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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1 – 19) in the reply filed on 11 May 2026 is acknowledged.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11 May 2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
858 as shown in Fig. 8A.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the word count of the abstract is above the 150 word limit. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
Page 24 of the Specification recites “As shown in FIG. 6, the fused portion 660 can be formed directly between the port tube 660 and the catheter shaft 610. The fused portion 660 can anchor the position of the port tube 660 with respect to the catheter shaft 610.” The Examiner suggests amending the each recited “fused portion 660” to recite “fused portion [[660]] 661” to correct the reference numeral for the fused portion .
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 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 7 recites the limitation "the port mandrel.” There is insufficient antecedent basis for this limitation in the claim.
Information Disclosure Statement
The information disclosure statements filed 7 March 2024 (19 pages), 7 March 2024 (11 pages), 7 March 2024 (16 pages), 7 March 2024 (35 pages), and 7 March 2024 (21 pages), 24 May 2024 each fail to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Each IDS has been placed in the application file, but the information referred to therein has not been considered.
Claim Rejections - 35 USC § 103
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) 1, 2, 4 – 9, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawajiri (EP 3266487 A1), Aggerholm (US 10,245,410 B2), and Grovender et al. (US 2010/0217234 A1) (hereinafter referred to as “Grovender”).
With regards to claim 1, Kawajiri discloses a method for manufacturing a catheter including a rapid exchange port (see Figs. 5a – 5e), the method comprising the steps of:
puncturing a port (10a) in a catheter shaft (5) (see [0029] and Fig. 5a);
inserting a port tube (30) into the port (see Fig. 5B);
skiving the port tube so that it is flush with the catheter shaft (see [0033] “the excess part of the tube member 30 protruding out from the proximal side wire insertion opening 10a is cut off”).
However Kawajiri is silent with regards to the steps of:
inserting a guidewire lumen into the port tube;
coupling the guidewire lumen to the port tube; and
skiving the guidewire lumen so that it is flush with the catheter shaft.
Nonetheless Aggerholm, which is within the analogous art of rapid exchange catheters (see abstract and title), teaches the steps of:
inserting a guidewire lumen (122) (see Col. 4, lines 55 – 67) into the port tube (16) (see Col. 5, lines 15 – 24);
coupling the guidewire lumen to the port tube (see Col. 4, line 55 – Col. 5, line 8 “The inner tube 122 forming the guide wire lumen 22 is bonded to the distal tube at its proximal end in the transition zone 16 and is bonded at its distal end to the catheter tip.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Kawajiri in view of a teaching of Aggerholm such that the method further comprises the steps of inserting a guidewire lumen into the port tube; coupling the guidewire lumen to the port tube. One of ordinary skill in the art would have been motivated to make this modification because manufacturing a catheter with a guidewire lumen is beneficial because the guidewire lumen can be used to guide a guide wire through the catheter and to the target vasculature of the patient (see Col. 6, lines 57 – 65 of Aggerholm).
The method of Kawajiri modified in view of a teaching of Aggerholm will hereinafter be referred to as the method of Kawajiri and Aggerholm.
However, neither Kawajiri nor Aggerholm teaches the step of skiving the guidewire lumen so that it is flush with the catheter shaft.
Nonetheless Grovender, which is within the analogous art of catheter with skived tubular members (see abstract), teaches (Figs. 4 – 5) the step of skiving the guidewire lumen (72) (see [0071]) so that it is flush with the catheter shaft (30) ([0090] “the inner tubular member 72 which extends outward from the outer surface of the skived tubular member 30 may be trimmed away as shown in FIG. 5.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Kawajiri and Aggerholm in view of a further teaching of Grovender such that the method further comprises the step of skiving the guidewire lumen so that it is flush with the catheter shaft. One of ordinary skill in the art would have been motivated to make this modification because trimming away the excess catheter creates a flush outer surface of the catheter shaft such that the catheter shaft can smoothly extend through the tortuous vasculature of the patient (see [0090] of Grovender).
The method of Kawajiri and Aggerholm modified in view of a teaching of Grovender will hereinafter be referred to as the method of Kawajiri, Aggerholm, and Grovender.
With regards to claim 2, the method of Kawajiri, Aggerholm, and Grovender teaches the claimed invention of claim 1, however, Kawajiri is silent with regards to the method further comprising the step of inserting a port mandrel into the port tube.
Nonetheless Grovender, which is within the analogous art of catheter with skived tubular members (see abstract), teaches (Figs. 4 – 6B) inserting a port mandrel (92) (see [0090]) into the port tube (60) (see Fig. 6 and Fig. 6B and [0107]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Kawajiri, Aggerholm, and Grovender in view of a further teaching of Grovender such that the method further comprises the step of inserting a port mandrel into the port tube. One of ordinary skill in the art would have been motivated to make this modification because using a mandrel within a method of manufacturing is beneficial because the mandrel maintains the lumen shape and size of the port tube, prevents deformation of the port tube during the manufacturing process, and ensures a smooth inner surface of the port tube(see [0084] of Grovender).
With regards to claim 4, the method of Kawajiri, Aggerholm, and Grovender teaches the claimed invention of claim 2, and the method of Kawajiri, Aggerholm, and Grovender further teaches wherein the port mandrel is at least partially curved (see Figure 6 of Grovender which shows the port mandrel 92 being at least partially curved and the rejection of Claim 2 above).
With regards to claim 5, the method of Kawajiri, Aggerholm, and Grovender teaches the claimed invention of claim 2, and the method of Kawajiri, Aggerholm, and Grovender further teaches the method further comprising the step of removing the port mandrel from the port tube (see [0156] “the mandrels 92, 94 may be removed from lumens” of Grovender and see the rejection of Claim 2 above).
With regards to claim 6, the method of Kawajiri, Aggerholm, and Grovender teaches the claimed invention of claim 1, however, Kawajiri is silent with regards to the method further comprising the step of inserting a catheter mandrel into the catheter shaft.
Nonetheless Grovender, which is within the analogous art of catheter with skived tubular members (see abstract), teaches (Figs. 4 – 6B) the method further comprising the step of inserting a catheter mandrel (94) (see [0156]) into the catheter shaft (30) (see Fig. 6 and [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Kawajiri, Aggerholm, and Grovender modified in view of a further teaching of Grovender such that the method further comprises the step of inserting a catheter mandrel into the catheter shaft. One of ordinary skill in the art would have been motivated to make this modification because using a mandrel within a method of manufacturing is beneficial because it maintains the lumen shape and size of the catheter shaft, prevents deformation of the catheter shaft during the manufacturing process, and ensures a smooth inner surface of the catheter shaft (see [0084] of Grovender).
With regards to claim 7, the method of Kawajiri, Aggerholm, and Grovender teaches the claimed invention of claim 6, however, Kawajiri is silent with regards to wherein the step of inserting the catheter mandrel into the catheter shaft includes positioning the port tube and the port mandrel in a curved portion of the catheter mandrel.
Nonetheless Grovender, which is within the analogous art of catheter with skived tubular members (see abstract), teaches (Figs. 4 – 6B) the step of inserting the catheter mandrel (94) (see [0084]) into the catheter shaft (30) (see [0084]) includes positioning the port tube (60) (see [0063]) and the port mandrel (92) (see [0090]) in a curved portion (see at 94 in Fig. 6B) of the catheter mandrel (see Fig. 6B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Kawajiri, Aggerholm, and Grovender in view of a further teaching of Grovender such that the method further comprises the step of inserting the catheter mandrel into the catheter shaft includes positioning the port tube and the port mandrel in a curved portion of the catheter mandrel. One of ordinary skill in the art would have been motivated to make this modification because using a mandrel within a method of manufacturing is beneficial because it maintains the lumen shape and size of the catheter, prevents deformation during the manufacturing process, and ensures a smooth inner surface (see [0084] of Grovender).
With regards to claim 8, the method of Kawajiri, Aggerholm, and Grovender teaches the claimed invention of claim 6, and the method of Kawajiri, Aggerholm, and Grovender further teaches the method further comprising the step of removing the catheter mandrel from the catheter shaft (see [0156] “the mandrels 92, 94 may be removed from lumens” of Grovender and see the rejection of Claim 6 above).
With regards to claim 9, the method of Kawajiri, Aggerholm, and Grovender teaches the claimed invention of claim 6, and the method of Kawajiri, Aggerholm, and Grovender further teaches wherein the catheter mandrel is substantially u- shaped (see [0107] “a mandrel 94 (also shown in FIG. 6), which may include a crescent-shaped portion” and see Fig. 6B of Grovender).
With regards to claim 17, the method of Kawajiri, Aggerholm, and Grovender teaches the claimed invention of claim 1, and Kawajiri further teaches wherein at least one of the guidewire lumen and the catheter shaft (5) is at least partially formed from a polymeric material (see [0022] “Also, the material of the catheter tube 5 is not particularly limited as long as it has elasticity, but preferably it is a polymer material, and polyamide resin or polyamide based elastomer are particularly preferable.”).
Claim(s) 3, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawajiri, Aggerholm, and Grovender as applied to claims 1 or 2 above, and further in view of Parodi et al. (US 2009/0088790 A1) (hereinafter referred to as “Parodi”).
With regards to claim 3, the method of Kawajiri, Aggerholm, and Grovender teaches the claimed invention of claim 2, however, Kawajiri is silent with regards to wherein the port mandrel is at least partially formed from a flexible material.
Nonetheless Parodi, which is within the analogous art of catheters (see abstract and title)¸teaches the port mandrel is at least partially formed from a flexible material (see [0050] “flexible mandrel”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the material of the mandrel of the method of Kawajiri, Aggerholm, and Grovender in view of a teaching of Parodi such that the port mandrel is at least partially formed from a flexible material. One of ordinary skill in the art would have been motivated to make this modification since it has been held that the selection of a known material based on its suitability for its intended use is a matter of obvious design choice. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960); MPEP 2144.07. Furthermore Parodi teaches that a mandrel may be formed of a flexible material (see [0050]) so a person having ordinary skill would refer to Parodi to determine what to manufacture the mandrel of.
With regards to claim 18, the method of Kawajiri, Aggerholm, and Grovender teaches the claimed invention of claim 1, however, Kawajiri is silent with regards to wherein the step of skiving the port tube is completed using a cutting tool.
Nonetheless Parodi, which is within the analogous art of catheters (see abstract and title)¸ teaches that skiving can be accomplished using a straight razor or suitable tool (see [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the skiving step of the method of Kawajiri, Aggerholm, and Grovender in view of a teaching of Parodi such that the step of skiving the port tube is completed using a cutting tool. One of ordinary skill in the art would have been motivated to make this modification because Parodi teaches that it is well known to perform skiving steps using a straight razor or cutting with a suitable tool (see [0030] of Parodi).
With regards to claim 19, the method of Kawajiri, Aggerholm, and Grovender teaches the claimed invention of claim 1, however, Kawajiri is silent with regards to wherein the step of skiving the guidewire lumen is completed using a cutting tool.
Nonetheless Parodi, which is within the analogous art of catheters (see abstract and title)¸ teaches that skiving can be accomplished using a straight razor or suitable tool (see [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the skiving step of the method of Kawajiri, Aggerholm, and Grovender in view of a teaching of Parodi such that the step of skiving the guidewire lumen is completed using a cutting tool. One of ordinary skill in the art would have been motivated to make this modification because Parodi teaches that it is well known to perform skiving steps using a straight razor or cutting with a suitable tool (see [0030] of Parodi).
Claim(s) 10 – 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawajiri, Aggerholm, and Grovender as applied to claim 1 above, and further in view of Tarunaga et al. (US 2018/0214677 A1) (hereinafter referred to as “Tarunaga”).
With regards to claim 10, the method of Kawajiri, Aggerholm, and Grovender teaches the claimed invention of claim 1, however, Kawajiri is silent with regards to further comprising the step of positioning a heat shrink over a portion of the catheter shaft.
Nonetheless Tarunaga, which is within the analogous art of balloon catheters and methods of manufacturing (see abstract and title), teaches (see Figs. 7A – 7B) the step of positioning a heat shrink (650) (see [0165]) over a portion of the catheter shaft (510) (see [0168]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Kawajiri, Aggerholm, and Grovender in view of a teaching of Tarunaga such that the step of positioning a heat shrink over a portion of the catheter shaft. One of ordinary skill in the art would have been motivated to make this modification because applying a heat shrink over the catheter shaft allows for the thermal fusion of components together (see [0175] of Tarunaga). The thermal fusion then secures components together so that they do not shift or move during use of the catheter.
The method of Kawajiri, Aggerholm, and Grovender modified in view of a teaching of Tarunaga will hereinafter be referred to as the method of Kawajiri, Aggerholm, Grovender and Tarunaga.
With regards to claim 11, the method of Kawajiri, Aggerholm, Grovender and Tarunaga teaches the claimed invention of claim 10, and the method of Kawajiri, Aggerholm, Grovender and Tarunaga further teaches wherein the heat shrink includes heat shrink tubing (see [0175] “heat-shrinkable tube” of Tarunaga and the rejection of claim 10 above).
With regards to claim 12, the method of Kawajiri, Aggerholm, Grovender and Tarunaga teaches the claimed invention of claim 10, and the method of Kawajiri, Aggerholm, Grovender and Tarunaga further teaches further comprising the step of applying heat to the heat shrink (see [0175] “heat is applied to the heat-shrinkable tube 650” and the rejection of claim 10 above).
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawajiri, Aggerholm, and Grovender as applied to claim 1 above, and further in view of Moloney et al. (US 2002/0177841 A1) (hereinafter referred to as “Moloney”).
With regards to claim 13, the method of Kawajiri, Aggerholm, and Grovender teaches the claimed invention of claim 1, further comprising the step of sealing a gap between the guidewire lumen and the port tube.
Nonetheless Moloney, which is within the analogous art of rapid exchange catheters (see abstract and title), teaches the step of sealing a gap between the guidewire lumen (14) (see [0056] “The inner tube 14 may be secured by adhesive or heat bonding to the inner wall surface of the distal outer tube segment”) and the port tube (32) (see [0050] The two outer tube segments 32, 34 could be adhesively bonded or heat bonded to each other.”) (Here the gap is the space that the adhesive of the adhesive bonding is located in prior to the adhesive bonding occurring).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Kawajiri, Aggerholm, and Grovender in view of a teaching of Moloney such that the method further comprises the step of sealing a gap between the guidewire lumen and the port tube. One of ordinary skill in the art would have been motivated to make this modification because Moloney teaches that a catheter can be manufactured using an adhesive to secure the guidewire lumen and the port tube together (see [0050] and [0056] of Moloney). It is beneficial for these structures to be secured together in order to keep these components in alignment so that a guidewire can be passed through the guidewire lumen and port tube towards the distal end of the catheter.
The method of Kawajiri, Aggerholm, and Grovender modified in view of a teaching of Moloney will hereinafter be referred to as the method of Kawajiri, Aggerholm, Grovender, and Moloney.
With regards to claim 14, the method of Kawajiri, Aggerholm, Grovender, and Moloney teaches the claimed invention of claim 13, and the method of Kawajiri, Aggerholm, Grovender, and Moloney teaches further teaches wherein the step of sealing the gap is completed using an adhesive (see [0050] and [0056] of Moloney and the rejection of claim 13 above).
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawajiri, Aggerholm, and Grovender as applied to claim 1 above, and further in view of Cook et al. (US 2021/0244473 A1) (hereinafter referred to as “Cook”).
With regards to claim 15, the method of Kawajiri, Aggerholm, and Grovender teaches the claimed invention of claim 1, however Kawajiri is silent with regards to the method further comprising the step of inserting an energy guide into the catheter shaft so that the energy guide is substantially parallel to the guidewire lumen.
Nonetheless Cook, which is within the analogous art of catheters with energy guides (see abstract and title)¸ teaches (see Fig. 1) the step of inserting an energy guide (122) (see [0045]) into the catheter shaft (110) (see [0047]) so that the energy guide is substantially parallel to the guidewire lumen (118) (see [0047], [0048], and [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Kawajiri, Aggerholm, and Grovender in view of a teaching of Cook such that the method further comprises the step of inserting an energy guide into the catheter shaft so that the energy guide is substantially parallel to the guidewire lumen. One of ordinary skill in the art would have been motivated to make this modification because Cook teaches including energy guides is advantageously generates pressure waves for disrupting vascular lesions (see [0040] of Cook).
The method of Kawajiri, Aggerholm, and Grovender modified in view of a teaching of Cook will hereinafter be referred to as the method of Kawajiri, Aggerholm Grovender and Cook.
With regards to claim 16, the method of Kawajiri, Aggerholm Grovender and Cook teaches the claimed invention of claim 15, and the method of Kawajiri, Aggerholm Grovender and Cook further teaches wherein the energy guide is an optical fiber (see [0048] of Cook and the rejection of claim 15 above).
Conclusion
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
06/01/2026
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