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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/09/2026 has been entered.
Response to Amendment
Applicant’s amendments filed on 02/09/2026 have been fully entered. Claims 10-11, 13, and 20-23, and 25-28 are pending in this application. Claims 10 and 23 are amended. Claims 1-9, 12, 14-19, 24, and 29-31 are cancelled.
Response to Arguments
Applicant’s arguments with respect to claim(s) 10 and 23 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.
Though overall some of the same prior art references are used herein, the applicant’s submission of amended claims 10 and 23 required a change in the grounds of rejection as detailed below in the prior art rejection. More specifically, the amended claims 10 and 23 changes the scope of the claimed invention by now requiring the central opening having circumferential, angled grooves in an outer surface of the hollow tube to permit unidirectional coaxial sliding of the external retainer toward the abdominal wall and to prevent reverse sliding and the tip of the internal retainer having an internal shelf or flange surround the opening.
Claim Objections
Claim 28 is objected to because of the following informalities: line 1: “…port of claim 10 wherein…” should read “…port of claim 10, wherein”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 27 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 recites the following limitations:
"a percutaneous transabdominal port" in line 1;
“an internal retainer” in line 4;
“a narrow first configuration” in line 4;
“a hollow tube” in line 5.
There is already antecedent basis for these limitation in the claim. The preceeding claim limitations are dependent and are defined by the method of claim 23, thus, the mentioned limitations should be changed to be “the [component]”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 10-11, 13, 20-23, and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki et al. (Publication No. US 2007/0016134 A1) in view of Goldhardt et al. (US Patent No. 5,336,203 A) and Buma (Patent No. US 5,092,850 A).
Regarding claim 10, Suzuki teaches a percutaneous transabdominal port (catheter 10; Paragraph 0058; Figure 13-14), comprising:
a hollow tube with an internal end and an external end (tube 11 with an internal end adjacent to the indwelling part 12 and external end with fixing part 14; Paragraph 0059; Figure 13-14), the hollow tube having an outer diameter small enough to fit through a tract through an abdominal wall (tube 11 has outer diameter to fit through tract of an abdominal wall adjacent to stomach; Paragraph 0058-0059);
a resiliently deformable internal retainer formed integral with the internal end of the hollow tube (internal indwelling part 12 is made of elastically deformable material and is a tip part of the tube 11; Paragraph 0059-0060; Figure 13-14) and having a first configuration with a first outer diameter small enough to fit through the tract (part 12 with a first configuration having a first smaller outer diameter to fit through tract; Paragraph 0076, 0079, 0087, and 0089; Figure 14) and a second configuration with a second outer diameter greater than the first outer diameter (part 12 with a second configuration having a second larger outer diameter; Figure 13; Paragraph 0076, 0079, and 0087);
wherein the transabdominal port is configured to permit instrumentation to access internal organs through the hollow tube (catheter 10 allows instruments such as obturator 20 and guidewire 40 enter internal organ through tube 11; Paragraph 0070; Figure 13-14); and
an elastomeric seal integrally formed with the internal retainer configured to seal around objects inserted through the hollow tube (one-way valve 16 is formed within the part 12 configured to seal around instruments inserted through tube 11; Paragraph 0067; Figure 13-14);
an external retainer (extracorporeal fixing part 14; Paragraph 0066; Figure 13-14), the external retainer having a flange that abuts against an external surface of the abdominal wall (part 14 is a flange that abuts the surface of the abdominal wall adjacent to the stomach; Paragraph 0066; Figure 13-14), and
wherein the internal retainer is configured to deform from the second configuration to the first configuration upon application of a mechanical force applied by a straightening rod configured to be inserted through the hollow tube (part 12 deforms from a second configuration, Figure 13, to a first configuration, Figure 14, when a mechanical force is applied by obturator 20; Paragraph 0076, 0079, 0087, and 0089);
wherein there is an opening at a tip of the internal retainer integral to the hollow tube (pore 15 at the tip of the part 12 that is integral to the tube 11; Figure 13-14), the opening aligned with an axis of the hollow tube (Figure 13-14), and the straightening rod being configured to engage the internal retainer without passing through the opening at the tip of the internal retainer (obturator engages part 12 without passing the pore 15 at the tip of part 12; Figure 12-13; Paragraph 0064-0065); and
wherein the tip of the internal retainer comprises an internal shelf or flange surrounding the opening (abutting part 18 with reinforcing member 19 is rigid and surrounds pore 15 at the tip of part 12; Figure 13-14; Paragraph 0064-0065), the straightening rod being configured to abut said shelf or flange without passing through the opening (Paragraph 0064-0065; Figure 13-14).
Suzuki does not teach the elastomeric seal in form of a duckbill valve.
However, Goldhardt teaches an elastomeric seal in form of a duckbill valve integrally formed with the internal retainer configured to seal around objects inserted through the hollow tube (seal is duckbill valve 42 that is integrally formed with dome 34 – since wall 40 of tube 41 is integrally formed with dome and valve is integrally formed with tubing – Column 5, lines 56-62; obvious that valve can seal around objects that pass through valve 42 since it is elastic; Figure 14; Column 3, lines 16-47 and Column 6, lines 8-20).
Suzuki and Goldhardt are considered to be analogous to the claimed invention because they are in the same field of medical port apparatuses. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Suzuki to incorporate the teachings of Goldhardt and have the elastomeric seal/duckbill valve of Goldhardt integrally formed with the internal retainer to replace the one-way valve of Suzuki. This allows for the one-way movement of fluids through the device or allowing for a sealed passage of an obturator (Goldhardt; Column 7, lines 8-20).
The combination of Suzuki in view of Goldhardt does not teach the external retainer configured to remain coupled to the hollow tube during implantation and use, the external retainer having a collar forming a central opening to accommodate the hollow tube, the central opening having circumferential, angled grooves in an outer surface of the hollow tube to permit unidirectional coaxial sliding of the external retainer toward the abdominal wall and to prevent reverse sliding.
However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have made the external retainer of Suzuki separable from the hollow tube, since that it has been held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961)(MPEP 2144.04 V.C.).
Furthermore, Buma teaches the external retainer configured to remain coupled to the hollow tube during implantation and use (external bolster 32 that is coupled to tube of catheter 10 at the outer wall 11; Figure 5 and 8-9; Column 3, lines 58-62), the external retainer having a collar forming a central opening to accommodate the hollow tube (ring 42 with central opening on bolster 32 to accommodate tube of catheter 10; Figure 7-9; Column 3, line 58 to Column 4, line 7), the central opening having circumferential, angled grooves in an outer surface of the hollow tube to permit unidirectional coaxial sliding of the external retainer toward the abdominal wall and to prevent reverse sliding (tube of catheter 10 has saw tooth rings 18, which are circumferential, angled grooves as seen in Figure 1, on the outer wall 11 to allow for coaxial sliding of the external bolster with corresponding crests 39 and valleys 40, as seen in Figure 7, to allow for unidirectional coaxial sliding, and prevents reverse sliding when tie 45 is applied; Figures 1, 7-9; Column 3, line 58 to Column 4, line 7 and Column 4, lines 18-41).
Suzuki in view of Goldhardt and Buma are considered to be analogous to the claimed invention because they are in the same field of medical port apparatuses. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Suzuki in view of Goldhardt to incorporate the teachings of Buma and have the separable external retainer with the sawtooth protrusions and the plug and the tie of Buma replace the external retainer of Suzuki in view of Goldhardt with the hollow tube of Buma with the sawtooth be the hollow tube of Suzuki in view of Goldhardt, integrally connected to the internal retainer of Suzuki in view of Goldhardt. This allows for the adjustment of the bolster against the surface of the skin for the customized sizing based on the patient and the permanent fixture after adjustment and during use (Buma; Column 4, lines 18-41).
Regarding claim 11, Suzuki in view of Goldhardt and Buma teaches the port of claim 10. Suzuki further teaches wherein the straightening rod is configured to apply mechanical force against an internal surface of the tip of the internal retainer (obturator 20 applied a mechanical force against the tip of part 12 at the internal surface; Paragraph 0064-0065 and 0070; Figure 13-14).
Regarding claim 13, Suzuki in view of Goldhardt and Buma teaches the port of claim 11. The combination of Suzuki in view of Goldhardt and Buma further teaches the elastomeric seal providing elastomeric seal to the instrumentation inserted through the hollow tube (duckbill valve of Goldhardt provides elastomeric seal to the instrumentation inserted through the hollow tube of Suzuki in view of Goldhardt and Buma; see rejection of claim 10 above; Goldhardt; elastomeric valve 42 allows for the obturator to pass through but also has sealing properties – obvious that the valve would be a seal to the obturator passing through with frictional force that is applied; Column 3, lines 4-15 and Column 8, lines 56-64).
Regarding claim 20, Suzuki in view of Goldhardt and Buma teaches the port of claim 10. The combination of Suzuki in view of Goldhardt and Buma further teaches further comprising a closure cap to seal the hollow tube external to the abdominal wall (Buma; plug 36 is to seal hollow tube external to abdominal wall; Figure 5 and 9; Column 4, lines 53-54).
Regarding claim 21, Suzuki in view of Goldhardt and Buma teaches the port of claim 20. The combination of Suzuki in view of Goldhardt and Buma further teaches the closure cap being integrally formed with an external retainer (Buma; cap 36 is molded with bolster; Figure 5 and 9; Column 3, lines 63-64).
Regarding claim 22, Suzuki in view of Goldhardt and Buma teaches the port of claim 20. The combination of Suzuki in view of Goldhardt and Buma does not teach the closure cap being integrally formed with the hollow tube.
However, modifying the device of Suzuki in view of Goldhardt and Buma to be formed integrally as claimed would be an obvious matter of design choice by someone of ordinary skill in the art before the effective filing date of the claimed invention. The skilled artisan would furthermore be motivated to try forming the parts in various ways in order to simply assembly, and minimize manufacturing time, errors, and costs. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, "that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.").
Regarding claim 23, Suzuki teaches a method of inserting a percutaneous transabdominal port having a hollow tube (method of inserting catheter 10 having tube 11; Abstract; Figure 13-14; Paragraph 0072), with an internal retainer at one end (tube 11 with an internal end adjacent to the indwelling part 12; Paragraph 0059; Figure 13-14) and an external retainer at an opposite end (tube 11 connected to extracorporeal fixing part 14; Paragraph 0066; Figure 13-14) through an abdominal wall into an organ (tube 11 has outer diameter to fit through tract of an abdominal wall adjacent to stomach; Paragraph 0058-0059), comprising:
converting the internal retainer to a narrow first configuration by inserting a straightening rod through the hollow tube of the percutaneous transabdominal port to the internal retainer and applying pressure through the straightening rod to the internal retainer (part 12 is in a narrow configuration when obturator is pushed through tube 11 of catheter 10 to part 12 and force is applied by obturator to the part 12; Paragraph 0064-0065, 0070, and 0074-0075; Figure 14);
inserting the internal retainer having an elastomeric seal, the elastomeric seal integrally formed with the internal retainer and configured to seal around objects inserted through the hollow tube, through a tract of the abdominal wall and into an organ (part 12, having a one-way valve 16 integrally formed and seals around the instruments inserted through tube 11, is inserted through the tract of abdominal wall towards stomach; Paragraph 0067 and 0076; Figure 13-14;
converting the internal retainer to a wide second configuration by removing the straightening rod (wide configuration of part 12 occurs when obturator is removed from part 12; Paragraph 0076 and 0079; Figures 13-14);
an opening (pore 15 at the tip of the part 12 that is integral to the tube 11; Figure 13-14), the opening aligned with an axis of the hollow tube (Figure 13-14), and the straightening rod is configured to engage the internal retainer without passing through the opening at the tip of the internal retainer (obturator engages part 12 without passing the pore 15 at the tip of part 12; Figure 12-13; Paragraph 0064-0065); and
wherein engaging the internal retainer includes abutting an internal shelf or flange surrounding the opening at the tip, without passing the straightening rod through the opening (abutting part 18 with reinforcing member 19 is rigid and surrounds pore 15 at the tip of part 12; Figure 13-14; Paragraph 0064-0065).
Suzuki does not teach the elastomeric seal in form of a duckbill valve, wherein the duckbill valve is configured to seal an opening at a tip of the internal retainer.
However, Goldhardt teaches the elastomeric seal in form of a duckbill valve (seal is duckbill valve 42 that is integrally formed with dome 34 – since wall 40 of tube 41 is integrally formed with dome and valve is integrally formed with tubing – Column 5, lines 56-62; obvious that valve can seal around objects that pass through valve 42 since it is elastic; Figure 14; Column 3, lines 16-47 and Column 6, lines 8-20), wherein the duckbill valve is configured to seal an opening at a tip of the internal retainer (valve 42 is located at the tip of the internal retainer, comprising dome 34 and end of tube 41 that is located within the dome 34, and is configured to seal the opening at the tip of the tube 41 in the internal retainer; Figure 14; Column 5, lines 56-62).
Suzuki and Goldhardt are considered to be analogous to the claimed invention because they are in the same field of medical port apparatuses. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Suzuki to incorporate the teachings of Goldhardt and have the elastomeric seal/duckbill valve of Goldhardt integrally formed with the internal retainer to replace the one-way valve of Suzuki. This allows for the one-way movement of fluids through the device or allowing for a sealed passage of an obturator (Goldhardt; Column 7, lines 8-20).
The combination of Suzuki in view of Goldhardt does not teach sliding the external retainer down the outer surface of the hollow tube until it reaches the external abdominal wall;
locking the external retainer in place on the hollow tube using a unidirectional coaxial ratchet that prevents reverse sliding; and
shortening the hollow tube to customize size of the percutaneous transabdominal port to a particular abdominal wall thickness.
However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have made the external retainer of Suzuki separable from the hollow tube, since that it has been held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961)(MPEP 2144.04 V.C.).
Furthermore, Buma teaches sliding the external retainer down the outer surface of the hollow tube until it reaches the external abdominal wall (bolster 32 is slide down the outer wall 11 of tube of catheter 10 until touches the wall of the skin; Figure 8-9; Column 4, lines 17-26);
locking the external retainer in place on the hollow tube using a unidirectional coaxial ratchet that prevents reverse sliding (tube of catheter 10 has saw tooth rings 18, which are circumferential, angled grooves as seen in Figure 1, on the outer wall 11 to allow for coaxial sliding of the external bolster with corresponding crests 39 and valleys 40, as seen in Figure 7, to allow for unidirectional coaxial sliding, and prevents reverse sliding when tie 45 is applied; Figures 1, 7-9; Column 3, line 58 to Column 4, line 7 and Column 4, lines 18-41); and
shortening the hollow tube to customize size of the percutaneous transabdominal port to a particular abdominal wall thickness (Column 4, lines 42-44).
Suzuki in view of Goldhardt and Buma are considered to be analogous to the claimed invention because they are in the same field of medical port apparatuses. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Suzuki in view of Goldhardt to incorporate the teachings of Buma and have the separable external retainer with the sawtooth protrusions, the plug, and the tie of Buma replace the external retainer of Suzuki in view of Goldhardt with the hollow tube of Buma with the sawtooth be the hollow tube of Suzuki in view of Goldhardt, integrally connected to the internal retainer of Suzuki in view of Goldhardt with the teachings of the methods of Buma to the device of Suzuki in view of Goldhardt and Buma. This allows for the adjustment of the bolster against the surface of the skin for the customized sizing based on the patient and the permanent fixture after adjustment and during use (Buma; Column 4, lines 18-41).
Regarding claim 25, Suzuki in view of Goldhardt and Buma teaches the method of claim 23. Suzuki further teaches further comprising:
inserting instrumentation through the percutaneous transabdominal port into the organ (obturator 20 and guidewire 40 is inserted through catheter 10 into the organ of the patient; Figure 13-14; Paragraph 0064, 0070-0071, and 0076); and
withdrawing instrumentation through the percutaneous transabdominal port and out of a body (obturator 20 and guidewire 40 can be removed from catheter 10 and out of the body, if desired; Paragraph 0076).
Regarding claim 26, Suzuki in view of Goldhardt and Buma teaches the method of claim 25. The combination of Suzuki in view of Goldhardt and Buma does not teach further comprising inserting instrumentation through a seal of the percutaneous transabdominal port.
However, Goldhardt teaches a seal of the percutaneous transabdominal port (mount 63 that comprises a valve 42 that allows for instrument to pass through but also is a seal for fluid flow; Figure 24; Column 8, lines 56-64 and Column 9, lines 27-33).
Since the applicant has not disclosed that placing a seal/valve at the port does anything more than produce predictable results (i.e. prevent unwanted entry of liquid or instrumentation into the port), the mere duplication of the seal/valve is not considered to have patentable significance. Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was made, to modify Suzuki in view of Goldhardt and Buma to include a second seal/valve at the entry of the port, in order to predictably have additional sealing in the port from unwanted fluids or instrumentation. The mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 124 USPQ 378 (CCPA 1960) (MPEP 2144.04(VI)(B)).
Regarding claim 27, Suzuki in view of Goldhardt and Buma teaches the method of claim 23. The combination of Suzuki in view of Goldhardt and Buma further teaches a method of inserting and removing a percutaneous transabdominal port (Suzuki; Paragraph 0076 and 0102), comprising:
the method of claim 23 (see rejection of claim 23 above),
converting an internal retainer to a narrow first configuration by reinserting the straightening rod through a hollow tube of the percutaneous transabdominal port to the internal retainer and applying pressure through the straightening rod to the internal retainer (Suzuki; obturator 20 can be reinserted into the tube 11 of catheter 10 and pushed against part 12 to move part 12 to narrow configuration; Figure 14; Paragraph 0076 and 0102); and
withdrawing the percutaneous transabdominal port out of the organ, through the abdominal tract and out of the body (Suzuki; catheter 10 is then removed out of the organ, through the tract, and out of the body; Paragraph 0102).
Regarding claim 28, Suzuki in view of Goldhardt and Buma teaches the port of claim 10. Suzuki further teaches wherein the straightening rod has a larger diameter than a diameter of the opening at the tip of the internal retainer (obturator 20 has a larger diameter than the pore 15 at the tip of part 12; Figure 13-14).
Conclusion
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781