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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the Kingdom of the Netherlands on 12/14/2021. It is noted, however, a certified copy of the NL2030128 application has not been received in this National Stage application from the International Bureau (PCT Rule 7.2(a)) as required by 37 CFR 1.55.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the other portion of the first cylindrical element, as recited in claim 1, and the extended tangential spacer, as recited in claim 16 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because reference sign 1094 has been used to describe both lips and radial spacers. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 1036. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 24-27 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. The term “substantially” in claims 1, 6-7, 12, 24 and 26 is a relative term which renders the claims indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The degree to which components have to be aligned, parallel, perpendicular, or constant is not clear from the claims or specification. Accordingly, the claims are rendered indefinite.
Claim 14 recites the limitation "said third cylindrical element" in third line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites, a plurality of tangential spacers …wherein between each adjacent longitudinal elements at least one tangential spacer and at least one radial spacer are provided. However, independent claim 1, from which claim 15 depends, recites, in pertinent part, at least one tangential spacer arranged tangentially adjacent to said at least one longitudinal element in an open space between at least one longitudinal element and an other portion of the first cylindrical element. It is not clear whether the at least one tangential spacer recited in claim 15 is the same at least one tangential spacer recited in independent claim 1. Further, independent claim 1 recites that the at least one tangential spacer is between at least one longitudinal element and an other portion of the first cylindrical element. However, claim 15 recites that the at least one tangential spacer is between each adjacent longitudinal elements. It is unclear how the at least one tangential spacer can be both between at least one longitudinal element and an other portion of the first cylindrical element, as recited in claim 1, and between adjacent longitudinal elements, as recited in claim 15. Applicant has not claimed that the an other portion of the first cylindrical element is a longitudinal element. Accordingly, claim 15 is rendered indefinite.
Claim 16 recites wherein said plurality of longitudinal elements comprises a first longitudinal element, a second longitudinal element, and a third longitudinal element, wherein, in said first intermediate part, a first open space is formed between said first longitudinal element and said second longitudinal element, a second open space is formed between said second longitudinal element and said third longitudinal element, wherein in the first open space at least one tangential spacer and at least one radial spacer are provided. However, independent claim 1, from which claim 16 depends, recites, in pertinent part, at least one tangential spacer arranged tangentially adjacent to said at least one longitudinal element in an open space between said at least one longitudinal element and an other portion of the first cylindrical element. Independent claim 1 recites that the at least one tangential spacer is between at least one longitudinal element and an other portion of the first cylindrical element. However, claim 16 recites that the at least one tangential spacer is between a first longitudinal element and a second longitudinal element. It is unclear how the at least one tangential spacer can be both between at least one longitudinal element and an other portion of the first cylindrical element, as recited in claim 1, and between first and second longitudinal elements, as recited in claim 16. Applicant has not claimed that the an other portion of the first cylindrical element is a longitudinal element. Further, independent claim 1 recites the at least one tangential element arranged in an open space between said at least one longitudinal element and an other portion of the first cylindrical element. However, claim 16 recites the tangential spacer being arranged in a first open space between the first and second longitudinal elements. It is not clear if the open space of claim 1 and the first open space of claim 16 are the same open spaces. Moreover, and similar to that discussed above, it is unclear how the at least one tangential spacer can be in an open space both between at least one longitudinal element and an other portion of the first cylindrical element, as recited in claim 1, and in a first open space between first and second longitudinal elements, as recited in claim 16. Furthermore, claim 16 recites wherein in the second open space an extended tangential spacer is provided, which extended tangential spacer extends substantially throughout the second space. The configuration of the extended tangential spacer is not clear as it is neither shown in the drawings nor described in the specification. It is not clear how the extended tangential spacer is different from the tangential spacer. Accordingly, claim 16 is rendered indefinite.
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) 1-5, 7-8, 11-15, 24 and 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thissen (US 2020/0129166 A1).
Regarding claim 1, Thissen discloses a steerable instrument for endoscopic and/or invasive type of applications, such as in surgery, the instrument comprising: a first cylindrical element (206; Fig. 6B; par. [0084], [0105] and [0109]) comprising a first proximal end part (226; Fig. 5C; par. [0084], [0105] and [0109]), a first distal end part (14/227; Figs. 6B and 5C; par. [0084], [0105] and [0109]) including at least one first flexible distal portion (14; Fig. 6B; par. [0109]), and a first intermediate part (Figs. 5C and 6B – intermediate part between 226 and 15/14) between said first proximal end part (226) and said first distal end part (14/227), and at least one longitudinal element (274/282; Fig. 6B; par. [0109]-[0119]) arranged for transferring a force from said first proximal end part to said at least one first flexible distal portion and thereby control bending of said at least one first flexible distal portion (par. [0109]); at least one tangential spacer (275/279; Figs. 6B, 7B and 11B; par. [0115]) arranged tangentially adjacent to said at least one longitudinal element (274/282; par. [0115]) in an open space (par. [0115] – between the longitudinal elements there is a space filled with one or more tangential spacers 275, 279) between said at least one longitudinal element (274/282) and an other portion of the first cylindrical element (274/282); a second cylindrical element (204; Fig. 6A and 11A; par. [0084], [0105] and [0136]) arranged coaxially with said first cylindrical element (par. [0137]), and comprising a second proximal end part (226; Fig. 5B; par. [0084] and [0105]), a second distal end part (14/227; Fig. 6A; par. [0084] and [0105]) including at least one second flexible distal portion (14; Fig. 6A; par. [0105]), and a second intermediate part (246; Fig. 6A; par. [0106]) between said second proximal end part (226) and said second distal end part (14/227), corresponding to and substantially aligned with said first proximal end part, said first distal end part and said first intermediate part of said first cylindrical element, respectively (Figs. 6A-6B and 11A-12); at least one radial spacer (294e; Fig. 11A; par. [0136]) attached to the second cylindrical element (204) and protruding into an aperture (320; Fig. 11B) in the tangential spacer (275/279; Figs. 11B-12); such that a movement of the tangential spacer (275/279) both in a longitudinal direction and in a tangential direction of the steerable instrument is confined by said at least one radial spacer (294e; Fig. 12), and optionally at least one further radial spacer attached to the second cylindrical element and protruding in the open space at a longitudinal end of the at least one tangential spacer (by use of the term optionally the at least one further radial spacer is not a required structural component of the claim).
Regarding claim 2, Thissen discloses the steerable instrument according to claim 1, wherein the first cylindrical element (206) is a first cylindrical tube (Figs. 6B and 11B), and both the at least one longitudinal element (274/282) and the at least one tangential spacer are portions (275/279) of the first cylindrical tube (Figs. 6B and 11B).
Regarding claim 3, Thissen discloses the steerable instrument according to claim 1, wherein the second cylindrical element (204) is a second cylindrical tube (Figs. 6A and 11A).
Regarding claim 4, Thissen discloses the steerable instrument according to claim 3, wherein said at least one radial spacer (294e; Fig. 11B) and said at least one further radial spacer (not a required structural component) are formed by a lip shaped portion (294e; par. [0136]) of the second cylindrical tube (204) and protruding from the second cylindrical tube (204; Fig. 12).
Regarding claim 5, Thissen discloses the steerable instrument according to claim 4, wherein the lip shaped portion (294e) has a lip shaped portion width (Fig. 11A) and the aperture (320) has an aperture width (Fig. 11B) wherein the lip shaped portion width (294e; Fig. 11A) is either smaller than the aperture width (Fig. 12, 394e has a smaller width to fit within the aperture) or is configured such that it clamps the tangential spacer when bent into the aperture.
Regarding claim 7, Thissen discloses the steerable instrument according to claim 1, wherein in said first intermediate part (Figs. 5C and 6B – intermediate part between 226 and 15/14) said at least one longitudinal element (portion 256 of 274 extends in the first intermediate part) has a length in the longitudinal direction and a width in a direction substantially perpendicular to said longitudinal direction (par. [0109]; Fig. 6B), wherein said width is substantially constant throughout said length (par. [0109] – width of 256 does not taper until it reaches the flexible region 14).
Regarding claim 8, Thissen discloses the steerable instrument according to claim 1, further comprising a third cylindrical element (208; Fig. 6C; par. [0084] and [0126]) arranged coaxially with said first cylindrical element (206) and said second cylindrical element (204), wherein said first cylindrical element (206) is arranged between said second cylindrical element (204) and said third cylindrical element (208; Fig. 12), and wherein at least one of the following applies: said at least one radial spacer (294e; Fig. 11A) or said at least one further radial spacer is arranged to abut said third cylindrical element (208; Fig. 12), is engaged with said third cylindrical element, and is attached to said third cylindrical element.
Regarding claim 11, Thissen discloses the steerable instrument according to claim 8, wherein said at least one radial spacer (294e; Fig. 11A) or said at least one further radial spacer forms a distance between said second cylindrical element (204) and said third cylindrical element (208) in a radial direction (Fig. 12) which is larger than a thickness of said at least one longitudinal element (274/282; Fig. 12) and said at least one tangential spacer (275/279; Fig. 12) in said radial direction.
Regarding claim 12, Thissen discloses the steerable instrument according to claim 8, wherein said third cylindrical element (208) comprises a third proximal end part (226; Fig. 5D; par. [0084] and [0105]), a third distal end part including at least one third flexible distal portion (14/227; Figs. 6C and 5D; par. [0084] and [0105]), and a third intermediate part (Figs. 5D and 6C – intermediate part between 226 and 15/14) between said third proximal end part (226) and said third distal end part (14/227), corresponding to and substantially aligned with, respectively, said first proximal end part, said first distal end part and said first intermediate part of said first cylindrical element (Figs. 6B-6C and 11A-12).
Regarding claim 13, Thissen discloses the steerable instrument according to claim 8, wherein said third cylindrical element (208) forms an inner cylindrical element (208; Fig. 12), said first cylindrical element forms (206) an intermediate cylindrical element (206; Fig. 12), and said second cylindrical (204) element forms an outer cylindrical element (204; Fig. 12).
Regarding claim 14, Thissen discloses the steerable instrument according to claim 1, wherein said first cylindrical element (206), said second cylindrical element (204), and, where present, said third cylindrical element (208), are provided with one or more flexible portions (14; Figs. 6A-6C and Fig. 4) throughout their lengths.
Regarding claim 15, Thissen discloses the steerable instrument according to claim 1, comprising a plurality of tangential spacers (275/279) and a plurality of radial spacers (275/279) as well as a plurality of longitudinal elements (274/282), wherein between each adjacent longitudinal elements (274/282) at least one tangential spacer (275/279) and at least one radial spacer (275/279) are provided.
Regarding claim 24, Thissen discloses a method of manufacturing a steerable instrument for endoscopic and/or invasive type of applications, such as in surgery, the method comprising: providing a first cylindrical element (206; Fig. 6B; par. [0084], [0105] and [0109]) comprising a first proximal end part (226; Fig. 5C; par. [0084], [0105] and [0109]), a first distal end part (14/227; Figs. 6B and 5C; par. [0084], [0105] and [0109]) including at least one first flexible distal portion (14; Fig. 6B; par. [0109]), and a first intermediate part (Figs. 5C and 6B – intermediate part between 226 and 15/14) between said first proximal end part (226) and said first distal end part (14/227); forming at least one longitudinal element (274/282; Fig. 6B; par. [0109]-[0119]) extending between said first proximal end part (226) and said first distal end part (14/227) and arranged for transferring a force from said first proximal end part to said at least one first flexible distal portion (par. [0109]) and thereby control bending of said at least one flexible distal portion; forming at least one tangential spacer (275/279; Figs. 6B, 7B and 11B; par. [0115]) tangentially adjacent to said at least one longitudinal element (274/282; par. [0115]), said at least one tangential spacer (275/279) being tangentially attached to said at least one longitudinal element (274/282) by at least one releasable attachment (316; par. [0119]); providing a second cylindrical element (204; Fig. 6A and 11A; par. [0084], [0105] and [0136]) comprising a second proximal end part (226; Fig. 5B; par. [0084] and [0105]), a second distal end part (14/227; Fig. 6A; par. [0084] and [0105]) including at least one second flexible distal portion (14; Fig. 6A; par. [0105]), and a second intermediate part (246; Fig. 6A; par. [0106]) between said second proximal end part (226) and said second distal end part (14/227); forming at least one lip shaped portion (294e; Fig. 11A; par. [0136]) defined by a first slot (slot formed around 294e in 204; Fig. 11A; par. [0136]) in a second wall of said second cylindrical element; providing a third cylindrical element (208; Fig. 6C; par. [0084] and [0126]) comprising a third proximal end part (226; Fig. 5D; par. [0084] and [0105]), a third distal end part including at least one third flexible distal portion (14/227; Figs. 6C and 5D; par. [0084] and [0105]), and a third intermediate part (Figs. 5D and 6C – intermediate part between 226 and 15/14) between said third proximal end part (226) and said third distal end part (14/227); sliding said cylindrical elements into one another (par. [0104]), such that said cylindrical elements are substantially coaxially aligned (Fig. 12); applying a force onto said at least one lip shaped portion (294e; par. [0137]) in a direction substantially perpendicular to said second wall of said second cylindrical element (Fig. 12), thereby bending said lip shaped portion in a radial direction (Fig. 12); such that after bending said at least one lip shaped portion (294e) forms at least one radial spacer protruding into in an aperture in the tangential spacer (Fig. 12); and such that, after said releasable attachments (316) have been released: movement of said tangential spacer along both said longitudinal direction and in a tangential direction of the steerable instrument is confined by said at least one radial spacer (294e).
Regarding claim 27, Thissen discloses the method according to claim 24, further comprising releasing said at least one releasable attachment (316; par. [0119]) of said at least one tangential spacer.
Allowable Subject Matter
Claims 6, 9-10 and 25-26 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding claim 6, the prior art of record does not specifically disclose, or otherwise render obvious, the steerable instrument according to claim 4 wherein said beam is further defined by a second slot provided in said wall in a direction substantially parallel to said beam axis at another side of said beam, in combination with the other elements of the claim.
Regarding claim 9, and claim 10 dependent therefrom, the prior art of record does not specifically disclose, or otherwise render obvious, the steerable instrument according to claim 8, wherein said third cylindrical element is a third cylindrical tube provided with at least one recess or aperture, and wherein said at least one radial spacer or said at least one further radial spacer protrudes into said at least one recess or aperture, in combination with the other elements of the claim.
Regarding claim 25, and claim 26 dependent therefrom, the prior art of record does not specifically disclose, or otherwise render obvious, the method according to claim 24, wherein said third cylindrical element is provided with at least one aperture or recess in a third wall of said third cylindrical element, and wherein after said bending said lip shaped portion engages with said aperture or recess, in combination with the other steps and elements of the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYNAE E BOLER whose telephone number is (571)270-3620. The examiner can normally be reached Mon - Fri 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
4/20/26
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