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 .
DETAILED ACTION
Response to Amendment
Applicant’s Amendment filed on July 7, 2025 has been fully considered and entered.
Claim Objections
Regarding claim 1, the limitation “the inner wall of the sleeve or tube” is objected to because only “a reflective standoff sleeve” was previously recited in the claim. A “sleeve” does not have sufficient antecedent basis and a “tube” was not recited at all. For the purposes of examination, the limitation will be changed to “the inner wall of the reflective standoff sleeve.”
Appropriate correction is required.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1, 2, 4-7, 10 and 14-29 are rejected under 35 U.S.C. 103(a) as being unpatentable over Brown et al. (US 2019/0321104 A1) in view of Hutchens et al. (“Hollow steel tips for reducing distal fiber burn-back…” from Applicant’s Information Disclosure Statement).
Regarding claim 1, Brown discloses a standoff sleeve arrangement for a laser surgery optical fiber (see abstract describing fiber used during a laser lithotripsy procedure for treating kidney stones), comprising: an optical fiber (1 in Fig. 4); and a standoff sleeve (2) having a reflective inner surface (paragraph 0036 discloses reflecting light away from the end of the fiber by use of reflective materials) and fixed (paragraph 0035 describes the sleeve fitted onto an end of the fiber and held in place by welding or a compression fit) to a region at an end of the optical fiber, wherein the reflective standoff sleeve extends a predetermined distance beyond the end face of the fiber to prevent contact between the end face of the fiber and a tissue targeted by a laser exiting the fiber (Fig. 4; paragraph 0035).
Still regarding claim 1, Brown teaches the claimed invention except for the reflective standoff sleeve acting as a waveguide. Hutchens discloses an optical fiber and a reflective standoff sleeve having a reflective inner surface configured to reflect laser light emitted through an end face of the optical fiber and thereby act as a waveguide for laser radiation exiting the fiber and incident on the inner wall of the sleeve (see Table 1, 2mm recession embodiment has “yes” for reflection in tube, and as shown in the drawing is able to guide the light exiting the fiber; section “4.2 Stone Ablation”, last sentence, states “polished inner tubing may show improved performance”). Since both inventions relate to standoff sleeves, one having ordinary skill in the art at the time of the invention would have found it obvious to use a reflective standoff sleeve as a waveguide as disclosed by Hutchens in the standoff sleeve arrangement of Brown for the purpose of directing off-axis light away from the fiber and towards the target tissue to enhance performance.
Regarding claim 2, Brown discloses the standoff sleeve is made of silica glass or sapphire, or ceramic in paragraph 0035.
Regarding claims 4, 6 and 15, the proposed combination of Brown and Hutchens teaches the claimed invention except for specifically stating a reflectivity-enhancing coating or structure on the inner diameter. However, as Brown discloses the sleeve made of a reflective material in paragraph 0036 and reflectivity-enhancing coatings and structures are ubiquitous in the art, one having ordinary skill in the art at the time of the invention would have found it obvious to use a reflectivity-enhancing coating or structure on the inner diameter for the purpose of aiding in directing light away from the tip of the optical fiber. Further, one having ordinary skill would find it obvious to have the reflective coating or structure facilitating welding of the reflective standoff sleeve to the end section of the fiber for the purpose of expediting the manufacturing process.
Regarding claims 5 and 14, Brown discloses the reflective standoff sleeve is made of metal and is welded to the fiber in paragraph 0035.
Regarding claim 7, Brown discloses the optical fiber is tapered to form a tapered section having a diameter that increases towards an end face of the fiber in paragraph 0043.
Regarding claim 10, Brown discloses the silica glass tube has a distal rounded end surface in paragraph 0043.
Regarding claims 16 and 17, the proposed combination of Brown and Hutchens teaches the claimed invention except for specifically stating an ETFE or PTFE sleeve with a heat resistant reflective coating. However, it would have been obvious to one having ordinary skill in the art at the time of the invention to form the sleeve from a ETFE or PTFE material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Further, Brown recognizes the issue of damage caused by overheating in paragraph 0008 and as such, one having ordinary skill would find it obvious to employ a heat resistant reflective coating or a heatsink at any predetermined location in order to reduce the effects of overheating.
Regarding claim 18, Brown discloses a distal end surface of the fiber is planar in paragraph 0043.
Regarding claim 19, Brown discloses a distal end surface of the fiber has a convex shape in paragraph 0043, which would naturally focus laser radiation exiting the fiber.
Regarding claims 20-24 and 26, the proposed combination of Brown and Hutchens teaches the claimed invention except for specifically stating a Thulium Fiber Laser. However, as Brown discloses the laser being a Holmium laser or other type conventionally used in lithotripsy procedures in paragraphs 0020-0021, one having ordinary skill in the art at the time of the invention would have found it obvious to use a Thulium Fiber Laser having a wavelength of 1900 to 2200 nm as a matter of obvious design choice depending on the application.
Regarding claim 25, the proposed combination of Brown and Hutchens teaches the claimed invention except for specifically stating the claimed dimensions. However, it would have been obvious to one having ordinary skill in the art at the time of the invention to arrive at the claimed diameter, numerical aperture and divergence output half angle, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 27, Brown discloses the laser surgery optical fiber is adapted for use in laser lithotripsy procedures in the abstract.
Regarding claims 28 and 29, the proposed combination of Brown and Hutchens teaches the claimed invention except for specifically stating a distal end of the standoff sleeve is expanded or swaged down. However, as Brown discloses tip of the fiber having various shapes such as being inwardly tapered or outwardly tapered in order to control the laser pulse output and power density in paragraphs 0043, one having ordinary skill in the art at the time of the invention would have found it obvious to taper the distal end of the standoff sleeve to further control the output power density of the laser pulse.
Claims 3, 8, 9, 11-13 are rejected under 35 U.S.C. 103(a) as being unpatentable over Brown et al. (US 2019/0321104 A1) in view of Hutchens et al. (“Hollow steel tips for reducing distal fiber burn-back…” from Applicant’s Information Disclosure Statement) and further in view of Farr et al. (6,572,609).
Regarding claims 3, 8, 11 and 12, Brown further discloses the standoff sleeve is a silica glass sleeve in paragraph 0043. The proposed combination of Brown and Hutchens teaches the claimed invention except for a reinforcing filler material. Farr discloses a standoff sleeve arrangement (Fig. 4) comprising a tapered conical reflector (31) and reinforcing filler material present in a space between a standoff sleeve and the tapered conical reflector, wherein the filler material has a high index of refraction in column 10, lines 1-7. Since all of the inventions relate to optical devices, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to use a high index of refraction filler material as disclosed by Farr in the device of the proposed combination of Brown and Hutchens for the purpose of filling in the gaps around the tapered optical portion to form a compact and robust structure while preventing energy from propagating back through the fiber. Further, in the proposed combination one having ordinary skill in the art would find it obvious to use a filler material having an index of refraction that is matched to or higher than an index of refraction of a cladding of the fiber to absorb, transmit, or scatter energy present in the cladding and prevent the energy from propagating back through the fiber since Farr discloses the reinforcing filler material having a high index of refraction and it is known that the cladding has a lower index of refraction. Furthermore, one having ordinary skill in the art would find it obvious to also have the standoff sleeve with a similar index of refraction that is matched to or higher than an index of refraction of a cladding for the same reason of preventing energy from propagating back through the fiber.
Regarding claims 9 and 13, the proposed combination of Brown, Hutchens and Farr teaches the claimed invention except for specifically stating a silica tube. However, it would have been obvious to one having ordinary skill in the art at the time of the invention to form the reinforcing filler material from a silica tube, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Response to Arguments
Applicant's arguments, filed July 7, 2025, with respect to claims have been considered but are moot in view of the new grounds of rejection.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRIS H CHU whose telephone number is (571)272-8655. The examiner can normally be reached on Mon-Fri 9AM-5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Uyen-Chau Le can be reached on 571-272-239797. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Any inquiry of a general or clerical nature should be directed to the Technology Center 2800 receptionist at telephone number (571) 272-1562.
Chris H. Chu
/CHRIS H CHU/Primary Examiner, Art Unit 2874 March 13, 2026