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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 53-56, and 63-64 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040158143 A1) in view of Moriuchi (US 5084015 A) in further view of Nentwick (US 20110245665 A1).
Regarding claim 53, Flaherty embodiment of Fig 10, hereinafter Flaherty-10 discloses a direct portal vein access catheter device (catheter device 200, Fig 10; [0102]; [0110]) comprising: a catheter body (catheter body 202, Fig 10) having a proximal end (1002, Annotated Fig 1), a distal end (1003, Annotated Fig 1), a main lumen (lumen 210, Fig 10), a balloon-fill lumen (1004, Annotated Fig 1), an anchor balloon (stabilizer balloon 216, Fig 10), mounted to said catheter body (202) having at least an inflatable state ([0102]), a balloon-fill port (1001, Annotated Fig 1), wherein: said main lumen (lumen 210, Fig 10) extends from said proximal end (1002, Annotated Fig 1) to said distal end (1003, Annotated Fig 1) and does not overlap said balloon-fill lumen (1004, Annotated Fig 1) said balloon-fill lumen (1004, Annotated Fig 1) extends from said balloon-fill port (1001, Annotated Fig 1) to said anchor balloon (balloon 216, Fig 10), said anchor balloon (402) is insertable into a portal vein and inflatable to engage said portal vein and prevent dislodgement ([0114]; [0110]; TIPS procedure), wherein the proximal end (1002, Annotated Fig 1) of the catheter (200) is configured to extend out of a patient's body (Annotated Fig 1).
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Flaherty-10 is silent regarding a subcutaneous port at said proximal end connected to said main lumen and said balloon-fill port and configured to be fully under the skin of a subject, wherein the subcutaneous port interfaces said main lumen to said subcutaneous port and said balloon- fill lumen to said balloon-fill port, and a tissue ingrowth cuff having a circumference configured to receive tissue therein and decrease the potential for infection and said tissue ingrowth cuff is mounted on the catheter body between the anchoring balloon and the proximal end.
Moriuchi teaches a device comprising 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 (first inlet ports 6, Fig 6) and configured to be fully under the skin of a subject (Col 2, lines 13-15), 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 method of Flaherty-10 to make the hub and associated infusion and inflation ports subcutaneous as taught by Moriuchi for the purpose of reducing risk of infection (Col 10, lines 60-64).
Flaherty-10/Moriuchi are silent regarding a tissue ingrowth cuff having a circumference configured to receive tissue therein and decrease the potential for infection and said tissue ingrowth cuff is mounted on the catheter body between the anchoring balloon and the proximal end.
Nentwick teaches a device having a tissue ingrowth cuff (Cuff 6, Fig 1) having a circumference (Fig 6) configured to receive tissue therein, and decrease the potential for infection ([0109]; [0106]) said tissue ingrowth cuff (6) is mounted on the catheter body between the anchoring balloon (24) and the proximal end (proximal end near the hub 17, Fig 1) .
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Flaherty-10/Moriuchi with similar tissue ingrowth cuff as taught by Nentwick for the purpose of allowing subcutaneous tissue to grow into the cuff and to help secure the catheter ([0060]; [0109]).
Regarding claim 54, Flaherty-10/Moriuchi/Nentwick discloses the device of claim 53. Flaherty-10 discloses wherein said catheter body (202) further comprises a tissue penetrator (tissue penetrating member 208, Fig 10).
Regarding claim 55, Flaherty-10/Moriuchi/Nentwick discloses the device of claim 53. Flaherty-10 discloses further comprising an imaging apparatus (imaging element 222, Fig 10) attached to said catheter body ([0103]).
Regarding claim 56, Flaherty-10/Moriuchi/Nentwick discloses the device of claim 53. Flaherty-10 discloses wherein said anchor balloon (216) is contained at said distal end (1003, Annotated Fig 1) of said catheter body (202).
Regarding claim 63, Flaherty-10/Moriuchi/Nentwick discloses the device of claim 53, Flaherty-10 discloses wherein the catheter body (202) further comprises a central venous lumen (1005, Annotated Fig 1) extending between said catheter body proximal end (1002, Annotated Fig 1) and a terminal end (1006, Annotated Fig 1) located between said main lumen distal end (distal end of lumen 210, Fig 10) and said catheter body proximal end (1002, Annotated Fig 1).
Regarding claim 64, Flaherty-10/Moriuchi/Nentwick discloses the device of claim 63. Flaherty-10/Moriuchi/Nentwick are silent wherein said central venous lumen terminal end is approximately 12 cm from the main lumen distal end.
Examiner notes that the instant disclosure does not describe the claim distance as contributing any unexpected result. As such, these parameters are deemed matters of design choice, lacking criticality (Page 3, line 1 of instant application), 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)).
Claims 57 is rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040158143 A1) in view of Moriuchi (US 5084015 A) in further view of Nentwick (US 20110245665 A1) in further view of Snow (US 5863366 A).
Regarding claim 57, Flaherty-10/Moriuchi/Nentwick discloses the device of claim 53. Flaherty-10/Moriuchi/Nentwick are silent wherein said device further comprises a hemostatic clamp about said catheter body located between the tissue ingrowth cuff and the catheter body proximal end.
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) that is clamped at clamp site 51.
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 Flaherty-10/Moriuchi/Nentwick to include similar clamp in the proximal section of shaft as taught by Snow to form a hemostatic seal (Col 4, lines 18-24).
Claims 58 is rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040158143 A1) in view of Moriuchi (US 5084015 A) in further view of Nentwick (US 20110245665 A1) in further view of Hubbell (US 6074367 A).
Regarding claim 58, Flaherty-10/Moriuchi/Nentwick discloses the device of claim 53. Flaherty-10 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 is disclosed since the catheter has an inherent length (Fig 1 from Nentwick) and can be cut to size for a given patient.)
Hubbell teaches a kit and a method for pre-insertion measuring of the optimal catheter length (Col 2, lines 47-61) wherein said catheter body has an initial length that can be cut to size for a given patient (Col 1, lines 56-59).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to implement a kit and adapted method, similar to the one taught by Hubell to obtain the optimal length of the catheter before insertion of device of Flaherty-10/Moriuchi/Nentwick and cut the original measurement of the body to the obtained optimal measurement. (Col 1, lines 56-59).
Response to Arguments
Applicant’s arguments with respect to claims 53-58, and 63-64 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. Current rejection relies on an alternative interpretation of the prior art of record.
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 Flaherty (US 20040158143 A1) 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 Flaherty to perform TIPS procedures for the treatment of liver cirrossis and portal hypertension ([0058]: “performing transjugular intrahepatic portosystemic shunt procedures for the treatment of liver cirrhosis and portal hypertension”, from Flaherty). 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 11 are based upon 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040158143 A1) in view of Moriuchi (US 5084015 A) in further view of Nentwick (US 20110245665 A1).
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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