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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 March 2026 has been entered.
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 10 March 2026 wherein Claims 1 and 11 – 15 are amended, no new claims are added, Claims 17 – 20 are previously withdrawn. Therefore, Claims 1 – 20 are currently pending wherein Claims 17 – 20 are withdrawn therefrom.
The Applicant’s amendment to the Claims dated 10 March 2026 has overcome each Claim Rejection set forth under 35 U.S.C. § 112(a) within the Final Rejection dated 10 November 2025.
Response to Arguments
Applicant’s arguments with respect to independent claim(s) 1 and its dependent claims 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 new ground of rejection is made in view of Turnlund et al. (US 2009/0043283 A1).
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11 recites “a polymer lining an exterior surface of the wall of the hypotube.” The Examiner finds this language to be confusing because the word “lining” can be read as either a noun or a verb within the claims. Claims 12 – 13 recite “the polymer lining” as a noun. However, Claim 11 independent of Claims 12 – 13 can be read where the word “lining” is verb. The Examiner suggests amending Claim 11 to recite “a polymer lining covering an exterior surface of the wall of the hypotube” or something similar to clarify the claim language.
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 16 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 16 recites “a portion of the polymer from which the distal tip is formed.” There is insufficient antecedent basis for this limitation within the claims. Claim 14 has been amended to remove the antecedent basis for this limitation. Therefore, Claim 16 is rejected for being indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 – 3 and 8 – 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Turnlund et al. (US 2009/0043283 A1; hereinafter referred to as “Turnlund”).
Turnlund is previously cited in the Notice of References Cited form dated 23 June 2023.
With regards to claim 1, Turnlund discloses (Figs. 1 – 3A) a catheter shaft (12) (see [0023] “Catheter 10 may include a generally elongate shaft 12”), comprising:
a hypotube (28) defining an entire length of the catheter shaft (see Fig. 1, [0023] “Shaft 12 may include a tubular member 28 having a plurality of slots 30 formed therein. Tubular member 28 may extend along the entire length of shaft 12 or any suitable portion of the length of shaft 12,” and [0052]));
flexibility enhancing cuts (30) (see [0044] “Slots 30 may be provided to enhance the flexibility of tubular member 28 while still allowing for suitable torque transmission characteristics.”) defined in the hypotube, oriented around at least a portion of a length of the hypotube (see Fig. 1); and
at least one liner (32) (see [0024] “a tubular liner 32 may be disposed within tubular member 28”) substantially covering an interior surface (40) (see [0026] “inner surface 40 of tubular member 28”) of a wall (see at 28 in Figs. 1 – 2) of the hypotube and extending along a majority of the length of the hypotube to seal the flexibility enhancing cuts (see [0024] “Liner 32 may extend along all or a portion of the length of tubular member 28” and [0025]).
With regards to claim 2, Turnlund discloses the claimed invention of Claim 1, and Turnlund further discloses (Figs. 1 – 3A) the flexibility enhancing cuts (30) (see [0044] “Slots 30 may be provided to enhance the flexibility of tubular member 28 while still allowing for suitable torque transmission characteristics.”) comprise cuts in the wall (see at 28 in Figs. 1 – 2) of the hypotube (28) (see [0047] “the structure of the tubular member 28 is formed by cutting and/or removing portions of the tube to form slots 30”).
With regards to claim 3, Turnlund discloses the claimed invention of Claim 2, and Turnlund further discloses (Figs. 1 – 3A) wherein the cuts comprise circumferential cuts and/or helically oriented cuts (see [0045] “ Additionally, slots 30 can be arranged along the length of, or about the circumference of, tubular member 28 to achieve desired properties…Other characteristics, such as slot size, slot shape and/or slot angle with respect to the longitudinal axis of tubular member 28, can also be varied along the length of tubular member 28 in order to vary the flexibility or other properties.” This paragraph describes the cuts being both circumferential cuts and helically oriented cuts).
With regards to claim 8, Turnlund discloses the claimed invention of Claim 1, and Turnlund further discloses (Figs. 1 – 3A) wherein the at least one liner (32) (see [0024] “a tubular liner 32 may be disposed within tubular member 28”) extends through substantially an entirety of the length of the hypotube (28) (see [0024] “Liner 32 may extend along all or a portion of the length of tubular member 28” and [0025]).
With regards to claim 9, Turnlund discloses the claimed invention of Claim 8, and Turnlund further discloses (Figs. 1 – 3A) wherein the at least one liner (32) (see [0024] “a tubular liner 32 may be disposed within tubular member 28”) comprises an expanded polytetrafluoroethylene tube secured to the interior surface of the wall of the hypotube (28) (see [0060] “liner 32 may be made from a lubricious, hydrophilic, protective, or other type of material. Alternatively, liner may include any other suitable material or combination of materials including any of those disclosed herein.…Suitable lubricious polymers are well known in the art and may include…polytetrafluoroethylene (PTFE)”).
With regards to claim 10, Turnlund discloses the claimed invention of Claim 8, and Turnlund further discloses (Figs. 1 – 3A) wherein the at least one liner (32) (see [0024] “a tubular liner 32 may be disposed within tubular member 28”) extends through the entirety of the length of the hypotube (28) (see [0024] “Liner 32 may extend along all or a portion of the length of tubular member 28” and [0025]).
With regards to claim 11, Turnlund discloses the claimed invention of Claim 1, and Turnlund further discloses (Figs. 1 – 3A) a polymer lining an exterior surface of the wall of the hypotube (28) (see [0059] “A sheath or covering (not shown) may be disposed over portions or all of catheter 10 that may define a generally smooth outer surface for catheter 10… The sheath may be made from a polymer or any other suitable material.” Here the polymer lining is the disclosed sheath or covering.).
With regards to claim 12, Turnlund discloses the claimed invention of Claim 11, and Turnlund further discloses (Figs. 1 – 3A) wherein the polymer lining comprises a contracted polyethylene terephthalate tube secured to the exterior surface of the wall of the hypotube (28) (see [0059] “A sheath or covering (not shown) may be disposed over portions or all of catheter 10 that may define a generally smooth outer surface for catheter 10… The sheath may be made from a polymer or any other suitable material. Some examples of suitable polymers may include…polyethylene terephthalate (PET).” Here the polymer lining is the disclosed sheath or covering.).
With regards to claim 13, Turnlund discloses the claimed invention of Claim 11, and Turnlund further discloses (Figs. 1 – 3A) wherein the polymer lining extends over substantially an entirety of the length of the hypotube (28) (see [0023] “Catheter 10 may include a generally elongate shaft 12…Shaft 12 may include a tubular member 28” and [0059] “A sheath or covering (not shown) may be disposed over portions or all of catheter 10 that may define a generally smooth outer surface for catheter 10.” Here the polymer lining is the disclosed sheath or covering.).
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) 4 – 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Turnlund and Banas (US 2002/0165600 A1; hereinafter referred to as “Banas”).
Banas is cited within the 892 form dated 12/15/2022.
With regards to claim 4, Turnlund discloses the claimed invention of Claim 1, however, Turnlund is silent with regards to wherein the hypotube further includes:
at least one operational feature located along another portion of the length of the hypotube, wherein the at least one operational feature defines an expandable section along the another portion of the length of the hypotube.
Nonetheless Banas which is within the analogous art of catheter-sheaths (see abstract and title), teaches (Figs. 5A-5C) the hypotube (see [0048] “catheter-sheath”) further includes:
at least one operational feature (110; see [0048] “longitudinal slots 110”) located along another portion of the length of the hypotube (see the location of the at least one operational feature/cuts 110 located along another portion of the length of the hypotube in Fig. 5a), wherein the at least one operational feature defines an expandable section (see at 110 and “Radial Expansion” in Fig. 5c) along the another portion of the length of the hypotube (see Fig. 5a which shows the at least one operational feature defining an expandable section, see at 110 in Fig. 5a, along the another portion of the length of the hypotube).
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 hypotube of the catheter shaft of Turnlund in view of a teaching of Banas such that the hypotube further includes: at least one operational feature located along another portion of the length of the hypotube, wherein the at least one operational feature defines an expandable section along the another portion of the length of the hypotube. One of ordinary skill in the art would have been motivated to make this modification, as the at least one operational feature/longitudinal slots provide for radial compliance (see [0048] of Banas)
The catheter shaft of Turnlund modified in view of Banas will hereinafter be referred to as the catheter shaft of Turnlund and Banas.
With regards to claim 5, the catheter shaft of Turnlund and Banas teaches the claimed invention of claim 4, however Turnlund is silent with regards to wherein the at least one operational feature is located adjacent to a distal end of the hypotube.
Nonetheless, Banas which is within the analogous art of catheter-sheaths (see abstract), further teaches (Figs. 5A-5C) the at least one operational feature (110; see [0048] “longitudinal slots 110”) is located adjacent to a distal end of the hypotube (see [0048] “catheter-sheath” and the location of the longitudinal slots/at least one operational feature 110 in Fig. 5a).
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 location of the at least one operational feature of the catheter shaft of Turnlund and Banas in view of a further teaching of Banas such that the at least one operational feature is located adjacent to a distal end of the hypotube. One of ordinary skill in the art would have been motivated to make this modification, as the at least one operational feature/longitudinal slots provide for radial compliance at the distal end of the hypotube (see [0048] of Banas).
With regards to claim 6, the catheter shaft of Turnlund and Banas teaches the claimed invention of claim 4, however Turnlund is silent with regards to wherein the at least one operational feature comprises cuts in the wall of the hypotube.
Nonetheless, Banas which is within the analogous art of catheter-sheaths (see abstract), further teaches (Figs. 5A-5C) the at least one operational feature (110; see [0048] “longitudinal slots 110”) comprises cuts in the wall of the hypotube (see [0048] “catheter-sheath” and see Fig. 5a).
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 at least one operational feature of the catheter shaft of Turnlund and Banas in view of a further teaching of Banas such that the at least one operational feature comprises cuts in the wall of the hypotube. One of ordinary skill in the art would have been motivated to make this modification, as Banas teaches the at least one operational feature/longitudinal slots provide for radial compliance (see [0048] of Banas)
With regards to claim 7, the catheter shaft of Turnlund and Banas teaches the claimed invention of claim 6, however Turnlund is silent with regards to wherein the at least one operational feature defines a radially expandable section of the hypotube.
Nonetheless, Banas which is within the analogous art of catheter sheaths, further teaches (Figs. 5a-5c) the at least one operational feature (110; see [0048]) defines a radially expandable section (see at 110 and “Radial Expansion” in Fig. 5C) of the hypotube (see [0048] “catheter-sheath”).
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 at least one operational feature of Turnlund and Banas with a further teaching of Banas such that the at least one operational feature defines a radially expandable section of the hypotube. One of ordinary skill in the art would have been motivated to make this modification, as the at least one operational feature/longitudinal slots provide for radial compliance (see [0048] of Banas).
Claim(s) 14 – 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Turnlund in view of Shimizu et al. (US 2017/0113018 A1; hereinafter referred to as “Shimizu”).
Shimizu is cited within the Notice of References Cited form dated 5/8/2024.
With regards to claim 14, Turnlund discloses the claimed invention of claim 11, however, Turnlund is silent with regards to a distal tip at a distal end of the hypotube, the distal tip assembled with the distal end of the hypotube, mechanically coupled to the distal end of the hypotube, and having an opening with an inner diameter that is the same as an inner diameter of a lumen of the catheter shaft.
Nonetheless, Shimizu which is within the analogous art of catheters (see abstract), teaches (Figs. 7) the catheter shaft (511; see [0089]) further comprising:
a distal tip (512; see [0096]) at a distal end of the hypotube (528; see [0089] and Fig. 7), the distal tip assembled with the distal end of the hypotube (see Fig. 7 and [0100-0101]), mechanically coupled to the distal end of the hypotube (see at 532 in Fig. 7 and [0100-0101]), and having an opening with an inner diameter that is the same as an inner diameter of a lumen of the catheter shaft (see Fig. 7 which shows the opening of the distal tip 512 with an inner diameter that is the same as an inner diameter of a lumen of the catheter shaft 511).
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 catheter shaft of Turnlund in view of a teaching of Shimizu such that the catheter shaft further comprises a distal tip at a distal end of the hypotube, the distal tip assembled with the distal end of the hypotube, mechanically coupled to the distal end of the hypotube, and having an opening with an inner diameter that is the same as an inner diameter of a lumen of the catheter shaft. One of ordinary skill in the art would have been motivated to make this modification, as Shimizu teaches the front end tip having a plasticity (flexibility) that is greater than the catheter body is beneficial (see [0028] of Shimizu). Furthermore, the structure of Shimizu prevents the front end tip from detaching from the catheter body (see [0006] and [0008] of Shimizu).
The catheter shaft of Turnlund modified in view of a teaching of Shimizu will hereinafter be referred to as the catheter shaft of Turnlund and Shimizu.
With regards to claim 15, the catheter shaft of Turnlund and Shimizu teaches the claimed invention of claim 14, however Turnlund is silent with regards to wherein the distal tip is assembled with the distal end of the hypotube in a manner that preserves the inner diameter of the lumen of the catheter shaft.
Nonetheless, Shimizu which is within the analogous art of catheters (see abstract), further teaches (Figs. 7) the distal tip (512; see [0096]) is assembled with the distal end of the hypotube (528; see [0089] and Fig. 7) in a manner that preserves the inner diameter of the lumen of the catheter shaft (see Fig. 7).
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 catheter shaft of Turnlund and Shimizu in view of a further teaching of Shimizu such that the distal tip is assembled with the distal end of the hypotube in a manner that preserves the inner diameter of the lumen of the catheter shaft. One of ordinary skill in the art would have been motivated to make this modification, as Shimizu teaches the front end tip having a plasticity (flexibility) that is greater than the catheter body is beneficial (see [0028] of Shimizu). Furthermore, the structure of Shimizu prevents the front end tip from detaching from the catheter body (see [0006] and [0008] of Shimizu).
With regards to claim 16, the catheter shaft of Turnlund and Shimizu teaches the claimed invention of claim 15, however Turnlund is silent with regards to wherein the hypotube includes at least one tip engagement recess in a surface of the hypotube adjacent to the distal end of the hypotube that receives a portion of the polymer from which the distal tip is formed.
Nonetheless Shimizu which is within the analogous art of catheters (see abstract), further teaches (Figs. 7) the hypotube (528; see [0089] and Fig. 7) includes at least one tip engagement recess (see near 532 in Fig. 7 and [0100-0101]) in a surface of the hypotube adjacent to the distal end of the hypotube that receives a portion of the polymer (see at 532 in Fig. 7 and abstract “resin front end tip”, [0007], [0097] “The material of the front end tip 512 may be similar to the material for the embodiments of Figs. 2-6” and [0029] “The material of the front end tip 12 may include any conventional and well-known resin material…For example, the material of the front end tip [12] may include polyurethane elastomers”) from which the distal tip (512; see [0096]) is formed.
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 catheter shaft of Turnlund and Shimizu in view of a further teaching of Shimizu such that the hypotube includes at least one tip engagement recess in a surface of the hypotube adjacent to the distal end of the hypotube that receives a portion of the polymer from which the distal tip is formed. One of ordinary skill in the art would have been motivated to make this modification because Shimizu teaches the front end tip having a plasticity (flexibility) that is greater than the catheter body is beneficial (see [0028] of Shimizu). Furthermore, the structure of Shimizu prevents the front end tip from detaching from the catheter body (see [0006] and [0008] of Shimizu).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
To et al. (US 2010/0049225 A1) previously cited in the Notice of References Cited form dated 23 June 2023. See Figure 7F, [0139], and [0140].
Method et al. (US 2026/0021275 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
04/06/2026