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 .
Response to Amendment
The Amendment filed on 2/27/2026 has been entered. Claims 17-19 and 22-28 remain pending in the application.
Applicants amendments to the claims have overcome the claim objections previously set forth in the Non-final Office Action mailed 12/5/2025.
Applicants amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 12/5/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/9/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 25-28 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.
In regard to claim 25,
Line 12 recites “the tubular support sheath”. There is insufficient antecedent basis for the limitation in this claim. Line 3 recites “a support sheath”. The support sheath of line 3 is not further defined as being tubular. It is unclear if the tubular support sheath of line 12 is intended to refer to the support sheath of line 3 or to “a tubular support sheath”. For examination purposes Examiner construes the tubular support sheath to be the same as the support sheath. Examiner suggests replacing “the tubular support sheath” in line 12 of claim 25 with “the support sheath”.
Examiner notes claims 26-28 are similarly rejected by virtue of their dependency on claim 25.
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.
Claims 17, 19, 22-26, and 28 rejected under 35 U.S.C. 103 as being unpatentable over Hinchliffe (U.S. PG publication 20100305475) further in view of Northrop (U.S. PG publication 20170281909) further in view of Ishikawa (U.S. PG publication 20170281269).
[AltContent: ]In regard to claim 17,
[AltContent: textbox (Support sheath)]Hinchliffe discloses a system (see all of figure 13B) for treating a stricture along the biliary and/or pancreatic tract (Examiner notes “for treating a stricture along the biliary and/or pancreatic tract” is a functional limitation. The system is fully capable of the recited function due to its structure), the system comprising:
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a support sheath (see figure 17 and 13B above wherein the support sheath is construed as item 230 not including the labeled tip member; paragraph [0088]) having a distal end region (see figure 17 above), a proximal end region (see figure 13B above), and a longitudinal axis (see figure 17 and 13B), the support sheath having a plurality of slots (figure 17, item 234) formed therein (see figure 17), wherein the plurality of slots define a plurality of beams (see beams formed by the spaces between slots; see first beam labeled below) including a first beam (see figure 17 below) and a plurality of rings (see spaces between slots which form rings; see first ring labeled below) including a first ring (see figure 17 below) in the support sheath (see figure 17), wherein the first beam has a first beam width measured in a circumferential direction around a circumference of the support sheath (see figure 17), wherein the first ring has a first ring length measured parallel to the longitudinal axis (see figure 17),
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a hub (figure 13B, item 231) secured to the proximal end region (see figure 13B);
a guidewire (figure 13B, item 220) slidably disposed within the support sheath (see figure 13 and paragraph [0088]); and
a tip member (see labeled tip member in figure 17 above) coupled to the distal end region of the support sheath (see figure 17 above),
wherein the hub is configured to secure the axial position of the guidewire relative to the support sheath (paragraph [0097]; Examiner notes “configured to secure the axial position of the guidewire relative to the support sheath” is a functional limitation. The hub is fully capable of the recited function due to its structure as supported by paragraph [0097]).
Hinchliffe is silent as to where the first beam width is substantially equal to the first ring length; and the tip member including a coil.
Northrop teaches where the first beam (figure 14A, item 24) width is substantially equal to the first ring (figure 14A, item 22) length (paragraph [0104]-[0105]; see also figure 15).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Hinchliffe to include where the first beam width is substantially equal to the first ring length, as taught by Northrop, for the purpose of having desired performance characteristics (paragraph [0002] and [0104]-[0105] of Northrop).
Hinchliffe in view of Northrop is silent as to the tip member including a coil.
Ishikawa teaches the tip member (tip side of the elongated part; paragraph [0011]) including a coil (item 30; paragraph [0062]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the tip member of Hinchliffe in view of Northrop to include a coil, as taught by Ishikawa, for the purpose of enabling visualization (paragraph [0053] of Ishikawa).
In regard to claim 19,
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Hinchliffe in view of Northrop in view of Ishikawa teaches the system of claim 17, wherein the support sheath has a proximal region (see figure 17 of Hinchliffe above) free of slots (see figure 17 of Hinchliffe above).
In regard to claim 22,
Hinchliffe in view of Northrop in view of Ishikawa teaches the system of claim 17, wherein the hub (figure 13B, item 231 of Hinchliffe) includes a locking member (figure 13B, item 233 of Hinchliffe) for securing the axial position of the support sheath relative to the guidewire (paragraph [0097] of Hinchliffe).
In regard to claim 23,
Hinchliffe in view of Northrop in view of Ishikawa teaches the system of claim 17, wherein the hub is secured to the support sheath (see figure 13B of Hinchliffe and paragraph [0097] of Hinchliffe).
In regard to claim 24,
Hinchliffe in view of Northrop in view of Ishikawa teaches the system of claim 17, wherein the support sheath defines a contrast lumen (see lumen 232 shown in figure 17 of Hinchliffe; Examiner notes the lumen is construes as contrast lumen as a contrast agent is capable of being within the lumen; paragraph [0013] and [0117] of Hinchliffe) for infusing contrast media (Examiner notes “for infusing contrast media” is functional limitation. The lumen is fully capable of the recited function as supported by paragraph [0013] and [0117] of Hinchliffe).
In regard to claim 25,
Hinchliffe discloses a system (see all of figure 13B) for treating a stricture along the biliary and/or pancreatic tract (Examiner notes “for treating a stricture along the biliary and/or pancreatic tract” is a functional limitation. The system is fully capable of the recited function due to its structure), the system comprising:
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a support sheath (see figure 17 and 13B above wherein the support sheath is construed as item 230 not including the labeled tip member; paragraph [0088]) having a distal end region (see figure 17 above), a proximal end region (see figure 13B above), a longitudinal axis (see figure 17 and 13B), and having a plurality of slots (figure 17, item 234) formed therein (see figure 17), wherein the plurality of slots define a plurality of beams (see beams formed by the spaces between slots; see first beam labeled below) including a first beam (see figure 17 below) and a plurality of rings (see spaces between slots which form rings; see first ring labeled below) including a first ring (see figure 17 below) in the support sheath (see figure 17), wherein the first beam has a first beam width measured in a circumferential direction around a circumference of the support sheath (see figure 17), wherein the first ring has a first ring length measured parallel to the longitudinal axis (see figure 17),
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a hub locking member (figure 13B, item 231 and 233) secured to the proximal end region of the support sheath (see figure 13B);
a guidewire (figure 13B, item 220) slidably disposed within the support sheath (see figure 13 and paragraph [0088]); and
a tip member (see labeled tip member in figure 17 above) coupled to the distal end region of the tubular support sheath (see figure 17 above),
wherein the hub locking member is configured to secure the axial position of guidewire relative to the support sheath (paragraph [0097]).
Hinchliffe is silent as to where the first beam width is substantially equal to the first ring length, and the tip member including a coil.
Northrop teaches where the first beam (figure 14A, item 24) width is substantially equal to the first ring (figure 14A, item 22) length (paragraph [0104]-[0105]; see also figure 15).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Hinchliffe to include where the first beam width is substantially equal to the first ring length, as taught by Northrop, for the purpose of having desired performance characteristics (paragraph [0002] and [0104]-[0105] of Northrop).
Hinchliffe in view of Northrop is silent as to the tip member including a coil.
Ishikawa teaches the tip member (tip side of the elongated part; paragraph [0011]) including a coil (item 30; paragraph [0062]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the tip member of Hinchliffe in view of Northrop to include a coil, as taught by Ishikawa, for the purpose of enabling visualization (paragraph [0053] of Ishikawa).
In regard to claim 26,
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Hinchliffe in view of Northrop in view of Ishikawa teaches the system of claim 25, wherein the support sheath has a proximal region (see figure 17 of Hinchliffe above) free of slots (see figure 17 of Hinchliffe above).
In regard to claim 28,
Hinchliffe in view of Northrop in view of Ishikawa teaches the system of claim 25, wherein the support sheath defines a contrast lumen (see lumen 232 shown in figure 17 of Hinchliffe; Examiner notes the lumen is construes as contrast lumen as a contrast agent is capable of being within the lumen; paragraph [0013] and [0117] of Hinchliffe) for infusing contrast media (Examiner notes “for infusing contrast media” is functional limitation. The lumen is fully capable of the recited function as supported by paragraph [0013] and [0117] of Hinchliffe).
Claims 18 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Hinchliffe (U.S. PG publication 20100305475) in view of Northrop (U.S. PG publication 20170281909) in view of Ishikawa (U.S. PG publication 20170281269) further in view of a second embodiment of Hinchliffe (U.S. PG publication 20100305475).
In regard to claim 18,
Hinchliffe in view of Northrop in view of Ishikawa teaches the system of claim 17, wherein the support sheath has a proximal portion having a first slot density (see proximal portion of slots 234 in figure 17 of Hinchliffe) and a distal portion (see distal portion of slots 234 in figure 17 of Hinchliffe).
The first embodiment of Hinchliffe in view of Northrop in view of Ishikawa fails to disclose a distal portion having a second slot density greater than the first slot density.
A second embodiment of Hinchliffe teaches a distal portion (portion that includes slots 231a) having a second slot density (see slot density of slots 231a) greater than the first slot density (see slot density of slots 231b).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Hinchliffe in view of Northrop in view of Ishikawa to include a distal portion having a second slot density greater than the first slot density, as taught by the second embodiment of Hinchliffe, for the purpose of providing more flexibility toward the distal end (paragraph [0089] of Hinchliffe).
In regard to claim 27,
Hinchliffe in view of Northrop in view of Ishikawa teaches the system of claim 25, wherein the support sheath has a proximal portion having a first slot density (see proximal portion of slots 234 in figure 17 of Hinchliffe) and a distal portion (see distal portion of slots 234 in figure 17 of Hinchliffe).
The first embodiment of Hinchliffe in view of Northrop in view of Ishikawa fails to disclose a distal portion having a second slot density greater than the first slot density.
The second embodiment of Hinchliffe teaches a distal portion (portion that includes slots 231a) having a second slot density (see slot density of slots 231a) greater than the first slot density (see slot density of slots 231b).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Hinchliffe in view of Northrop in view of Ishikawa to include a distal portion having a second slot density greater than the first slot density, as taught by the second embodiment of Hinchliffe, for the purpose of providing more flexibility toward the distal end (paragraph [0089] of Hinchliffe).
Response to Arguments
Applicant’s arguments with respect to claims 17-19 and 22-28 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.
Applicant argues that support for the amended limitation is provided in paragraph [0040]. It is noted that paragraph [0040] describes the guidewire with a distal tip. The claims, however, require the tip member to be coupled to the distal end region of the support sheath, not the guidewire. Paragraph [0051] discusses a tip member coupled to the distal end region, not paragraph [0040].
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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (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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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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