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 .
Drawings
The amended drawings were received on 6/29/26. The drawings are accepted.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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.
Claims 1-10 and 21-23 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.
Claim 1 recites the limitation "the third channel" in line 14. There is insufficient antecedent basis for this limitation in the claim. It will be assumed this was intend to say “the
Claims 2-10 and 21-23 are rejected as they depend from claim 1.
Claim 24 recites “the first and second valve ports” in line 4. There is insufficient antecedent basis for this limitation in the claim. It will be assumed this was intend to say “the first and second valved ports”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-5, 8, and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martin et al. (US 5,195,962), hereafter “Martin”, in view of Fantuzzi (US 2021/0085923 A1), cited previously and hereafter “Fantuzzi”.
As to claim 1, Martin discloses an introducer device (see Figs. 2-12) comprising:
a proximal hub (30) including a first port (94), a second port (96), and a third port (98);
a first elongate lumen (50) projecting distally from the proximal hub (Figs. 9, 12), the first elongate lumen being in fluid communication with the first port (see Figs. 9, 12, para beginning line 22 col. 8);
a second elongate lumen (52) projecting distally from the proximal hub (Figs. 9, 12), the second elongate lumen being in fluid communication with the second port and fluidly isolated from the first elongate lumen (see Figs. 9, 12, para beginning line 22 col. 8);
an outer tube (interpreted as all of 26 except 30) projecting distally from the proximal hub (Fig. 2, 3, 8-11), the first elongate lumen and the second elongate lumen positioned within the outer tube (Figs. 3-12); and
a channel (54) projecting distally from the proximal hub, the channel being in fluid communication with the third port (Figs. 11-12), the channel formed without a dedicated structure, the third channel formed by space within the outer tube and between the first elongate lumen and the second elongate lumen (see Figs. 9-12; the lumen 54 is not a separate dedicated structure and is merely a space within the tube 26 between 50 and 52).
Martin is silent to first and second fluid valves associated with the first port and the second port, respectively.
Fantuzzi teaches a proximal hub (120) including a first port (120) and a second port (150) as well as first (138) and second (158) fluid valves associated with the first port and the second port, respectively (para 0027).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Martin by modifying the hub of Martin to include first and second fluid valves associated with the first port and the second port, respectively. One would have been motivated to do so maintain hemostasis when a device is inserted through the hub (see para 0027 of Martin).
As to claim 2, Martin in view of Fantuzzi teaches the introducer device of claim 1, wherein the first elongate lumen, the second elongate lumen, and the outer tube are part of an elongate access sheath structure (all are part of catheter 20 of Martin which can be considered an elongate access sheath structure).
As to claim 3, Martin in view of Fantuzzi teaches the introducer device of claim 1, wherein the outer tube surrounds an entirety of the first elongate lumen and the second elongate lumen (Figs. 1-14 of Martin).
As to claim 4, Martin in view of Fantuzzi teaches the introducer device of claim 1, wherein the channel is configured to enable a dilator to project from a distal end of the introducer between the first elongate lumen and the second elongate lumen (see Fig. 3, para beginning line 50 col. 8, para beginning line 60 col. 8 of Martin).
As to claim 5, Martin in view of Fantuzzi teaches the introducer device of claim 4, wherein the first and second ports are configured to receive catheters (32 and 34 – see Fig. 12, para beginning line 21 col. 8); and the third port is configured to receive a dilator (see Fig. 3, para beginning line 50 col. 8, para beginning line 60 col. 8 of Martin).
As to claim 8, Martin in view of Fantuzzi teaches the introducer device of claim 1, wherein the first and second elongate lumens are fluidly isolated from one another (Figs. 1-13 of Martin).
As to claim 21, Martin in view of Fantuzzi teaches the introducer device of claim 1, wherein the third port is located centrally on a proximal side of the proximal hub (Figs. 1, 2, 11, 12 of Martin).
As to claim 22, Martin in view of Fantuzzi teaches the introducer of claim 21, wherein the first port and the second port are located peripherally to the third port (Figs. 1, 2, 11, 12 of Martin).
As to claim 23, Martin in view of Fantuzzi teaches the introducer of claim 1 as described above. Martin does not expressly recite a third fluid valve associated with the third port, however, Fantuzzi teaches “the introducer system may further comprise at least one third arm coupled to the first arm, each third arm having a third lumen and a third hemostasis valve, the third lumen and third hemostasis valve configured for the passage of a third medical device” (see para 0005, portion on page 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further include a third fluid valve associated with the third port for the purpose of maintaining hemostasis in the third port (see para 0005 of Fantuzzi).
Claim(s) 1-5, 8, and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trerotola (US 2005/0055012 A1) in view of Gregory et al. (US 6,290,668 A1), hereafter “Gregory”.
As to claim 1, Trerotola discloses an introducer device (see Figs. 1A-8) comprising:
a proximal hub (42) including a first port (first of luer connectors 44), a second port (other of luer connectors 44), and a third port (port where obturator 40 enters 42);
a first elongate lumen (12, 22, or 36; see Figs. 1A-3B showing three possible embodiments for catheter) projecting distally from the proximal hub, the first elongate lumen being in fluid communication with the first port (see Figs. 4A-8, para 0026, 0027);
a second elongate lumen (14, 24, or 38) projecting distally from the proximal hub, the second elongate lumen being in fluid communication with the second port and fluidly isolated from the first elongate lumen (see Figs. 4A-8, para 0026, 0027);
an outer tube (10, 20, or 34) projecting distally from the proximal hub (see Figs. 4A-8, para 0026, 0027), the first elongate lumen and the second elongate lumen positioned within the outer tube (Figs. 1A-3B); and
a channel (19, 29, 30, or 32) projecting distally from the proximal hub, the channel being in fluid communication with the third port (Figs. 1A-3B, para 0026, 0027), the channel formed without a dedicated structure, the third channel formed by space within the outer tube and between the first elongate lumen and the second elongate lumen (see 1A-3B, each embodiment of the channel is a not a dedicated structure but is integrated into the catheter, including in embodiments where the channel is merely a dead space between the first and second lumens).
Trerotola is silent to first and second fluid valves associated with the first port and the second port, respectively.
Gregory discloses a proximal hub (16) including a plurality of ports (32A, 32B, 34A, 34B) and teaches “The first and second ports may be hemostatic valves and the third and fourth ports may be Leur connectors. A check valve may be provided on each of the Leur connectors.” (see para beginning line 7 col. 3; as well as para beginning line 19 col. 5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Trerotola to include to first and second fluid valves associated with the first port and the second port, respectively. One would have been motivated to do so in order to ensure hemostasis and/or one-way fluid flow (see para beginning line 7 col. 3; as well as para beginning line 19 col. 5 of Gregory).
As to claim 2, Trerotola in view of Gregory teaches the introducer device of claim 1, wherein the first elongate lumen, the second elongate lumen, and the outer tube are part of an elongate access sheath structure (see para 0002, 0008, 0011).
As to claim 3, Trerotola in view of Gregory teaches the introducer device of claim 1, wherein the outer tube surrounds an entirety of the first elongate lumen and the second elongate lumen (both lumens found within the outer tube and therefore surrounded by it - see Figs. 1A-8, para 0026, 0027 of Trerotola).
As to claim 4, Trerotola in view of Gregory teaches the introducer device of claim 1, wherein the channel is configured to enable a dilator (40) to project from a distal end of the introducer between the first elongate lumen and the second elongate lumen (para 0028, 0031, Fig. 5A of Trerotola).
As to claim 5, Trerotola in view of Gregory teaches the introducer device of claim 4, wherein: the first and second ports are configured to receive catheters (ports 44 are described as luer connections in para 0028); and the third port is configured to receive a dilator (40; para 0028, 0031 of Trerotola).
As to claim 8, Trerotola in view of Gregory teaches the introducer device of claim 1, wherein the first and second elongate lumens are fluidly isolated from one another (Figs. 1A-8, para 0026, 0027).
As to claim 21, Trerotola in view of Gregory teaches the introducer device of claim 1, wherein the third port is located centrally on a proximal side of the proximal hub (see Figs. 4B, 6A, 7A-8 of Trerotola).
As to claim 22, Trerotola in view of Gregory teaches the introducer device of claim 21, wherein the first port and the second port are located peripherally to the third port (see Figs. 4B, 6A, 7A-8 of Trerotola).
As to claim 23, Trerotola in view of Gregory teaches the introducer device of claim 1 as described above, further comprising a third fluid valve (50) associated with the third port (para 0059; the examiner notes that “associated with” is not a requirement that the third fluid valve must be within the port; the valve 50 is associated with the third port as it found at the opposite side of the same lumen and would affect entry of fluid into that lumen from a distal side)..
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trerotola in view of Gregory, and further in view of Khurana et al. (US 2019/0201660 A1, hereafter “Khurana”).
As to claim 7, Trerotola in view of Gregory teaches the introducer device of claim 1, but does not expressly recite wherein the proximal hub further includes a fluid inlet port.
Khurana teaches a proximal hub including four ports (122, 124, 126, and 128; see para 0039, Fig. 2) and teaches “Each of the ports is configured to receive a wire, catheter and/or a substance that is provided through delivery sheath 110” (para 0039).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included a fourth port in the proximal hub of Trerotola. One would have been motivated to do so for any of the purposes mentioned by Khurana, which includes fluid inlet (see para 0039 of Khurana).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trerotola in view of Gregory as applied to claim 1 above, and further in view of Harrah et al. (US 2017/0215965 A1, cited previously and hereafter “Harrah”).
As to claim 9, Trerotola in view of Gregory teaches the introducer device of claim 1 as described above, but is silent to wherein distal openings of the first and second elongate lumens are tapered towards one another.
Harrah discloses wherein distal openings of first (112) and second (114) elongate lumens are tapered towards one another (Figs. 2-3B). Harrah further teaches “A distal end of distal portion 115 may include any number, shape and/or configuration of distal openings. As shown in FIG. 3A, distal portion 115 may include a first distal opening and a second distal opening in fluid communication with first and second lumens 112 and 114, respectively. As shown, these distal openings are approximately semi-circular in shape and include angled walls” (see para 0047).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Trerotola (as already modified above) to include distal openings such that the distal openings of the first and second elongate lumens are tapered towards one another. One would have been motivated to do so based off Harrah, which teaches modifying the shape and/or configuration of the distal openings based on the needs of the particular procedure (see para 0035, 0040, 0047 of Harrah).
Allowable Subject Matter
Claims 6, 10 and 24 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 11 and 15-20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: .
As to claim 6, while two rejections were given for claim 1 above, none of the prior art of record appears to teach or make obvious the limitations of wherein: the proximal hub further includes a proximal flange and a valve seal housing; the valve seal housing houses the first and second fluid valves; and the first and second elongate lumens project distally from the valve seal housing in combination with the limitations of claim 1.
As to claim 10, while two rejections were given for claim 1 above, none of the prior art of record appears to teach or make obvious the limitations of a first elongate shaft that forms the first elongate lumen; and a second elongate shaft that forms the second elongate lumen in combination with the limitations of claim 1.
As to claim 11, the claim has incorporated limitations from previous claims 12, 13, 14 and 15. It was noted in the previous office action that doing so would result in an allowable claim (see 3/27/26 Non-Final rejection).
Response to Arguments
Applicant’s Remarks submitted 6/29/26 have been considered.
The Remarks are either persuasive or moot based off the claim amendments. However, the amendments to the claims have also resulted in the new prior art rejections above.
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 James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D Ponton/Primary Examiner, Art Unit 3783
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