DETAILED ACTION
This office action is in response to applicant’s amendment filed on November 19, 2025. Claims 1, 3-5, 9-14, 16-18, and 22-26 are under consideration.
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.
Claims 1, 5, 10-14, 18, and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Douk et al. (US 2022/0142462 A1, herein “Douk”) in view of Brown et al. (US 20190083177 A1, herein “Brown”) and Wu (US10,561,303 B2, herein “Wu”).
Claim 1. Douk discloses a medical device (optical imaging catheter or endoscope’s optical system (Col. 1, line 7-15) comprising:
a flexible member (shaft 81) having a hollow cavity extending between a proximal end (at connector 82 shown in Fig. 1) and a distal end (1209);
an optical fiber (with optical core 110) extending through the hollow cavity; and
distal optics at the distal end of the flexible member (optical assembly 115 in Fig. 3B);
a potting material (gel 180) surrounding the distal end of the optical fiber region to secure and pot the optical fiber region (Fig. 1A, Para [0138])
However, Douk does not explicitly disclose the optical fiber having a buffered optical fiber region and a stripped optical fiber region. Douk also does not explicitly disclose a rebuffer heat shrink tube surrounding the stripped optical fiber region with a gap between the stripped optical fiber region and the heat shrink tube filled with the potting material.
Brown teaches protective caps of tips for surgical laser fibers. Brown teaches the fiber tip in the device is stripped of its buffer layer (76, Fig. 5). The protective cap that is formed over the stripped fiber has a rebuffer heat shrink tube (85 in Fig. 5C) surrounding a stripped area (Fig. 5B shows stripped buffer 82 removed from fiber) of the optical fiber (core 70 and clad 72) with a gap between the optical fiber and the heat shrink tube filled with the potting material (soft tip 80). The potting material secure the optical fiber and distal optics (as implied: endoscope with laser for targeting stone or object or tissue (Para [0013]) to inhibit damage to the distal end of the optical fiber (Para [0018]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to recognize the rebuffering of the stripped fiber with the potting material is an obvious modification to the distal fiber end of Douk’s imaging probe. One would be motivated to rebuffer the optical fiber tip with the potting material to protect the newly cleaved fiber and connected fiber, and limit the fiber tip erosion (Brown: Para [0018]).
Douk in view of Brown do not teach:
a spacer,
a distal end of the stripped optical fiber region being fused to the spacer;
a potting material surrounding the distal end of the stripped optical fiber region to secure and pot the stripped optical fiber region and the spacer;
a rebuffer heat shrink tube surrounding the stripped optical fiber region with a gap between the stripped optical fiber region and the heat shrink tube filled with the potting material,
the potting material is a dual-cure adhesive inside the rebuffer heat shrink tube.
Wu teaches optical probes with correction components for astigmatism correction. The embodiment in Fig. 16 shows, the first light guiding component (1601) is “fused” or bonded to spacer (1602) and further bonded to a ball lens (1603). Shrink tube (1605) is filled with epoxy (1606) is fitted over the ball lens, spacer, and the first light guiding component. Wu further teaches the method step wherein the epoxy is cured, and then the mandrel is removed. The mandrel may have a coating such that its surface is smooth and easy to detach from the epoxy. Once the curing is finished, removing the mandrel leaves the angled surface. Also, in some embodiments, some curing is done after the mandrel is removed, which suggests the epoxy (“potting material”) is a dual-cure adhesive (Col. 13, line 63 to Col. 14, line 2).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to recognize the teaching of Brown wherein the buffer layer of the fiber must be removed for the fiber to properly fuse and couple light to the lens efficiently. The shrink tube in Wu’s invention teaches the rebuffer shrink tube surrounding the stripped optical fiber region with a gap between the stripped optical fiber region and the heat shrink tube filled with the potting material. One would be motivated to rebuffer the fiber, spacer, and lens in within the shrink tube in an assembly held together with an epoxy to ensure the calibrated astigmatism correction is maintained (Col. 13, lines 1-31).
Claim 5. Douk in view of Brown and Wu teach the optical fiber is a buffered optical fiber (Brown: Fig. 5).
Claim 10, Douk / Brown / Wu teach the invention of claim 1, Wu further discloses the distal optics comprise a lens (ball lens 1603) and a reflector (1613 in Fig. 16).
Claim 11, Douk / Brown / Wu teach the invention of claim 1, Douk further discloses the imaging probe shown in Figs 2 and 2A is a catheter (Para [0067]) The catheter probe can be detached from the main controller and be disposed of.
Claim 12, Douk / Brown / Wu teach the invention of claim 1, Douk further discloses the catheter is an multimodal optical coherence tomography catheter-based probe (Para [0110], [0125]).
Claim 13. Douk / Brown / Wu teach the invention of claim 1, Douk further discloses the medical device functionally interacts with a display to display images, data or other information (Console 50, Para [0126]).
Claim 14. Douk discloses a medical apparatus comprising:
a processor (processor 52); and
a medical device (probe 100), the medical device including
a flexible member (shaft 81) having a hollow cavity extending between a proximal end (at connector 82 shown in Fig. 1) and a distal end (1209);
an optical fiber (with optical core 110) extending through the hollow cavity; and
distal optics at the distal end of the flexible member (optical assembly 115 in Fig. 3B);
a potting material (gel 180) surrounding the distal end of the optical fiber region to secure and pot the optical fiber region (Fig. 1A, Para [0138])
However, Douk does not explicitly disclose the optical fiber having a buffered optical fiber region and a stripped optical fiber region. Douk also does not explicitly disclose a rebuffer heat shrink tube surrounding the stripped optical fiber region with a gap between the stripped optical fiber region and the heat shrink tube filled with the potting material.
Brown teaches protective caps of tips for surgical laser fibers. Brown teaches the fiber tip in the device is stripped of its buffer layer (76, Fig. 5). The protective cap that is formed over the stripped fiber has a rebuffer heat shrink tube (85 in Fig. 5C) surrounding a stripped area (Fig. 5B shows stripped buffer 82 removed from fiber) of the optical fiber (core 70 and clad 72) with a gap between the optical fiber and the heat shrink tube filled with the potting material (soft tip 80). The potting material secure the optical fiber and distal optics (as implied: endoscope with laser for targeting stone or object or tissue (Para [0013]) to inhibit damage to the distal end of the optical fiber (Para [0018]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to recognize the rebuffering of the stripped fiber with the potting material is an obvious modification to the distal fiber end of Douk’s imaging probe. One would be motivated to rebuffer the optical fiber tip with the potting material to protect the newly cleaved fiber and connected fiber, and limit the fiber tip erosion (Brown: Para [0018]).
Douk in view of Brown do not teach:
a spacer,
a distal end of the stripped optical fiber region being fused to the spacer;
a potting material surrounding the distal end of the stripped optical fiber region to secure and pot the stripped optical fiber region and the spacer;
a rebuffer heat shrink tube surrounding the stripped optical fiber region with a gap between the stripped optical fiber region and the heat shrink tube filled with the potting material,
the potting material is a dual-cure adhesive inside the rebuffer heat shrink tube.
Wu teaches optical probes with correction components for astigmatism correction. The embodiment in Fig. 16 shows, the first light guiding component (1601) is “fused” or bonded to spacer (1602) and further bonded to a ball lens (1603). Shrink tube (1605) is filled with epoxy (1606) is fitted over the ball lens, spacer, and the first light guiding component. Wu further teaches the method step wherein the epoxy is cured, and then the mandrel is removed. The mandrel may have a coating such that its surface is smooth and easy to detach from the epoxy. Once the curing is finished, removing the mandrel leaves the angled surface. Also, in some embodiments, some curing is done after the mandrel is removed, which suggests the epoxy (“potting material”) is a dual-cure adhesive (Col. 13, line 63 to Col. 14, line 2).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to recognize the teaching of Brown wherein the buffer layer of the fiber must be removed for the fiber to properly fuse and couple light to the lens efficiently. The shrink tube in Wu’s invention teaches the rebuffer shrink tube surrounding the stripped optical fiber region with a gap between the stripped optical fiber region and the heat shrink tube filled with the potting material. One would be motivated to rebuffer the fiber, spacer, and lens in within the shrink tube in an assembly held together with an epoxy to ensure the calibrated astigmatism correction is maintained (Col. 13, lines 1-31).
Claim 18. Douk / Brown / Wu teach the invention of claim 14, Brown also teaches the optical fiber is a buffered fiber (Figs. 5A-5B).
Claim 23, Douk / Brown / Wu teach the invention of claim 14, Douk further discloses the distal optics comprise a lens (1151 in Fig. 3A).
Claim 24, Douk / Brown / Wu teach the invention of claim 14, Douk further discloses the imaging probe shown in Figs 2 and 2A is a catheter (Para [0067]) The catheter probe can be detached from the main controller and be disposed of.
Claim 25, Douk / Brown / Wu teach the invention of claim 14, Douk further discloses the catheter is an multimodal optical coherence tomography catheter-based probe (Para [0110], [0125]).
Claim 26. Douk / Brown / Wu teach the invention of claim 14, Douk further discloses the medical device functionally interacts with a display to display images, data or other information (Console 50, Para [0126]).
Claims 3-4 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Douk in view of Brown and Wu (herein “Douk / Brown / Wu”) as applied to claim 1 and claim 14 above, and further in view of Fathi et al. (US 2016/0362534 A1, herein "Fathi”).
Douk / Brown / Wu teach the invention of claim 1, but Douk / Brown / Wu do not explicitly teach the dual-cure adhesive is an ultraviolet curable adhesive, and the dual-cure adhesive is a secondary heat-curable-adhesive.
Fathi teaches the state of the art of polymeric bonding chemistries wherein dual-cure adhesive was developed to over the disadvantages in UV curing adhesive. The dual-cure adhesive allows the first curing step to chemically stabilize the adhesive with UV radiation and then thermally cure the adhesive to overcome the depth disadvantage and non-transparent filler materials that UV radiation cannot penetrate cure (Para [0115]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to recognize the dual-cure adhesive is readily available to practitioners in the art of optical assembly. One would be motivated to employ dual-cure adhesive to ensure optical bonds, and thus alignment(s).
Claims 9 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Douk/ Brown / Wu as applied to claim 1 above, and further in view of Goldfarb et al. (US 2007/0282305 A1, hereinafter “Goldfarb”).
Douk / Brown / Wu teach the invention of claim 1 and claim 14, respectively, and Wu also teaches the optical fiber (Col. 3, lines 55-57) with the rebuffer heat shrink tube (1605).
Douk / Brown / Wu do not teach the rebuffer heat shrink tube is on a guidewire.
Goldfarb teaches the step of installing the endoscopic connector to the fiber. The fiber is passed through guidewire (110) and the guidewire runs along side within the endoscopic tubular body (see at least Para [0156]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to recognize the teaching of Goldfarb providing a guidewire to support the optical fiber through the endoscope body. Since the rebuffer of Douk / Brown / Wu is taught to form a continuous support for the optical fiber, spacer, and lens, one would recognize the shrink tube would be provided on the guidewire to connect the probe or guidewire to the endoscope connector.
Response to Arguments
Applicant’s arguments with respect to claims 1, 3-5, 9-14, 16-18, and 22-26 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.
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 Erin D Chiem whose telephone number is (571)272-3102. The examiner can normally be reached 10 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas A. Hollweg can be reached at (571) 270-1739. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN D CHIEM/Examiner, Art Unit 2874
/THOMAS A HOLLWEG/Supervisory Patent Examiner, Art Unit 2874
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