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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-15 drawn to a steerable medical device with a distal end of the first wire is fixed relative to a distal end the second wire classified in A61B1/01
II. Claim 16-17, drawn to a steerable medical device having a distance between the first portion of the first wire and the second wire is smaller than a distance between the second portion of the first wire and the second wire, classified in A61B1/008.
III. Claim 18-20, drawn to steerable medical device having a cross-sectional width of the first wire varies along a length of the first wire such that a distance between the first wire and the second wire varies, classified in A61B1/012.
The inventions are independent or distinct, each from the other because:
Inventions I-III are directed to related products The related inventions are distinct if:
(1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect;
(2) the inventions do not overlap in scope, i.e., are mutually exclusive; and
(3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j).
In the instant case, the inventions as claimed have structural differences that would result in materially different design, mode of operation, function, or effect, for example the product of Group I requires a distal end of a first wire to be fixed relative to a distal end of a second wire, that the products of Groups II-III do not require. The product of Group II requires a device with a a distance between the first portion of the first wire and the second wire is smaller than a distance between the second portion of the first wire and the second wire, that the products of Groups I and III do not require.
The product of Group III requires, a cross-sectional width of the first wire varies along a length of the first wire such that a distance between the first wire and the second wire varies, that the products in Groups I and I do not require.
Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: the inventions require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Juan Gutierrez on August 13, 2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Objections
Claim 1 is objected to because of the following informalities: line 6 reads “relative to a distal end the second wire” it should be “of the second wire”.
Appropriate correction is required.
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.
Claim(s) 1-5, 7- 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamada et al. (US 20190335977) hereinafter Yamada.
Regarding claim 1, Yamada teaches a steerable medical device comprising:
a first wire (32a); and a second wire (32b)
wherein the first wire includes a first portion having a first width (see figure 1b, width direction H) and a second portion having a second width (diameter 30a of the first wire), wherein the second width is smaller than the first width (see Figures 1a-1c),
wherein a distal end of the first wire is fixed relative to a distal end the second wire (by means of sheath 2), and wherein a proximal end of one or more of the first wire or the second wire is moveable distally or proximally with respect to the other of the first wire or the second wire in order to bend a distal portion of the steerable medical device (see figure 5).
Regarding claim 2, Yamada teaches the first portion has a D-shaped cross-section or a round cross-section (See Figure 3).
Regarding claim 3, Yamada teaches a central longitudinal axis of the first portion is offset from a central longitudinal axis of the second portion (see Figure 1a-1c).
Regarding claim 4, Yamada teaches the second wire (32b) includes a third portion having a third width (width of 32b, in the width direction H shown in figures 1b-1c) and a fourth portion having a fourth width (diameter), wherein the fourth width is smaller than the third width (see Figure 1a-1c).
Regarding claim 5, Yamada teaches a flat surface of the first portion faces a flat surface of the third portion (see figure 3).
Regarding claim 7, Yamada teaches the first portion, the second portion, and the third portion are covered by a coating or a sheath (2), and wherein the fourth portion is uncovered by the coating or the sheath (the D-shaped face section of the fourth portion is not covered by the sheath 2).
Regarding claim 8, Yamada teaches the second wire has a uniform width along an entire length of the second wire (the second width is uniform along the length).
Regarding claim 9, The steerable medical device of claim 1, wherein the first wire (32a) further includes a third portion (portion from the flat surface to the most curved portion of the first wire) having a third width, and wherein the second width is smaller than the third width (of the first wire), See figure 3.
Regarding claim 10, Yamada teaches wherein the second portion is between the first portion and the third portion (see Figure 3).
Regarding claim 11, Yamada teaches the first width is approximately the same as the third width (see Figure 3).
Claim(s) 1, 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chikama (US 5106381).
Regarding claim 1, Chikama teaches a steerable medical device comprising:
a first wire (51); and a second wire (51)
wherein the first wire includes a first portion having a first width (length of wire) and a second portion having a second width (diameter of the first wire), wherein the second width is smaller than the first width (see Figures 1 and 3),
wherein a distal end of the first wire is fixed relative to a distal end the second wire (See Fig2-3, col. 4, lines 17-25), and wherein a proximal end of one or more of the first wire or the second wire is moveable distally or proximally with respect to the other of the first wire or the second wire in order to bend a distal portion of the steerable medical device (See figure 1, col. 4 lines 35-65).
Regarding claim 13, Chikama teaches a handle (10) having an actuator (10) that is configured to move a proximal end of the first wire (Refer to col. 3 lines 66-68, col. 4, lines 53-65, when the manipulating dial 12 is angularly moved in a clockwise direction, the operating wire 51 is pulled).
Regarding claim 14, Chikama teaches a proximal end of the second wire is fixed relative to the handle (Refer to col. 3, lines 66-68).
Regarding claim 15, Chikama teaches the actuator is configured to transition between a first configuration, in which the actuator is disengaged from the first wire and a second configuration, in which the actuator is engaged with the first wire (in the clockwise configuration wire 52 is loosened from the actuator 12, and when in the counterclockwise configuration wire 51 is loosened. See Col. 4, lines 35-65).
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamada in view of Hammerslang et al. (US 5203772) hereinafter Hammerslang.
Regarding claim 6, Yamada teaches a wire is positioned between the flat surface of the first portion and the flat surface of the third portion (present via a wire or a tube (Not shown, Refer to paragraph [0102]) that is disposed between them.
Yamada fails to explicitly teach the wire or tube is flat.
Hammerslang teaches a flat wire (202) between two steering tubes (see Figure 21).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use a flat wire between the first and third portions of the wires of Yamada, as taught by Hammerslang, since a flat wire would fit between the parts without creating a bulge.
Claim(s) 12, is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamada in view of Ash et al. (US 2011/0313401) hereinafter Ash.
Regarding claim 12, Yamada fails to explicitly teach the first wire includes a tapered portion tapering between the first width and the second width.
Ash teaches a first wire including a tapered portion (114- See Figures 6-8, Paragraph 52) tapering between the first width and the second width.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have a tapering distal tip in the device of Yamada, as taught by Ash, since doing so can increase the flexibility of the distal tip of the wire.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDELMIRA BOSQUES whose telephone number is (571)270-5614. The examiner can normally be reached 9:00am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edelmira Bosques can be reached at 571-270-5614.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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