discloses that a working diameter of about 3.2mm is large enough for the insertion of many standard surgical devices (paragraph 0035).
Lu is considered to be analogous to the claimed invention because it is in the same field of endoscope systems with a treatment tool pipe line. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the endoscope of Sugisawa to incorporate the teachings of Lu by adjusting the dimensions of the treatment tool pipe line and the distal tip so that a ratio of an inner diameter of the treatment tool pipe line to an outer diameter of a distal end portion of the insertion part is 35% or more, and the inner diameter is 3mm or more. Doing so would allow many standard surgical devices to fit into the treatment tool pipe line, as recognized by Lu. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Regarding claim 19, Sugisawa, as previously modified by Lu, discloses the endoscope according to claims 1 and 19. However, Sugisawa, as modified by Lu, does not explicitly disclose wherein the outer diameter of the distal end portion is 7.6 mm or more and 8.5 mm or less. Lu discloses an outer diameter of the distal end portion is 6 mm (overall diameter of about 6mm without any bump or protrusion; Fig. 4D, paragraph 0051).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the endoscope of Sugisawa, as modified by Lu, by adjusting the dimensions of the distal end portion to be 7.6 mm or more and 8.5 mm or less. A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). In addition, a change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Allowable Subject Matter
Claims 5-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 5, Sugisawa, as modified above, discloses the endoscope according to claims 1 and 4. Sugisawa does not explicitly disclose wherein a fourth incorporated object, which is a non-hollow incorporated object and is one of the plurality of incorporated objects, is further disposed in the one of the second spaces in which the third incorporated object is disposed. Sugisawa does disclose a non-hollow fourth incorporated object (the optical fibers 50; Fig. 4, paragraph 0044). However, it would not be obvious for one of ordinary skill in the art to modify the endoscope of Sugisawa to have a light guide positioned in the same virtual space as one of the branch channels as the branch channels split from a main channel located proximal to the bending section.
U.S. Patent Appl. Publ. No. 2020/0000312 A1 to Nakaji (“Nakaji”) was considered for an anticipation or obviousness type rejection.
Regarding claim 5, Nakaji teaches an endoscope comprising:
an insertion part (flexible insertion portion 5; Fig. 1, paragraph 0025) including a bendable portion configured by connecting a plurality of annular members (the bending portion 11 includes a bending piece group 35 composed of a plurality of first bending pieces 36; Fig. 12, paragraph 0040),
wherein the bendable portion has a plurality of incorporated objects comprising a treatment tool pipe line into which a treatment tool is to be inserted (the treatment instrument insertion channel 21 that is one of the internal components inserted through the insertion portion 5; Fig. 11, paragraph 0035) and a wire that is to perform a bending operation of the bendable portion (the pulling wires 20 are inserted in the respective wire insertion holes 40 formed in the respective first bending pieces 36; Fig. 11, paragraph 0062),
a pair of insertion members into which the wire is inserted are provided in the annular member to face each other (each of the thick portions 36d includes a wire insertion hole 40 penetrating through each of the thick portions 36 in the direction of the longitudinal axis O; Fig. 11, paragraphs 0044-0045), and
in a state of being viewed in an axial direction of the insertion part,
the insertion members included respectively in two of the annular members connected with each other are disposed at different positions along a circumferential direction of the annular member (the thick portions 36d are formed at symmetric positions that correspond to the positions of the first contact surfaces 37 and the second contact surfaces 38 so as to be respectively located at 90-degree rotation positions; Fig. 11 and 13, paragraph 0044),
the treatment tool pipe line is disposed in a first space partitioned by a virtual inscribed circle inscribed in the four insertion members of the two of the annular members connected with each other (a center region 39a surrounded by protruding end portions of the respective thick portions 36d is formed in the through hole 36c… the center region 39a is a region through which the treatment instrument insertion channel 21 is insertable; Fig. 11 and 13, paragraph 0044), and
a first incorporated object, which is a non-hollow incorporated object and is one of the plurality of incorporated objects, and a second incorporated object, which is a non-hollow incorporated object and is other one of the plurality of incorporated objects, are disposed in one of virtual second spaces (the first to fourth small regions 39b to 39e are regions through which the video cable 22 or the light guide cable 23 is arbitrarily insertable; Fig. 11, paragraph 0044), each of the second spaces being partitioned by adjacent two of the four insertion members, an inner peripheral surface of the annular member, and the first space (inside the through hole 36c, first to fourth small regions 39b to 39e that are surrounded by side portions of the respective thick portions 36d are formed around the center region 39a at the symmetric positions so as to be located respectively at 90-degree rotation positions; Fig. 11, paragraph 0044).
However, Nakaji does not explicitly teach wherein a fourth incorporated object, which is a non-hollow incorporated object and is one of the plurality of incorporated objects, is further disposed in the one of the second spaces in which the third incorporated object, which is hollow, is disposed. It would not be obvious for one of ordinary skill in the art to modify the endoscope of Nakaji with a hollow incorporated object in an adjacent second space as the thick portions 41d prevent additional incorporated objects from being added (Fig. 9-10).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Appl. Publ. No. 2021/0244267 A1 to Shtul et al. teaches an endoscope with a bendable section and a treatment tool pipe as described in Fig. 9 and the descriptive text.
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/OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795