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 of Group I in the reply filed on 04/22/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 25-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04/22/2026.
Claim Objections
Claims 9, 14, and 24 are objected to because of the following informalities:
Claim 9, line 2, “,” should be inserted after “the expandable end portion”.
Claim 14, line 2, “first” should be inserted before “inner sheath space”.
Claim 24, line 19, “wall.” should read “wall,”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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) 1-11 and 17-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0224290 (Chanduszko).
1. A percutaneous assembly (catheter 10), comprising:
a percutaneous sheath (tube 14) having a tubular wall extending to a distal end portion thereof, the tubular wall defining a lumen (lumen 16) having an inner diameter (FIG. 1; P0044);
a percutaneous dilator tip (balloon 12) including a radially expandable member (body of balloon 12) and an elongated control member (first and second tubes 18a, 18b)(FIG. 1; P0045-P0046);
the radially expandable member having an expandable end portion (proximal end 12a) removably engageable to the distal end portion of the tubular wall (see balloon 12 not being directly affixed to the tube 14 at FIG. 1 and P0040 such that it is removably engageable with the tube 14)(also see FIG. 3 and P0049), the radially expandable member being adjustable in an expanded configuration (FIG. 1 and 4; P0054) in which the expandable end portion is configured to conform to the distal end portion of the tubular wall when engaged thereto (FIG. 1 and 4; P0054), and a contracted configuration (FIG. 6; P0055) in which the expandable end portion has a contracted outer diameter that is smaller than the inner diameter of the lumen of the tubular wall (see at least a portion of balloon 12 being smaller than lumen 16 in FIG. 6 or threaded engagement in FIG. 3); and the elongated control member being operatively coupled to the radially expandable member for adjusting the radially expandable member in at least one of the expanded configuration and the contracted configuration (FIG. 1; P0044-P0045), the elongated control member further being longitudinally movable relative to the tubular wall when the expandable end portion of the radially expandable member is in the contracted configuration (FIG. 1; P0044-P0045), the elongated control member further being eccentrically positioned relative to the lumen of the tubular wall (FIG. 2-2c).
2. The expandable end portion of the radially expandable member is removably engageable by being removably insertable in the lumen of the tubular wall at the distal end portion thereof (FIG. 1 and 3; P0040 and P0049).
3. The distal end portion of the tubular wall is configured for fitting snuggly with the expandable end portion of the radially expandable member adjusted in the expanded configuration when inserted in the lumen of the tubular wall (FIG. 1 and 3; P0040 and P0049).
4. The distal end portion of the tubular wall includes an intraluminal portion having an inner diameter that is smaller than the expanded outer diameter of the expandable end portion of the radially expandable member when inserted in the lumen of the tubular wall (FIG. 1 and 4).
5. The expandable end portion of the radially expandable member adjusted in the expanded configuration has an expanded outer diameter that is substantially equal to the inner diameter of the lumen of the tubular wall when the expandable end portion is connected thereto (FIG. 1 and 4).
6. The elongated control member is longitudinally slidably receivable in the lumen of the tubular wall (FIG. 1-2c; P0045-P0046).
7. The percutaneous sheath includes a secondary tubular wall (partition 24) extending at least partially along the tubular wall and defining a secondary lumen (outer lumen defined by partition 24), the elongated control member being longitudinally slidably receivable in the secondary lumen (FIG. 1-2c; P0045-P0047).
8. The percutaneous assembly has a catheter (partition 24) for guiding the percutaneous assembly over a guidewire along a body conduit of a subject, the catheter being positioned eccentrically relative to the lumen of the tubular wall along at least a portion thereof (FIG. 2b; P0047).
9. The radially expandable member includes a tapered end portion (distal end 12b) longitudinally opposed to the expandable end portion the tapered end portion of the radially expandable member comprising a reinforced distalmost narrower end (FIG. 2; P0041).
10. The radially expandable member is a balloon member of a balloon catheter (FIG. 1; P0040).
11. The elongated control member is a hose member of the balloon catheter and is configured for adjusting the balloon member in the expanded configuration by inflation and in the contracted configuration by deflation (FIG. 1-2c, 4, and 6; P0045-P0046).
17. A percutaneous assembly (catheter 10), comprising:
a percutaneous sheath (tube 14) having a tubular wall extending to a distal end portion thereof, the tubular wall having a circumference and defining a lumen (lumen 16) having an inner diameter (FIG. 1; P0044);
a percutaneous dilator tip (balloon 12) including a radially expandable member (body of balloon 12) and an elongated control member (first and second tubes 18a, 18b)(FIG. 1; P0045-P0046);
the radially expandable member having an expandable end portion (proximal end 12a) fixedly attached on a portion of the circumference of the tubular wall at the distal end portion thereof (FIG. 1 and 3; P0040 and P0049), the radially expandable member being adjustable in an expanded configuration (FIG. 1 and 4; P0054) in which the expandable end portion is configured to conform to the distal end portion of the tubular wall (FIG. 1 and 4; P0054), and a contracted configuration (FIG. 6; P0055) in which the expandable end portion has a contracted outer diameter that is smaller than the inner diameter of the lumen of the tubular wall (see at least a portion of balloon 12 being smaller than lumen 16 in FIG. 6 or threaded engagement in FIG. 3); and the elongated control member being operatively coupled to the radially expandable member for adjusting the radially expandable member in at least one of the expanded configuration and the contracted configuration (FIG. 1; P0044-P0045), the elongated control member further being longitudinally disposed relative to the tubular wall and eccentrically positioned relative to the lumen thereof (FIG. 2-2c).
18. The expandable end portion of the radially expandable member is received in the lumen of the tubular wall at the distal end portion thereof (FIG. 1-2c; P0045-P0046).
19. The elongated control is structurally integrated to the tubular wall (FIG. 1; P0045-P0046).
20. The percutaneous assembly has a catheter (partition 24) for guiding the percutaneous assembly over a guidewire (guidewire G) along a body conduit of a subject, the catheter being positioned eccentrically relative to the lumen of the tubular wall along at least a portion thereof (FIG. 1-2c; P0046-P0047).
21. The catheter is structurally integrated to the tubular wall (FIG. 1-2c; P0046-P0047).
22. The radially expandable member is a balloon member of a balloon catheter (FIG. 1; P0040).
23. The elongated control member is a hose member of the balloon catheter and is configured for adjusting the balloon member in the expanded configuration by inflation and in the contracted configuration by deflation (FIG. 1-2c, 4, and 6; P0045-P0046).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12-15 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0224290 (Chanduszko) in view of US 2012/0109056 (Rasmussen).
24. A kit (catheter 10), comprising:
a) a percutaneous sheath (tube 14) having a tubular wall extending to a distal end portion thereof, the tubular wall defining a lumen (lumen 16) having an inner diameter (FIG. 1; P0044);
b) a percutaneous dilator tip (balloon 12) including a radially expandable member (body of balloon 12) and an elongated control member (first and second tubes 18a, 18b)(FIG. 1; P0045-P0046);
the radially expandable member having an expandable end portion (proximal end 12a) removably engageable to the distal end portion of the tubular wall (see balloon 12 not being directly affixed to the tube 14 at FIG. 1 and P0040 such that it is removably engageable with the tube 14)(also see FIG. 3 and P0049), the radially expandable member being adjustable in an expanded configuration (FIG. 1 and 4; P0054) in which the expandable end portion is configured to conform to the distal end portion of the tubular wall when engaged thereto (FIG. 1 and 4; P0054), and a contracted configuration (FIG. 6; P0055) in which the expandable end portion has a contracted outer diameter that is smaller than the inner diameter of the lumen of the tubular wall (see at least a portion of balloon 12 being smaller than lumen 16 in FIG. 6 or threaded engagement in FIG. 3); and the elongated control member being operatively coupled to the radially expandable member for adjusting the radially expandable member in at least one of the expanded configuration and the contracted configuration (FIG. 1; P0044-P0045), the elongated control member further being longitudinally movable relative to the tubular wall when the expandable end portion of the radially expandable member is in the contracted configuration (FIG. 2-2c; P0044-P0046), the elongated control member further being eccentrically positioned relative to the lumen of the tubular wall (FIG. 2-2c).
Chanduszko discloses the invention substantially as claimed as discussed above and further discloses a medical device (stent S)(FIG. 4 and 6). However, Chanduszko does not disclose the medical device contained in the lumen of the tubular wall of the sheath. Rasmussen teaches an assembly/kit in the same field of endeavor having a percutaneous sheath (sheath 16) containing the medical device (medical device 12) in its lumen (FIG. 6; P0030) for the purpose of securely holding the medical device before expansion and deployment (FIG. 1, 6, and 10; P0030). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly/kit of Chanduszko to contain the medical device in the lumen of the sheath as taught by Rasmussen in order to secure hold the medical device before expansion and deployment.
12. Rasmussen teaches the medical device contained in the lumen of the tubular wall (FIG. 1 and 6; P0030), the at least one medical device being movable longitudinally outwardly from the lumen, at the distal end portion of the tubular wall, when the expandable end portion of the radially expandable member is removed from the distal end portion of the tubular wall (FIG. 1 and 10).
13. Rasmussen teaches the at least one medical device and the tubular wall together define a first inner sheath space therebetween where the elongated control member passes therethrough (FIG. 6; P0035).
14. The contracted outer diameter of the radially expandable member is smaller than the inner sheath space (Chanduszko: FIG. 6; Rasmussen: FIG. 6).
15. The at least one medical device is free of an opening through which the elongated control member can be passed (Chanduszko: FIG. 6; Rasmussen: FIG. 6).
Allowable Subject Matter
Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771
Prosecution Insights