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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/30/2026 has been entered.
Response to Amendment
The Amendment filed on 5/29/2026 has been entered. Claims 1-20 remain pending in the application.
Applicants amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Final Office Action mailed 3/30/2026.
Claim Rejections - 35 USC § 103
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 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 1-5 and 7-16 are rejected under 35 U.S.C. 103 as being unpatentable over Martin (U.S. patent no 5195962) and further in view of Chesnin (U.S. PG publication 20090247868).
In regard to claim 1,
Martin discloses a system (figure 2, item 20), comprising:
a catheter (figure 2 and 3, item 26 and 29 not including item 56 or item 60) comprising:
[AltContent: connector][AltContent: rect][AltContent: textbox (Portion of the first lumen)][AltContent: textbox (Distal tip structure)][AltContent: connector][AltContent: rect]
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an elongate tube (see figure 2 and 3, item 26 wherein the elongate tube is construed as item 26 not including the labeled distal tip structure 29 above) including a proximal end and a distal end (see figure 2 and 3) and defining a plurality of lumens (figure 3 and 4, item 50, 52, and 54) longitudinally extending between the proximal end and the distal end (see figure 3), wherein the plurality of lumens are separated by at least one septum (see figure 3 and 4), and
a distal tip structure (figure 3, item 29; see figure 3 above) coupled to the distal end (see figure 3), wherein the distal tip structure includes a distal lumen aperture in fluid communication with at least one lumen of the plurality of lumens (see figure 3); and
a first plug of filler (figure 3, item 56) configured for positioning in a portion of a first lumen (figure 3, item 50; see figure 3 above) of the plurality of lumens proximal the distal tip (see figure 3 above) to block flow through the portion of the first lumen (column 6, line 10-13 and column 4, line 2-8), wherein the first plug of filler is defined as having a cross-sectional shape shaped to the first lumen (column 6, line 52-54: The inserts are shaped to the cross-section of the lumens; column 5, line 65-column 6, line 2: wherein the cross-section is c-shaped; column 9, line 57-61: wherein the cross-section is not limited).
Martin fails to disclose wherein the first plug of filler is defined as having an oval cross-sectional shape.
Chesnin teaches a c-shaped lumen and an elliptical shaped lumen could all be used to achieve the same result (paragraph [0017] and [0032]) and thus a c-shaped lumen and an elliptical shaped lumen were art-recognized equivalents before the effective filing date of the claimed invention.
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 substitute elliptical shaped lumens in place of the C-shaped lumens 50 and 52 of Martin since it has been held that substituting parts of an invention involves only routine skill in the art. Examiner notes as the plugs of filler 56 and 60 of Martin are shaped to the cross-section of the lumens (column 6, line 52-54 of Martin), the plugs of filler 56 and 60 of Martin would also be modified to be elliptical shaped, therefore resulting in wherein the first plug of filler is defined as having an oval cross-sectional shape. Martin also supports in column 9, line 57-61 of Martin that the cross-section is not limited.
In regard to claim 2,
Martin in view of Chesnin teaches the system of claim 1, further comprising a second plug of filler (figure 3, item 60 of Martin) positioned in a portion of a second lumen (figure 3, item 52 of Martin) of the plurality of lumens to block flow through the portion of the second lumen (column 6, line 26-28 of Martin), wherein the second plug of filler is defined as having the oval cross-sectional shape (see analysis of claim 1 above wherein item 60 of Martin has been modified to have an elliptical shape therefore resulting in the second plug of filler is defined as having the oval cross-sectional shape).
In regard to claim 3,
Martin in view of Chesnin teaches the system of claim 2, wherein the first plug of filler and the second plug of filler are positioned in different lumens of the plurality of lumens (see figure 3 of Martin).
In regard to claim 4,
Martin in view of Chesnin teaches the system of claim 1, wherein the first plug of filler is formed of a biocompatible polymeric material (column 6, line 10-13 of Martin).
In regard to claim 5,
Martin in view of Chesnin teaches the system of claim 4, wherein the biocompatible polymeric material includes one or more of silicone, nylon, polyurethane, polyethylene terephthalate, a latex, a plastic, a thermoset, or a thermoplastic elastomer (column 6, line 10-13 of Martin).
In regard to claim 7,
Martin in view of Chesnin teaches the system of claim 1, wherein the first plug of filler includes a cross-section having a first line of symmetry (see analysis of claim 1 above, wherein due to the first plug of filler being elliptical, the first plug of filler includes a cross-section having a first line of symmetry).
In regard to claim 8,
Martin in view of Chesnin teaches the system of claim 7.
Martin in view of Chesnin is silent as to wherein a length of the first line of symmetry is within a range of 0.035-0.050 inches.
It would have been an obvious matter of design choice to modify Martin in view of Chesnin to include a length of the first line of symmetry is within a range of 0.035-0.050 inches since applicant has not disclosed that having a length of the first line of symmetry is within a range of 0.035-0.050 inches 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 length of the first line of symmetry is within a range of 0.035-0.050 inches, 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). Additionally, it would have been an obvious matter of design choice to modify Martin in view of Chesnin to include a length of the first line of symmetry is within a range of 0.035-0.050 inches 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. Paragraph [00044] of the instant application further supports fillers can have other shapes with other lines of symmetry. Examiner notes the size of the filler would also depend on the size of the lumens of the catheter.
In regard to claim 9,
Martin in view of Chesnin teaches the system of claim 8.
Martin in view of Chesnin is silent as to wherein the length of the first line of symmetry is 0.041+0.002 inches.
It would have been an obvious matter of design choice to modify Martin in view of Chesnin to include wherein the length of the first line of symmetry is 0.041+0.002 inches since applicant has not disclosed that having wherein the length of the first line of symmetry is 0.041+0.002 inches 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 length of the first line of symmetry is 0.041+0.002 inches, 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). Additionally, it would have been an obvious matter of design choice to modify Martin in view of Chesnin to include wherein the length of the first line of symmetry is 0.041+0.002 inches 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. Paragraph [00044] of the instant application further supports fillers can have other shapes with other lines of symmetry. Examiner notes the size of the filler would also depend on the size of the lumens of the catheter.
In regard to claim 10,
Martin in view of Chesnin teaches the system of claim 7, wherein the first plug of filler includes a cross-section having a second line of symmetry (see analysis of claim 1 above, wherein due to the first plug of filler being elliptical, the first plug of filler includes a cross-section having a second line of symmetry).
In regard to claim 11,
Martin in view of Chesnin teaches the system of claim 10.
Martin in view of Chesnin is silent as to wherein a length of the second line of symmetry is within a range of 0.0175-0.035 inches.
It would have been an obvious matter of design choice to modify Martin in view of Chesnin to include a length of the second line of symmetry is within a range of 0.0175-0.035 inches since applicant has not disclosed that having a length of the second line of symmetry is within a range of 0.0175-0.035 inches 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 length of the second line of symmetry is within a range of 0.0175-0.035 inches, 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). Additionally, it would have been an obvious matter of design choice to modify Martin in view of Chesnin to include a length of the second line of symmetry is within a range of 0.0175-0.035 inches 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. Paragraph [00044] of the instant application further supports fillers can have other shapes with other lines of symmetry. Examiner notes the size of the filler would also depend on the size of the lumens of the catheter.
In regard to claim 12,
Martin in view of Chesnin teaches the system of claim 11.
Martin in view of Chesnin is silent as to wherein the length of the second line of symmetry is 0.0250+0.0015 inches.
It would have been an obvious matter of design choice to modify Martin in view of Chesnin to include wherein the length of the second line of symmetry is 0.0250+0.0015 inches since applicant has not disclosed that having wherein the length of the second line of symmetry is 0.0250+0.0015 inches 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 length of the second line of symmetry is 0.0250+0.0015 inches, 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). Additionally, it would have been an obvious matter of design choice to modify Martin in view of Chesnin to include wherein the length of the second line of symmetry is 0.0250+0.0015 inches 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. Paragraph [00044] of the instant application further supports fillers can have other shapes with other lines of symmetry. Examiner notes the size of the filler would also depend on the size of the lumens of the catheter.
In regard to claim 13,
Martin in view of Chesnin teaches the system of claim 1, wherein the oval cross-sectional shape of the first plug of filler includes a first vertex and a second vertex (see analysis of claim 1 above wherein due to the shape of the first plug of filler, the oval cross-sectional shape of the first plug of filler includes a first vertex and a second vertex), wherein the first plug of filler is configured such that either the first vertex or the second vertex may be positioned near an upper side of the first lumen without causing bulging of a wall of the first lumen (see figure 3 of Martin; Examiner notes “configured such that either the first vertex or the second vertex may be positioned near an upper side of the first lumen without causing bulging of a wall of the first lumen” is a functional limitation. The first plug of filler is fully capable of the recited function due to its structure).
In regard to claim 14,
[AltContent: textbox (Distal section of the catheter)][AltContent: ][AltContent: textbox (Portion of the first lumen)][AltContent: connector][AltContent: rect]
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Martin in view of Chesnin teaches the system of claim 1, wherein the portion of the first lumen is located in a distal section of the catheter (see figure 3 of Martin above).
In regard to claim 15,
[AltContent: textbox (Medial section of the catheter)][AltContent: ][AltContent: textbox (Portion of the first lumen)][AltContent: connector][AltContent: rect]
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Martin in view of Chesnin teaches the system of claim 1, wherein the portion of the first lumen is located in a medial section of the catheter (see figure 3 of Martin above).
In regard to claim 16,
[AltContent: textbox (Proximal section of the catheter)][AltContent: ][AltContent: textbox (Portion of the first lumen)][AltContent: connector][AltContent: rect]
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Martin in view of Chesnin teaches the system of claim 1, wherein the portion of the first lumen is located in a proximal section of the catheter (see figure 3 of Martin above).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Martin (U.S. patent no 5195962) in view of Chesnin (U.S. PG publication 20090247868) further in view of Mueller (U.S. Patent no 4577637).
In regard to claim 6,
Martin in view of Chesnin teaches the system of claim 1.
Martin in view of Chesnin is silent as to wherein the first plug of filler is formed of a radiopaque material.
Mueller teaches wherein the first plug of filler (figure 1, item 26) is formed of a radiopaque material (column 1, line 44-47 and column 2, line 19-29).
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 Martin in view of Chesnin to include wherein the first plug of filler is formed of a radiopaque material, as taught by Mueller, for the purpose of avoiding injury (column 1, line 25-28 of Mueller).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Martin (U.S. patent no 5195962) in view of Chesnin (U.S. PG publication 20090247868) further in view of McGuckin (U.S. PG publication 20020107506) further in view of Appling (U.S. PG publication 20100191165).
In regard to claim 17,
Martin in view of Chesnin teaches the system of claim 1, wherein the plurality of lumens includes the first lumen (figure 3 and 4, item 50 of Martin), a second lumen (figure 3 and 4, item 52 of Martin), a third lumen (figure 3 and 4, item 54 of Martin), wherein at least two lumens of the plurality of lumens are bisected by one of a minor axis or a major axis of the catheter (see figure 4 of Martin).
Martin in view of Chesnin fails to disclose wherein the plurality of lumens includes a fourth lumen, at least one lumen of the plurality of lumens being power injectable.
McGuckin teaches wherein the plurality of lumens includes a fourth lumen (figure 9B, item 60C).
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 Martin in view of Chesnin to include wherein the plurality of lumens includes a fourth lumen, as taught by McGuckin, for the purpose of providing for additional flow (paragraph [0138] of McGuckin).
Martin in view of Chesnin in view of McGuckin is silent as to at least one lumen of the plurality of lumens being power injectable.
Appling teaches at least one lumen (item 32) of the plurality of lumens being power injectable (paragraph [0054]).
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 third lumen 54 of Martin in view of Chesnin in view of McGuckin to be power injectable, therefore resulting in at least one lumen of the plurality of lumens being power injectable, as taught by Appling, for the purpose of enabling rapid infusion (paragraph [0054] of Appling).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Martin (U.S. patent no 5195962) in view of Chesnin (U.S. PG publication 20090247868) further in view of Patterson (U.S. PG publication 20120209221).
In regard to claim 18,
Martin in view of Chesnin teaches the system of claim 1.
Martin in view of Chesnin is silent as to wherein a proximal portion of the elongate tube defines a circular cross-section and a distal portion of the elongate tube defines an elliptical cross-section.
Patterson teaches wherein a proximal portion of the elongate tube defines a circular cross-section and a distal portion of the elongate tube defines an elliptical cross-section (paragraph [0043]-[0045]).
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 Martin in view of Chesnin to include a proximal portion of the elongate tube defines a circular cross-section and a distal portion of the elongate tube defines an elliptical cross-section, as taught by Patterson, for the purpose of providing a catheter that is less likely to flip in a desired section when maneuvered and has low hydraulic resistance in a desired section (paragraph [0044]-[0045] of Patterson).
In regard to claim 19,
Martin in view of Chesnin teaches the system of claim 1.
Martin in view of Chesnin is silent as to wherein a proximal portion of the elongate tube defines an elliptical cross-section and a distal portion of the elongate tube defines a circular cross-section.
Patterson teaches a proximal portion of the elongate tube defines an elliptical cross-section and a distal portion of the elongate tube defines a circular cross-section (paragraph [0043]-[0045]).
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 Martin in view of Chesnin to include a proximal portion of the elongate tube defines an elliptical cross-section and a distal portion of the elongate tube defines a circular cross-section, as taught by Patterson, for the purpose of providing a catheter that is less likely to flip in a desired section when maneuvered and has low hydraulic resistance in a desired section (paragraph [0044]-[0045] of Patterson).
In regard to claim 20,
Martin in view of Chesnin teaches the system of claim 1.
Martin in view of Chesnin is silent as to wherein at least one lumen of the plurality of lumens includes a cross-sectional profile that is generally triangular or kidney shaped.
Patterson teaches wherein at least one lumen (figure 4, item 14C) of the plurality of lumens includes a cross-sectional profile that is generally triangular or kidney shaped (triangular; see figure 4).
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 lumen 54 of Martin in view of Chesnin to have a cross-sectional profile that is generally triangular, therefore resulting in wherein at least one lumen of the plurality of lumens includes a cross-sectional profile that is generally triangular or kidney shaped, as taught by Patterson, for the purpose of enabling relatively high fluid flow rates (paragraph [0032] of Patterson).
Response to Arguments
Applicant’s arguments with respect to claims 1-20 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
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
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