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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 10.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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 Objections
Claims 4-5, 7, and 14-15 are objected to because of the following informalities:
Claim 4, line 1 “the telescopic elements” should be “the at least two telescopic elements”.
Claim 5, line 1 “the telescopic elements” should be “the at least two telescopic elements”.
Claim 7, line 4 “(5b)” and “(8)” should be removed for consistency with the rest of the claims, which have been amended to remove references to elements of the drawings.
Claim 7, line 3 and 5-6 “the telescopic elements” should be “the at least two telescopic elements”.
Claim 14, line 2 “(4)” should be removed for consistency with the rest of the claims, which have been amended to remove references to elements of the drawings.
Claim 15, “wherein the connecting portion is located opposite an outlet for the catheter from the handle” should be “the connection portion is located at an opposite end of the handle from the catheter” or similar, as the current claim construction implies the connecting portion is located opposite from an outlet and from the handle.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-1 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.
Regarding claims 1 and 12, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 12 recites the limitation “its front end”. The limitation is unclear as “its” may refer to either the holder or the connecting portion. The limitation is currently interpreted as referring to a front end of the holder.
Claims 2-16 are additionally rejected under 35 U.S.C. 112(b) as indefinite due to their dependence on claim 1, which has been rejected as indefinite.
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, 5, and 8-15 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Ishida (US 20180207406 A1).
Regarding claim 1, Ishida discloses a holder (14) for connecting to a handle (Catheter operation member 24 including operation plate portion 54 which includes tabs 60, 62; paragraph 0110-0112) and for holding a guidewire (80) and positioning a catheter relative to the guidewire during a vascular treatment (Paragraph 0013-0016),
the holder comprising a capturing portion (84), a connecting portion (Needle hub 22 including First fitting portion 48), and a translating portion (Guide member 82, Body portion 88, Cover 86 including Tubular members 104, 106, 108), wherein the capturing portion is connected to the translating portion, and the translating portion is connected to the connecting portion (See arrangement in Fig. 1),
- the capturing portion configured for capturing the guidewire to restrict movement, in particular rotation and translation, of the guidewire relative to the capturing portion (Paragraph 0125, 0136--wire operation member 84 fixed to a proximal end portion of the guide wire 80…wire operation member 84 is configured to support the guide wire 80, be capable of performing relative displacement in the axial direction with respect to the guide member 82, and moves the guide wire 80 with respect to the guide member 82 along with the displacement. In the present embodiment, the wire operation member 84 is a narrow round bar-shaped member and is fixed to the proximal end portion of the guide wire 80),
- the connecting portion configured for connecting the holder to the handle to restrict movement, in particular rotation, between the connecting portion and the handle (Fig. 1; paragraph 0105, 0127, 0154),
- the translating portion configured for translating the capturing portion relative to the connecting portion between a shortened state and an extended state of the holder along a length direction, while the guidewire is captured by the capturing portion, wherein the translating portion is configured to shorten and extend the holder in the length direction, while rotation of the translating portion relative to the capturing portion and the connecting portion is restricted (Paragraph 0138-0141-- The cover 86 is formed in a hollow cylindrical shape so as to cover the guide wire 80 between the guide member 82 and the wire operation member 84 in the initial state, and is configured to axially contract as the wire operation member 84 moves in the distal end direction with respect to the guide member 82. In the present embodiment, the cover 86 has a telescopic structure in which a plurality of tubular members having different sizes is combined so as to be relatively movable in the axial direction….first tubular member 104 is formed to have a smaller diameter than the body portion 88 of the guide member 82 and is inserted inside the body portion 88 so as to be axially slidable…),
- such that the holder is configured to facilitate relative movement between the catheter and the guidewire in the length direction while restricting rotation of the guidewire relative to the handle (Paragraph 0009-0014, 0136-0141--he wire operation member 84 is configured to support the guide wire 80, be capable of performing relative displacement in the axial direction with respect to the guide member 82, and moves the guide wire 80 with respect to the guide member 82 along with the displacement…).
Regarding claim 2, Ishida teaches the holder of claim 1. Ishida additionally teaches wherein the translating portion is configured to house a section of the guidewire when the translating portion is in the retracted state or the extended state (Paragraphs 0136-0141; Fig. 1, 9 shows the wire 80 housed in the translating portion in an extended state while Fig. 10 shows the guidewire housed in the translating portion in the retracted state).
Regarding claim 3, Ishida teaches the holder of claim 1. Ishida additionally teaches wherein the translating portion includes at least two telescopic elements which are configured to telescope relative to each other in the length direction of the guidewire (Paragraphs 0136-0141; Guide member 82, Body portion 88, Cover 86 including Tubular members 104, 106, 108), the capturing portion being stationary relative to at least one of the at least two telescopic elements (Capturing element 84 is stationary relative to tube member 108, Figs. 1, 9-10) and the connecting portion being stationary relative to the other one of the at least two telescopic elements (Connecting portion 48 is stationary relative to guide member 82/body portion 88, Figs. 1, 9-10).
Regarding claim 4, Ishida teaches the holder of claim 3. Ishida additionally teaches wherein each of the telescopic elements has a length between 50 and 300 mm (Paragraph 0090; Figs. 1, 9-10).
Regarding claim 6, Ishida teaches the holder of claim 3. Ishida additionally teaches wherein the at least two telescopic elements comprise an inner telescopic element and an outer telescopic element at least partially receiving the inner telescopic element (Paragraphs 0136-0141; Figs. 1, 9-10).
Regarding claim 8, Ishida teaches the holder of claim 1. Ishida additionally teaches wherein the connecting portion is configured to establish a friction fit relative to the handle (Paragraph 0102-0106, 0110-0115, Figs. 1-2).
Regarding claim 9, Ishida teaches the holder of claim 1. Ishida additionally teaches wherein the capturing portion is configured to establish a friction fit relative to the guidewire (Paragraph 0125, 0136).
Regarding claim 10, Ishida teaches the holder of claim 1. Ishida additionally teaches wherein the capturing portion is configured to establish a form fit relative to the translating portion (Form fit via mating portions of elements 48 and 90, Fig. 1; paragraph 0105, 0127, 0132).
Regarding claim 11, Ishida teaches the holder of claim 1. Ishida additionally teaches wherein the capturing portion is provided at a rear end of the holder (Fig. 1, 9-10 show the capturing portion at a rear end, opposite the end having the catheter 16).
Regarding claim 12, Ishida teaches the holder of claim 1. Ishida additionally teaches wherein the holder, in particular the connecting portion, is configured to connect at its front end to a rear end of the handle (See Fig. 1-2—connecting portion 22 positioned at a rear of the handle).
Regarding claim 13, Ishida teaches the holder of claim 1. Ishida additionally teaches wherein components are positioned in the following order from a front end to a rear end of the holder: connecting portion, translating portion, capturing portion (See Figs. 1, 9-10).
Regarding claim 14, Ishida teaches a set comprising the handle and the holder of claim 1. Ishida additionally teaches wherein the connecting portion connects the handle and the holder (See Figs. 1-2).
Regarding claim 15, Ishida teaches the set of claim 14. Ishida additionally teaches wherein the connecting portion is located opposite an outlet for the catheter from the handle (See Fig. 1-2—connecting portion 22 positioned at a rear of the handle opposite the catheter outlet).
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) 5 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishida in view of Felkins (US 20170043137 A1).
Regarding claim 5, Ishida teaches the holder of claim 3. Ishida additionally teaches wherein each of the telescopic elements are tubular (Figs. 1, 9-10) and each have a diameter of less than the next tubular element (Paragraph 0019, 0138, 0182; Figs. 1, 9-10).
However, Ishida does not explicitly disclose wherein each of the telescopic elements are tubular and each have a diameter of less than 20 mm.
Felkins, in the same field of endeavor of a device for manipulating a guidewire, discloses that a guidewire ranges in diameter from 0.299mm to 0.965mm (Paragraph 0020). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the diameters of the telescopic elements to be as small as possible while remaining capable of passing the guidewire therethrough, thus having a diameter of less than 20mm, in order to minimize the materials and cost of the device.
Regarding claim 16, Ishida teaches the holder of claim 1. However, Ishida does not explicitly disclose an atherectomy or thrombectomy system.
Felkins, in the same field of endeavor of a device for manipulating a guidewire, discloses that a guidewire manipulation device capable of capturing a guidewire and increasing pushability of the guidewire may be used in thrombectomy or atherectomy devices (Paragraph 0020-0021).
It would have been obvious to one having ordinary skill in the art at the time of filing to have applied a holder as described by Ishida to alternative fields of use which require translation of a guidewire such as atherectomy or thrombectomy as a substitution for other guidewire manipulation means.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishida in view of Jamous (US 20220287737 A1).
Regarding claim 7, Ishida teaches the holder of claim 3. However, Ishida does not explicitly disclose wherein one of the at least two telescopic elements at least partially comprises a receiving feature extending along a length direction of the telescopic elements; and the other one of the at least two telescopic elements (Sb) comprises an engagement feature (8)at least partially received in the receiving feature such that rotation of the telescopic elements relative to each other is restricted and translation of the telescopic elements relative each other in the length direction is possible.
Jamous, in analogous art of telescoping elements in a catheter holding device, discloses wherein one of the at least two telescopic elements at least partially comprises a receiving feature extending along a length direction of the telescopic elements; and the other one of the at least two telescopic elements comprises an engagement feature at least partially received in the receiving feature such that rotation of the telescopic elements relative to each other is restricted and translation of the telescopic elements relative each other in the length direction is possible (Paragraph 0036-- a pair of tracks 237 (only one is shown) extending longitudinally along opposite exterior side surfaces of the guide section… The tracks 237 are configured to receive tabs of respective slides 233 on the proximal guide section 231A to guide movement of the intermediate guide section 231B relative to the proximal guide section…; Figs. 7-10).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the telescoping elements of Ishida with the tracks and tabs of Jamous in order to predictably improve the device by increasing the strength and stability of the telescoping elements which would prevent accidental non-translational movement.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Burkholz (US 20190321590 A1) discloses a holder as claimed in claim 1.
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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