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
The Amendment filed on 5/5/2026 has been entered. Claims 1-4 and 6-15 remain pending in the application. Claims 21-25 are new. Claims 2, 7, and 11 have been withdrawn from further consideration as detailed in the Non-final Office Action mailed 2/5/2026.
Applicants amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 2/5/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/8/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, 3-4, 6, 8-10, 12-15, and 21-25 are 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.
In regard to claim 1,
Line 2-3 recites “a first outer diameter in accordance with a bare-wire portion of the guidewire”. It is unclear what is meant by “in accordance with a bare-wire portion of the guidewire”. It is unclear due to the phrase “in accordance with” if the proximal portion with the first outer diameter is a bare-wire portion of the guidewire. Based on the disclosure, Examiner construes “a proximal portion having a first outer diameter in accordance with a bare-wire portion of the guidewire” to require the proximal portion to be a bare-wire portion. Examiner suggests replacing “a proximal portion having a first outer diameter in accordance with a bare-wire portion of the guidewire” in line 2-3 of claim 1 with “a proximal portion having a first outer diameter, the proximal portion is a bare-wire portion of the guidewire”.
Line 4-5 recites “a second outer diameter in accordance with a wound portion of the guidewire”. It is unclear due to the phrase “in accordance with” if the dilated section with the second outer diameter is a wound portion of the guidewire. Based on the disclosure, Examiner construes “a dilated section having a second outer diameter in accordance with a wound portion of the guidewire” to require the dilated section to be a wound portion of the guidewire. Examiner suggests replacing “a dilated section having a second outer diameter in accordance with a wound portion of the guidewire” in line 4-5 of claim 1 with “a dilated section having a second outer diameter, the dilated section is a wound portion of the guidewire”.
Line 10-11 recites “the guidewire is withdrawn in a proximal direction by the proximal portion of the guidewire”. It is unclear due to the phrase “is withdrawn” if a method step is being claimed. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). It is unclear if the dilated section of the guidewire is configured to butt up against a stylet tip of a stylet when the guidewire is disposed in the stylet with a corresponding orientation and when the guidewire is withdrawn in a proximal direction by the proximal portion of the guidewire or if the guidewire is configured to be withdrawn in a proximal direction by the proximal portion of the guidewire. For examination purposes Examiner construes “the guidewire is withdrawn in a proximal direction by the proximal portion of the guidewire” to be “the guidewire is configured to be withdrawn in a proximal direction by the proximal portion of the guidewire”. Examiner suggests replacing “the guidewire is withdrawn in a proximal direction by the proximal portion of the guidewire” in line 10-11 of claim 1 with “the guidewire is configured to be withdrawn in a proximal direction by the proximal portion of the guidewire”. Alternatively, Examiner suggests replacing “and the guidewire is withdrawn in a proximal direction by the proximal portion of the guidewire” in line 10-11 of claim 1 with “and when the guidewire is withdrawn in a proximal direction by the proximal portion of the guidewire”.
Examiner notes claims 3-4 and 21-25 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 6,
Line 3-4 recites “a first outer diameter in accordance with a bare-wire portion of the guidewire”. It is unclear what is meant by “in accordance with a bare-wire portion of the guidewire”. It is unclear due to the phrase “in accordance with” if the proximal portion with the first outer diameter is a bare-wire portion of the guidewire. Based on the disclosure, Examiner construes “a proximal portion having a first outer diameter in accordance with a bare-wire portion of the guidewire” to require the proximal portion to be a bare-wire portion. Examiner suggests replacing “a proximal portion having a first outer diameter in accordance with a bare-wire portion of the guidewire” in line 3-4 of claim 6 with “a proximal portion having a first outer diameter, the proximal portion is a bare-wire portion of the guidewire”.
Line 5-6 recites “a second outer diameter in accordance with a wound portion of the guidewire”. It is unclear due to the phrase “in accordance with” if the dilated section with the second outer diameter is a wound portion of the guidewire. Based on the disclosure, Examiner construes “a dilated section having a second outer diameter in accordance with a wound portion of the guidewire” to require the dilated section to be a wound portion of the guidewire. Examiner suggests replacing “a dilated section having a second outer diameter in accordance with a wound portion of the guidewire” in line 5-6 of claim 6 with “a dilated section having a second outer diameter, the dilated section is a wound portion of the guidewire”.
Examiner notes claims 8-9 are similarly rejected by virtue of their dependency on claim 6.
In regard to claim 10,
Line 3-4 recites “a first outer diameter in accordance with a bare-wire portion of the guidewire”. It is unclear what is meant by “in accordance with a bare-wire portion of the guidewire”. It is unclear due to the phrase “in accordance with” if the proximal portion with the first outer diameter is a bare-wire portion of the guidewire. Based on the disclosure, Examiner construes “a proximal portion having a first outer diameter in accordance with a bare-wire portion of the guidewire” to require the proximal portion to be a bare-wire portion. Examiner suggests replacing “a proximal portion having a first outer diameter in accordance with a bare-wire portion of the guidewire” in line 3-4 of claim 10 with “a proximal portion having a first outer diameter, the proximal portion is a bare-wire portion of the guidewire”.
Line 5-6 recites “a second outer diameter in accordance with a wound portion of the guidewire”. It is unclear due to the phrase “in accordance with” if the dilated section with the second outer diameter is a wound portion of the guidewire. Based on the disclosure, Examiner construes “a dilated section having a second outer diameter in accordance with a wound portion of the guidewire” to require the dilated section to be a wound portion of the guidewire. Examiner suggests replacing “a dilated section having a second outer diameter in accordance with a wound portion of the guidewire” in line 5-6 of claim 10 with “a dilated section having a second outer diameter, the dilated section is a wound portion of the guidewire”.
Examiner notes claims 12-15 are similarly rejected by virtue of their dependency on claim 10.
In regard to claim 14,
Line 3-5 recites “a proximal portion of each extension leg of the three extension legs coupled to a Luer connector of three Luer connectors”. It is unclear if a proximal portion of each extension leg of the three extension legs is required to be coupled to a single Luer connector of three Luer connectors i.e. each extension leg is couped to the same Luer connector or if a proximal portion of each extension leg of the three extension legs is required to be coupled to a respective Luer connector of three Luer connectors. Based on the disclosure, it appears each extension leg is coupled to a respective Luer connector. Examiner suggests replacing “a proximal portion of each extension leg of the three extension legs coupled to a Luer connector of three Luer connectors” in line 3-5 of claim 14 with “a proximal portion of each extension leg of the three extension legs coupled to a respective Luer connector of three Luer connectors”.
In regard to claim 25,
Line 1-3 recites “wherein the wound portion of the guidewire is wound with windings of one or more round wires around a core wire that are subsequently ground down to flatten the windings of the one or more round wires and form the taper”. Claim 3, which claim 25 depends on, requires the taper to be from the dilated section to a remainder of the guidewire with the first outer diameter. Claim 1, which claim 25 also depends on, requires the dilated section to be a wound portion of the guidewire. It is unclear how the wound portion of the guidewire, which is the dilated section and does not include the taper as claimed in claim 3, forms the taper. For examination purposes Examiner construes “wherein the wound portion of the guidewire is wound with windings of one or more round wires around a core wire that are subsequently ground down to flatten the windings of the one or more round wires and form the taper” to be “wherein the taper comprises windings of one or more round wires around a core wire that are subsequently ground down to flatten the windings of the one or more round wires”. Examiner suggests replacing “wherein the wound portion of the guidewire is wound with windings of one or more round wires around a core wire that are subsequently ground down to flatten the windings of the one or more round wires and form the taper” in line 1-3 of claim 25 with “wherein the taper comprises windings of one or more round wires around a core wire that are subsequently ground down to flatten the windings of the one or more round wires”.
Claim Rejections - 35 USC § 102
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 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 1, 3-4, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nobles (U.S. PG publication 20080058839).
In regard to claim 1,
Nobles discloses a guidewire (figure 1, item 10), comprising:
a proximal portion (figure 1, item 12) having a first outer diameter in accordance with a bare-wire portion of the guidewire (see figure 1);
PNG
media_image1.png
275
646
media_image1.png
Greyscale
a distal portion (figure 1, item 14) including a dilated section (see figure 1 wherein the portion of item 14 not including the guidewire tip is construed as the dilated section, as shown in figure 1 item 14 is dilated relative to item 12) having a second outer diameter in accordance with a wound portion of the guidewire (see figure 1; paragraph [0055]), the second outer diameter greater than the first outer diameter (see figure 1); and
a guidewire tip (see figure 1 above) in the distal portion of the guidewire (see figure 1), the dilated section of the guidewire configured to butt up against a stylet tip of a stylet when the guidewire is disposed in the stylet with a corresponding orientation (Examiner notes “configured to butt up against a stylet tip of a stylet when the guidewire is disposed in the stylet with a corresponding orientation” is a functional limitation. A stylet and stylet tip are not positively required by the claim. The distal section of the guidewire is fully capable of the recited function due to its structure. An appropriately sized/shaped stylet is fully capable of being used with the guidewire as claimed), and the guidewire is withdrawn in a proximal direction by the proximal portion of the guidewire (see 112 rejection above. As noted above, “the guidewire is withdrawn in a proximal direction by the proximal portion of the guidewire” is being construed as “the guidewire is configured to be withdrawn in a proximal direction by the proximal portion of the guidewire” which is a functional limitation. Examiner notes the guidewire is fully capable of being withdrawn in a proximal direction by the proximal portion of the guidewire).
In regard to claim 3,
Nobles discloses the guidewire of claim 1, wherein the guidewire includes a taper (figure 1, item 18) from the dilated section with the second outer diameter to a remainder of the guidewire with the first outer diameter (see figure 1).
In regard to claim 4,
Nobles discloses the guidewire of claim 1, wherein the guidewire tip is an atraumatic 'J'-shaped guidewire tip (see figure 1 above).
In regard to claim 21,
Nobles discloses the guidewire of claim 1, wherein the wound portion of the guidewire is wound with windings of one or more round wires around a core wire (paragraph [0055]).
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.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Nobles (U.S. PG publication 20080058839) further in view of Davidson (U.S. Patent no 5107852).
In regard to claim 22,
Nobles disclose the guidewire of claim 1, wherein the wound portion of the guidewire is wound with windings of either one or more tapes around a core wire or one or more round wires around the core wire (paragraph [0055]).
Nobles is silent as to wherein the wound portion of the guidewire is wound with windings of either one or more tapes around a core wire or one or more round wires around the core wire that are subsequently ground down to flatten the windings of the one or more round wires.
Davidson teaches one or more round wires that are subsequently ground down to flatten the windings of the one or more round wires (column 1, line 31-41).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more round wires of Nobles to include one or more round wires that are subsequently ground down to flatten the windings of the one or more round wires, therefore resulting in wherein the wound portion of the guidewire is wound with windings of either one or more tapes around a core wire or one or more round wires around the core wire that are subsequently ground down to flatten the windings of the one or more round wires, as taught by Davidson, for the purpose of providing a flat surface to the tissue wall (column 1, line 39-41 of Davidson).
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Nobles (U.S. PG publication 20080058839).
In regard to claim 23,
Nobles disclose the guidewire of claim 3, wherein the taper has a length (see figure 1; see also paragraph [0052]: wherein the length and diameter of guidewire 10 may be varied to suit the particular procedures in which it is to be used and the materials from which it is constructed).
Nobles is silent as to wherein the taper has a length ≤ 5% of a length of the dilated section of the guidewire.
It would have been an obvious matter of design choice to modify Nobles to include wherein the taper has a length ≤ 5% of a length of the dilated section of the guidewire since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Additionally, it would have been an obvious matter of design choice to modify Nobles to include wherein the taper has a length ≤ 5% of a length of the dilated section of the guidewire since applicant has not disclosed that having wherein the taper has a length ≤ 5% of a length of the dilated section of the guidewire solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the taper has a length ≤ 5% of a length of the dilated section of the guidewire, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 24,
Nobles disclose the guidewire of claim 3, wherein the taper has a length (see figure 1; see also paragraph [0052]: wherein the length and diameter of guidewire 10 may be varied to suit the particular procedures in which it is to be used and the materials from which it is constructed).
Nobles is silent as to wherein the taper has a length ≥ 25% of a length of the dilated section of the guidewire.
It would have been an obvious matter of design choice to modify Nobles to include wherein the taper has a length ≥ 25% of a length of the dilated section of the guidewire since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Additionally, it would have been an obvious matter of design choice to modify Nobles to include wherein the taper has a length ≥ 25% of a length of the dilated section of the guidewire since applicant has not disclosed that having wherein the taper has a length ≥ 25% of a length of the dilated section of the guidewire solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the taper has a length ≥ 25% of a length of the dilated section of the guidewire, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Nobles (U.S. PG publication 20080058839) further as evidenced by Keary (U.S. PG publication 20200338318).
In regard to claim 25,
Nobles disclose the guidewire of claim 3, wherein the wound portion of the guidewire is wound with windings of one or more round wires around a core wire (paragraph [0055]) that are subsequently ground down to flatten the windings of the one or more round wires and form the taper (Examiner notes the claimed phrase “that are subsequently ground down to flatten the windings of the one or more round wires and form the taper” is being treated as a product-by-process limitation and since it has been held that a product-by-process limitation is not construed as being limited to the product formed by the specific process recited, therefore, even though Nobles is silent as to the process used to make the taper, it appears that the guidewire of Nobles would be the same or similar as that claimed and further as evidenced by Keary which supports a wire with a round cross-sectional shape can be ground down to form a transition portion as detailed in paragraph [0066] of Keary).
Claims 1, 3-4, 6, 8-10, 12-13, 21, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Semrad (U.S. patent no 5059183) further in view of Nobles (U.S. PG publication 20080058839).
In regard to claim 1,
Semrad discloses a guidewire (figure 4, item 10), comprising:
a proximal portion (figure 4, item 13) having a first outer diameter (see figure 4);
a distal portion (see figure 4 wherein the distal portion is construed as the portion of item 10 shown in figure 4 outside of item 20 which includes item 11 and part of item 14) including a dilated section (see figure 4 wherein item 11 and the part of item 14 outside of item 20 is dilated relative to item 13) having a second outer diameter (see figure 4), the second outer diameter greater than the first outer diameter (see figure 4; column 3, line 22-35); and
PNG
media_image2.png
450
609
media_image2.png
Greyscale
a guidewire tip (see figure 4 above) in the distal portion of the guidewire (see figure 4 wherein a portion of item 11 is construed as the guidewire tip), the dilated section of the guidewire configured to butt up against a stylet tip (figure 4, item 21) of a stylet (figure 4, item 20) when the guidewire is disposed in the stylet (see figure 4 and 1B) with a corresponding orientation (see figure 4; Examiner notes “configured to butt up against a stylet tip of a stylet when the guidewire is disposed in the stylet with a corresponding orientation” is a functional limitation. The stylet and stylet tip are not positively required by the claim. The dilated section of the guidewire is fully capable of the recited function due to its structure and as supported by column 4, line 19-31 and figure 4), and the guidewire is withdrawn in a proximal direction by the proximal portion of the guidewire (see 112 rejection above. As noted above, “the guidewire is withdrawn in a proximal direction by the proximal portion of the guidewire” is being construed as “the guidewire is configured to be withdrawn in a proximal direction by the proximal portion of the guidewire” which is a functional limitation. Examiner notes the guidewire is fully capable of being withdrawn in a proximal direction by the proximal portion of the guidewire).
Semrad fails to disclose a proximal portion having a first outer diameter in accordance with a bare-wire portion of the guidewire and a distal portion including a dilated section having a second outer diameter in accordance with a wound portion of the guidewire.
Nobles teaches a guidewire (figure 1, item 10), comprising: a proximal portion (figure 1, item 12) having a first outer diameter in accordance with a bare-wire portion of the guidewire (see figure 1); and a distal portion (figure 1, item 14) including a dilated section (see figure 1 wherein the portion of item 14 not including the guidewire tip is construed as the dilated section, as shown in figure 1 item 14 is dilated relative to item 12) having a second outer diameter in accordance with a wound portion of the guidewire (see figure 1; paragraph [0055]), the second outer diameter greater than the first outer diameter (see figure 1).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Semrad to substitute a proximal portion having a first outer diameter in accordance with a bare-wire portion of the guidewire and a distal portion including a dilated section having a second outer diameter in accordance with a wound portion of the guidewire in place of the proximal portion and distal portion of Semrad, as taught by Nobles, because the substitution is a simple substitution that would yield the same predictable result of enabling positioning a component while having a distal portion with less stiffness (column 3, line 36-49 of Semrad and paragraph [0055] and [0003] of Nobles) Furthermore, Semrad discloses modifications can be made (column 7, line 54-63 of Semrad)
In regard to claim 3,
PNG
media_image3.png
439
569
media_image3.png
Greyscale
Semrad in view of Nobles teaches the guidewire of claim 1, wherein the guidewire includes a taper (see figure 4 above of Semrad) from the dilated section with the second outer diameter to a remainder of the guidewire with the first outer diameter (see figure 4 above of Semrad).
In regard to claim 4,
Semrad in view of Nobles teaches the guidewire of claim 1, wherein the guidewire tip is an atraumatic 'J'-shaped guidewire tip (see analysis of claim 1 and figure 4 above of Semrad).
In regard to claim 6,
Semrad discloses a stylet assembly (figure 4, item 10 and 20), comprising:
a guidewire (figure 4, item 10) including:
a proximal portion (figure 4, item 13) having a first outer diameter (see figure 4);
a distal portion (see figure 4 wherein the distal portion is construed as the portion of item 10 shown in figure 4 outside of item 20 which includes item 11 and part of item 14) including a dilated section (see figure 4 wherein item 11 and the part of item 14 outside of item 20 is dilated relative to item 13) having a second outer diameter (see figure 4), the second outer diameter greater than the first outer diameter (see figure 4; column 3, line 22-35); and
PNG
media_image4.png
435
610
media_image4.png
Greyscale
a guidewire tip (see figure 4 above) in the distal portion of the guidewire (see figure 4 wherein a portion of item 11 is construed as the guidewire tip); and
a stylet (figure 4, item 20) including:
a stylet tip (figure 4, item 21); and
a stylet lumen (see lumen of item 20 which item 10 is within) having a stylet inner diameter (see figure 4), the guidewire disposed in the stylet lumen of the stylet with a corresponding orientation (see figure 4), and the dilated section of the guidewire configured to butt up against the stylet tip (see figure 4) when the guidewire is proximally withdrawn from a catheter for automatically withdrawing the stylet from the catheter with the guidewire (Examiner notes “configured to butt up against the stylet tip when the guidewire is proximally withdrawn from a catheter for automatically withdrawing the stylet from the catheter with the guidewire” is a functional limitation. Examiner notes the catheter is not positively required by the claim. The dilated section of the guidewire is fully capable of the recited function due to its structure and as supported by column 4, line 19-31 and figure 4).
Semrad fails to disclose a proximal portion having a first outer diameter in accordance with a bare-wire portion of the guidewire, a distal portion including a dilated section having a second outer diameter in accordance with a wound portion of the guidewire, and a stylet inner diameter commensurate with the first outer diameter of the guidewire.
Nobles teaches a guidewire (figure 1, item 10), comprising: a proximal portion (figure 1, item 12) having a first outer diameter in accordance with a bare-wire portion of the guidewire (see figure 1); and a distal portion (figure 1, item 14) including a dilated section (see figure 1 wherein the portion of item 14 not including the guidewire tip is construed as the dilated section, as shown in figure 1 item 14 is dilated relative to item 12) having a second outer diameter in accordance with a wound portion of the guidewire (see figure 1; paragraph [0055]), the second outer diameter greater than the first outer diameter (see figure 1).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Semrad to substitute a proximal portion having a first outer diameter in accordance with a bare-wire portion of the guidewire and a distal portion including a dilated section having a second outer diameter in accordance with a wound portion of the guidewire in place of the proximal portion and distal portion of Semrad, as taught by Nobles, because the substitution is a simple substitution that would yield the same predictable result of enabling positioning a component while having a distal portion with less stiffness (column 3, line 36-49 of Semrad and paragraph [0055] and [0003] of Nobles) Furthermore, Semrad discloses modifications can be made (column 7, line 54-63 of Semrad).
Semrad in view of Nobles fails to disclose a stylet inner diameter commensurate with the first outer diameter of the guidewire.
It would have been an obvious matter of design choice to modify Semrad in view of Nobles to include a stylet inner diameter commensurate with the first outer diameter of the guidewire since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Further, it would have been an obvious matter of design choice to modify Semrad in view of Nobles to include a stylet inner diameter commensurate with the first outer diameter of the guidewire since applicant has not disclosed that having a stylet inner diameter commensurate with the first outer diameter of the guidewire solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of a stylet inner diameter commensurate with the first outer diameter of the guidewire, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). Examiner notes paragraph [0051] of the instant disclosure states “The stylet lumen has a stylet inner diameter commensurate with or greater than the first outer diameter of the guidewire 106”. It is noted that the inner diameter of the stylet lumen of the prior art is greater than the first outer diameter of the guidewire.
In regard to claim 8,
PNG
media_image5.png
446
551
media_image5.png
Greyscale
Semrad in view of Nobles teaches the stylet assembly of claim 6, wherein the guidewire includes a taper (see figure 4 above of Semrad) from the dilated section with the second outer diameter to a remainder of the guidewire with the first outer diameter (see figure 4 of Semrad).
In regard to claim 9,
Semrad in view of Nobles teaches the stylet assembly of claim 6, wherein the guidewire tip is an atraumatic 'J'- shaped guidewire tip (see analysis of claim 6 and figure 4 of Semrad above).
In regard to claim 10,
Semrad discloses a catheter assembly (see all of figure 4), comprising:
a guidewire (figure 4, item 10) including:
a proximal portion (figure 4, item 13) having a first outer diameter (see figure 4);
a distal portion (see figure 4 wherein the distal portion is construed as the portion of item 10 shown in figure 4 outside of item 20 which includes item 11 and part of item 14) including a dilated section (see figure 4 wherein item 11 and the part of item 14 outside of item 20 is dilated relative to item 13) having a second outer diameter (see figure 4), the second outer diameter greater than the first outer diameter (see figure 4; column 3, line 22-35); and
a guidewire tip (see figure 4 above) in the distal portion of the guidewire (see figure 4 wherein a portion of item 11 is construed as the guidewire tip);
a stylet (figure 4, item 20) including:
a stylet tip (figure 4, item 21); and
a stylet lumen (see lumen of item 20 which item 10 is within) having a stylet inner diameter (see figure 4); and
a catheter (figure 4, item 40) including:
a catheter tube (see structure of item 40 which forms a catheter tube) including a catheter tip (see distal most portion of the catheter tube which forms the catheter tip); and
a primary lumen (see lumen which item 20 and 10 are within) having a catheter inner diameter (see figure 4) commensurate with a stylet outer diameter (see figure 4) within at least the catheter tube (see figure 4), the stylet disposed in the primary lumen of the catheter with a corresponding orientation (see figure 4), the guidewire disposed in the stylet lumen of the stylet with a corresponding orientation (see figure 4), and the dilated section of the guidewire configured to butt up against the stylet tip (see figure 4) when the guidewire is proximally withdrawn from the catheter for automatically withdrawing the stylet from the catheter with the guidewire (Examiner notes “configured to butt up against the stylet tip when the guidewire is proximally withdrawn from the catheter for automatically withdrawing the stylet from the catheter with the guidewire” is a functional limitation. The dilated section of the guidewire is fully capable of the recited function due to its structure and as supported by column 4, line 19-31 and figure 4).
Semrad fails to disclose a proximal portion having a first outer diameter in accordance with a bare-wire portion of the guidewire; a distal portion including a dilated section having a second outer diameter in accordance with a wound portion of the guidewire, and a stylet inner diameter commensurate with the first outer diameter of the guidewire.
Nobles teaches a guidewire (figure 1, item 10), comprising: a proximal portion (figure 1, item 12) having a first outer diameter in accordance with a bare-wire portion of the guidewire (see figure 1); and a distal portion (figure 1, item 14) including a dilated section (see figure 1 wherein the portion of item 14 not including the guidewire tip is construed as the dilated section, as shown in figure 1 item 14 is dilated relative to item 12) having a second outer diameter in accordance with a wound portion of the guidewire (see figure 1; paragraph [0055]), the second outer diameter greater than the first outer diameter (see figure 1).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Semrad to substitute a proximal portion having a first outer diameter in accordance with a bare-wire portion of the guidewire and a distal portion including a dilated section having a second outer diameter in accordance with a wound portion of the guidewire in place of the proximal portion and distal portion of Semrad, as taught by Nobles, because the substitution is a simple substitution that would yield the same predictable result of enabling positioning a component while having a distal portion with less stiffness (column 3, line 36-49 of Semrad and paragraph [0055] and [0003] of Nobles) Furthermore, Semrad discloses modifications can be made (column 7, line 54-63 of Semrad).
Semrad in view of Nobles fails to disclose a stylet inner diameter commensurate with the first outer diameter of the guidewire.
It would have been an obvious matter of design choice to modify Semrad in view of Nobles to include a stylet inner diameter commensurate with the first outer diameter of the guidewire since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Further, it would have been an obvious matter of design choice to modify Semrad in view of Nobles to include a stylet inner diameter commensurate with the first outer diameter of the guidewire since applicant has not disclosed that having a stylet inner diameter commensurate with the first outer diameter of the guidewire solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of a stylet inner diameter commensurate with the first outer diameter of the guidewire, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). Examiner notes paragraph [0051] of the instant disclosure states “The stylet lumen has a stylet inner diameter commensurate with or greater than the first outer diameter of the guidewire 106”. It is noted that the inner diameter of the stylet lumen of the prior art is greater than the first outer diameter of the guidewire.
In regard to claim 12,
PNG
media_image5.png
446
551
media_image5.png
Greyscale
Semrad in view of Nobles teaches the catheter assembly of claim 10, wherein the guidewire includes a taper (see figure 4 above of Semrad) from the dilated section with the second outer diameter to a remainder of the guidewire with the first outer diameter (see figure 4 of Semrad).
In regard to claim 13,
Semrad in view of Nobles teaches the catheter assembly of claim 10, wherein the guidewire tip is an atraumatic 'J'-shaped guidewire tip (see analysis of claim 10 and figure 4 of Semrad above).
In regard to claim 21,
Semrad in view of Nobles teaches the guidewire of claim 1, wherein the wound portion of the guidewire is wound with windings of one or more round wires around a core wire (paragraph [0055] of Nobles, see analysis of claim 1 above).
In regard to claim 23,
Semrad in view of Nobles teaches the guidewire of claim 3, wherein the taper has a length (see figure 1 of Nobles and figure 1 of Semrad).
Semrad in view of Nobles is silent as to wherein the taper has a length ≤ 5% of a length of the dilated section of the guidewire.
It would have been an obvious matter of design choice to modify Semrad in view of Nobles to include wherein the taper has a length ≤ 5% of a length of the dilated section of the guidewire since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). See also column 3, line 44-45 of Semrad which supports the location of the stop 15 can vary.
Additionally, it would have been an obvious matter of design choice to modify Semrad in view of Nobles to include wherein the taper has a length ≤ 5% of a length of the dilated section of the guidewire since applicant has not disclosed that having wherein the taper has a length ≤ 5% of a length of the dilated section of the guidewire solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the taper has a length ≤ 5% of a length of the dilated section of the guidewire, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 24,
Semrad in view of Nobles teaches the guidewire of claim 3, wherein the taper has a length (see figure 1 of Nobles and figure 1 of Semrad).
Semrad in view of Nobles is silent as to wherein the taper has a length ≥ 25% of a length of the dilated section of the guidewire.
It would have been an obvious matter of design choice to modify Semrad in view of Nobles to include wherein the taper has a length ≥ 25% of a length of the dilated section of the guidewire since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). See also column 3, line 44-45 of Semrad which supports the location of the stop 15 can vary.
Additionally, it would have been an obvious matter of design choice to modify Semrad in view of Nobles to include wherein the taper has a length ≥ 25% of a length of the dilated section of the guidewire since applicant has not disclosed that having wherein the taper has a length ≥ 25% of a length of the dilated section of the guidewire solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the taper has a length ≥ 25% of a length of the dilated section of the guidewire, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Semrad (U.S. Patent no 5059183) in view of Nobles (U.S. PG publication 20080058839) further in view of Martin (U.S. patent no 5195962).
In regard to claim 14,
Semrad in view of Nobles teaches the catheter assembly of claim 10.
Semrad in view of Nobles fails to disclose wherein the catheter is a triluminal catheter including a trifurcated catheter hub coupled to a proximal portion of the catheter tube and three extension legs extending from the catheter hub, a proximal portion of each extension leg of the three extension legs coupled to a Luer connector of three Luer connectors.
Martin teaches wherein the catheter (figure 2, item 20) is a triluminal catheter (see figure 3 and 5 wherein 3 lumens are present) including a trifurcated catheter hub (figure 2, item 30) coupled to a proximal portion of the catheter tube (see figure 2) and three extension legs (figure 2, item 32, 35, and 34) extending from the catheter hub (see figure 2), a proximal portion of each extension leg of the three extension legs coupled to a Luer connector (figure 2, item 39, 36, and 37) of three Luer connectors (see figure 3).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Semrad in view of Nobles to include a second lumen with a second opening and a third lumen with a third opening in addition to the primary lumen of Semrad and to include a trifurcated catheter hub and three extension legs and three luer connectors therefore resulting in wherein the catheter is a triluminal catheter including a trifurcated catheter hub coupled to a proximal portion of the catheter tube and three extension legs extending from the catheter hub, a proximal portion of each extension leg of the three extension legs coupled to a Luer connector of three Luer connectors, as taught by Martin, for the purpose of providing a catheter that has utility in other procedures and that can remove and/or inject a fluid if desired using the same catheter (column 3, line 38-47 of Martin and column 3, line 26-37 of Martin). Examiner notes paragraph [0067] of the instant disclosure further supports that the catheter can alternatively include one, two, or four-six lumens and it appears having three lumens does not solve any stated problem or is for any particular purpose.
In regard to claim 15,
Semrad in view of Nobles in view of Martin teaches the catheter assembly of claim 14, wherein the primary lumen (item 54 of Martin/lumen which item 20 and 10 are within of Semrad; see analysis of claim 14 above) extends from an opening in a proximal end of a first Luer connector of the three Luer connectors (see figure 2 of Martin) to an opening (figure 3, item 64 of Martin and figure 4, item 41 of Semrad) in the catheter tip (see figure 2 and 3 of Martin; column 5, line 53-62 of Martin), a secondary lumen (figure 3, item 52 of Martin) extends from an opening in a proximal end of a second Luer connector of the three Luer connectors (see figure 2 of Martin) to a secondary-lumen opening (figure 3, item 45 of Martin; column 5, line 53-62 of Martin) in a distal portion of the catheter tube (see figure 3 of Martin and the analysis of claim 14 above), and a tertiary lumen (figure 3, item 50 of Martin) extends from an opening in a proximal end of a third Luer connector of the three Luer connectors (see figure 2 of Martin) to a tertiary-lumen opening (figure 3, item 44 of Martin) in the distal portion of the catheter tube proximal of the secondary-lumen opening (see figure 3 of Martin and the analysis of claim 14 above).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Semrad (U.S. patent no 5059183) in view of Nobles (U.S. PG publication 20080058839) further in view of Davidson (U.S. Patent no 5107852).
In regard to claim 22,
Semrad in view of Nobles teaches the guidewire of claim 1, wherein the wound portion of the guidewire is wound with windings of either one or more tapes around a core wire or one or more round wires around the core wire (paragraph [0055] of Nobles, see analysis of claim 1 above).
Semrad in view of Nobles is silent as to wherein the wound portion of the guidewire is wound with windings of either one or more tapes around a core wire or one or more round wires around the core wire that are subsequently ground down to flatten the windings of the one or more round wires.
Davidson teaches one or more round wires that are subsequently ground down to flatten the windings of the one or more round wires (column 1, line 31-41).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more round wires of Semrad in view of Nobles to include one or more round wires that are subsequently ground down to flatten the windings of the one or more round wires, therefore resulting in wherein the wound portion of the guidewire is wound with windings of either one or more tapes around a core wire or one or more round wires around the core wire that are subsequently ground down to flatten the windings of the one or more round wires, as taught by Davidson, for the purpose of providing a flat surface to the tissue wall (column 1, line 39-41 of Davidson).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Semrad (U.S. patent no 5059183) in view of Nobles (U.S. PG publication 20080058839) further as evidenced by Keary (U.S. PG publication 20200338318).
In regard to claim 25,
Semrad in view of Nobles teaches the guidewire of claim 3, wherein the wound portion of the guidewire is wound with windings of one or more round wires around a core wire (paragraph [0055] of Nobles, see analysis of claim 1 and 3 above) that are subsequently ground down to flatten the windings of the one or more round wires and form the taper (Examiner notes the claimed phrase “that are subsequently ground down to flatten the windings of the one or more round wires and form the taper” is being treated as a product-by-process limitation and since it has been held that a product-by-process limitation is not construed as being limited to the product formed by the specific process recited, therefore, even though Semrad in view of Nobles is silent as to the process used to make the taper, it appears that the guidewire of Semrad in view of Nobles would be the same or similar as that claimed and further as evidenced by Keary which supports a wire with a round cross-sectional shape can be ground down to form a transition portion as detailed in paragraph [0066] of Keary).
Response to Arguments
Applicant’s arguments with respect to claims 1, 3-4, 6, 8-10, 12-15, and 21-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights