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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/20/2026 has been entered.
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 over Keimel et al. (US 20080140048 A1) in view of Moriuchi (US 5084015 A).
Regarding claim 53, Keimel discloses a direct portal vein access catheter (catheter 100, Fig 3; [0036]) device comprising a catheter body (body of catheter 100, Fig 3) having a proximal end (Proximal end 10, Fig 3), a distal end (distal end 30, Fig 3), a main lumen (lumen 50, Fig 5; [0040]), wherein said main lumen extends between said proximal end (10) to said distal end (30), a subcutaneous port (access port 320, Fig 3 is subcutaneous since the device is implantable) at said proximal end (10) connected to said main lumen (50) and configured to be fully under the skin of a subject (implantable; [0035]), wherein the subcutaneous port (320) interfaces said main lumen (50) to said subcutaneous port (320).
Keimel is silent regarding a balloon-fill lumen, wherein said balloon-fill lumen extends from a balloon-fill port to an anchor balloon; the subcutaneous port connected to said balloon-fill port; and said balloon-fill lumen to wherein the subcutaneous port interfaces said balloon-fill port.
Moriuchi teaches a catheter (hypodermically embeddable catheter assembly 40, Fig 6) further comprising a balloon-fill lumen (second lumens 22, Fig 6), wherein said balloon-fill lumen (22) extends from a balloon-fill port (first inlet port 6, Fig 6) to an anchor balloon (balloon 28, Fig 6); 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 (third lumen 46, Fig 7) and said balloon-fill port (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 (46) to said subcutaneous port (41) and a balloon-fill lumen (22) to said balloon-fill port (6).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Keimel to incorporate a radiopaque balloon and corresponding balloon-fill port as taught by Moriuchi for the purpose of securing the catheter in place and having a clear image of the position (Col 7, lines 24-28).
Regarding claim 54, Keimel/Moriuchi discloses the device of Claim 53. Keimel is silent regarding wherein said subcutaneous port is configured perpendicular in relation to said balloon-fill port.
Johnson teaches a port (connector 20, Fig 1) is configured perpendicular in relation to said balloon-fill port (port of connector22, Fig 1) ([0052]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Keimel/Moriuchi with similar perpendicular orientation of inflation port as taught by Johnson for the purpose of reducing the probability of confusing the ports and be less likely to obstruct the rest of the ports ([0052]).
Regarding claim 57, Keimel/Moriuchi discloses the device of Claim 53. Keimel is silent wherein said main lumen does not overlap said balloon-fill lumen.
Moriuchi teaches wherein said main lumen (third lumen 46, Fig 7) does not overlap said balloon-fill lumen (22) (Fig 7).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Keimel/Moriuchi with non-overlapping lumens as taught by Moriuchi for the purpose of having independent function (Col 5, lines 40-43)
Regarding claim 60, Keimel/Moriuchi discloses the device of Claim 53. Keimel is silent wherein said anchor balloon is contained at said distal end of said catheter body.
Moriuchi teaches wherein said anchor balloon (28) is contained at said distal end (Fig 6) of said catheter body (tube body 21, Fig 6).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Keimel/Moriuchi with similar relative position of the balloon as taught by Moriuchi for the purpose of securing the catheter in place and having a clear image of the position (Col 7, lines 24-28).
Regarding claim 63, Keimel/Moriuchi discloses the device of Claim 53, Keimel 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 3 and can be cut to size for a given patient).
Regarding claim 64, Keimel/Moriuchi discloses the device of Claim 53. Keimel is silent wherein the catheter body further comprises a central venous lumen having a proximal end connected to said subcutaneous port, and a terminal end located between said main lumen distal end and said proximal end.
Moriuchi teaches wherein the catheter body (tube body 21, Fig 6) further comprises a central venous lumen (26) having a proximal end (1000, Annotated Fig 1) connected to said subcutaneous port (41), and a terminal end (slits 24a, Fig 6) located between said main lumen (46) distal end (slits 24b, Fig 6) and said proximal end (1000, Annotated Fig 1).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the central venous catheter of device of Keimel/Moriuchi to have an additional lumen of the in the relative position taught by Moriuchi to accommodate a situation where it is desired to infuse different types of medicaments at different flow rates (Col 10, lines 23-25).
Regarding claim 65, Keimel/Moriuchi discloses the device of Claim 64. Keimel/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, Keimel/Moriuchi discloses the device of Claim 64. Keimel is silent wherein the subcutaneous port further comprises a first access port connected to said main lumen, and a second access port connected to said central venous lumen and said balloon-fill port connected to said balloon-fill lumen.
Moriuchi teaches wherein the subcutaneous port (41) further comprises a first access port (third inlet port 42, Fig 6) connected to said main lumen (46), and a second access port (second inlet port 7, Fig 6) connected to said central venous lumen (26), and said balloon-fill port (first inlet port 6, Fig 6) connected to said balloon-fill lumen (first lumen 22, Fig 7).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Keimel/Moriuchi with similar access ports as taught by Moriuchi for the purpose of having functionally independent areas for insertion of medical fluids or inflation fluids when necessary (Col 8, lines 6-17).
Claims 62 are rejected under 35 U.S.C. 103 as being over Keimel et al. (US 20080140048 A1) in view of Moriuchi (US 5084015 A) in further view of Miyauchi (US 5700251 A).
Regarding claim 62, Keimel/Moriuchi discloses the device of Claim 53. Keimel discloses a subcutaneous port (300). Keimel/Moriuchi aresilent 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 Keimel/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 over Keimel et al. (US 20080140048 A1) in view of Moriuchi (US 5084015 A) in further view of Snow (US 5863366 A).
Regarding claim 56, Keimel/Moriuchi discloses the device of Claim 53. However, Keimel/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 Keimel/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, Keimel/Moriuchi discloses the device of Claim 53. Keimel/Moriuchi are 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 Keimel/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, Keimel/Moriuchi discloses the device of Claim 66. Keimel/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 Keimel/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 over Keimel et al. (US 20080140048 A1) in view of Moriuchi (US 5084015 A) in further view of Flaherty (US 20040158143 A1).
Regarding claim 58, Keimel/Moriuchi discloses the device of Claim 53. Keimel/Moriuchi are silent regarding said 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 Keimel/Moriuchi to incorporate 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, Keimel/Moriuchi discloses discloses the device of Claim 53. Keimel/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 Keimel/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 over Keimel et al. (US 20080140048 A1) 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, Keimel/Moriuchi discloses the device of Claim 66. Keimel discloses the subcutaneous port (300). Keimel/Moriuchi are silent regarding 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 Keimel/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: Keimel/Moriuchi/Miyauchi as modified above discloses a connector (2, from Miyauchi) interposed between said subcutaneous port (port 300 of Keimel modified with teaching of Moriuchi) and said catheter (100, from Keimel) interfacing said central venous lumen (26, from Moriuchi) to said second access port (7, from Moriuchi), said main lumen (46, from Moriuchi) to said first access port (42, From Moriuchi), and said balloon-fill lumen (22, from Moriuchi) to said balloon-fill port (6, from Moriuchi).
However, Keimel/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 Keimel/Moriuchi/Miyauchi to be made of titanium as taught by Burbank because of the benefit of its inherent properties (Col 11, lines 28-40; 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 with respect to 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.
The affidavit under 37 CFR 1.132 filed 04/20/2026 is insufficient to overcome the rejection of claim 53 based upon 35 U.S.C. 103 as being unpatentable over Nentwick (US 20110245665 A1) in view of Mann (US 6722370 B1) in further view of Moriuchi (US 5084015 A) as set forth in the last Office action because a person of ordinary skill in the art would have been motivated to modify the device of Nentwick to be inserted into the hepatic portal system as taught by Mann to deliver treatment for disease of the liver (Col 1, lines 47-50 of Mann). Adjustments of size and length would have been predictable design modifications within ordinary skill and would not alter the device principle of operation.
However, in efforts to advance prosecution new grounds of rejection for claim 53 are based upon 35 U.S.C. 103 as being unpatentable over Keimel et al. (US 20080140048 A1) in view of Moriuchi (US 5084015 A).
Conclusion
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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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/Primary Examiner, Art Unit 3783
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