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 .
Election/Restrictions
Applicant’s election without traverse of invention I, species A, and subspecies C in the reply filed on 1/14/2026 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, and claims 2, 5, 7, and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species/subspecies there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/14/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/23/2023, 3/23/2023, 6/22/2023, 9/21/2023, 1/12/2024, 4/25/2024, 11/7/2024, 5/22/2025, and 1/21/2026 are 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, and 14-15 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 7 recites “therein”. It is unclear if “therein” refers to within the stylet, the stylet tip, or within a different structure. For examination purposes Examiner construes “therein” to be “within the stylet”. Examiner suggests replacing “therein” in line 7 of claim 1 with “within the stylet”.
Line 8 recites “and withdrawn”. It is unclear if claim 1 is attempting to claim that the dilated section is configured to be withdrawn therefrom i.e. “the dilated section of the guidewire configured to butt against a stylet tip of a stylet when at least the proximal portion of the guidewire is disposed therein with a corresponding orientation and configured to be withdrawn therefrom in a proximal direction by the proximal portion of the guidewire” or if claim 1 is attempting to claim that the dilated section is butt against a stylet tip of a stylet when at least the proximal portion of the guidewire is disposed therein with a corresponding orientation and has been withdrawn therefrom in a proximal direction by the proximal portion of the guidewire. For examination purposes Examiner construes “the dilated section of the guidewire configured to butt against a stylet tip of a stylet when at least the proximal portion of the guidewire is disposed therein with a corresponding orientation and withdrawn therefrom in a proximal direction by the proximal portion of the guidewire” to be “the dilated section of the guidewire configured to butt against a stylet tip of a stylet when at least the proximal portion of the guidewire is disposed within the stylet with a corresponding orientation and has been withdrawn from the stylet in a proximal direction by the proximal portion of the guidewire”. Examiner suggests clarifying the claim language in line 8.
Line 8 recites “therefrom”. It is unclear if “therefrom” refers to from the stylet, the stylet tip, or from a different structure. For examination purposes Examiner construes “therefrom” to be “from the stylet”. Examiner suggests replacing “therefrom” in line 8 of claim 1 with “from the stylet”.
Examiner notes claims 3-4 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 14,
Line 4 recites “the extension leg”. Claim 14 requires three extension legs. It is unclear which extension leg “the extension leg” refers to. For examination purposes Examiner construes “each extension leg of the three extension legs including a Luer connector coupled to a proximal portion of the extension leg” to be “a proximal portion of each extension leg of the three extension legs including a Luer connector”. Examiner suggests replacing “each extension leg of the three extension legs including a Luer connector coupled to a proximal portion of the extension leg” in line 3-4 of claim 14 with “a proximal portion of each extension leg of the three extension legs including a Luer connector”.
Examiner notes claim 15 is similarly rejected by virtue of its dependency on claim 14.
In regard to claim 15,
Line 2 recites “a first Luer connector”. Claim 15 depends on claim 14 and 10. Claim 14 states that each extension leg of the three extension legs includes a Luer connector. It is unclear if the first Luer connector is of the three extension legs or if the first Luer connector is in addition to the Luer connectors of each extension leg i.e. four Luer connectors total are required. For examination purposes Examiner construes the first Luer connector to be one of the Luer connectors of the three extension legs. Examiner suggests replacing “a first Luer connector” in line 2 of claim 15 with “a first Luer connector of the Luer connectors of each extension leg of the three extension legs”.
Line 3 recites “a second Luer connector”. Claim 15 depends on claim 14 and 10. Claim 14 states that each extension leg of the three extension legs includes a Luer connector. It is unclear if the second Luer connector is of the three extension legs or if the second Luer connector is in addition to the Luer connectors of each extension leg and the first Luer connector i.e. five Luer connectors total are required. For examination purposes Examiner construes the second Luer connector to be one of the Luer connectors of the three extension legs. Examiner suggests replacing “a second Luer connector” in line 3 of claim 15 with “a second Luer connector of the Luer connectors of each extension leg of the three extension legs”.
Line 5 recites “a third Luer connector”. Claim 15 depends on claim 14 and 10. Claim 14 states that each extension leg of the three extension legs includes a Luer connector. It is unclear if the third Luer connector is of the three extension legs or if the third Luer connector is in addition to the Luer connectors of each extension leg, the first Luer connector, and the second Luer connector i.e. six Luer connectors total are required. For examination purposes Examiner construes the third Luer connector to be one of the Luer connectors of the three extension legs. Examiner suggests replacing “a third Luer connector” in line 5 of claim 15 with “a third Luer connector of the Luer connectors of each extension leg of the three extension legs”.
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 and 3-4 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Semrad (U.S. Patent no 5059183).
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) greater than the first outer diameter (see figure 4; column 3, line 22-35); and
[AltContent: textbox (Guidewire tip)][AltContent: connector][AltContent: rect]
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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 against a stylet tip (figure 4, item 21) of a stylet (figure 4, item 20) when at least the proximal portion of the guidewire is disposed therein (see figure 4 and 1B) with a corresponding orientation (see figure 4) and withdrawn therefrom in a proximal direction by the proximal portion of the guidewire (see figure 4; column 4, line 19-31; Examiner notes “configured to butt against a stylet tip of a stylet when at least the proximal portion of the guidewire is disposed therein with a corresponding orientation and withdrawn therefrom in a proximal direction by the proximal portion of the guidewire” 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).
In regard to claim 3,
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Semrad discloses the guidewire of claim 1, wherein the guidewire includes a taper (see figure 4 above) from the dilated section with the second outer diameter to a remainder of the guidewire with the first outer diameter (see figure 4).
In regard to claim 4,
Semrad discloses 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).
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.
Claims 6, 8-10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Semrad (U.S. Patent no 5059183).
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) greater than the first outer diameter (see figure 4; column 3, line 22-35); and
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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), at least the proximal portion of 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 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 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 to 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 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 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,
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Semrad teaches the stylet assembly of claim 6, wherein the guidewire includes a taper (see figure 4 above) from the dilated section with the second outer diameter to a remainder of the guidewire with the first outer diameter (see figure 4).
In regard to claim 9,
Semrad 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 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) 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), at least the proximal portion of 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 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 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 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 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 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,
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Semrad teaches the catheter assembly of claim 10, wherein the guidewire includes a taper (see figure 4 above) from the dilated section with the second outer diameter to a remainder of the guidewire with the first outer diameter (see figure 4).
In regard to claim 13,
Semrad 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 above).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Semrad (U.S. Patent no 5059183) further in view of Martin (U.S. patent no 5195962).
In regard to claim 14,
Semrad teaches the catheter assembly of claim 10.
Semrad 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, each extension leg of the three extension legs including a Luer connector coupled to a proximal portion of the extension leg.
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), each extension leg of the three extension legs including a Luer connector (figure 2, item 39, 36, and 37) coupled to a proximal portion of the extension leg (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 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, each extension leg of the three extension legs including a Luer connector coupled to a proximal portion of the extension leg, 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 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 (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 (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 (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).
Conclusion
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.
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783