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 .
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 by Nentwick (US 20110245665 A1) over Flaherty (US 20040158143 A1) 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), a balloon-fill lumen (inflation lumen 43, Fig 3A), an anchor balloon (balloon 24, Fig 1) mounted to said catheter body (3) having at least an inflatable state (Fig 1), a balloon-fill port (inflation port 63, Fig 1), and a tissue ingrowth cuff (Cuff 6, Fig 1) having a circumference (Fig 1) configured to receive tissue therein ([0060]) and decrease the potential for infection (Product by process limitation: Structure is disclosed (Cuff 6, Fig 1) and capable of performing the claim function; ([0105]: “In one aspect, the dimensions of the collars 10A, B can be identical to the shape of cuff 6”; [0106]; [0109]: “preventing migration and infection of the catheter shaft 3 at the insertion site 95”), wherein: said main lumen (36) extends from said proximal end (1001) to said distal end (1002) and does not overlap said balloon-fill lumen (Fig 2A and 3A; [0072]), said balloon-fill lumen (43) extends from said balloon-fill port (63) to said anchor balloon (24) (Fig 2A and 3A), and said tissue ingrowth cuff (6) is mounted on the catheter body (3) between the anchoring balloon (24) and the proximal end (1001), wherein the proximal end (1001) of the catheter (1) is configured to extend out of a patient's body (Shown in Fig 11A ).
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Nentwick further discloses said anchor balloon (24) is insertable and inflatable to prevent dislodgement ([0075]: “the balloon 24 has a first diameter in the expanded or anchoring state and a second diameter in the deflated state.”
Nentwick is silent regarding the catheter being a direct portal vein access catheter and said anchor balloon (24) is insertable into a portal vein and inflatable to engage said portal vein and prevent dislodgement; 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 a subject, wherein the subcutaneous port interfaces said main lumen to said subcutaneous port and said balloon- fill lumen to said balloon-fill port
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]) and inflatable to engage said portal vein and prevent dislodgement (Claim 46).
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 device of Nentwick with the appropriate dimensions and incorporate a penetration member similar to the one 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”)
Nentwick/Flaherty are silent 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.
Moriuchi teaches a method comprising a catheter (hypodermically embedable 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), 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 Nentwick/Flaherty 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 54, Nentwick/Flaherty/Moriuchi discloses the device of claim 53. Nentwick/Flaherty disclose wherein said catheter body (3, from Nentwick) further comprises a tissue penetrator (tissue penetrating member of Nentwick/Flaherty/Moriuchi; see modification of claim 53 with the teaching of Flaherty [0058])
Regarding claim 55, Nentwick/Flaherty/Moriuchi discloses the device of claim 53. Nentwick is silent regarding further comprising 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) and 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/Flaherty/Moriuchi by incorporating an imaging element 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]).
Regarding claim 56, Nentwick/Flaherty/Moriuchi discloses the device of claim 53. Nentwick discloses wherein said anchor balloon (24) is contained at said distal end (1002, Annotated Fig 1) of said catheter body (3).
Regarding claim 63, Nentwick/Flaherty/Moriuchi discloses the device of claim 53. Nentwick discloses wherein the catheter body (3) further comprises a central venous lumen (lumen 39, Fig 3A; Examiner note: The structure of Lumen 39 is able to be inserted in the central venous system as taught by combination of claim 53) extending between said catheter body (3) proximal end (1001) and a terminal end (catheter tip 15, Fig 1) located between said main lumen (36) distal end (13) and said catheter body (3) proximal end (1001).
Regarding claim 64, Nentwick/Flaherty/Moriuchi discloses the device of claim 63. Nentwick/Flaherty/Moriuchi are silent wherein said central venous lumen (39 form Nentwick) terminal end (15) is approximately 12 cm from the main lumen (36) distal end (catheter tip 13, Fig 1).
Examiner notes that the drawing might be not to be 1:1 scale, therefore the actual value could be in a broader range including 12cm. On the other hand, the instant disclosure does not describe it 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)).
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable by Nentwick (US 20110245665 A1) over Flaherty (US 20040158143 A1) in view of Moriuchi (US 5084015 A) in further view of Snow (US 5863366 A).
Regarding claim 57, Nentwick/Flaherty/Moriuchi discloses the device of claim 53. However, Nentwick/Flaherty/Moriuchi 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 Nentwick/Flaherty/Moriuchi to include similar clamp in the proximal section of shaft as taught by Snow to form a hemostatic seal (Col 4, lines 18-24).
Claim 58 is rejected under 35 U.S.C. 103 as being unpatentable by Nentwick (US 20110245665 A1) over Flaherty (US 20040158143 A1) in view of Moriuchi (US 5084015 A) in further view of Hubbell (US 6074367 A).
Regarding claim 58, Nentwick/Flaherty/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 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 Nentwick/Flaherty/Moriuchi and cut the original measurement of the body to the obtained optimal measurement. (Col 1, lines 56-59).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 53 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 11,147,946 B2 in view of Nentwick (US 20110245665 A1).
With regard to claim 53, claim 18 of U.S. Patent No. 11,147,946 B2 discloses a direct portal vein access catheter device comprising: a catheter body having a proximal end, a distal end, a main lumen, a balloon-fill lumen, an anchor balloon mounted to said catheter body having at least an inflatable state, a balloon-fill port, 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, wherein: said main lumen extends from said proximal end to said distal end, and does not overlap said balloon-fill lumen, said balloon-fill lumen extends from said balloon-fill hub to said anchor balloon, said anchor balloon is insertable into a portal vein and inflatable to engage said portal vein and prevent dislodgement; and said tissue ingrowth cuff is mounted on the catheter body between the anchoring balloon and the proximal end, wherein the proximal end of the catheter is configured to extend out of a patient's body. However, U.S. Patent No. 11,147,946 B2 is silent regarding “a tissue ingrowth cuff having a circumference configured to receive tissue therein and decrease the potential for infection”
Nentwick teaches 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), a balloon-fill lumen (inflation lumen 43, Fig 3A), an anchor balloon (balloon 24, Fig 1) mounted to said catheter body (3) having at least an inflatable state (Fig 1), a balloon-fill hub (inflation port 63, Fig 1), and a tissue ingrowth cuff (Cuff 6, Fig 1) having a circumference (Fig 1) configured to receive tissue therein ([0060]) and decrease the potential for infection ([0105]: “In one aspect, the dimensions of the collars 10A, B can be identical to the shape of cuff 6”; [0106]; [0109]: “preventing migration and infection of the catheter shaft 3 at the insertion site 95”))
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 U.S. Patent No. 11,147,946 B2 to include the teachings of Nentwick of a tissue ingrowth cuff between the anchoring balloon and the proximal end to prevent migration and infection of the catheter ([0060]; [0109]).
Claims 53 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 57 of co-pending Application No. 17/501,148 in view of Nentwick (US 20110245665 A1).
With regard to claim 53, claim 57 of the co-pending application 17/501,148 discloses a direct portal vein access catheter device comprising: a catheter body having a proximal end, a distal end, a main lumen, a balloon-fill lumen, an anchor balloon mounted to said catheter body having at least an inflatable state, a balloon-fill port, 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, wherein: said main lumen extends from said proximal end to said distal end and does not overlap said balloon-fill lumen, said balloon-fill lumen extends from said balloon-fill hub to said anchor balloon, said anchor balloon is insertable into a portal vein and inflatable to engage said portal vein and prevent dislodgement; and said tissue ingrowth cuff is mounted on the catheter body between the anchoring balloon and the proximal end, wherein the proximal end of the catheter is configured to extend out of a patient's body. However, co-pending application is silent regarding “a tissue ingrowth cuff having a circumference configured to receive tissue therein and decrease the potential for infection”
Nentwick teaches 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), a balloon-fill lumen (inflation lumen 43, Fig 3A), an anchor balloon (balloon 24, Fig 1) mounted to said catheter body (3) having at least an inflatable state (Fig 1), a balloon-fill hub (inflation port 63, Fig 1), and a tissue ingrowth cuff (Cuff 6, Fig 1) having a circumference (Fig 1) configured to receive tissue therein ([0060]) and decrease the potential for infection ([0105]: “In one aspect, the dimensions of the collars 10A, B can be identical to the shape of cuff 6”; [0106]; [0109]: “preventing migration and infection of the catheter shaft 3 at the insertion site 95”))
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 Co-pending Application 17/501,148 to include the teachings of Nentwick of a tissue ingrowth cuff between the anchoring balloon and the proximal end to prevent migration and infection of the catheter ([0060]; [0109])
This is a provisional nonstatutory double patenting 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]).
In regards to the Non-statutory Double Patenting, applicant submits that a person of ordinary skill in the art would not be motivated to modify a portal vein access catheter of the '946 Patent or the '148 application with the teachings of Nentwick related to bronchial catheters, to arrive at the presently claimed direct portal vein access catheter device. Examiner respectfully disagrees. A person of ordinary skill in the art would have been motivated to include a tissue ingrowth cuff between the anchoring balloon and the proximal end to prevent migration and infection of the catheter ([0060]; [0109], From Nentwick); ingrowth cuff are not exclusive of applications in bronchial catheters and could be used in portal vein access catheter. An artisan can adapt known element where the function and purpose of the element is sufficiently related.
Applicant’s arguments with respect to amended claim limitations regarding 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.
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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