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 .
Terminal Disclaimer
The terminal disclaimer filed on 07/21/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Patent No. 11,147,946 and copending Application No. 17/317,717 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claim 66 objected to because of the following informalities: "balloon-hub" on line 4 should read "balloon-fill port" . Appropriate correction is required.
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.
Claims 53-54, 57, 60, and 63-66, are rejected under 35 U.S.C. 103 as being unpatentable by Nentwick (US 20110245665 A1) over Mann (US 6722370 B1) in view of Moriuchi (US 5084015 A).
Regarding claim 53, Nentwick discloses catheter device (catheter assembly 1, Fig 1) comprising a catheter body (catheter shaft 3, Fig 1) having a proximal end (1001, Annotated Fig 1), a distal end (1002, Annotated Fig 1), a main lumen (infusion lumen 36, Fig 3A), wherein said main lumen (36) extends between said proximal end (1001) to said distal end (1002), a balloon-fill lumen (inflation lumen 43, Fig 3A), wherein said balloon-fill lumen (43) extends from a balloon-fill port (inflation port 63, Fig 1) to an anchor balloon (balloon 24, Fig 1); a port (hub 17, Fig 1) at said proximal end (1001) connected to said main lumen (36) and said balloon-fill port (63), wherein the port (17) interfaces said main lumen (36) to said port (17) and said balloon-fill lumen (43) to said balloon-fill port (63)
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However, Nentwick is silent regarding the catheter being a direct portal vein access catheter and the port being a subcutaneous port and configured to be fully under the skin of a subject.
Mann further teaches a direct portal access catheter (Transcutaneous Transhepatic Approach; Col 8, lines 13-28).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to do the necessary dimensional modifications and to implement a puncturing element and imaging modalities to the catheter disclosed by Nentwick similar to the teaching of Transcutaneous Transhepatic Approach of Mann to achieve a non-surgical, percutaneous approach access to the liver (Col 8, line 8-12) and treat a disease of the liver (Col 1, lines 47-50: “A process for facilitating delivery of a composition (e.g., a drug) to the liver would be useful in treating, or at least alleviating the symptoms of, a disease of the liver.”).
However, Nentwick/Mann are silent regarding the port being a subcutaneous port and configured to be fully under the skin of a subject.
Moriuchi teaches a catheter (hypodermically embeddable catheter assembly 40, Fig 6) further comprising a subcutaneous port (medicament infusion implement 41, Fig 6 is hypodermically recessed; Col 9 lines 35-36) at said proximal end (proximal end of catheter 40, Fig 6) connected to said main lumen (second lumen 26, Fig 7) and a balloon-fill port (resilient member 8, Fig 6) and configured to be fully under the skin of the subject (catheter is hypodermically embedded), wherein the subcutaneous port (41) interfaces said main lumen (26) to said subcutaneous port (41) and a balloon-fill lumen (22) to said balloon-fill port (8).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Nentwick/Mann to make the hub and associated access ports subcutaneous as taught by Moriuchi for the purpose of reducing risk of infection (Col 10, lines 60-64).
Regarding claim 54, Nentwick/Mann/Moriuchi discloses the device of Claim 53. Nentwick/Mann/Moriuchi discloses a subcutaneous port (17 of Nentwick modified in claim 53 with teaching of Moriuchi); the subcutaneous port (17) is configured perpendicular in relation to said balloon-fill port (63) (Note: access ports of subcutaneous port 17 of Nentwick/Mann/Moriuchi will be located on the top surface of subcutaneous port 17 as modified by Moriuchi which is perpendicular to the lateral ballon fill port 69).
Regarding claim 57, Nentwick/Mann/Moriuchi discloses the device of Claim 53. Nentwick discloses wherein said main lumen (36) does not overlap said balloon-fill lumen (43) (Fig 1 and 3A).
Regarding claim 60, Nentwick/Mann/Moriuchi discloses the device of Claim 53. Nentwick discloses wherein said anchor balloon (24) is contained at said distal (1002) end of said catheter body (3) (Annotated Fig 1).
Regarding claim 63, Nentwick/Mann/Moriuchi discloses the device of Claim 53, Nentwick discloses wherein said catheter body has an initial length (length of the catheter body) that is cut to size for a given patient (Product by process limitation: Structure of the catheter length is disclosed see (Fig 1 from Nentwick) and can be cut to size for a given patient).
Regarding claim 64, Nentwick/Mann/Moriuchi discloses the device of Claim 53. Nentwick discloses wherein the catheter body (3) further comprises a central venous lumen (39) having a proximal end (1003: proximal end of lumen 39, Annotated Fig 1) connected to said port (17), and a terminal end (15) located between said main lumen distal end (13) and said proximal end (1003).
Nentwick is silent wherein the port is a subcutaneous port.
Moriuchi teaches a catheter (hypodermically embeddable catheter assembly 40, Fig 6) further comprising a subcutaneous port (medicament infusion implement 41, Fig 6 is hypodermically recessed; Col 9 lines 35-36)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Nentwick/Mann/Moriuchi to make the hub and associated ports subcutaneous as taught by Moriuchi for the purpose of reducing risk of infection (Col 10, lines 60-64).
Regarding claim 65, Nentwick/Mann/Moriuchi discloses the device of Claim 64. Nentwick/Mann/Moriuchi are silent regarding wherein said central venous lumen terminal end is approximately 12 cm from the catheter body distal end. The instant disclosure does not describe this length as contributing any unexpected result. As such, these parameters are deemed matters of design choice (lacking criticality), well within the skill of the ordinary artisan, obtained through routine experimentation to determine optimum results.
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the distance between the distal ends of the lumens to include a particular distance of 12 cm; since such modification would merely involve the optimization of a result effective variable, obtained through routine experimentation in determining optimum results which has been held to be within the skill of the ordinary artisan (see MPEP 2144.05 (II)).
Regarding claim 66, Nentwick/Mann/Moriuchi discloses the device of Claim 64. Nentwick discloses wherein the port (17) further comprises a first access port (1004, Annotated Fig 1) connected to said main lumen (36), and a second access port (1005, Annotated Fig 1) connected to said central venous lumen (39) ([0062]: “Lumens 39, 36, are in fluid communication with first and second extension tubes 19, 21, and distal tips 15, 13, respectively.”) ([0096]: “Although the lumens 39 and 36 have been designated as aspiration and infusion lumens, respectively, the functions of these lumens can be reversed, if desired.”; Both, lumen 36 and 39 have the structure and can be configured as infusion lumen), and said balloon-hub (63) connected to said balloon-fill lumen (43) (Fig 2A and 3A).
Nentwick is silent wherein the port is a subcutaneous port.
Moriuchi teaches a catheter (hypodermically embeddable catheter assembly 40, Fig 6) further comprising a subcutaneous port (medicament infusion implement 41, Fig 6 is hypodermically recessed; Col 9 lines 35-36) comprising a first access port (First inlet port 6, Fig 6) and second access port (Second inlet port 7, Fig 6) (Col 3, lines 43-45).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Nentwick/Mann/Moriuchi to make the hub and associated access ports subcutaneous as taught by Moriuchi for the purpose of reducing risk of infection (Col 10, lines 60-64) and allow admission of different types of fluid (Col 3, lines 43-45).
Claims 62 are rejected under 35 U.S.C. 103 as being unpatentable by Nentwick (US 20110245665 A1) over Mann (US 6722370 B1) in view of Moriuchi (US 5084015 A) in further view of Miyauchi (US 5700251 A).
Regarding claim 62, Nentwick/Mann/Moriuchi discloses the device of Claim 53. Nentwick/Mann/Moriuchi discloses a subcutaneous port (17 of Nentwick modified in claim 53 with teaching of Moriuchi).
Nentwick/Mann/Moriuchi are silent wherein said catheter body is surrounded by a ring slide for securing the catheter body proximal end to the subcutaneous port.
Miyauchi teaches a device (catheter, Fig 1) comprising a body (body 1, Fig 1) and a port (member 3, Fig 1); said catheter body (1) is surrounded by a ring slide (member 2, Fig 1) for securing the catheter body (1) proximal end to said port (3) (Col 4, lines 66-67 – Col 5, lines 1-2)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the device of Nentwick/Mann/Moriuchi to include a slide ring surrounding the proximal end of the catheter body and secured to the port as taught by Miyauchi to further protect the catheter body from torsion during assembly (Col 5, lines 34-41).
Claims 56, 61 and 68 are rejected under 35 U.S.C. 103 as being unpatentable by Nentwick (US 20110245665 A1) over Mann (US 6722370 B1) in view of Moriuchi (US 5084015 A) in further view of Snow (US 5863366 A).
Regarding claim 56, Nentwick/Mann/Moriuchi discloses the device of Claim 53. However, Nentwick/Mann/Moriuchi are silent regarding further comprising a hemostatic clamp mounted about the catheter body, said hemostatic clamp having a closed state to prevent a flow through said main lumen.
Snow teaches a device (catheter 95, Fig 1-4) comprising a body (body 51, Fig 1); a hemostatic clamp (Vorse type tube occluding clamp; Col 4, lines 18-24) mounted about the catheter body (clamp site 56), said hemostatic clamp having a closed state to prevent a flow through said main lumen (Col 7, lines 9-11: “clamp is applied to the distal clamp site 56 to stop further blood flow”)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the device of Nentwick/Mann/Moriuchi to include a similar clamp in the proximal section of catheter body as taught by Snow to form a hemostatic seal (Col 4, lines 18-24).
Regarding claim 61, Nentwick/Mann/Moriuchi discloses the device of Claim 53. Nentwick/Mann/Moriuchi is silent wherein said catheter body is surrounded by a hemostatic clamp.
Snow teaches a device (catheter 95, Fig 1-4) comprising a body (body 51, Fig 1); a hemostatic clamp (Vorse type tube occluding clamp; Col 4, lines 18-24) mounted about the catheter body (clamp site 56), said hemostatic clamp having a closed state to prevent a flow through said main lumen (Col 7, lines 9-11: “clamp is applied to the distal clamp site 56 to stop further blood flow”; clamp surrounds the catheter body to stop blood flow).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the device of Nentwick/Mann/Moriuchi to include a clamp in the proximal section of catheter body as taught by Snow to form a hemostatic seal (Col 4, lines 18-24).
Regarding claim 68, Nentwick/Mann/Moriuchi the device of Claim 66. Nentwick/Mann/Moriuchi are silent regarding further comprising a hemostatic clamp mounted about the catheter body, said hemostatic clamp having a closed state to prevent a flow through said main lumen.
Snow teaches a device (catheter 95, Fig 1-4) comprising a body (body 51, Fig 1); a hemostatic clamp (Vorse type tube occluding clamp; Col 4, lines 18-24) mounted about the catheter body (clamp site 56), said hemostatic clamp having a closed state to prevent a flow through said main lumen (Col 7, lines 9-11: “clamp is applied to the distal clamp site 56 to stop further blood flow”; clamp surrounds the catheter body to stop blood flow in a closed state)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the device of Nentwick/Mann/Moriuchi to include a clamp in the proximal section of catheter body as taught by Snow to form a hemostatic seal (Col 4, lines 18-24).
Claims 58 and 59 are rejected under 35 U.S.C. 103 as being unpatentable by Nentwick (US 20110245665 A1) over Mann (US 6722370 B1) in view of Moriuchi (US 5084015 A) in further view of Flaherty (US 20040158143 A1).
Regarding claim 58, Nentwick/Mann/Moriuchi discloses the device of Claim 53. Nentwick/Mann/Moriuchi discloses a direct portal access catheter (Transcutaneous Transhepatic Approach; Col 8, lines 13-28; from Mann as modified in claim 53). However, Nentwick/Mann/Moriuchi are silent regarding catheter body is further configured with a tissue penetrator.
Flaherty teaches a direct portal vein access catheter (stabilized tissue penetrating catheter device 400; Fig 13) comprising a tissue penetrator (tissue penetrating member 404, Fig 13) an anchor balloon (balloon 402, Fig 13) and said anchor balloon (402) is insertable into a portal vein ([0114])
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the catheter body of Nentwick/Mann/Moriuchi with a similar tissue penetrator as taught by Flaherty for insertion in the portal vein to perform TIPS procedures for the treatment of liver cirrossis and portal hypertension ([0058]: “performing transjugular intrahepatic portosystemic shunt procedures (TIPS Procedures) for the treatment of liver cirrhosis and portal hypertension”)
Regarding claim 59, Nentwick/Mann/Moriuchi discloses the device of Claim 53. Nentwick/Mann/Moriuchi are silent wherein said device further comprises an imaging apparatus attached to said catheter body.
Flaherty teaches a direct portal vein access catheter (stabilized tissue penetrating catheter device 400; Fig 13) comprising a tissue penetrator (tissue penetrating member 404, Fig 13) an anchor balloon (balloon 402, Fig 13) and said anchor balloon (402) is insertable into a portal vein ([0114]) Flaherty further teaches an imaging apparatus ([0114]: “imaging element 406 and may be provided on or within the catheter 400 to image the portal vein”) attached to said catheter body (Fig 13).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the device of Nentwick/Mann/Moriuchi by incorporating an imaging apparatus on the catheter body similar to the one disclosed by Flaherty to image the portal vein and facilitate rotational orientation and position of the catheter, which enhances the accuracy of the medical procedure ([0114]).
Claim 67 are rejected under 35 U.S.C. 103 as being unpatentable by Nentwick (US 20110245665 A1) over Mann (US 6722370 B1) in view of Moriuchi (US 5084015 A) in further view of Miyauchi (US 5700251 A) in view of Burbank et al. (US 6007516 A).
Regarding claim 67, Nentwick/Mann/Moriuchi discloses the device of Claim 66. Nentwick/Mann/Moriuchi discloses a subcutaneous port (17 of Nentwick modified in claim 53 with teaching of Moriuchi).
Nentwick/Mann/Moriuchi are silent regarding further comprising a metal connector interposed between said subcutaneous port and said catheter interfacing said central venous lumen to said second access port, said main lumen to said first access port, and said balloon-fill lumen to said balloon-fill port.
Miyauchi teaches a device (catheter, Fig 1) comprising a catheter (body 1, Fig 1) and a port (member 3, Fig 1); a female-threaded axial cavity 31; Miyauchi further teaches a connector (member 2, Fig 1) interposed between said port (3) and said catheter (1).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the device of Nentwick/Mann/Moriuchi to include a similar connector in threaded connection to the port as taught by Miyauchi to protect the catheter body from torsion (Col 5, lines 34-41).
Note: Nentwick/Mann/Moriuchi/Miyauchi as modified above discloses a connector (2, from Miyauchi) interposed between said subcutaneous port (port 17 of Nentwick modified with teaching of Moriuchi) and said catheter (3, from Nentwick) interfacing said central venous lumen (39) to said second access port (7, from Moriuchi), said main lumen (36) to said first access port (6, From Moriuchi), and said balloon-fill lumen (43, from Nentwick ) to said balloon-fill port (8, from Nentwick).
However, Nentwick/Mann/Moriuchi/Miyauchi are silent wherein the connector is a metal connector.
Burbank teaches a device (catheter, Fig 6) comprising a connector (connector 320, Fig 6) made of metal (titanium Col 11, lines 28-40: “The connector 320 comprises a metal, usually titanium, fitting which is received within the lumen of the silicone conduit 314”)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the material of the connector of Nentwick/Mann/Moriuchi/Miyauchi to be made of titanium as taught by Burbank (Col 11, lines 28-40) because of the benefit of its inherent properties. Since the connector will be subcutaneously inserted, the biocompatibility, corrosion resistance and durability of titanium will reduce the risk of adverse immune reactions, inflammation or rejection.
Response to Arguments
Applicant's arguments filed 07/21/2025 have been fully considered but they are not persuasive. Applicant submits that modifying the dimensions or shape of the Nentwick catheter for placement into portal vein would go against the express purpose of the invention in Nentwick. Examiner respectfully disagrees. Nentwick discloses that catheter is not limited to the lung and can be configured to be inserted into other openings of the human body ([0053]: “At least a portion of the distal end 14 of the catheter assembly 1 can be configured to be inserted into at least a portion of an anatomical bodily opening of a human body, such as, but not limited to, a target location in a human lung”).
Applicant submits that modification of the Nentwick catheter in view of the teachings of Mann would change the principle of operation of the Nentwick catheter. Examiner respectfully disagrees. Nentwick discloses in that either of the lumens can function as an aspiration or infusion lumen ([0096]). Nentwick device can have at least one lumen (claim 1). Modifying the dimensions of the catheter for placement into portal vein for infusion of medicament does not change the principle of operation of device; the structure will remain the same and will function in the same manner. Even if the aspiration capability of the catheter is no needed for infusion of the composition to the portal vein, the device still functions as intended and is not inoperable. Alternatively, as disclosed each of the lumen can function as an aspiration or infusion lumen; therefore both lumens can be used as infusion for application of the catheter into the portal vein since the device is structurally capable of such operation and is supported by the disclosure of Nentwick ([0096]).
Applicant submits that modification of the Nentwick catheter in view of Mann would still not result in the device of claim 53. Specifically, the device for delivering a composition to the liver as disclosed in Mann requires at least 2 catheters. Mann provides no teaching or suggestion for implementing its method without the use of multiple catheters. Examiner respectfully disagrees. Claim 53 does not limit the number of catheters used for the procedure which does not exclude the assistance of additional catheters.
Applicant’s arguments with respect to amended claim limitations regarding claims 53-54, and 56-68 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached on (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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