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 .
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 3/24/26. The claims 1-20 are pending. The claims 1, 13, and 16 are amended.
Response to Arguments
Applicant’s arguments, filed 3/24/26 with respect to the rejections of claims 1-20 under 103 as being unpatentable over Sawa (US2006/0025720) in view of Gonzalez (WO2016/160348) and Mugan (US2018/0235585) have been fully considered but are not persuasive. Applicant argues, the combination does not teach the distal portion of the wire being fixed on a portion in a circumferential direction of an inner peripheral surface of the tubular member as recited in claim 1, where the distal portion of the wire is provided at a portion in a circumferential direction of the tubular member so as to not hinder flow within the tubular member as recited in claim 13; or the distal portion of the wire being fixed only at a portion in a circumferential direction of an inner peripheral surface of the tubular member as recited in claim 16. Examiner disagrees, as stated in the rejection below with regard to claim 1, the portion of the inner circumferential surface (inner surface of the walls extending from needle 700, see Fig. 25) is interpreted as a portion of the surface of the inner circumferential surface. The claim does not require the portion to be limited. With regard to claim 13, the portion of the inner circumferential surface (inner surface of the walls extending from needle 700, see Fig. 25) is interpreted as a portion of the surface of the inner circumferential surface. Where the flow would not be hindered within the needle 700 (tubular member) by the joint being formed with no openings therefore fluid would flow through the needle unhindered (see Fig. 25). With regard to claim 16, the portion of the inner circumferential surface (inner surface of the walls extending from needle 700, see Fig. 25) is interpreted as a portion of the surface of the inner circumferential surface. Where the fixation only occurs at the portion of the surface of the inner circumferential surface. Examiner suggests including an amendment to the claims to recite another portion of the same inner circumferential surface that is free of fixation. Since only a portion could be interpreted as the entirety of the portion of the inner circumferential surface. Therefore, the rejection has been maintained.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“needle fixing portion” in claim 12. For examination purposes the “needle fixing portion” is interpretated as a portion with “welding, adhesion, or the like” described in paragraphs [0050 and 0211] of the instant specification and its equivalents.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 of this title, 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sawa (US2006/0025720) in view of Gonzalez (WO2016/160348) and Mugan (US2018/0235585).
Regarding claim 1, Sawa discloses a guide wire (14/16/42) for guiding an elongated tubular body (where the assembly is within the lumen of the catheter 10 and is capable of guiding the catheter 10, [0065]) that is configured to be inserted into a living body, the guide wire comprising:
a flexible and elongated shaft (shaft of 32, the shaft is flexible, [0079]), the shaft being an elongated wire (the shaft of 32 is interpreted as a wire by being an elongate rod);
a tubular member (needle portion 14/shaft portion 16) disposed on the distal portion of the wire and configured to form a hole in living body tissue ([0080]);
a cover (protection member 42) that is elastically deformable ([0088]) and configured to cover and extend distal of the tubular member (see Fig. 3), wherein the cover has a helical shape ([0088], see Fig. 3), and the cover is fixed on the distal portion of the wire ([0091]); and when the cover is exposed from the elongated tubular body (exposed by being exposed from lumen of the catheter 10, see Fig. 5), the cover covers the tubular member (the cover, covers the tubular member some degree when the needle portion 14 is outside of the catheter 10, see Fig. 5, [0095]), and at least one of the cover and the wire is bent (needle portion is bent out of the lumen by being guided on the surface, [0114], see Fig. 5).
However, Sawa is silent regarding the wire including a decreasing diameter portion between a proximal portion of the wire and a distal portion of the wire. Gonzalez, in the same field of endeavor of needles inserted into a catheter for liquid injections (see [0003], [0032]). Gonzalez further teaches needles may have any cross section suitable, for example the cross-section may be constant, may vary, may taper, may be irregular, may be a shape, or a combination thereof ([0033]). Since, Gonzalez teaches altering the shaft of the needle would have been obvious for a suitable purpose, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to configure the needle shaft of Sawa to have a decreasing diameter portion. Where the modified invention would result in the cover being fixed to the decreasing diameter portion in the same manner as stated in paragraph [0091] of Sawa. Examiner interprets the components as being “fixed” by not being movable relative to each other by the swaging process of the cover to the needle 14 ([0091]).
Sawa is silent regarding the distal portion of the wire being fixed on a portion in a circumferential direction of an inner peripheral surface of the tubular member. Mugan teaches a needle 700 (tubular member) connected to a tube (wire) by a joint (see Fig. 25-27, where the joint has an exterior ring of the needle over the tubular member, [0116]). Where the portion of the inner circumferential surface (inner surface of the walls extending from needle 700, see Fig. 25) is interpreted as a portion of the surface of the inner circumferential surface. It would have been obvious to one having ordinary skill in the art to have modified the distal portion of the wire to be fixed on an inner peripheral surface of the tubular member, as taught by Mugan, in order to provide a lap joint arrangement that permits a clinician to detach the distal portion of the needle ([0116]). Additionally, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Regarding claim 2, Sawa/Gonzalez/Mugan makes obvious the guide wire according to claim 1, Sawa further discloses wherein at least one of the cover and the wire is deformable into a rectilinear shape by being accommodated in the elongated tubular body (the protection member 42 is capable of compressing to a rectilinear shape when compressed flat when accommodated in the tubular body, [0088]).
Regarding claim 3, Sawa/Gonzalez/Mugan makes obvious the guide wire according to claim 1, Sawa further discloses wherein the cover, in a state of being accommodated inside the elongated tubular body, is configured to receive a proximally directed force at a distal end of the cover to be elastically shrunk (first spring portion 54 is compressible and is therefore shrunk in the proximal direction, [0090]), thereby exposing the tubular member, and the cover, in a state of being located outside the elongated tubular body (the spring portion 52 is interpreted as being outside of the elongated tubular body when it is extended out of the lumen and into the tapered portion 24, [0095]), is configured to maintain a state of accommodating the tubular member while covering the tubular member (covers the tubular member as shown in Figs. 3 & 5).
Regarding claim 4, Sawa/Gonzalez/Mugan makes obvious the guide wire according to claim 1, Sawa further discloses wherein at least one of the cover and the wire includes a curved portion which is bent in a natural state (curved portion of the helical spring 52 is one of the windings of the spring and is interpreted as bent in a natural state, see Fig. 3).
Regarding claim 5, Sawa/Gonzalez/Mugan makes obvious the guide wire according to claim 4, Sawa further discloses wherein a proximal end of the curved portion (curved portion of helical spring 52 is one of the windings of the spring 52 at a proximal end) is located on a distal side of the tubular member (the distal side of the tubular member/needle 14 is interpreted as one side of the needle, if the needle were separated by the longitudinal axis of the needle, and the curved portion surrounds the needle, see annotated Fig. 3).
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Regarding claim 6, Sawa/Gonzalez/Mugan makes obvious the guide wire according to claim 4, Sawa further discloses wherein a distal end of the curved portion (distal end of helical spring 52 near the closer to the hole 20, see Fig. 3) is located on a proximal side of the tubular member (the proximal side of the tubular member 14/16 is interpreted as the other side of the needle), if the needle were separated by the longitudinal axis of the needle, see annotated Fig. 3, and the curved portion surrounds the needle, see Fig. 3). The term “side” has been given its broadest reasonable interpretation, since the claims do not recite the location of a “proximal side” relative to other components of the device.
Regarding claim 7, Sawa/Gonzalez/Mugan makes obvious the guide wire according to claim 1, Sawa further discloses wherein the tubular member has a through-hole penetrating in an axial direction (the needle is tubular, therefore the lumen of the needle is interpreted as the through-hole, [0077]); yet, does not explicitly disclose the distal portion of the wire having a constant outer diameter portion extending from the decreasing diameter portion of the wire toward a distal end of the wire. Gonzalez, in the same field of endeavor of needles inserted into a catheter for liquid injections (see [0003], [0032]). Gonzalez further teaches needles may have any cross section suitable, for example the cross-section may be constant, may vary, may taper, may be irregular, may be a shape, or a combination thereof ([0033]). Since, Gonzalez teaches altering the shaft of the needle would have been obvious for a suitable purpose and further teaches it would have been obvious to combine a constant cross section with a tapered cross section, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to have the shaft have the decreasing diameter portion extend to a constant outer diameter portion.
Regarding claim 8, Sawa/Gonzalez/Mugan makes obvious the guide wire according to claim 1, Sawa further discloses wherein at least portion of the cover has a gap between adjacent loops of a wire member aligned while forming a helix (gaps between loops of helical coil, [0088], see Fig. 3).
Regarding claim 9, Sawa/Gonzalez/Mugan makes obvious the guide wire according to claim 8, Sawa further discloses wherein the cover includes a coarse pitch portion (54) that has a gap between adjacent loops of the wire member aligned while forming the helix, and a dense pitch portion (52) that is located on a proximal side or a distal side of the coarse pitch portion and that is shorter than the coarse pitch portion in pitch distance of the wire member aligned while forming a helix ([0088], see Fig. 3).
Regarding claim 10, Sawa/Gonzalez/Mugan makes obvious the guide wire according to claim 1, Sawa further discloses comprising:
a distal portion of the tubular member having an inclined surface inclined relative to a center axis of the tubular member ([0085]);
a sharp needle portion of the tubular member is located at a distal end of the inclined surface ([0085]);
and a direction in which at least one of the cover and the wire is bent coincides with a direction in which the needle portion is located at the inclined surface (the bend occurs proximal to the inclined surface, see Fig. 3).
Regarding claim 11, Sawa/Gonzalez makes obvious the guide wire according to claim 1, Sawa further discloses wherein the cover includes a stopper (tapered portion of the lumen 12, [0095]) for limiting an axial movement of the tubular member portion relative to the cover.
Regarding claim 12, Sawa/Gonzalez/Mugan makes obvious the guide wire according to claim 1, the modified invention further discloses wherein the tubular member includes an inclined surface provided at a distal portion of the tubular member and inclined relative to a center axis of the tubular member (needle has an inclined surface, [0085]), and a through-hole penetrating from the inclined surface toward a proximal side (the needle is tubular, therefore the lumen of the needle is interpreted as the through-hole, [0077]);
the wire being fixed to the inner peripheral surface of the tubular member in the through-hole with a needle fixing portion (the invention of Sawa as modified by Mugan teaches the wire being fixed to the inner peripheral surface of the tubular member, where this fixing would be in the through-hole of the needle; where this portion is interpreted as the needle fixing portion under 112(f) being by a surface of the tubular member that is joined to the wire by adhesion or the like, [0116] of Mugan); and
at least a portion of the needle fixing portion protrudes to outside of a surface at which a ring-shaped inner edge portion (inner edge of the needle see annotated Fig. 27 of Mugan) of an opening of the through-hole in the inclined surface is located (the through-hole would extend through the needle portion and therefore the inner edge of the needle as shown in Fig. 27 of Mugan would be part of an opening of the through-hole).
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Regarding claim 13, Sawa discloses a guide wire (14/16/42) for guiding an elongated tubular body that is configured to be inserted into a living body (where the assembly is within the lumen of the catheter 10 and is capable of guiding the catheter 10, [0065]), the guide wire comprising:
a flexible and elongated shaft (shaft of 32, the shaft is flexible, [0079]), the shaft being an elongated wire (the shaft 32 is interpreted as being a wire by being an elongate rod), the wire including a distal portion (distal end of shaft 32 as shown in Fig. 3);
a tubular member (needle portion 14 and shaft 16) disposed on the distal portion of the wire and configured to form a hole in living body tissue ([0080]), the tubular member having a distal portion having an inclined surface inclined relative to a center axis of the tubular member ([0085]), and a sharp needle portion of the tubular member located at a distal end of the inclined surface ([0085]);
a cover (protection member 42) that is elastically deformable ([0088]) and configured to cover and extend distal of the tubular member (see Fig. 3), wherein the cover has a helical shape ([0088], see Fig. 3), and the cover is fixed on the tapered distal end of the shaft ([0091]), and when the cover is exposed from the elongated tubular body, the cover covers the tubular member (the cover, covers the tubular member some degree when the needle portion 14 is outside of the catheter 10, see Fig. 5, [0095), and at least one of the cover and the wire is bent (needle portion is bent out of the lumen by being guided on the surface, [0114], see Fig. 5); and wherein at least one of the cover and the shaft is deformable into a rectilinear shape by being accommodated in the elongated tubular body (the protection member 42 is capable of compressing to a rectilinear shape when compressed flat when accommodated in the tubular body, [0088]).
The needle 16 of Sawa includes a larger diameter portion 32 that extends to a smaller diameter portion ([0078]). However, Sawa is silent regarding the wire including a decreasing diameter portion between a proximal portion of the wire and a distal portion of the wire. Gonzalez, in the same field of endeavor of needles inserted into a catheter for liquid injections (see [0003], [0032]). Gonzalez further teaches needles may have any cross section suitable, for example the cross-section may be constant, may vary, may taper, may be irregular, may be any shape, or a combination thereof ([0033]). Since, Gonzalez teaches altering the shaft of the needle would have been obvious for a suitable purpose, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to configure the needle shaft of Sawa to have a decreasing diameter portion. Where the modified invention would result in the cover being fixed to the decreasing diameter portion in the same manner as stated in paragraph [0091] of Sawa.
Sawa is silent regarding the distal portion of the wire being fixed on an inner peripheral surface of the tubular member and wherein the distal portion of the wire is provided at a portion in a circumferential direction of the tubular member so as to not hinder flow within the tubular member. Mugan teaches a needle 700 (tubular member) connected to a tube (wire) by a joint (see Fig. 25-27, where the joint has an exterior ring of the needle over the tubular member, [0116]). Where the portion of the inner circumferential surface (inner surface of the walls extending from needle 700, see Fig. 25) is interpreted as a portion of the surface of the inner circumferential surface. Where flow is not hindered within the needle 700 (tubular member) by the tubular member being circumferential with no openings therefore fluid would flow through the needle unhindered. It would have been obvious to one having ordinary skill in the art to have modified the distal portion of the wire to be fixed on an inner peripheral surface of the tubular member as taught by Mugan in order to provide a lap joint arrangement that permits a clinician to detach the distal portion of the needle ([0116]). Additionally, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Regarding claim 14, Sawa/Gonzalez/Mugan makes obvious the guide wire according to claim 13, Sawa further discloses the cover, in a state of being accommodated inside the elongated tubular body, is configured to receive a proximally directed force at a distal end of the cover to be elastically shrunk (first spring portion 54 is compressible and is therefore shrunk in the proximal direction, [0090]), thereby exposing the tubular member; and the cover, in a state of being located outside the elongated tubular body (the spring portion 52 is interpreted as being outside of the elongated tubular body when it is extended out of the lumen and into the tapered portion 24, [0095]), is configured to maintain a state of accommodating the tubular member while covering the tubular member (covers the tubular member as shown in Figs. 3 & 5).
Regarding claim 15, Sawa/Gonzalez/Mugan makes obvious the guide wire according to claim 13, Sawa further discloses wherein at least one of the cover and the wire includes a curved portion which is bent in a natural state (curved portion of the helical spring 52 is a single winding of the spring and is interpreted as bent in a natural state, see Fig. 3).
Regarding claim 16, Sawa discloses a medical device (14/16/42) configured to form a hole in living body tissue of a living body ([0080]), the medical device comprising:
an elongated tubular body (catheter 10) configured to be inserted into the living body; and
a guide wire (14/16/32) configured to be insertable in the elongated tubular body ([0093]), the guide wire comprising:
a flexible and elongated shaft (shaft of 32, the shaft is flexible, [0079]), the shaft being an elongated wire (the shaft 32 is interpreted as being a wire by being an elongate rod), the elongated wire including a distal portion (distal end of the shaft 32 as shown in Fig. 3);
a tubular member (needle portion 14 and shaft 16) that is disposed at a distal portion of the wire and that forms the hole in the living body tissue (see Fig. 3, [0080]); and
a cover (protective member 42) that is elastically deformable ([0088]) and that covers and extends distally of the tubular member (see Fig. 3), wherein the cover has a helical shape ([0088], see Fig. 3), and the cover is fixed on the distal portion of the wire ([0091]); and
when the cover is exposed from the elongated tubular body, the cover covers tubular member, and at least one of the cover and the wire is bent (cover is exposed by being exposed from the lumen of the elongated tubular body 10, needle portion 14 is bent out of the lumen by being guided on the surface, [0114], see Fig. 5).
The needle 16 of Sawa includes a larger diameter portion 32 that extends to a smaller diameter portion ([0078]). Sawa is silent regarding the elongated wire including a decreasing diameter portion between a proximal portion of the wire and a distal portion of the wire. Gonzalez, in the same field of endeavor of needles inserted into a catheter for liquid injections (see [0003], [0032]). Gonzalez further teaches needles may have any cross section suitable, for example the cross-section may be constant, may vary, may taper, may be irregular, may be any shape, or a combination thereof ([0033]). Since, Gonzalez teaches altering the shaft of the needle would have been obvious for a suitable purpose, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to configure the needle shaft of Sawa to have a decreasing diameter portion. Where the modified invention would result in the cover being fixed to the decreasing diameter portion in the same manner as stated in paragraph [0091] of Sawa. Examiner interprets the components as being “fixed” by not being movable relative to each other by the swaging process of the cover to the needle 14 ([0091]).
Sawa is silent regarding the distal portion of the wire being fixed only at a portion in a circumferential direction on an inner peripheral surface of the tubular member. Mugan teaches a needle 700 (tubular member) connected to a tube (wire) by a joint (see Fig. 25-27, where the joint has an exterior ring of the needle over the tubular member, [0116]). Where the portion of the inner circumferential surface (inner surface of the walls extending from needle 700, see Fig. 25) is interpreted as a portion of the surface of the inner circumferential surface. Where the fixation only occurs at the portion of the surface of the inner circumferential surface. It would have been obvious to one having ordinary skill in the art to have modified the distal portion of the wire to be fixed on an inner peripheral surface of the tubular member as taught by Mugan in order to provide a lap joint arrangement that permits a clinician to detach the distal portion of the needle ([0116]). Additionally, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Regarding claim 17, Sawa/Gonzalez/Mugan makes obvious the medical device according to claim 16, Sawa further discloses wherein at least one of the cover and the wire is deformable into a rectilinear shape by being accommodated in the elongated tubular body (the protection member 42 is capable of compressing to a rectilinear shape when compressed flat when accommodated in the tubular body, [0088]).
Regarding 18, Sawa/Gonzalez/Mugan makes obvious the medical device according to claim 16, Sawa further discloses wherein the cover, in a state of being accommodated inside the elongated tubular body, is configured to receive a proximally directed force at a distal end of the cover to be elastically shrunk (first spring portion 54 is compressible and is therefore shrunk in the proximal direction, [0090]), thereby exposing the tubular member; and the cover, in a state of being located outside the elongated tubular body (the spring portion 52 is interpreted as being outside of the elongated tubular body when it is extended out of the lumen and into the tapered portion 24, [0095]), is configured to maintain a state of accommodating the tubular member while covering the tubular member (covers the tubular member as shown in Figs. 3 & 5).
Regarding claim 19, Sawa/Gonzalez/Mugan makes obvious the medical device according to claim 16, Sawa further discloses wherein at least one of the cover and the wire includes a curved portion which is bent in a natural state (curved portion of the helical spring 52 is a single winding of the spring and is interpreted as bent in a natural state, see Fig. 3).
Regarding claim 20, Sawa/Gonzalez/Mugan makes obvious the medical device according to claim 16, Sawa further discloses wherein the elongated tubular body is a dilator (the tubular member discussed in [0065] is capable of being used as a dilator since it would have some outer dimension that could dilate the access site).
Conclusion
THIS ACTION IS MADE FINAL. 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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached on (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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