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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11-12, 17, 20, and 38 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).
Regarding claim 11, Flaherty embodiment of Fig 13-14, hereinafter Flaherty-13, discloses a method for treating a subject exhibiting at least one symptom of a disorder ([0047]; Fig 13), comprising: a) providing; i) a portal access catheter (catheter device 400, Fig 13) comprising a proximal end (proximal end 1000, Annotated Fig 1), a distal end (1001, Annotated Fig 1), an anchor balloon (stabilizer balloon 402, Fig 13) at said distal end (1001, Annotated Fig 1), and a main lumen (a lumen (not shown), [0115]) extending between said proximal end (1000, Annotated Fig 1) to said distal end (1001, Annotated Fig 1) terminating at said distal end (1001, Annotated Fig 1), a balloon-fill lumen ([0115]; balloon is inflated); and ii) a composition (chemotherapeutic therapeutic agent, [0115]) capable of reducing said at least one symptom of said disorder (tumor T, Fig 14); b) inserting said portal access catheter (400) into a subject's portal venous system (TEPS procedure; [0114]); c) stabilizing said inserted portal access catheter (400) in place by expanding said anchor balloon (402) ([0114]); and d) administering said composition (chemotherapeutic therapeutic agent, [0115]) through said portal access catheter main lumen (a lumen (not shown), [0115]) into said portal venous system ([0114]) under conditions such that said at least one symptom of said disorder is reduced (tumor T, Fig 14).
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Flaherty-13 is silent wherein said balloon-fill lumen extends from a balloon-fill port to the anchor balloon, and 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 the subject, wherein the subcutaneous port interfaces said main lumen to said subcutaneous port and said balloon-fill lumen to said balloon-fill port.
Moriuchi teaches a method for treating a subject exhibiting at least one symptom of a disorder (cancer; abstract), comprising a catheter (hypodermically embeddable catheter assembly 40, Fig 6); a balloon-fill lumen (first lumen 22, Fig 7) extends from a balloon-fill port (6) to the anchor balloon (28), and a subcutaneous port at said proximal end connected to said main lumen (second lumen 26, Fig 2) and said balloon-fill port (6) and configured to be fully under the skin of the subject, wherein the subcutaneous port (medicament infusion implement 41, Fig 6 is hypodermically recessed; Col 9 lines 35-36) interfaces said main lumen (26) to said subcutaneous port (41) and said 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 method of Flaherty-13 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).
Regarding claim 12, Flaherty-13/Moriuchi discloses the method of Claim 11. Flaherty-13 discloses wherein said portal access catheter (400) is a transjugular portal access catheter (TEPS procedure; [0114]). Flaherty-13 is silent regarding further comprising a central venous lumen.
Flaherty embodiment of Fig 10, hereinafter Flaherty-10, teaches a method comprising a central venous lumen (guidewire lumen 210, Fig 10; [0097])
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Flaherty-13/Moriuchi with similar central venous lumen as taught by Flaherty-10 for the purpose of guiding the catheter to the target location ([0102]).
Regarding claim 17, Flaherty-13/Moriuchi discloses the method of claim 11. Flaherty-13 discloses wherein said at least one symptom is selected from the group consisting of hepatic toxicity, a metabolic marker, hepatic cirrhosis, portal hypertension, elevated transaminase levels, viral titer, perisinusoidal fibrosis, elevated albumin levels, hepatocellular carcinoma size, and gastroesophageal varices size ([0047]).
Regarding claim 20, Flaherty-13/Moriuchi discloses the method of claim 11. Flaherty-13 discloses wherein said disorder comprises a portal hypertension disorder ([0047]).
Regarding claim 38, Flaherty-13/Moriuchi discloses the method of claim 11. Flaherty-13 discloses wherein said disorder comprises a cirrhosis disorder ([0047])
Claims 13, 15-16 and 53 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 Mann (US 6722370 B1).
Regarding claim 13, Flaherty-13/Moriuchi discloses the method of claim 11. Flaherty-13 is silent wherein said portal access catheter is a direct portal access catheter.
Mann further teaches a method comprising 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 modify the insertion approach of catheter disclosed by Flaherty-13/Moriuchi with the teaching of Transcutaneous Transhepatic Approach as taught by Mann to achieve a non-surgical, percutaneous direct approach (Col 8, lines 8-12; Claim 32).
Regarding claim 15, Flaherty-13/Moriuchi/Mann discloses the method of claim 13. Flaherty-13 is silent wherein said direct portal access catheter is a transabdominal catheter.
Mann teaches wherein said direct portal access catheter is a transabdominal catheter (Transcutaneous Transhepatic Approach; Col 8, lines 13-28: “The transcutaneous transhepatic approach involves the direct puncture of the skin and the abdominal wall overlying the liver”)
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 method of Flaherty-13/Moriuchi/Mann with similar Transcutaneous Transhepatic Approach as taught by Mann to achieve a non-surgical, percutaneous approach through direct puncture (Col 8, line 8-12).
Regarding claim 16, Flaherty-13/Moriuchi/Mann discloses the method of claim 15. Flaherty-13 is silent wherein said transabdominal catheter is inserted via a percutaneous abdominal puncture.
Mann teaches wherein said transabdominal catheter is inserted via a percutaneous abdominal puncture (Transcutaneous Transhepatic Approach; Col 8, lines 13-28: “The transcutaneous transhepatic approach involves the direct puncture of the skin and the abdominal wall overlying the liver”)
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 method of Flaherty-13/Moriuchi/Mann with similar Transcutaneous Transhepatic Approach as taught by Mann to achieve a non-surgical, percutaneous approach through direct puncture (Col 8, line 8-12).
Regarding claim 53, Flaherty-13/Moriuchi/Mann discloses the method of claim 13. Flaherty-13 discloses wherein administering said composition further comprises administering two doses of said composition while said portal access catheter remains inserted and stabilized ([0115]: “the catheter 400 may be permitted to remain indwelling for a period of time to permit repeated dosing of the therapeutic agent or other substance to the tumor T”; during treatment there is a point in time in which two doses has been delivered).
Flaherty-13 is silent wherein said portal access catheter is a direct portal access catheter.
Mann further teaches a method comprising 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 modify the insertion approach of catheter disclosed by Flaherty-13/Moriuchi with the teaching of Transcutaneous Transhepatic Approach as taught by Mann to achieve a non-surgical, percutaneous direct approach (Col 8, line 8-12).
Claims 55 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 Mann (US 6722370 B1) in further view of Nentwick (US 20110245665 A1).
Regarding claim 55, Flaherty-13/Moriuchi/Mann discloses the method of claim 13. Flaherty-13 is silent wherein providing said direct portal vein catheter further comprises providing a portal vein catheter having a tissue ingrowth cuff having a circumference configured to receive tissue therein, said tissue ingrowth cuff being disposed between a proximal end of said catheter and said anchor balloon
Mann further teaches a method comprising 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 modify the insertion approach of catheter disclosed by Flaherty-13/Moriuchi with the teaching of Transcutaneous Transhepatic Approach as taught by Mann to achieve a non-surgical, percutaneous direct approach (Col 8, line 8-12).
Flaherty-13/Moriuchi/Mann are silent regarding the catheter having a tissue ingrowth cuff having a circumference configured to receive tissue therein, said tissue ingrowth cuff being disposed between a proximal end of said catheter and said anchor balloon.
Nentwick teaches a method having a tissue ingrowth cuff (Cuff 6, Fig 1) having a circumference (Fig 6) configured to receive tissue therein ([0060]), said tissue ingrowth cuff (6) being disposed between a proximal end (12) of said catheter and said anchor balloon (24).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Flaherty-13/Moriuchi/Mann 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]).
Claim 14 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 Wilson et al. (US 20060276773 A1).
Regarding claim 14, Flaherty-13/Moriuchi/Flaherty-10 discloses the method of Claim 12. Flaherty-13 discloses wherein said transjugular portal access catheter (400) is inserted via the jugular vein (TEPS procedure; [0114]) wherein the distal end of said catheter inserts into a hepatic portal vein (Fig 13; [0047]).
Flaherty-13/Moriuchi/Flaherty-10 are silent wherein the distal end of said central venous lumen inserts into a cardiac right itrium.
Wilson teaches a catheter (multi-lumen catheter assembly 10, Fig 1) wherein the distal end of said central venous lumen (tip 14, Fig 1) inserts into a cardiac right atrium ([0039]).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the placement of the central venous lumen of Flaherty-13/Moriuchi/Flaherty-10 to be positioned in the right atrium to provide rapid infusion of a composition into the heart chamber ([0039]). Additionally, the instant disclosure does not describe the position as contributing any unexpected result or function. As such, the location of the catheter tip is deemed matters of design and placement choice (lacking criticality), well within the skill of the ordinary artisan.
Claims 18 and 28 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 Joseph et al. (US 20130041238 A1).
Regarding claim 18, Flaherty-13/Moriuchi discloses the method of claim 11. However, Flaherty-13/Moriuchi are silent regarding wherein said composition is selected from the group consisting of a total parenteral nutrition composition and a therapeutic compound composition.
Josepth teaches the need to supply a total parenteral nutrition during prolonged use of catheter ([0091]).
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 composition of Flaherty-13/Moriuchi to include a total parenteral nutrition as taught by Josepth in addition to the therapeutic composition to meet all patient dietary needs during the treatment period ([0091]).
Regarding claim 28, Flaherty-13/Moriuchi discloses the method of claim 11. Flaherty-13/Moriuchi are silent regarding wherein said administering said composition further comprises administering a total parenteral nutrition composition.
Josepth teaches the need to supply a total parenteral nutrition during prolonged use of catheter ([0091]).
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 composition of Flaherty-13/Moriuchi to include a total parenteral nutrition as taught by Josepth in addition to the therapeutic composition to meet all patient dietary needs during the treatment period ([0091]).
Claims 19 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 Joseph et al. (US 20130041238 A1) in further view of Figler et al. (WO 8602625 A1).
Regarding claim 19, Flaherty-13/Moriuchi/Joseph discloses the method of claim 18. Flaherty-13/Moriuchi/Joseph are silent regarding wherein said total parenteral nutrition composition comprises a plurality of amino acids, vitamins and folic acid.
Figler discloses a method for compounding of total parenteral nutrition composition (hyperalimentation therapy; page 1, lines 6-14) comprising a plurality of amino acids, vitamins and folic acid ((page 1, lines 6-14): “The protein may be in the form of free-amino acids or protein hydrolysate and the carbohydrate commonly is dextrose. In addition to the protein and carbohydrate, vitamins (water-soluble and fat-soluble) and electrolytes also can be supplied in this therapy.” (page 14, lines 33-35 – page 15, lines (1-8): “The additives, such as sodium chloride, sodium acetate, calcium, gluconate, iron, selenium, zinc, multi-vitamin 12, heparin and folic acid are typically added into the medication port of the bag 18 by a syringe after the bag has been compounded.”)
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 method of Flaherty-13/Moriuchi/Joseph to incorporate in the total parenteral nutrition composition comprising amino acids, vitamins and folic acid similar to the hyperalimentation therapy taught by Figler to meet the patient's protein and caloric requirements which are unable to be satisfied by oral feeding (page 1, lines 6-14). Additionally, folic acid role in cell division and tissue health is well known in the art.
Claims 25 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 Zhao et al. (US 20060189559 A1).
Regarding claim 25, Flaherty-13/Moriuchi discloses the method of claim 11. Flaherty-13/Moriuchi are silent wherein said disorder comprises a chronic viral hepatitis disorder.
Zhao discloses a method for treating a subject exhibiting a disorder wherein said disorder comprises a chronic viral hepatitis disorder (viral hepatitis caused by Hepatitis C virus, [0003]; [0005]; [0013]; claim 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 composition being administered by the method of Flaherty-13/Moriuchi to a similar composition of HCV inhibitors as taught by Zhao to treat viral hepatitis by delivering medication directly to the liver the effects of Hepatitis C are more effectively reduced and avoid side effects by controlling drug plasma concentration ([0025]-[0027]).
Claims 30 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 Yuda et al. (US 20030139361 A1).
Regarding claim 30, Flaherty-13/Moriuchi discloses the method of claim 11. Flaherty-13/Moriuchi are silent regarding wherein said disorder comprises a liver transplant.
Yuda teaches the intraportal administration of a composition (IDO gene; [0047]) using a balloon catheter to treat rejection at the time of liver transplantation ([0047]). Yuda further teaches the administration of immunosuppressants for medical transplant of liver is well known in the art ([0002])
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 composition being administered by Flaherty-13/Moriuchi to a similar composition of IDO gene as taught by Yuda to treat liver transplant rejection ([0047]).
Claims 32 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 Bodden (US 5411479 A).
Regarding claim 32 Flaherty-13/Moriuchi discloses the method of claim 11. Flaherty-13 discloses wherein said disorder comprises a carcinoma disorder ([0048]).
Flaherty-13/Moriuchi are silent said disorder comprises a hepatocellular carcinoma disorder.
Bodden teaches that treatment for a subject exhibiting a disorder (hepatocellular tumor) administrating a composition (5-FU and FUDR) is well known in the art (Col 2, lines 30-42: “Hepatic artery infusion (HAI) of chemotherapy has been widely investigate& Arterial infusion of 5-FU and FUDR increases their effectiveness by delivering the drug directly to liver tumor cells before its dilution by the systemic circulation. This approach is attractive because hepatocellular tumors frequently remains localized to the liver”)
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 composition being administered by Nentwick/Mann/Moriuchi to a similar composition of 5-FU and FUDR as taught by Bodden to treat liver hepatocellular tumor (Col 2, lines 30-42)
Claims 40 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 Dzhalalov et al. (RU 2134073 C1).
Regarding claim 40, Flaherty-13/Moriuchi discloses the method of claim 11. Flaherty-13/Moriuchi are silent regarding wherein said the disorder comprises a hepatic thrombosis.
Dzhalalov teaches a method for treating a subject exhibiting a disorder (portal vein thrombosis, [0008]) administering a composition (rheopolyglucin – 500 ml, trental - 0.1 g, heparin - 5000 U).
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 composition being administered by Flaherty-13/Moriuchi to a similar composition of rheopolyglucin – 500 ml, trental - 0.1 g, heparin - 5000 U as taught by Dzhalalov to increase the effectiveness of treatment of patients with portal vein thrombosis ([0007]).
Claim 41 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 Joseph et al. (US 20130041238 A1) in further view of Dzhalalov et al. (RU 2134073 C1)
Regarding claim 41, Flaherty-13/Moriuchi/Joseph discloses the method of claim 18, Flaherty-13/Moriuchi/Joseph are silent wherein said therapeutic compound composition is selected from the group consisting of heparin, unfractionated heparin, low-molecular-weight heparin, aspirin, coumadin, warfarin, a vitamin K antagonist, and fondaparinux.
Dzhalalov teaches a method for treating a subject exhibiting a disorder (portal vein thrombosis, [0008]) administering a composition (rheopolyglucin – 500 ml, trental - 0.1 g, heparin - 5000 U).
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 composition being administered by Flaherty-13/Moriuchi/Joseph to a similar composition of rheopolyglucin – 500 ml, trental - 0.1 g, heparin - 5000 U as taught by Dzhalalov to increase the effectiveness of treatment of patients with portal vein thrombosis ([0007]).
Claims 54 is rejected under 35 U.S.C. 103 as being unpatentable by over Flaherty et al. (US 20040158143 A1) in view of Moriuchi (US 5084015 A) in further view of Perchik et al. (US 20110224618 A1).
Regarding claim 54, Flaherty-13/Moriuchi/Mann discloses the method of claim 13. Flaherty-13 is silent wherein said portal access catheter is a direct portal access catheter.
Mann teaches a method comprising 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 modify the insertion approach of catheter disclosed by Flaherty-13/Moriuchi with the teaching of Transcutaneous Transhepatic Approach as taught by Mann to achieve a non-surgical, percutaneous direct approach (Col 8, line 8-12).
Flaherty-13/Moriuchi/Mann are silent wherein the catheter comprises providing a long-term tunneled catheter.
Perchik teaches a method comprising a long-term tunneled catheter ([0012]; [0094]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Nentwick/Mann/Moriuchi with similar long term tunneling method as taught by Perchik for the purpose of decrease infection rates at the site of cutaneous insertion ([0012]; [0094]).
Response to Arguments
Applicant’s arguments with respect to claims 11-20, 25, 28, 30, 32, 38, 40-41, and 53-55 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 11 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 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).
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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