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
Election/Restrictions
Applicant's election with traverse of Invention I in the reply filed on April 1, 2026 is acknowledged. The traversal is on the grounds that the assertion “that the method can be practiced with an apparatus lacking a collet chuck and lock nut” is “directed to dependent claim 6, not independent claim 1.” The applicant therefore states that “Restriction on this basis is therefore improper as between the broadest claims of each group.” This is not found persuasive because, regardless of this argument, “The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product” (see restriction requirement, page 2). “Additionally, the product may be used in different laser surgeries besides lithotripsy, where there is a desire for spacing the end of the laser fiber a specified distance from the target, including procedures that do not require invasive access (e.g., see US Patent 5,738,679 which includes spacing element 14 for providing skin treatment)” (see restriction requirement, page 2). Therefore, the restriction is justified on the grounds that “(2) the product as claimed can be used in a materially different process of using that product”.
The applicant also argues that there is no serious search burden for search and examination. The examiner respectfully disagrees and notes that the restriction requirement already illustrated how and why there is a search burden, and the applicant’s traversal does not identify any reasons why that rationale was in error.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on April 1, 2026.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 is objected to because line 2 should read “a collet chuck defining a collet chuck bore to receive the laser fiber through the collet chuck; and”.
Appropriate correction is required.
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 1-2, 11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Assaf et al. (US Patent Pub. No. 2014/0324034) in view of Zhang (US Paten Pub. No. 2016/0081749).
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Assaf discloses a universal accessory adapter (see Abstract). Below is a reproduction of Figure 2, and a rendition of Figure 3B in which a “waveguide tip 300” has been removed, leaving a side view of the “universal accessory adapter 200” which is illustrated three-dimensionally in Figure 2.
As can be seen in Figure 3B above, optical fiber 140 includes cladding 142 and core 144 is positioned through sheath 125 and may extend through universal accessory adapter 200 through working channel 128. Universal accessory adapter 200, which reads on the claimed “mounting assembly” is movably secured with the optical fiber via the sheath by way of a snap ring member 210 that engages grooves 127 (see paragraph 31, 1st sentence). “The universal accessory adapter 200 further includes an accessory fastener 220 that includes an opening 230 exposing the working channel 128” (see paragraph 31). In the full version of Figure 3B, the accessory fastener 220 is
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seen engaging with the proximal end of the waveguide tip 300. “FIG. 5 is a diagram illustrating a spatula 500 accessory coupled to the universal accessory adapter 200” (see paragraph 35). “Spatula tip 512 provides at least two functions. First, it functions as a physical limiter, preventing working channel 128 from coming any closer to the tissue under treatment than the length of spatula tip 512 will permit” (see paragraph 35). Therefore, spatula accessory 500 reads on the claim limitation of a guide and the requirements of the guide, as illustrated and annotated in the reproduction of Figure 5 shown above.
However, as mentioned above, the universal accessory adapter 200 and accessories therefore are configured for attachment to the sheath of Assaf, and not directly to the optical fiber.
Zhang teaches a surgical laser system and laser lithotripsy techniques (see Title). Zhang teaches a “fiber tip 114 [that] is attached to the laser fiber 112, as shown in FIGS. 2 and 5-7. In some embodiments, this involves attaching the fiber tip 114 to a core of the optical fiber 112, cladding of the optical fiber 112, and/or a jacket surrounding the cladding and core of the optical fiber 112, which are not shown in order to simplify the illustrations. In some embodiments, the fiber tip 114 is removably attached to the optical fiber 112” (see paragraph 26). “[T]he fiber tip 114 includes a spacer portion 142 that defines the distal terminating end 120 of the fiber tip 114… In some embodiments, the distal terminating end 120 of the spacer portion 142 is annular, as shown in FIG. 5. In other embodiments, the distally extending spacer portion 142 may comprise one or more projections” (see paragraph 30). Also see Figure 5.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide connection of a tip attachment (i.e., tip 114 of Zhang, and Universal accessory adapter 200 and accessories therefore from Assaf) to any one of a jacket/support/sheath of an optical fiber (as in Assaf and paragraph 26 of Zhang) or directly to the core or cladding of the optical fiber (as stated by paragraph 26 of Zhang) where the tip attachment provides spacing between the fiber end and the tissue (as taught in paragraph 30 of Zhang, and taught in paragraph 35 of Assaf), because the use of either point of connection amount to choosing from a finite number of attachment mechanisms available in the art at the time of the invention, which has previously been held as unpatentable (KSR v. Teleflex).
Regarding claim 2, it is noted that the prong 512 of spatula accessory has an inner wall that is curved, which therefore defines a pathway to provide visual access through the guide.
Regarding claim 11, while Assaf illustrates a single spatula extension, it is noted that Zhang teaches that “the distally extending spacer portion 142 may comprise one or more projections” (see paragraph 30). Without specifying an exact number, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that “one or more projections” would mean two, and more preferably three because less than three projections would not provide for balanced support in three dimensions, in much the same way that a tripod has three legs and without the third leg a tripod would fall over. In this same way, a tip of an optical fiber with two projections would more easily lose support and shift or slip during laser lithotripsy.
Regarding claim 19, Assaf teaches a mounting assembly (see reproduction of Figures 2 and 3B above in the rejection of claim 1), and a guide comprising: a body (see portion of Figure 5 reproduced above in the rejection of claim 1 that extends between 128
the distal end and the proximal end) configured to receive the mounting assembly at least partially therein to releasably secure the mounting assembly and the laser fiber to the guide(see full version of Figure 3B of Assaf illustrating that the mounting assembly 220 extends into the accessory which is connected thereto), the body defining a guide bore to receive the laser fiber therethrough when the mounting assembly is secured to the guide (see in Figure 3B how the optical fiber extends passed the universal accessory adapter 200 and into the waveguide tip accessory 300); and at least one prong extending distally from the body (see Figure 5 of Assaf, illustrating a prong; see the explanation of Figure 5 above in the rejection of claim 1), the at least one prong configured to at least partially surround the laser fiber when the laser fiber extends through the guide bore (note that the fiber may extend out of working channel 128 (see Figure 2), and will then be partially surrounded by prong/spatula 512; also see Figure 6 and 7 of Assaf were the prong/spatula is larger and surrounds the area more than in Figure 5).
Allowable Subject Matter
Claims 3-10 and 20 are 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.
Claim 3 is indicated as objected to but otherwise allowable because the prior art fails to teach the “at least one prong” as recited in claim 1 is “engageable with a distal portion of a working channel of an endoscope” and also specifically to provide the functionality of “to releasably secure the guide to the endoscope”. Additionally, claim 4 depends from claim 3 and is allowable for at least the same reasons.
Claim 5 is indicated as objected to but otherwise allowable because the prior art fails to teach barbs on a mounting assembly, as claimed, such that the barbs are for securing the mounting assembly to a column sheath of the laser fiber.
Claims 6 and 20 are indicated as objected to but otherwise allowable because the prior art fails to teach a mounting assembly, as claimed, that includes a collet chuck with a bore for receiving a laser [fiber], and a lock nut having a bore to receive a laser fiber such that the lock nut threads onto the collet chuck to secure the collet chuck to clamp on the laser fiber. Additionally, claims 7-10 each depend from claim 6 and are allowable for at least the same reasons.
The following prior art is herein made of record is considered pertinent to applicant's disclosure, but not relied upon in the rejections above:
Okada (US Patent No. 5,002,042) – see cover figure, see Figures 13-14
Anderson (US Patent No. 5,290,278) – see Figure 2A and 8
Eloy (WO 95/07368) – see ring 34 within figures
Lennox et al. (US Patent No. 5,454,807) – see Figure 5, standoff 70
JP 3285367 B2 – “To ensure the desired distance of the fiber tip from the tissue of interest, a holder or probe has been developed as shown in the accompanying drawings”
Temelkuran et al. (US Patent No. 7,167,622) – see standoff 144 in Figure 1
Schmid et al. (US Patent No. 7,284,987) – see Figures 3-4
Anastassiou et al. (WO 2014/043697) – see Figures 1B-1C illustrating a rotary coupler at a proximal end of an optical fiber (see Figure 1A), and a distal tip portion having a standoff (see Figure 2A).
St. George (US Patent Pub. No. 2014/0121673) – see Figures 2-3, illustrating multi-prong distal end in a lithotripsy system
Brown et al. (WO 2017/192869) – “A distal end of an optical fiber may be protected by a variety of alternative protective caps, tips, and/or sleeves. In one example, a generally cylindrical soft tip is arranged to fit over the end of the fiber” (see Abstract).
Khachaturov et al. (US Patent Pub. No. 2019/0298449) – see Figures 5A-5D
Brown et al. (US Patent Pub. No. 2019/0321104) – see Figures 1-5; “A method of reducing retro-repulsion of a stone during a laser lithotripsy procedure involves the use of a spacer tip or standoff sleeve to create a passage between the tip of a fiber and a stone” (see Abstract).
Brown et al. (US Patent Pub. No. 2020/0054397) – see Figures 2A-2C and 4.
Malphurs (US Patent Pub. No. 2020/0070427) – see Figure 1 and paragraph 23.
Brown et al. (US Patent Pub. No. 2020/0069371) – see Figure 1.
Wang et al. (CN 111544084 A) – see Figure 2.
Desroches et al. (US Patent Pub. No. 2020/0288943) – see Figures 1-6.
Barros et al. (US Patent Pub. No. 2020/0330186) – see Figures 3-4.
Brown et al. (US Patent Pub. No. 2021/0369347) – see numeral 8 in Figure 3.
Brown et al. (US Patent Pub. No. 2023/0101488) – see Figures 1-5.
Song (WO 2024/096426) – see Figures 2 and 4A-D.
Brown et al. (US Patent Pub. No. 2024/0164836) – see Figures 1-3 and 7.
Dong (C 118285725 A) – see Figure 1A, element 2.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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