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 .
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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 1 and 8-9 are objected to because of the following informalities:
Claim 1 recites the limitation “wherein the first wire and the second wire directly and circumferentially adjacent to one another” in lines 14-15, which it appears should instead recite “wherein the first wire and the second wire are directly and circumferentially adjacent to one another”.
Claim 8 recites the limitation “the plurality of first wires comprises first size and the plurality of second wires comprises a second size larger than the first size” in lines 2-3, which it appears should instead recite “the plurality of first wires comprises a first size and the plurality of second wires comprises a second size larger than the first size”.
Claim 9 recites the limitation “the plurality of second wires evenly distributed circumferentially” in lines 1-2, which it appears should instead recite “the plurality of second wires are evenly distributed circumferentially”.
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-12, 14, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stigall et al. (US Patent No. 10,413,273 B2), further in view of Nishihara et al. (US Patent No. 10,919,929 B2).
Regarding claim 1, Stigall et al. discloses an apparatus, comprising:
an intravascular imaging catheter (102) comprising:
a flexible elongate member (132) configured to be positioned within a blood vessel of a patient, wherein the flexible elongate member comprises a proximal portion and a distal portion (see Figures 2-3B);
an intravascular imaging sensor (138) disposed at the distal portion and configured to obtain an intravascular ultrasound (IVUS) image of the blood vessel or an optical coherence tomography (OCT) image of the blood vessel (see col. 6, lines 51-61 – “In some particular embodiments, the present disclosure incorporates a focusing transducer. The transducer may be a piezoelectric micromachined ultrasound transducer (PMUT) fabricated on a microelectromechanical system (MEMS) substrate using a polymer piezoelectric material, for example as disclosed in U.S. patent application Ser. No. 13/892,045, filed May 10, 2013, and/or U.S. Pat. No. 6,641,540, each of which is hereby incorporated by reference in its entirety. In some embodiments of the present disclosure, the IVUS imaging system 100 is a PMUT rotational IVUS imaging system” and col. 8, lines 22-25 – “In the illustrated embodiment, the PMUT MEMS 138 includes a spherically focused transducer 142 and carries an application-specific integrated circuit (ASIC) 144”); and
a reinforcement layer configured to support the flexible elongate member, wherein the reinforcement layer comprises a plurality of helically twisted wires (see col. 8, lines 17-22 – “In some embodiments, the flexible drive cable 132 of the imaging core 110 includes two or more layers of counter wound stainless steel wires, welded, or otherwise secured to the housing 116 such that rotation of the flexible drive cable also imparts corresponding rotation on the housing 116”).
It is noted Stigall et al. does not specifically teach the plurality of helically twisted wires comprises: a first wire comprising a first shape; and a second wire comprising a different, second shape, wherein the first wire and the second wire directly and circumferentially adjacent to one another. However, Nishihara et al. teaches a reinforcement layer configured to support the flexible elongate member, wherein the reinforcement layer comprises a plurality of helically twisted wires, wherein the plurality of helically twisted wires comprises: a first wire (3a, 3b, 3c, 3d, 3e, 3f, 3g, 3h) comprising a first shape (see Figures 1-3 and col. 4, lines 24-25 – “The first wire of the present embodiment (3a-3h) is substantially circular in a cross-sectional view”); and a second wire (5a, 5b, 5c, 5d, 5e, 5f, 5g, 5h) comprising a different, second shape (see Figures 1-3 and col. 4, lines 47-52 – “The second wire (5a-5h) of the present embodiment has a convex annular sector shape (arch shape) in the transverse plane radial direction. For example, the second wire 5a has an annular sector shape (arch shape) having a convex outer arc 5ap and a convex inner arc 5aq in the transverse plane radial direction as shown in FIG. 3”), wherein the first wire and the second wire directly and circumferentially adjacent to one another (see Figures 1-3 and col. 4, lines 60-67 – “Incidentally, in the tubular body 1 of the present embodiment, each end of two second wires adjacent to both sides of the first wire is in contact with each one point of the outside and inside. For example, in two second wires 5a and 5b adjacent to both sides of the first wire 3a, two ends of the outer side are in contact with one point 7a, the two ends of the inner side are also in contact with one point 9a as shown in FIGS. 1 to 3”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Stigall et al. to include the plurality of helically twisted wires comprises: a first wire comprising a first shape; and a second wire comprising a different, second shape, wherein the first wire and the second wire directly and circumferentially adjacent to one another, as disclosed in Nishihara et al., so as to prevent the deviations between the first wires and the second wires to improve the torque transmissibility and pushing force of the elongate member (see Nishihara et al.: col. 5, lines 37-40).
Regarding claim 2, Nishihara et al. teaches the first shape comprises a first cross-sectional shape and the second shape comprises a second cross-sectional shape (see Figures 1-3 and col. 4, lines 24-25 – “The first wire of the present embodiment (3a-3h) is substantially circular in a cross-sectional view” and col. 4, lines 47-52 – “The second wire (5a-5h) of the present embodiment has a convex annular sector shape (arch shape) in the transverse plane radial direction. For example, the second wire 5a has an annular sector shape (arch shape) having a convex outer arc 5ap and a convex inner arc 5aq in the transverse plane radial direction as shown in FIG. 3”).
Regarding claim 3, Nishihara et al. teaches the first shape comprises a circular shape and the second shape comprises a non-circular shape (see Figures 1-3 and col. 4, lines 24-25 – “The first wire of the present embodiment (3a-3h) is substantially circular in a cross-sectional view” and col. 4, lines 47-52 – “The second wire (5a-5h) of the present embodiment has a convex annular sector shape (arch shape) in the transverse plane radial direction. For example, the second wire 5a has an annular sector shape (arch shape) having a convex outer arc 5ap and a convex inner arc 5aq in the transverse plane radial direction as shown in FIG. 3”).
Regarding claim 4, Nishihara et al. teaches the first wire comprises a first size and the second wire comprises a second size larger than the first size (see Figures 1-3 and 7-9 and col. 7, lines 26-32 – “To produce the tubular body 10, firstly, a manufacturer prepares a stranded wire 12 configured to wind eight first wires (13a-13h) of circular cross-section and eight second wires (15a-15h) of circular cross-section, wherein the diameter of the second wire is larger than the diameter of the first wire, in a spiral manner around a circumference of a core wire 2”).
Regarding claim 5, Nishihara et al. teaches the first wire comprises a first size and the second wire comprises a different, second size (see Figures 1-3 and 7-9 and col. 7, lines 26-32 – “To produce the tubular body 10, firstly, a manufacturer prepares a stranded wire 12 configured to wind eight first wires (13a-13h) of circular cross-section and eight second wires (15a-15h) of circular cross-section, wherein the diameter of the second wire is larger than the diameter of the first wire, in a spiral manner around a circumference of a core wire 2”).
Regarding claim 6, Nishihara et al. teaches the plurality of helically twisted wires comprises: a plurality of first wires comprising the first shape (see Figures 1-3 and col. 4, lines 24-25 – “The first wire of the present embodiment (3a-3h) is substantially circular in a cross-sectional view”); and a plurality of second wires comprising the second shape (see Figures 1-3 and col. 4, lines 47-52 – “The second wire (5a-5h) of the present embodiment has a convex annular sector shape (arch shape) in the transverse plane radial direction. For example, the second wire 5a has an annular sector shape (arch shape) having a convex outer arc 5ap and a convex inner arc 5aq in the transverse plane radial direction as shown in FIG. 3”), wherein the plurality of first wires and the plurality of second wires are directly and circumferentially adjacent to one another (see Figures 1-3 and col. 4, lines 60-67 – “Incidentally, in the tubular body 1 of the present embodiment, each end of two second wires adjacent to both sides of the first wire is in contact with each one point of the outside and inside. For example, in two second wires 5a and 5b adjacent to both sides of the first wire 3a, two ends of the outer side are in contact with one point 7a, the two ends of the inner side are also in contact with one point 9a as shown in FIGS. 1 to 3”).
Regarding claim 7, Nishihara et al. teaches a first quantity of the plurality of first wires is different than a second quantity of the plurality of second wires (see Figures 1-3 and 12-13 and col. 5, lines 44-49 – “In the present embodiment, the number of the first wire and the second wire is eight each, it is not limited to eight. Two or more first wires and two or more second wires may be used in a tubular body. That is, it may be a tubular body comprising a plurality of first wires and a plurality of second wires” and col. 11, lines 17-24 – “The tubular body 30 of the present embodiment differs from the tubular body 10 of the second embodiment, each of first wires (33a˜33h) is configured to wind seven fourth wires. Specifically, the first wire 33a is configured to wind seven fourth wires (33a1, 33a2, 33a3, 33a4, 33a5, 33a6, 33a7), the first wire 3b is configured to wind seven fourth wires (33b1, 33b2, 33b3, 33b4, 333b5, 33b6, 33b7) as shown in FIG. 13”).
Regarding claim 8, Nishihara et al. teaches the plurality of first wires comprises first size and the plurality of second wires comprises a second size larger than the first size (see Figures 12-13), wherein the first quantity is larger than the second quantity (see col. 5, lines 44-49 – “In the present embodiment, the number of the first wire and the second wire is eight each, it is not limited to eight. Two or more first wires and two or more second wires may be used in a tubular body. That is, it may be a tubular body comprising a plurality of first wires and a plurality of second wires” and col. 11, lines 17-24 – “The tubular body 30 of the present embodiment differs from the tubular body 10 of the second embodiment, each of first wires (33a˜33h) is configured to wind seven fourth wires. Specifically, the first wire 33a is configured to wind seven fourth wires (33a1, 33a2, 33a3, 33a4, 33a5, 33a6, 33a7), the first wire 3b is configured to wind seven fourth wires (33b1, 33b2, 33b3, 33b4, 333b5, 33b6, 33b7) as shown in FIG. 13”).
Regarding claim 9, Nishihara et al. teaches the plurality of second wires evenly distributed circumferentially (see Figures 1-3).
Regarding claim 10, Nishihara et al. teaches in a cross-section of the plurality of helically twisted wires, one of the plurality of second wires is positioned at a 12 o’clock position and one of plurality of second wires is positioned at a 6 o’clock position (see Figures 1-3).
Regarding claim 11, Nishihara et al. teaches in the cross-section of the plurality of helically twisted wires, one of the plurality of second wires is positioned at a 3 o’clock position and one of plurality of second wires is positioned at a 9 o’clock position (see Figures 1-3).
Regarding claim 12, Nishihara et al. teaches a subset of the plurality of first wires (33a1, 33a2, 33a3, 33a4, 33a5, 33a6, 33a7)is positioned between two of the plurality of second wires (35a, 35b), wherein the subset comprises more than two of the plurality of first wires (see Figure 13).
Regarding claim 14, Nishihara et al. teaches the plurality of helically twisted wires comprises an inner profile and an outer profile, wherein at least one of the inner profile or the outer profile is constant (see Figures 1-3 and col. 4, lines 19-23 – “Further, the tubular body 1 includes a substantially circular outer peripheral surface and a substantially circular inner peripheral surface in a cross-sectional view, and the tubular body 1 forms a hollow portion 6 in an inside of the inner peripheral surface thereof”).
Regarding claim 16, Stigall et al. teaches the flexible elongate member further comprises an outer polymer layer (160), wherein the outer polymer layer is positioned around the plurality of helically twisted wires (see Figure 3B and col. 9, lines 18-28 – “The polymer layer 160 may be fixedly secured to the drive shaft 132 so that it is positioned between the sheath 112 and the imaging core 110 to facilitate low-friction, uniform rotation of the drive cable transducer 142. The polymer layer 160 can be formed of a material having less friction than the drive cable 132. For example, the polymer layer 160 may include high-density polyimide ethylene (HDPE) material, low-density polyimide ethylene (LDPE) material, or polyimide ethylene (PE) material. The polymer layer 160 may also include nylon, pebax, or any other common metric material”).
Regarding claim 17, Stigall et al. teaches the intravascular imaging catheter further comprises one or more signal lines (134) coupled to the intravascular imaging sensor, wherein the flexible elongate member comprises a lumen configured to accommodate a guidewire and the one or more signal lines (see Figures 3A-B and col. 8, lines 36-42 – “An electrical cable 134 with optional shield 136 is attached to the ASIC/MEMS hybrid assembly 146 with solder 140. The electrical cable 134 extends through an inner lumen of the flexible drive cable 132 to the proximal end of the imaging core 110 where it is terminated to the electrical connector portion of the rotational interface 114 shown in FIG. 2”).
Regarding claim 18, Stigall et al. teaches the plurality of the helically twisted wires is configured to stiffen the flexible elongate member for movement into an obstruction within the blood vessel without kinking (see col. 11, lines 17-22 – “Thus, the tightly wound sections 150 form flexible radiopaque markers that are capable of curving with the catheter 102 as it traverses through tortuous anatomy without causing the inadvertent catheter kinking and/or trauma that can be caused by rigid marker bands”.
Claim(s) 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stigall et al. and Nishihara et al., further in view of Ishikawa (US Patent No. 9,597,481 B2).
Regarding claim 13, it is noted neither Stigall et al. nor Nishihara et al. specifically teach the plurality of helically twisted wires comprises an inner profile and an outer profile, wherein at least one of the inner profile or the outer profile is varying. However, Ishikawa teaches the plurality of helically twisted wires comprises an inner profile and an outer profile, wherein at least one of the inner profile or the outer profile is varying (see Figures 5-6 and col. 4, lines 35-42 – “The thick wires 45b are not ground at the proximal end portion 34b of the catheter 3, and thus unevenness may form on the outer peripheral surface of the coil body 34, as shown in FIG. 5. This may moderately increase and thus secure sliding resistance at the proximal end portion 34b of the catheter 3, which makes it possible to easily fix the catheter 3 inserted in, for example, a lumen of a blood vessel at a desired position”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Stigall et al. and Nishihara et al. to include the plurality of helically twisted wires comprises an inner profile and an outer profile, wherein at least one of the inner profile or the outer profile is varying, as disclosed in Ishikawa, so as to moderately increase the sliding resistance at the proximal end of the catheter so as to easily fix the catheter in a lumen of a blood vessel at a desired position (see Ishikawa: col. 4, lines 38-42).
Regarding claim 15, it is noted neither Stigall et al. nor Nishihara et al. specifically teach the flexible elongate member further comprises an inner polymer layer, wherein the plurality of helically twisted wires is positioned around the inner polymer layer. However, Ishikawa teaches the flexible elongate member further comprises an inner polymer layer (20), wherein the plurality of helically twisted wires (30, 41, 42) is positioned around the inner polymer layer (see Figure 2 and col. 2, lines 59-67 – “As illustrated in FIG. 2, the catheter shaft 10 is a tubular structural body that may include an inner layer 20, a coil body 30 as a reinforcing layer covering the inner layer 20, and an outer layer 50 covering the coil body 30. The inner layer 20 may be formed of resin. The resin material forming the inner layer 20 is not especially limited. However, polytetrafluoroethylene (PTFE) is a preferred material considering slidability with an inserted instrument (for example, a guide wire or a catheter)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Stigall et al. and Nishihara et al. to include the flexible elongate member further comprises an inner polymer layer, wherein the plurality of helically twisted wires is positioned around the inner polymer layer, as disclosed in Ishikawa, so as to improve slidability with an inserted instrument such as a guide wire (see Ishikawa: col. 2, lines 65-67).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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