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 group I, claims 1-16 and 35-36, in the reply filed on 10 February 2026 is acknowledged.
Claims 17-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 February 2026.
Response to Amendment
The amendments filed 10 February 2026 are entered.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 2 and 6 are objected to because of the following informalities:
Claim 2, line 2-3 “operating mode” should be “operation mode”.
Claim 6, line 3 “the operating” should be “operating”.
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.
Claim 10 is 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 “in general” in claim 10 is a relative term which renders the claim indefinite. The term “in general, tapering” 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. It is not clear if “in general” is meant to refer to an amount or degree or change to be considered tapering, or if it refers to a general tapering from one end to another.
Claim 10 additionally recites the limitation "the movable longitudinal portion" in line 4. There is insufficient antecedent basis for this limitation in the claim. The limitation is interpreted as referring to the first longitudinal element.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4, 6-7, and 35 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Alvarez (US 20100228191 A1).
Regarding claim 1, Alvarez teaches a cylindrical instrument comprising a tube (paragraph 0001) extending in a longitudinal direction (figure 1H shows the cylindrical instrument comprising a tube and extending longitudinally; paragraph 0039) and having at least a movable element (Tubular support structure 4; Fig. 1E) and at least a first further element (Tubular support structure 2, Fig. 1E),
the movable element having a movable element extending portion adjacent to a movable element indented portion (Fig. 1E-1F—movable element 4 includes sawtooth structures shown in Fig. 1F as surface configurations 24),
in a manufactured state the movable element extending portion being located opposite a first further element indented portion at a first distance and the movable element indented portion being located opposite a first further element extending portion at a second distance (Fig. 1E-1F—movable element 4 includes sawtooth structures shown in Fig. 1F as surface configurations 24 and corresponding surface configurations 22 which can contact at area 32; paragraph 0039-- The non-smooth surfaces are specifically configured to prevent relative motion upon contact (32), thus enabling a change of a locking state from "unlocked" to "locked" with contact), and wherein
the tube is configured to allow relative sideways movement from the manufactured state to a reduced play state between the movable element and the first further element in which said movable element extending portion is, at least partly, opposite said first further element extending portion at a third distance which is smaller than said first and said second distance and can sideways move with said reduced play relative to said first further element extending portion caused by operating the cylindrical element until a predetermined maximum operating limit (Fig. 1E-1F—movable element 4 includes sawtooth structures shown in Fig. 1F as surface configurations 24 and corresponding surface configurations 22 which can contact at area 32, wherein Fig. 1F demonstrates a third distance when the extending portions of the movable element and first further element are in contact (e.g. a smallest distance) with one another, rather than at a first or second distance where the extending portions and indented portions are opposite one another; paragraph 0039--it is free to rotate, as depicted in FIGS. 1C and 1D, until a compressive load exceeding a transverse member (10) spring deflection load is applied urging the two support structures (2, 4) toward each other. A stop (18) is formed into the transverse member (10) to prevent overdeflection…The non-smooth surfaces are specifically configured to prevent relative motion upon contact (32), thus enabling a change of a locking state from "unlocked" to "locked" with contact).
Regarding claim 2, Alvarez teaches the cylindrical instrument according to claim 1. Alvarez additionally teaches wherein the movable element and the first further element are opposite portions of a hinge and the operating mode of the cylindrical instrument causes a deflection between the opposite portions of the hinge, wherein the predetermined maximum operating limit is a maximum deflection angle between the opposite portions of the hinge (Fig. 1E—the support structures 2 and 4 function as opposite portions of a hinge which can be deflected to a maximum operating limit before locking to prevent further rotation; Paragraph 0039).
Regarding claim 3, Alvarez teaches the cylindrical instrument according to claim 2. Alvarez additionally teaches wherein the maximum deflection angle has a value in a range of at least one of -2 to -45 degrees and +2 to +45 degrees. (Fig. 1E, 1H-1I shows that the deflection can occur in either direction (negative or positive angle) and is limited to less than 45 degrees).
Regarding claim 4, Alvarez teaches the cylindrical instrument according to claim 2. Alvarez additionally teaches wherein the movable element is a convex portion rotatably arranged inside the first further element which is a concave portion (See Fig. 1E, movable element 4 is a convex portion which is rotatably arranged inside the first further element 2 which is concave).
Regarding claim 6, Alvarez teaches the cylindrical instrument according to claim 1. Alvarez additionally teaches wherein the movable element is a first longitudinal element extending in the longitudinal direction of the tube (See the extension of element 4 in the longitudinal direction of the tube, Figs. 1E and 1H) and the operating of the cylindrical instrument causes a mutual longitudinal displacement between the first longitudinal element and the first further element and the predetermined maximum operating limit is a maximum mutual longitudinal displacement (see Fig. 1A which demonstrates a small longitudinal displacement between the elements 2 and 4).
Regarding claim 7, Alvarez teaches the cylindrical instrument according to claim 6. Alvarez additionally teaches wherein the first longitudinal element is attached to a bendable portion of the tube at a distal end of the tube such as to transfer a longitudinal movement of the longitudinal element to a bending of the bendable portion (see configuration of tube members in Figs. 6A-6C having a bendable portion of the tube at a distal end of the tube such that a longitudinal movement would transfer to this portion; paragraph 0047).
Regarding claim 35, Alvarez teaches the cylindrical instrument according to claim 1. Alvarez additionally teaches wherein at least one of the movable element extending portion and the first further element extending portion has a smooth surface (See Fig. 1F, the surfaces having the extending portions 22 and 24 are smooth).
Claim(s) 1, 6-7, 9-12, and 35-36 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Verbeek (US 20140018620 A1).
Regarding claim 1, Verbeek teaches a cylindrical instrument comprising a tube extending in a longitudinal direction (Steerable tube 1; paragraph 0057-0058) and having at least a movable element and at least a first further element (longitudinal elements 2, 3 which couple with the longitudinal protrusions 11), the cylindrical instrument having a first state and a second state, the first state being a manufactured state obtained directly after manufacturing and the second state being a reduced-play state coinciding with an operation mode (Paragraph 0066-0068-- a state for enabling the length of at least one longitudinal element 2 of the set of longitudinal elements 2,3 to be adjusted…In the state of the coupling arrangement 10 shown in FIG. 2a, the longitudinal elements 2,3 and the longitudinal protrusions 11 are arranged for allowing them to move freely with respect to each other… a displacement of longitudinal element 2 for adjusting its length between the proximal 4 and distal 5 end portions of the steerable tube 1 for compensating a path length difference at least between longitudinal elements 2,3 as a result of bending of the flexible body of the steerable tube; Figs. 2a-2c ),
the movable element having a movable element extending portion adjacent to a movable element indented portion, in the manufactured state the movable element extending portion being located opposite a first further element indented portion at a first distance and the movable element indented portion being located opposite a first further element extending portion at a second distance (Paragraph 0066-0068-- Both the protrusions 11 and the longitudinal elements 2,3 comprise serrated portions 12,13 having interlocking structures, in this example triangles, for establishing a form closed coupling upon engagement of the longitudinal elements 2,3 and the longitudinal protrusions 11. It will be clear to the person skilled in the art that the serrated portions 12,13 can be provided with any suitable structures for establishing a form closed coupling; Figs. 2a-2c show the serrated portions 12,13 which have extending portions and indent portions which are movable relative to one another), and
wherein the tube is configured to allow relative sideways movement from the manufactured state to the state between the movable element and the first further element (Paragraph 0066-0068-- the longitudinal elements 2,3 and the longitudinal protrusions 11 are arranged for allowing them to move freely with respect to each other)
wherein in the reduced-play state said movable element extending portion is, at least partly, opposite said first further element extending portion such that said movable element extending portion and said first further element extending portion can sideways move relative to one another and slide along one another as caused by operating the cylindrical instrument until a predetermined maximum operating limit (Paragraphs 0066-0068; Fig. 2a-2c showing maximum displacement).
Regarding claim 6, Verbeek teaches the cylindrical instrument according to claim 1. Verbeek additionally teaches wherein the movable element is a first longitudinal element extending in the longitudinal direction of the tube and the operating of the cylindrical instrument causes a mutual longitudinal displacement between the first longitudinal element and the first further element and the predetermined maximum operating limit is a maximum mutual longitudinal displacement (paragraph 0066-0068-- enabling the length of at least one longitudinal element 2 of the set of longitudinal elements 2,3 to be adjusted, Figs. 2a-2c—displacement is longitudinal).
Regarding claim 7, Verbeek teaches the cylindrical instrument according to claim 6. Verbeek additionally discloses wherein the first longitudinal element is attached to a bendable portion of the tube at a distal end of the tube such as to transfer a longitudinal movement of the longitudinal element to a bending of the bendable portion (paragraph 0066-0068--a displacement of longitudinal element 2 for adjusting its length between the proximal 4 and distal 5 end portions of the steerable tube 1 for compensating a path length difference at least between longitudinal elements 2,3 as a result of bending of the flexible body of the steerable tube…the distal end portion 5 can be steered by manipulating the proximal end portion 4 of the steerable tube 1; Figs. 1a-1e and 2a-2c).
Regarding claim 9, Verbeek teaches the cylindrical instrument according to claim 6. Verbeek additionally teaches wherein first further element extending portion is resilient in a tangential direction of the tube (paragraph 0067-0069, Figs. 2b-2c).
Regarding claim 10, Verbeek teaches the cylindrical instrument according to claim 6. Verbeek additionally teaches wherein the movable element extending portion and movable element indented portion are part of a plurality of movable element extending portions and movable element indented portions (See Figs. 2a-2c—serrated edges include a plurality of triangle shapes and corresponding indents) configured such that the movable longitudinal portion is, in general, tapering towards one of its longitudinal ends (Paragraph 0066-0068).
Regarding claim 11, Verbeek teaches the cylindrical instrument according to claim 6. Verbeek additionally teaches wherein the first further element is a second longitudinal element extending in the longitudinal direction of the tube (Paragraph 0066-0068--longitudinal protrusions 11 and at the longitudinal elements 2,3; Figs. 2a-2c—elements extend in the longitudinal direction of the tube).
Regarding claim 12, Verbeek teaches the cylindrical instrument according to claim 11. Verbeek additionally teaches wherein the second longitudinal element is attached to a bendable portion of the tube at a distal end of the tube such as to transfer a longitudinal movement of the second longitudinal element to a bending of the bendable portion (paragraph 0066-0068--a displacement of longitudinal element 2 for adjusting its length between the proximal 4 and distal 5 end portions of the steerable tube 1 for compensating a path length difference at least between longitudinal elements 2,3 as a result of bending of the flexible body of the steerable tube…the distal end portion 5 can be steered by manipulating the proximal end portion 4 of the steerable tube 1; Figs. 1a-1e and 2a-2c).
Regarding claim 35, Verbeek teaches the cylindrical instrument according to claim 11. Verbeek additionally teaches wherein at least one of the movable element extending portion and the first further element extending portion has a smooth surface (Fig. 2a-2c—the surfaces having the extending portions are smooth; paragraph 0066-0068).
Regarding claim 36, Verbeek teaches the cylindrical instrument according to claim 11. Verbeek additionally teaches wherein the movable element is a first longitudinal element extending in the longitudinal direction of the tube and the operating of the cylindrical instrument causes a mutual longitudinal displacement between the first longitudinal element and the first further element and the predetermined maximum operating limit is a maximum mutual longitudinal displacement (paragraph 0066-0068-- enabling the length of at least one longitudinal element 2 of the set of longitudinal elements 2,3 to be adjusted…, Figs. 2a-2c—displacement occurs in a longitudinal direction until a maximum is reached).
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alvarez in view of Wallace (US 11246726 B1).
Regarding claim 8, Alvarez teaches the cylindrical instrument according to claim 1.
However, Alvarez does not explicitly disclose wherein the maximum mutual longitudinal displacement has a value in a range of at least one of -0.5 to -40mm and +0.5 to +40mm.
Wallace, in the same field of endeavor of a cylindrical instrument including first and second longitudinal portions, discloses wherein the maximum mutual longitudinal displacement has a value in a range of at least one of -0.5 to -40mm and +0.5 to +40mm (Col. 17, line 40-42-- The maximum longitudinal separation along the opening 1614 may be in the range of 0.6 mm to 0.9 mm, 0.4 mm to 1 mm, or 0.2 mm to 1.2 mm.; Fig. 16M).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the instrument of Alvarez with the particular displacement of Wallace in order to predictably prevent undesired bending or weakness of the tube caused by too great of a displacement relative to the length of the device.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verbeek in view of Wallace (US 11246726 B1).
Regarding claim 8, Verbeek teaches the cylindrical instrument according to claim 7.
However, Verbeek does not explicitly disclose wherein the maximum mutual longitudinal displacement has a value in a range of at least one of -0.5 to -40mm and +0.5 to +40mm.
Wallace, in the same field of endeavor of a cylindrical instrument including first and second longitudinal portions, discloses wherein the maximum mutual longitudinal displacement has a value in a range of at least one of -0.5 to -40mm and +0.5 to +40mm (Col. 17, line 40-42-- The maximum longitudinal separation along the opening 1614 may be in the range of 0.6 mm to 0.9 mm, 0.4 mm to 1 mm, or 0.2 mm to 1.2 mm.; Fig. 16M).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the instrument of Verbeek with the particular displacement of Wallace in order to predictably prevent undesired bending or weakness of the tube caused by too great of a displacement relative to the length of the device.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alvarez in view of Thissen (US 20200129166 A1).
Regarding claim 15, Alvarez teaches the cylindrical instrument according to claim 1. However, Alvarez fails to explicitly disclose wherein the tube has a wall with a thickness in a range of 0.03-2.0 mm.
Thissen, in the same field of endeavor of a steerable instrument including a tube comprising a movable element and a further element, teaches wherein the tube has a wall with a thickness in a range of 0.03-2.0 mm (Paragraph 0104-- The thickness of the cylindrical elements may be in a range of 0.1-2.0 mm, preferably 0.1-1.0 mm, more preferably 0.1-0.5 mm, and most preferably 0.2-0.4 mm).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the instrument of Alvarez with the tube wall thickness of Thissen in order to predictably improve the device by ensuring that it has sufficient resilience and strength while also being small enough to maneuver throughout a desired location of a body.
Regarding claim 16, Alvarez teaches the cylindrical instrument according to claim 1. However, Alvarez fails to explicitly disclose wherein the tube has a diameter in a range of 0.5-20 mm.
Thissen, in the same field of endeavor of a steerable instrument including a tube comprising a movable element and a further element, teaches wherein the tube has a diameter in a range of 0.5-20 mm (Paragraph 0104-- The diameters of the cylindrical elements may be in a range of 0.5-20 mm, preferably 0.5-10 mm, more preferably 0.5-6 mm).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the instrument of Alvarez with the tube radius of Thissen in order to predictably improve the device by ensuring that it has sufficient resilience and strength while also being small enough to maneuver throughout a desired location of a body.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verbeek in view of Thissen (US 20200129166 A1).
Regarding claim 15, Verbeek teaches the cylindrical instrument according to claim 1. However, Verbeek fails to explicitly disclose wherein the tube has a wall with a thickness in a range of 0.03-2.0 mm.
Thissen, in the same field of endeavor of a steerable instrument including a tube comprising a movable element and a further element, teaches wherein the tube has a wall with a thickness in a range of 0.03-2.0 mm (Paragraph 0104-- The thickness of the cylindrical elements may be in a range of 0.1-2.0 mm, preferably 0.1-1.0 mm, more preferably 0.1-0.5 mm, and most preferably 0.2-0.4 mm).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the instrument of Verbeek with the tube wall thickness of Thissen in order to predictably improve the device by ensuring that it has sufficient resilience and strength while also being small enough to maneuver throughout a desired location of a body.
Regarding claim 16, Verbeek teaches the cylindrical instrument according to claim 1. However, Verbeek fails to explicitly disclose wherein the tube has a diameter in a range of 0.5-20 mm.
Thissen, in the same field of endeavor of a steerable instrument including a tube comprising a movable element and a further element, teaches wherein the tube has a diameter in a range of 0.5-20 mm (Paragraph 0104-- The diameters of the cylindrical elements may be in a range of 0.5-20 mm, preferably 0.5-10 mm, more preferably 0.5-6 mm).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the instrument of Verbeek with the tube radius of Thissen in order to predictably improve the device by ensuring that it has sufficient resilience and strength while also being small enough to maneuver throughout a desired location of a body.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verbeek in view of Longo (US 10449073 B1).
Regarding claim 13, Verbeek teaches the cylindrical instrument according to claim 1. Verbeek additionally teaches the movable element extending portion and movable element indented portion may have any shape (Paragraph 0066-0068).
However, Verbeek does not explicitly disclose wherein the movable element has a transition edge portion between the movable element extending portion and the movable element indented portion, wherein the transition edge portion has an obtuse angle relative to the movable element indented portion.
Longo, in analogous art of a medical instrument having parts which interlock via extending and indented portions, discloses wherein the transition edge portion has an obtuse angle relative to the movable element indented portion (Fig. 12; Col. 9, line 20-31-- Exemplary belt teeth are shown in FIG. 12. As illustrated in FIG. 12, exemplary belt teeth 471 may have a tapered shape with a flat top, e.g., trapezoidal cross-section, to allow for engagement with the barrel teeth 230 or groove 232. Although a trapezoidal cross section is shown, the teeth are not so limited and may be of any cross section that may engage with the barrel teeth sufficiently to allow belt movement to be actuated by barrel rotation. Other possible shapes, without limitation, include; without limitation, include circular, cylindrical, diamond, square, triangular or any variation thereof.).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the extending and indented portions of Verbeek with the particular shape of Longo as a matter of simple substitution of elements known in the art, in this case the substitution of a trapezoidal shape in place of the triangular shape protrusion and indentation.
Regarding claim 14, Verbeek teaches the cylindrical instrument according to claim 1. Verbeek additionally teaches the first further element extending portion and first further element indented portion may have any shape (Paragraph 0066-0068).
However, Verbeek does not explicitly disclose wherein the first further element has a transition edge portion between the first further element extending portion and the first further element indented portion, wherein the transition edge portion has an obtuse angle relative to the first further element indented portion.
Longo, in analogous art of a medical instrument having parts which interlock via extending and indented portions, discloses wherein the transition edge portion has an obtuse angle relative to the movable element indented portion (Fig. 12; Col. 9, line 20-31-- Exemplary belt teeth are shown in FIG. 12. As illustrated in FIG. 12, exemplary belt teeth 471 may have a tapered shape with a flat top, e.g., trapezoidal cross-section, to allow for engagement with the barrel teeth 230 or groove 232. Although a trapezoidal cross section is shown, the teeth are not so limited and may be of any cross section that may engage with the barrel teeth sufficiently to allow belt movement to be actuated by barrel rotation. Other possible shapes, without limitation, include; without limitation, include circular, cylindrical, diamond, square, triangular or any variation thereof.).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the extending and indented portions of Verbeek with the particular shape of Longo as a matter of simple substitution of elements known in the art, in this case the substitution of a trapezoidal shape in place of the triangular shape protrusion and indentation.
Conclusion
Claim 5 is not currently rejected under 35 U.S.C. 102/103. Alvarez, which discloses the limitations of claim 4, does not disclose and/or fairly suggest wherein the convex portion of the movable element has a center point, the movable element extending portion has a height and a curved side facing the first further element and is located on a circle with a radius about the center point, the first further element extending portion has a curved further side which is located on a further circle with a further radius about the center point and in the manufactured state is at a distance from the movable element, wherein the height and distance are equal within manufacturing tolerances.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA ROBERTS/Examiner, Art Unit 3791
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