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 .
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 limitation(s) is/are: “a first limiting portion” and “a second limiting portion” in claims 4 and 15, “a third limiting portion” and “a fourth limiting portion” in claims 5 and 16, “a first driving module” and “a second driving module” in claim 7; “a first driver” in claim 8, “a second driver” in claim 9; “a driving mechanism” in claim 10, “a first clamping element” and “a second clamping element” in claim 11, “a first driving module” and “a second driving module” in claim 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/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 § 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 5-6, 9-11 and 17 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.
Claim 5 recites, in pertinent part, “a third limiting portion” and “a fourth limiting portion”. Claim 5 depends from independent claim 1, which does not recite a limiting portion. Applicant recites a third limiting portion and a fourth limiting portion without reciting a first limiting portion and a second limiting portion. It is not clear what comprises the first and second limiting portions. Accordingly, the claim is rendered in indefinite.
Claims 6 and 17 each recite a driving wire passing through the first through hole and the second through hole; wherein the first through hole has a first inner diameter, the first inner diameter is smaller than an outer diameter of the driving wire, the second through hole has a second inner diameter, and the second inner diameter is smaller than the outer diameter of the driving wire. Applicant has claimed that the inner diameters of the first and second through holes are smaller than the outer diameter of the driving wire. It is not clear how the driving wire can pass through the first and second through holes, if its outer diameter is larger than the inner diameter of the first and second through holes. Applicant has not claimed any structural features and/or materials of the drive wire that would allow it to be inserted into the smaller diameter first and second through holes. Accordingly, the claims are rendered indefinite. For purposes of examination, the outer diameter of the driving wire is interpreted as having an outer diameter that is either smaller than or equal to the inner diameters of the first and second through holes.
Regarding claim 9, the claim limitation “a second driver” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function of the second driver in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 10 recites, in pertinent part, “a driving mechanism configured for connecting the flexible tube”. It is not clear if the driving mechanism is for connecting the flexible tube to another component, or if it is for connecting to the flexible tube. Accordingly, the claim is rendered in indefinite. For purposes of examination, the limitation is interpreted as a driving mechanism configured for connecting to the flexible tube.
Claim 11 recites, in pertinent part, “a first clamping element configured for clamping the flexible tube and rotating the flexible tube”. The specification and drawings disclose the first clamping element clamping the connecting tube (140), not the flexible tube (100). It is not clear how the first clamping element clamps the flexible tube. Accordingly, the claim is rendered indefinite. For purposes of examination, the claim limitation is interpreted as a first clamping element configured for clamping a connecting tube and rotating the connecting tube and the flexible tube.
Claim 18 recites, in pertinent part, “the driving wire passes through the first connecting section and the second connecting section and interferes with the first connecting section and the second connecting section”. The claim does not make clear how the driving wire interferes with the first and second connecting sections. Is it merely inserted through the connecting sections? Is it inserted in guides provided in the connecting sections? Or is there a different way that it interferes with the connecting sections? Accordingly, the claim is rendered indefinite. For purposes of examination, the driving wire interfering with the first and second connecting sections is interpreted as the driving wire being inserted through the connection sections.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis (US 2022/0105312 A1).
Regarding claim 1, Davis discloses a flexible tube (Fig. 5A), comprising: a first connecting section (114; Fig. 5A; par. [0029]); and a second connecting section (adjacent 114; Fig. 5A; par. [0029]) integrally connected with the first connecting section (via 112; Fig. 5A; par. [0029]); wherein the first connecting section (114; Fig. 5A; par. [0029]) has a first end surface (proximal end surface of 114; Fig. 5B par. [0029]), and the second connecting section (adjacent 114; Fig. 5A; par. [0029]) has a second end surface (distal end surface of adjacent 114; Fig. 5B; par. [0029]), and there is an acute angle (Figs. 5A –5B) between the first end surface (proximal end surface of 114; Fig. 5B; par. [0029]) and the second end surface (distal end surface of adjacent 114; Fig. 5B; par. [0029]) based on the first connecting section and the second connecting section being in a straight state (Figs. 5A –5B).
.Regarding claim 2, Davis discloses the flexible tube as claimed in claim 1, wherein the first connecting section (114; Fig. 5A; par. [0029]) and the second connecting section (adjacent 114; Fig. 5A; par. [0029]) respectively have a first cutting slot (116 at proximal end of 114; Fig. 5B; par. [0031]-[0032]; see A of inserted Fig. 5B) and a second cutting slot (116 at distal end of adjacent 114; Fig. 5B; par. [0031]-[0032]; see B of inserted Fig. 5B), the first cutting slot and the second cutting slot are connected to each other (Figs. 5A –5B), the first connecting section and the second connecting section respectively comprises a first connecting portion (portion of 112 at proximal end of 114; Fig. 5B; see C of inserted Fig. 5B) and a second connecting portion (portion of 112 at distal end of adjacent 114; Fig. 5B; see D of inserted Fig. 5B), the first connecting portion and the second connecting portion are connected to each other and adjacent to the first cutting slot and the second cutting slot (Figs. 5A –5B).
Regarding claim 3, Davis discloses the flexible tube as claimed in claim 2, wherein the first connecting section further has a third cutting slot (116 at proximal end of 114 on opposing side of 112; Figs. 5A-5B; par. [0031]-[0032]; see E of inserted Fig. 5B), the second connecting section further has a fourth cutting slot (116 at distal end of adjacent 114 on opposing side of 112; Figs. 5A-5B; par. [0031]-[0032]; see F of inserted Fig. 5B), the first connecting portion (portion of 112 at proximal end of 114; Fig. 5B; see C of inserted Fig. 5B) of the first connecting section is formed between the first cutting slot (116 at proximal end of 114; Fig. 5B; par. [0031]-[0032]; see A of inserted Fig. 5B) and the third cutting slot (116 at proximal end of 114 on opposing side of 112; Figs. 5A-5B; par. [0031]-[0032]; see E of inserted Fig. 5B), and the second connecting portion of the second connecting section is formed between the second cutting slot (116 at distal end of adjacent 114; Fig. 5B; par. [0031]-[0032]; see B of inserted Fig. 5B) and the fourth cutting slot (116 at distal end of adjacent 114 on opposing side of 112; Figs. 5A-5B; par. [0031]-[0032]; see F of inserted Fig. 5B).
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Siegel et al. (US 2021/0251757 A1).
Regarding claim 1, Siegel discloses a flexible tube (Figs. 8A-8B), comprising: a first connecting section (38; Figs. 8A-8B; par. [0125]-[0126]); and a second connecting section (adjacent 38; Figs. 8A-8B; par. [0125]-[0126]) integrally connected with the first connecting section; wherein the first connecting section has a first end surface (proximal end surface of 38; Figs. 8A-8B), and the second connecting section has a second end surface (distal end surface of adjacent 38; Figs. 8A-8B), and there is an acute angle between the first end surface (proximal end surface of 38; Figs. 8A-8B) and the second end surface (distal end surface of adjacent 38; Figs. 8A-8B) based on the first connecting section and the second connecting section being in a straight state (Figs. 8A-8B).
Regarding claim 4, Siegel discloses the flexible tube as claimed in claim 1, wherein the first connecting section comprises a first limiting portion (32; Figs. 8A-8B; par. [0126]-[0127]), the second connecting section comprises a second limiting portion (35; Figs. 8A-8B; par. [0127]-[0128]), the first limiting portion is protruded (32; Figs. 8A-8B) or recessed relative to the first end surface (proximal end surface of 38; Figs. 8A-8B), the second limiting portion is recessed (35; Figs. 8A-8B) or protruded relative to the second end surface (distal end surface of adjacent 38; Figs. 8A-8B), and the first limiting portion (32) and the second limiting portion (32) are selectively separated or engaged (par. [0127]-[0128]).
Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cuscuna et al. (US 2019/0117193 A1).
Regarding claim 1, Cuscuna discloses a flexible tube, comprising: a first connecting section (11; Figs. 1, 2 and 5; par. [0016]); and a second connecting section (adjacent 11; Figs. 1, 2 and 5; par. [0016]) integrally connected with the first connecting section; wherein the first connecting section has a first end surface (proximal end surface of 11; Figs. 1 and 5; par. [0016] and [0020]), and the second connecting section has a second end surface (distal end surface of adjacent 11; Figs. 1 and 5; par. [0016] and [0020]), and there is an acute angle between the first end surface (proximal end surface of 11; Figs. 1 and 5; par. [0016] and [0020]) and the second end surface (distal end surface of adjacent 11; Figs. 1 and 5; par. [0016] and [0020]) based on the first connecting section and the second connecting section being in a straight state (Figs. 1 and 5; par. [0016] and [0020]).
Regarding claim 5, Cuscuna discloses the flexible tube as claimed in claim 1, wherein the first connecting section (11; Figs. 1, 2 and 5; par. [0016]) and the second connecting section (adjacent 11; Figs. 1, 2 and 5; par. [0016]) respectively comprises a third limiting portion (16; Figs. 1, 2 and 5; par. [0017]) and a fourth limiting portion (16; Figs. 1, 2 and 5; par. [0017]), the third limiting portion (16; Figs. 1, 2 and 5; par. [0017]) is connected to a first inner sidewall of the first connecting section (inner sidewall of 11; Figs. 1, 2 and 5; par. [0016]-[0017]), there is a first through hole formed between the third limiting portion and the first inner sidewall (Figs. 2 and 2A; par. [0017]), the fourth limiting portion (16; Figs. 1, 2 and 5; par. [0017]) is connected to a second inner sidewall of the second connecting section (inner sidewall of adjacent 11; Figs. 1, 2 and 5; par. [0016]-[0017]), there is a second through hole formed between the fourth limiting portion and the second inner sidewall (Figs. 2 and 2A; par. [0017]).
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uesugi (US 2021/0121250 A1) in view of Chan et al. (US 2020/0222666 A1).
Regarding claim 7, Uesugi discloses a driving mechanism, adapted for driving a flexible tube (7; Fig. 1; par. [0024]), the flexible tube (7) is connected to a connecting tube (portion of 5 proximal 7; Fig. 1; par. [0024]), and the driving mechanism comprises: a first driving module (8; Fig. 1; par. [0024]) configured for controlling the flexible tube (7; Fig. 1; par. [0024]) to bend; and a second driving module (9; Fig. 1; par. [0024]) connected to the connecting tube (portion of 5 proximal 7; Fig. 1; par. [0024]) and configured for driving the connecting tube to rotate for driving the flexible tube to rotate (par. [0024]).
Although Uesugi teaches a flexible tube (7), it does not disclose its structure, such that it does not specifically disclose the flexible tube comprises a first connecting section and a second connecting section integrally connected with the first connecting section, the first connecting section has a first end surface, the second connecting section has a second end surface, there is an acute angle between the first end surface and the second end surface based on the first connecting section and the second connecting section being in a straight state, or a driving wire passes through the flexible tube and the connecting tube. Chan teaches an analogous flexible tube (404; Figs. 4A and 5A; par. [0067] and [0080]) wherein the flexible tube comprises a first connecting section (511; Fig. 5A; par. [0081]) and a second connecting section (512; Fig. 5A; par. [0081]) integrally connected with the first connecting section; the first connecting section has a first end surface (proximal end surface of 511; Fig. 5A), the second connecting section has a second end surface (distal end surface of 512; Fig. 5A), there is an acute angle between the first end surface (proximal end surface of 511; Fig. 5A) and the second end surface (distal end surface of 512; Fig. 5A) based on the first connecting section and the second connecting section being in a straight state (Fig. 5A), and wherein a driving wire (421; par. [0069]) passes through the flexible tube (400; Figs. 4A and 5A; par. [0067]) and connecting tube (402; Figs. 4A and 5A; par. [0067]). Chan teaches that its flexible tube is designed to prevent damage to the medical device and patient due to applied axial loads (par. [0003]-[0004]). It would have been obvious to one having ordinary skill in the art to use the configuration of the flexible tube of Chan in the device of Uesugi in order to prevent damage to the medical device and patient due to applied axial loads, as taught by Chan.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uesugi in view of Chan as applied to claim 7 above, and further in view of Connolly et al. (US 2019/0000568 A1).
Regarding claim 8, Uesugi in view of Chan disclose the driving mechanism as claimed in claim 7, wherein the first driving module (8; Fig. 1; par. [0024]) comprises: a first driver (8; Fig. 1; par. [0024] - motor); but does not specifically disclose that it also comprises a driving wheel connected to the first driver; wherein the driving wire is wound around the driving wheel. Connolly teaches an analogous driving mechanism (500; Fig. 5; par. [0086]) wherein the driving module comprises a driving wheel (555; Fig. 5; par. [0086]) connected to the first driver (551; Fig. 5; par. [0086]); wherein the driving wire (556) is wound around the driving wheel (555). Connolly teaches that the driving wire may either be coupled to the first driver (551) via the driving wheel (555) or the driving wire may be directly attached output shaft of the first driver (551) without a driving wheel (555; par. [0086]). It would have been obvious to one having ordinary skill in the art to include the driving wheel with the first driver in the driving mechanism of Uesugi, as Connolly teaches that it is known to couple the driving wire to the first driver with or without a driving wheel, as they are suitable alternative.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uesugi in view of Chan as applied to claim 7 above, and further in view of Black et al. (US 2022/0125464 A1).
Regarding claim 9, Uesugi in view of Chan disclose the driving mechanism as claimed in claim 7, wherein the second driving module (9; Fig. 1; par. [0024]) comprises: a second driver (par. [0024] - motor), but does not specifically disclose that it comprises a gear set connected to the second driver; wherein the connecting tube is fixed to the gear set. Black teaches an analogous driving mechanism wherein driving module comprises: a gear set (1148/1176; Fig. 23A; par. [0115]-[0116], [0144] and [0195]-[0196]) connected to the second driver (66; Fig. 5; par. [0115]-[0116]); wherein the connecting tube (1075; Fig. 18; par. [0173]) is fixed to the gear set (Fig. 23A; par. [0196]). It would have been obvious to one having ordinary skill in the art to include a gear set in the second driving module in order to selectively fix the flexible tube in any rotational position about the longitudinal axis, as taught by Black (par. [0130]).
Claim(s) 10, 12-14 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura (US 2022/0218180 A1) in view of Chan et al. (US 2020/0222666 A1).
Regarding claim 10, Nishimura discloses a control system, comprising: a flexible tube (13; Fig. 1; par. [0044]); a driving mechanism (142/144; Fig. 2A; par. [0041], [0044] and [0046]) configured for connecting the flexible tube (13); and a controller (240; Fig. 2A; par. [0047] and [0052]) electrically connected to the driving mechanism (142/144) and configured for controlling the driving mechanism to drive the flexible tube (par. [0052], [0054] and [0056]-[0057]).
Although Nishimura teaches a flexible tube (13), it does not disclose its structure, such that it does not specifically disclose the flexible tube comprises a first connecting section and a second connecting section integrally connected with the first connecting section, the first connecting section has a first end surface, the second connecting section has a second end surface, there is an acute angle between the first end surface and the second end surface based on the first connecting section and the second connecting section being in a straight state, or a driving wire passes through the flexible tube and the connecting tube. Chan teaches an analogous flexible tube (404; Figs. 4A and 5A; par. [0067] and [0080]) wherein the flexible tube comprises a first connecting section (511; Fig. 5A; par. [0081]) and a second connecting section (512; Fig. 5A; par. [0081]) integrally connected with the first connecting section; the first connecting section has a first end surface (proximal end surface of 511; Fig. 5A), the second connecting section has a second end surface (distal end surface of 512; Fig. 5A), there is an acute angle between the first end surface (proximal end surface of 511; Fig. 5A) and the second end surface (distal end surface of 512; Fig. 5A) based on the first connecting section and the second connecting section being in a straight state (Fig. 5A), and wherein a driving wire (421; par. [0069]) passes through the flexible tube (400; Figs. 4A and 5A; par. [0067]) and connecting tube (402; Figs. 4A and 5A; par. [0067]). Chan teaches that its flexible tube is designed to prevent damage to the medical device and patient due to applied axial loads (par. [0003]-[0004]). It would have been obvious to one having ordinary skill in the art to use the configuration of the flexible tube of Chan in the device of Nishimura in order to prevent damage to the medical device and patient due to applied axial loads, as taught by Chan.
Regarding claim 12, Nishimura in view of Chan disclose the control system as claimed in claim 10, further comprising a driving wire (par. [0044] – plurality of wires; Chan - 421) and a connecting tube (14; par. [0030]), wherein the driving wire passes through the flexible tube and the connecting tube (par. [0032] and [0054]; Chan – par. [0069]; Fig. 4A), the flexible tube (13) is connected to the connecting tube (14; Fig. 1), and the driving mechanism (142/144) comprises: a first driving module (142; par. [0044]; Fig. 2A) connected to the driving wire and configured for driving the driving wire to control the flexible tube to bend (par. [0044]); and a second driving module (144) connected to the connecting tube and configured for driving the connecting tube to rotate, so as to drive the flexible tube to rotate (par. [0046]).
Regarding claim 13, Nishimura in view of Chan disclose the control system as claimed in claim 10, wherein the first connecting section (Chan - 511; Fig. 5A; par. [0081]) and the second connecting section (Chan - 512; Fig. 5A; par. [0081]) respectively have a first cutting slot (see A in inserted Fig. 5A of Chan below) and a second cutting slot (see B in inserted Fig. 5A of Chan below), the first cutting slot and the second cutting slot are connected to each other (Chan - Fig. 5A); the first connecting section and the second connecting section respectively comprises a first connecting portion (see C in inserted Fig. 5A of Chan below) and a second connecting portion (see D in inserted Fig. 5A of Chan below), the first connecting portion and the second connecting portion are connected to each other and adjacent to the first cutting slot and the second cutting slot (Chan - Fig. 5A).
Regarding claim 14, Nishimura in view of Chan disclose the control system as claimed in claim 13, wherein the first connecting section further has a third cutting slot (see E in inserted Fig. 5A of Chan below), the second connecting section further has a fourth cutting slot (see E in inserted Fig. 5A of Chan below), the first connecting portion of the first connecting section is formed between the first cutting slot and the third cutting slot (Chan - Fig. 5A), and the second connecting portion of the second connecting section is formed between the second cutting slot and the fourth cutting slot (Chan - Fig. 5A).
Regarding claim 18, Nishimura discloses a control method, adapted for driving a flexible tube (13; Fig. 1; par. [0044]), wherein the flexible tube (13; Fig. 1; par. [0044]) comprises a first connecting section (par. [0044] – bending piece), a second connecting section (par. [0044] – proximally adjacent bending piece) and a driving wire (par. [0044] – wire), and the control method comprises: pushing the drive wire toward a direction close to the flexible tube to increase a bending degree of the flexible tube (par. [0044] – to bend 13); and pulling back the drive wire toward a direction away from the flexible tube to reduce the bending degree of the flexible tube (par. [0044] – to unbend, straighten or bend 13 toward a different direction).
Although Nishimura teaches a flexible tube (13), it does not disclose its structure, such that it does not specifically disclose the second connecting section is integrally connected with the first connecting section, the first connecting section has a first end surface, the second connecting section has a second end surface, there is an acute angle between the first end surface and the second end surface based on the first connecting section and the second connecting section being in a straight state, the driving wire passes through the first connecting section and the second connecting section and interferes with the first connecting section and the second connecting section. Chan teaches an analogous flexible tube (404; Figs. 4A and 5A; par. [0067] and [0080]) wherein the flexible tube comprises a first connecting section (511; Fig. 5A; par. [0081]) and a second connecting section (512; Fig. 5A; par. [0081]) integrally connected with the first connecting section; the first connecting section has a first end surface (proximal end surface of 511; Fig. 5A), the second connecting section has a second end surface (distal end surface of 512; Fig. 5A), there is an acute angle between the first end surface (proximal end surface of 511; Fig. 5A) and the second end surface (distal end surface of 512; Fig. 5A) based on the first connecting section and the second connecting section being in a straight state (Fig. 5A), and wherein a driving wire (421; par. [0069]) passes through the flexible tube (400; Figs. 4A and 5A; par. [0067]) and connecting tube (402; Figs. 4A and 5A; par. [0067]). Chan teaches that its flexible tube is designed to prevent damage to the medical device and patient due to applied axial loads (par. [0003]-[0004]). It would have been obvious to one having ordinary skill in the art to use the configuration of the flexible tube of Chan in the device of Nishimura in order to prevent damage to the medical device and patient due to applied axial loads, as taught by Chan.
Regarding claim 19, Nishimura in view of Chan disclose the control method as claimed in claim 18, further comprising: rotating the flexible tube (via 144; par. [0046]).
Regarding claim 20, Nishimura in view of Chan disclose the control method as claimed in claim 18, further comprising: pulling back the drive wire toward the direction away from the flexible tube until the flexible tube is in the straight state (par. [0044] – to straighten 13); and rotating the flexible tube when the flexible tube is in the straight state (via 144; par. [0046]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura in view of Chan as applied to claim 10 above, and further in view of Iida (US 2013/0089392 A1).
Regarding claim 11, Nishimura in view of Chan disclose the control system as claimed in claim 10, further comprising: a drive wire (par. [0044]) passing through the flexible tube (13; par. [0044]); wherein the driving mechanism (142/144) comprises: a first clamping element (par. [0046] – grasping member) configured for clamping the flexible tube and rotating the flexible tube (par. [0046] – grasping member grasps and rotates the flexible tube).
However, Nishimura does not specifically disclose a second clamping element configured for clamping the driving wire and controlling the driving wire to move relative to the flexible tube. Iida discloses an analogous system having a clamping element (108; Fig. 2; par. [0038]) configured for clamping the driving wire (95/96; Fig. 2; par. [0038]) and controlling the driving wire to move relative to the flexible tube (92; Fig. 2; par. [0037] and [0041]). It would have been obvious to one having ordinary skill in the art to include a clamping element for clamping the driving wire, as taught by Iida, in order to control the degree of bending of the flexible tube.
Claim(s) 10 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jeong et al. (US 2013/0253271 A1) in view of Tanaka (US 2011/0275896 A1).
Regarding claim 10, Jeong discloses a control system, comprising: a flexible tube (70; Fig. 1; par. [0053]) comprising: a first connecting section (71; Fig. 3; par. [0058]); and a second connecting section (proximally adjacent 71; Fig. 3; par. [0058]) integrally connected with the first connecting section; wherein the first connecting section (71; Fig. 3; par. [0058]) has a first end surface (proximal end surface of 71; Fig. 3; par. [0058]), and the second connecting section (proximally adjacent 71; Fig. 3; par. [0058]) has a second end surface (distal end surface of proximally adjacent 71; Fig. 3; par. [0058]), and there is an acute angle between the first end surface and the second end surface based on the first connecting section and the second connecting section being in a straight state (Fig. 3); a driving mechanism (51/53; Fig. 7; par. [0061] and [0073]) configured for connecting the flexible tube (70); and a controller (54; Fig. 7; par. [0073]) connected to the driving mechanism (51/53) and configured for controlling the driving mechanism to drive the flexible tube (par. [0073]).
Although Jeong teaches a controller, it does not specifically disclose that is electrically connected to the driving mechanism. Jeong, however, does teach that an electrically driven motor may be provided between the controller and the driving mechanism (par. [0073]). Tanaka teaches an analogous system (Figs. 1 and 2) wherein a controller (18/5; Fig. 2; par. [0043]-[0044]) is electrically connected to the driving mechanism (50; Fig. 2; par. [0058]) and configured for controlling the driving mechanism to drive the flexible tube (par. [0071]-[0074]). It would have been obvious to one having ordinary skill in the art to provide an electrically driven motor in the driving mechanism and a controller that is electrically connected to the driving mechanism in the system of Jeong, as taught by Tanaka, and as contemplated by Jeong, to drive the flexible tube.
Regarding claim 15, Jeong in view of Tanaka disclose the control system as claimed in claim 10, wherein the first connecting section (71; Fig. 3; par. [0058]) comprises a first limiting portion (protruding portion of 75; Fig. 3), the second connecting section (proximally adjacent 71; Fig. 3; par. [0058]) comprises a second limiting portion (recessed portion of 74; Fig. 3), the first limiting portion is protruded (protruding portion of 75; Fig. 3) or recessed relative to the first end surface (proximal end surface of 71; Fig. 3; par. [0058]), the second limiting portion is recessed (recessed portion of 74; Fig. 3) or protruded relative to the second end surface (distal end surface of proximally adjacent 71; Fig. 3; par. [0058]), and the first limiting portion and the second limiting portion are selectively separated or engaged (Figs. 3 and 4).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura in view of Chan as applied to claim 10 above, and further in view of Cuscuna (US 2019/0117193 A1).
Regarding claim 16, Nishimura in view of Chan disclose the control system as claimed in claim 10, but does not specifically disclose wherein the first connecting section and the second connecting section respectively comprises a third limiting portion and a fourth limiting portion, the third limiting portion is connected to a first inner sidewall of the first connecting section, there is a first through hole formed between the third limiting portion and the first inner sidewall, the fourth limiting portion is connected to a second inner sidewall of the second connecting section, there is a second through hole formed between the fourth limiting portion and the second inner sidewall.
Like Chan, Cuscuna teaches an analogous system wherein the driving wire can be disposed in a groove (12; Figs. 1-1A; par. [0016]). Cuscuna teaches an alternative driving wire guide embodiment (Figs. 2 and 2A; par. [0017]) wherein the first connecting section (11; Figs. 1, 2 and 5; par. [0016]) and the second connecting section (adjacent 11; Figs. 1, 2 and 5; par. [0016]) respectively comprises a third limiting portion (16; Figs. 1, 2 and 5; par. [0017]) and a fourth limiting portion (16; Figs. 1, 2 and 5; par. [0017]), the third limiting portion (16; Figs. 1, 2 and 5; par. [0017]) is connected to a first inner sidewall of the first connecting section (inner sidewall of 11; Figs. 1, 2 and 5; par. [0016]-[0017]), there is a first through hole formed between the third limiting portion and the first inner sidewall (Figs. 2 and 2A; par. [0017]), the fourth limiting portion (16; Figs. 1, 2 and 5; par. [0017]) is connected to a second inner sidewall of the second connecting section (inner sidewall of adjacent 11; Figs. 1, 2 and 5; par. [0016]-[0017]), there is a second through hole formed between the fourth limiting portion and the second inner sidewall (Figs. 2 and 2A; par. [0017]). It would have been obvious to one having ordinary skill in the art to provide the third and fourth limiting portions in the flexible tube of Nishimura, as a simple substitution of one driving wire guide configuration for another, having the predictable result of driving the flexible tube, and as taught by Cuscuna as an alternative embodiment.
Inserted Figure 5B of Davis
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Inserted Figure 5A of Chan
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Conclusion
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
02/20/26