DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Objections
Claim 32 is objected to because of the following informalities: line 2 should be amended to – the first structural member is in [[the]] a lumen of the elongated tube-. Appropriate correction is required.
Claim 40 is objected to because of the following informalities: line 9 should be amended to – [[wherien]] wherein the first actuating element -. Appropriate correction is required.
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.
The following claim limitations
first actuating element (claims 21, 31 and 40)
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
element (first actuating element - claims 21, 31 and 40)
coupled with functional language
actuatable to induce stress and/or displacement at the first structural member to cause the elongated tube to bend (first actuating element - claims 21, 31 and 40)
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 21, 31 and 40 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
a piezo element, a balloon, an electroactive polymer, or a shape-memory element (¶0017 in the specification)(first actuating element - claims 21, 31 and 40)
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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.
Claims 21-32 and 34-40 rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20100228191 A1 to Alvarez et al. (Alvarez).
Alvarez discloses:
Regarding claim 21:
A medical device (figures 8a-8c and 13a-13c), comprising:
an elongated tube (72, 90, 92, 94, 96 and 98) having a wall (58/60) and an opening (see the opening A in figure 1 below) at the wall;
a first structural member (31) associated with the opening at the wall of the elongated tube (adjacent to the opening A in figure 1 below);
a second structural member (see the second structural member B in figure 1 below);
a bridging element (29) located between the first structural member and the second structural member (as shown in figure 1 below), wherein the bridging element is fixedly coupled to the first structural member and the second structural member (29 is fixedly connected to 31 and B as shown in figure 1 below); and
a first actuating element (132/134/136/138) coupled to the bridging element (16) (the first actuating element 132/134/136/138 is coupled to the wall 56/60 which is coupled to the bridging element 31), the first actuating element (132/134/136/138) actuatable to induce stress and/or displacement at the first structural member (31) to cause the elongated tube (72, 90, 92, 94, 96 and 98) to bend (as shown in figure 13b or 13c the actuating element 132/134/136/138 results in the deformation or bending of the tube 72, 90, 92, 94, 96 and 98).
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Figure 1 – figure 13a of Alvarez, annotated by the examiner
Regarding claim 22:
The medical device of claim 21, wherein the elongated tube (72, 90, 92, 94, 96 and 98) comprises a lumen (catheter as described in ¶0001), and wherein a portion of the first structural member (31) is in the lumen (see the termination units 118 or termination structures 129 as shown in figure 8a that are connected to and part of first structural member 14/12 and that extend into the lumen within the tube) of the elongated tube.
Regarding claim 23:
The medical device of claim 21, wherein the elongated tube comprises a lumen (catheter as described in ¶0001), and wherein at least a part of the first actuating element (132/134/136/138) is in the lumen (132, 134, 136 and 138 extend through the lumen as shown in figure 8a) of the elongated tube (72, 90, 92, 94, 96 and 98).
Regarding claim 24:
The medical device of claim 21, wherein the first structural member (12/14) is at a first radial distance (on the exterior of 60/58) from a longitudinal axis of the elongated tube (72, 90, 92, 94, 96 and 98), wherein a center of the first actuating element (132/134/136/138) is at a second radial distance (the first actuating element is within the elongated tube and therefore closer to the longitudinal axis then the first structural member) from the longitudinal axis of the elongated tube (72, 90, 92, 94, 96 and 98), and wherein the first radial distance is larger than the second radial distance (first structural member is on the exterior of tubing 58/60 (first distance) and the first actuating element is within the elongated tube 58/60 (second distance) and therefore the first distance is larger than the second distance).
Regarding claim 25:
The medical device of claim 21, wherein the first actuating element (132/134/136/138) is configured to apply a force (force exerted by 132/134/136/138) to the first structural member (12/14) in a direction that is non-parallel (when tubing 72, 90, 92, 94, 96 is bent as shown in figures 8b/8c the force is not parallel to the longitudinal axis of 72, 90, 92, 94, 96) to a longitudinal axis of the elongated tube (72, 90, 92, 94, 96 and 98).
Regarding claim 26:
The medical device of claim 21, further comprising a user interface (76) configured to allow a user to provide an input for provisioning a control signal (¶0049 indicates electromechanically manipulated), the control signal being an electrical signal (¶0049 indicates electromechanically manipulated) or a radiofrequency signal, wherein the first actuating element (132/134/136/138) is actuatable in response to the control signal (as indicated in ¶0049), wherein the user interface (76) is at a handle or at an electronic device (76) communicatively coupled with a part of the medical device (¶0049 and ¶0054).
Regarding claim 27:
The medical device of claim 21, wherein the first actuating element (132/134/136/138) is actuatable to induce the stress and/or the displacement at the first structural member (31) in response to electrical energy (¶0049 indicates electromechanically manipulated), radiofrequency energy, heat, pressure, or fluid.
Regarding claim 28:
The medical device of claim 21, further comprises a second actuating element (second cable of 134 on the opposite side (C as shown in figure 2 below) of the tubing as shown in figure 8a-8c), wherein the first actuating element (132/134/136/138 on side B as shown in figure 2 below) is actuatable to cause the elongated tube (72, 90, 92, 94, 96 and 98) to bend by a first amount (the actuators on side B result in the tubing bending as shown in figure 8b), and wherein the first actuating element (132/134/136/138) and the second actuating element are actuatable to cause the elongated tube (72, 90, 92, 94, 96 and 98) to bend by a second amount (as shown in figure 8c as shown in figure 8c with the serpentine shape because of actuators on side B and C in figure 2 below) that is different from the first amount (bending in figure 8b is different from the bending as shown in figure 8c).
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Figure 2 – figure 8a of Alvarez, annotated by the examiner
Regarding claim 29:
The medical device of claim 21, wherein the first actuating element (132/134/136/138) is actuatable to cause the elongated tube (72, 90, 92, 94, 96 and 98) to bend by a first amount (amount as shown in figure 8b), and also actuable to cause the elongated tube (72, 90, 92, 94, 96 and 98) to bend by a second amount (amount as shown in figure 8c) that is different from the first amount (see different bending as shown in figure 8b or 8c).
Regarding claim 30:
The medical device of claim 21, wherein the elongated tube (72, 90, 92, 94, 96 and 98) is a part of a catheter (¶0001), a guidewire, or an implant.
Regarding claim 31:
A medical device (figures 8a-8c and 13a-13c), comprising:
an elongated tube (72, 90, 92, 94, 96 and 98) having a wall (58/60) and an opening (A in figure 1 above) at the wall (58/60);
a first structural member (31) associated with the opening (A in figure 1 above) at the wall of the elongated tube (adjacent to the opening A in figure 1 below); and
a first actuating element (132/134/136/138) actuatable to induce stress and/or displacement at the first structural member (31) to cause the elongated tube (72, 90, 92, 94, 96 and 98) to bend (as shown in figure 8a-8c the actuating element 132/134/136/138 results in the deformation or bending of the tube 72, 90, 92, 94, 96 and 98 and the included structural member 12/14);
wherein the elongated tube (72, 90, 92, 94, 96 and 98) comprises a first longitudinal side (see the longitudinal side F in figure 3 below) and a second longitudinal side (see the longitudinal side G in figure 3 below) that is opposite from the first longitudinal side (as shown in figure 3 below), and wherein at least a part of the first actuating element (130/132/134/136/138 in 78 which extends transverse to the axis of 72 as shown in figure 8a or 3 below) extends transversely with respect to a longitudinal axis of the elongated tube (as shown in figure 8 within 78) from a first position (see position of 138 at location H) to a second position (see position of 138 at location I), the first position being closer to the first longitudinal side than the second longitudinal side (as shown in figure 3 below H is closer to side F than G), the second position being closer to the second longitudinal side (as shown in figure 3 below I is closer to side G than F) than the first longitudinal side.
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Figure 3 – figures 8a-8c of Alvarez, annotated by the examiner
Regarding claim 32:
All limitations of the claim are taught by the 35 USC 102 rejection of claim 22 by Alvarez.
Regarding claim 34:
All limitations of the claim are taught by the 35 USC 102 rejection of claim 25 by Alvarez.
Regarding claim 35:
All limitations of the claim are taught by the 35 USC 102 rejection of claim 26 by Alvarez.
Regarding claim 36:
All limitations of the claim are taught by the 35 USC 102 rejection of claim 27 by Alvarez.
Regarding claim 37:
All limitations of the claim are taught by the 35 USC 102 rejection of claim 28 by Alvarez.
Regarding claim 38:
All limitations of the claim are taught by the 35 USC 102 rejection of claim 27 by Alvarez.
Regarding claim 39:
All limitations of the claim are taught by the 35 USC 102 rejection of claim 30 by Alvarez.
Regarding claim 40:
A medical device (figures 8a-8c and 13a-13c), comprising:
an elongated tube (72, 90, 92, 94, 96 and 98) having a wall (58/60) and an opening (A in figure 1 above) at the wall;
a first structural member (31) associated with the opening (A in figure 1 above) at the wall of the elongated tube (adjacent to the opening A in figure 1 below); and
a first actuating element (132/134/136/138) actuatable to induce stress and/or displacement at the first structural member (31) to cause the elongated tube to bend (as shown in figure 13b or 13c the actuating element 132/134/136/138 results in the deformation or bending of the tube 72, 90, 92, 94, 96 and 98);
wherein the elongated tube (72, 90, 92, 94, 96 and 98) comprises a lumen (catheter as described in ¶0001), and wherein at least a part of the first actuating element (132/134/136/138) is in the lumen (132, 134, 136 and 138 extend through the lumen as shown in figure 8a) of the elongated tube (72, 90, 92, 94, 96 and 98); and
wherien the first actuating element (132/134/136/138) is configured to apply a force in a direction to induce the stress and/or displacement (see the stress/bending of 31 in figures 13a-13c) at the first structural member (31), and wherein the force has a major force component that is non-parallel with respect to a longitudinal axis of the elongated tube (see figures 8a-8c where the major force component of 132/134/136/138 extends transverse or non-parallel to the longitudinal axis of 72 in the structure 76).
Response to Arguments
Applicant's arguments filed 7/31/26 have been fully considered but they are not persuasive.
Regarding the 35 USC 102 rejections of the claims:
The applicant’s amendments to the claims are persuasive regarding the embodiment shown in figures 3 and 4 and for this reason the above rejections have been modified to the embodiment shown in figures 13a-13c. The embodiment shown in figures 13a-13c reads on the claims and for this reason the above rejections are maintained.
Regarding the drawing objections:
The applicant’s amendments to the figures have addressed the previous drawing objections and for this reason they have been accepted.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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