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 12/10/2025 has been entered. Claims 1-20 remain pending in the application.
Applicants amendments to the specification have overcome the specification objections previously set forth in the Non-final Office Action mailed 9/17/2025.
Applicants amendments to the claims have overcome the claim objections previously set forth in the Non-final Office Action mailed 9/17/2025.
Applicants amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 9/17/2025.
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 14-16 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 14,
Line 1 recites “the first portion”. There is insufficient antecedent basis for the limitation in this claim. Claim 14 depends on claim 1. Claim 1 introduces a portion of a first lumen. It is unclear if the first portion of claim 14 is intended to be the same as the portion of the first lumen of claim 1 or refer to a first portion. For examination purposes Examiner construes “the first portion” to be “the portion of the first lumen”. Examiner suggests replacing “the first portion” in line 1 of claim 14 with “the portion of the first lumen”.
In regard to claim 15,
Line 1 recites “the first portion”. There is insufficient antecedent basis for the limitation in this claim. Claim 15 depends on claim 1. Claim 1 introduces a portion of a first lumen. It is unclear if the first portion of claim 15 is intended to be the same as the portion of the first lumen of claim 1 or refer to a first portion. For examination purposes Examiner construes “the first portion” to be “the portion of the first lumen”. Examiner suggests replacing “the first portion” in line 1 of claim 15 with “the portion of the first lumen”.
In regard to claim 16,
Line 1 recites “the first portion”. There is insufficient antecedent basis for the limitation in this claim. Claim 16 depends on claim 1. Claim 1 introduces a portion of a first lumen. It is unclear if the first portion of claim 16 is intended to be the same as the portion of the first lumen of claim 1 or refer to a first portion. For examination purposes Examiner construes “the first portion” to be “the portion of the first lumen”. Examiner suggests replacing “the first portion” in line 1 of claim 16 with “the portion of the first lumen”.
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, 7, 10, 13-16, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olsen (U.S. PG publication 20050245887).
In regard to claim 1,
Olsen discloses a system (figure 2, item 50), comprising:
a catheter (figure 2, item 22, 200, 208, and 210) comprising:
an elongate tube (see tube formed by item 22 and 200) including a proximal end (end of item 22 connected to item 24) and a distal end (distal end of item 200 formed by outlet fitting 214) and defining a plurality of lumens (figure 3A, item 204 connected to item 214 forms a lumen and item 206 connected to item 214 forms a lumen) longitudinally extending between the proximal end and the distal end (see figure 3A and 2 wherein the plurality of lumens are between the proximal end and the distal end), wherein the plurality of lumens are separated by at least one septum (see figure 3A and 3B), and
a distal tip structure (figure 2 and 3B, item 208) coupled to the distal end (see figure 2), 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 2 and paragraph [0046] and [0072]); and
a first plug of filler (Figure 3A and 3B, item 232 located in outlet port 204; paragraph [0064]) configured for positioning in a portion of a first lumen (lumen of item 204) of the plurality of lumens proximal the distal tip (see figure 3A and 3B), wherein the first plug of filler is defined as having an oval cross-sectional shape (paragraph [0037]: wherein the flow restrictors can have an oval cross-sectional shape).
In regard to claim 2,
Olsen discloses the system of claim 1, further comprising a second plug of filler (Figure 3A and 3B, item 232 located in outlet port 206; paragraph [0064]) positioned in a portion of a second lumen (lumen of item 206) of the plurality of lumens, wherein the second plug of filler is defined as having the oval cross-sectional shape (paragraph [0037]: wherein the flow restrictors can have an oval cross-sectional shape).
In regard to claim 3,
Olsen discloses 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 analysis of claim 1 and 2 above and figure 3A and 3B).
In regard to claim 7,
Olsen discloses the system of claim 1, wherein the first plug of filler includes a cross-section having a first line of symmetry (paragraph [0037]; Examiner notes due to the first plug of filler being an oval, the first plug of filler includes a cross-section having a first line of symmetry).
In regard to claim 10,
Olsen discloses the system of claim 7, wherein the first plug of filler includes a cross-section having a second line of symmetry (paragraph [0037]; Examiner notes due to the first plug of filler being an oval, the first plug of filler includes a cross-section having a second line of symmetry).
In regard to claim 13,
Olsen discloses 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 (paragraph [0037]; Examiner notes due to the first plug of filler being an oval, 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 3B; 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 as supported by figure 3B wherein no bulging is shown).
In regard to claim 14,
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Olsen discloses the system of claim 1, wherein the first portion of the first lumen is located in a distal section of the catheter (see figure 2 above).
In regard to claim 15,
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Olsen discloses the system of claim 1, wherein the first portion of the first lumen is located in a medial section of the catheter (see figure 2 above).
In regard to claim 16,
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Olsen discloses the system of claim 1, wherein the first portion of the first lumen is located in a proximal section of the catheter (see figure 2 above).
In regard to claim 20,
Olsen discloses the system of claim 1, wherein at least one lumen (lumen of item 206) of the plurality of lumens includes a cross-sectional profile that is generally triangular or kidney shaped (paragraph [0037]).
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 4-6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen (U.S. PG publication 20050245887) and further in view of Elsberry (U.S. Patent no 6551290).
In regard to claim 4,
Olsen discloses the system of claim 1.
Olsen is silent as to wherein the first plug of filler is formed of a biocompatible polymeric material.
Elsberry teaches wherein the first plug of filler (figure 4A, item 70’) is formed of a biocompatible polymeric material (column 7, line 28-55 and column 1, line 58-60)
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the material of the first plug of filler to be formed of sintered polyethylene, as taught by Elsberry, for the purpose of using a suitable material to enable flow balance (column 1, line 58-60 of Elsberry).
In regard to claim 5,
Olsen in view of Elsberry 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 (see analysis of claim 4 above).
In regard to claim 6,
Olsen discloses the system of claim 1.
Olsen is silent as to wherein the first plug of filler is formed of a radiopaque material.
Elsberry teaches wherein the first plug of filler is formed of a radiopaque material (column 2, line 57-61; see also claim 12 of Elsberry).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the material of the first plug of filler to be formed of s a radiopaque material, as taught by Elsberry, for the purpose of enabling imaging (column 2, line 57-61 of Elsberry).
In regard to claim 17,
Olsen discloses the system of claim 1, wherein the plurality of lumens includes the first lumen (lumen of item 204), a second lumen (lumen of item 206), 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 2 and 3B), at least one lumen of the plurality of lumens being power injectable (see figure 2 and 3B wherein at least one lumen of the plurality of lumens is connected to pump 20. Examiner notes “at least one lumen of the plurality of lumens being power injectable” does not positively require a power injector. At least one lumen of the plurality of lumens is fully capable of being power injectable due to its structure).
Although Olsen supports that flow can be separated into three or more legs of a branching catheter (paragraph [0012] of Olsen), Olsen is silent as to a third lumen, and a fourth lumen.
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Elsberry teaches wherein the plurality of lumens includes the first lumen (see figure 4B above), a second lumen (see figure 4B above), a third lumen (see figure 4B above), and a fourth lumen (see figure 4B above).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Olsen to include a third lumen and a fourth lumen, as taught by Elsberry, for the purpose of enabling delivery of a drug to more than two targeted patient sites (column 6, line 37-39 of Elsberry). Further, as noted above, Olsen supports three or more legs of a branching catheter (paragraph [0012] of Olsen).
Claims 8-9 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen (U.S. PG publication 20050245887).
In regard to claim 8,
Olsen discloses the system of claim 7.
Olsen is silent as to wherein a length of the first line of symmetry is within a range of 0.035-0.050 inches. Examiner notes Olsen does not provide dimensions of an oval restrictor.
It would have been an obvious matter of design choice to modify Olsen 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 Olsen 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 which could be modified.
In regard to claim 9,
Olsen teaches the system of claim 8.
Olsen is silent as to wherein the length of the first line of symmetry is 0.041+0.002 inches. Examiner notes Olsen does not provide dimensions of an oval restrictor.
It would have been an obvious matter of design choice to modify Olsen 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 Olsen 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 which could be modified.
In regard to claim 11,
Olsen discloses the system of claim 10.
Olsen is silent as to wherein a length of the second line of symmetry is within a range of 0.0175-0.035 inches. Examiner notes Olsen does not provide dimensions of an oval restrictor.
It would have been an obvious matter of design choice to modify Olsen 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 Olsen 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 which could be modified.
In regard to claim 12,
Olsen teaches the system of claim 11.
Olsen is silent as to wherein the length of the second line of symmetry is 0.0250+0.0015 inches. Examiner notes Olsen does not provide dimensions of an oval restrictor.
It would have been an obvious matter of design choice to modify Olsen 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 Olsen 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 which could be modified.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen (U.S. PG publication 20050245887) further in view of Patterson (U.S. PG publication 20120209221).
In regard to claim 18,
Olsen discloses the system of claim 1.
Olsen 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 item 22 of Olsen 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 (paragraph [0044]-[0045]] of Patterson).
In regard to claim 19,
Olsen discloses the system of claim 1.
Olsen 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 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 (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 item 22 of Olsen 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 (paragraph [0044]-[0045] 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
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.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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