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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/10/2026 has been entered.
Response to Arguments
Applicant’s arguments, see page 7, filed 07/10/2026, with respect to specification objections have been fully considered and are persuasive. The objection to the specification has been obviated by an amendment to the specification. The specification objections have been withdrawn.
Applicant’s arguments, see page 7, filed 07/10/2026, with respect to claim objections have been fully considered and are persuasive. The claim objections have been obviated by amendments to the claims. The claim objections have been withdrawn.
Applicant’s arguments, see page 7, filed 07/10/2026, with respect to 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections have been obviated by an amendment to the claim. The 35 U.S.C. 112(b) rejections have been withdrawn.
Applicant’s arguments, see pages 7-9, filed 07/10/2026, with respect to 35 U.S.C. 103 rejections have been fully considered but they are not persuasive. The Applicant argues that the 35 U.S.C. 103 rejection of claims 11-13 and 15 over Zerfas, in view of Bruce, is unwarranted. The Applicant argues that the lens formed by the method of claim 11 overcomes problem of breakage at the relatively weak juncture between the narrow fiber and the larger spherical lens by elongating the proximal end of the lens into a conical shape, providing a uniform change in diameter between the fiber and the lens all the way up to the maximum diameter of the lens. The Applicant argues that neither Zerfas, nor Bruce disclose such a uniform conical shape for the working end of the fiber. The Applicant argues that both Zerfas and Bruce disclose distal lenses that include a "neck" or "transition" region between the fiber and the lens, with the lens being substantially spherical-shaped up to the neck. The Applicant further argues that while Bruce may describe this transition as "smoothly flaring" or as "smoothly connecting" the lens to the fiber, that does not require a conical shape to that transition. The Applicant further argues that all of the figures relating to the transition show a connection that is curved, e.g., like the flare of a horn on a musical instrument, not conical (i.e., with substantially straight sides) as in the present claims - such a curved transition is still "smoothly flaring".
This is not found persuasive. The Examiner maintains that Zerfas teaches the elongated conical-shaped region at the proximal end of the lens, under broadest reasonable interpretation. The term “conical-shaped” is interpreted broadly and does not require the region at the proximal end of the lens to be a perfect geometric cone with a perfectly uniform/constant diameter change (e.g., straight sides), as Applicant appears to argue. Instead, the term “conical-shaped” is interpreted more broadly to mean “substantially” or “generally” conical, which the Examiner maintains that Zerfas discloses. Claim 11 further includes the limitation that “the elongated conical-shaped region having a diameter that decreases in a proximal direction from the maximum lens diameter to a diameter of the laser fiber”. The Examiner maintains that Zerfas also discloses this limitation, as is shown in the 35 U.S.C. 103 rejections below and for example in Zerfas’ annotated Fig. 7 below. It is emphasized that Zerfas was relied upon to teach these particular limitations, and not Bruce. Therefore, Applicant’s arguments regarding what Bruce teaches in reference to these particular limitations is currently irrelevant. Please see 35 U.S.C. 103 rejections hereinbelow.
The Applicant further argues that regarding claim 15, neither Zerfas, nor Bruce, nor the combination thereof discloses blending of the cladding and the core in the working distal end of the fiber. The Applicant argues that Zerfas teaches melting of the cladding and the fiber, but does not teach or suggest that the core and the fiber are blended, as it is possible that these materials can melt, but not blend together. The Applicant argues that in addition, Bruce explicitly teaches removing the cladding before heating to form the lens (see Bruce, page 58, lines 29-32).
This is not found persuasive. The Examiner maintains that Zerfas continues to disclose the indicated limitation of claim 15, that is wherein the heating of the exposed distal end of the fiber causes the core and the cladding to melt and bulge which blends the core and cladding circumferentially over the distal end of the lens. Zerfas teaches (Fig. 7) “the optical component 758 (i.e., lens) of a substantially spherical shape may be formed at the distal end of the cleaved optical fiber 700 by melting the cladding layer 784 and the fiber core 786 at a distal portion of the optical fiber 700. The optical component 758 may be formed by melting a portion of the optical fiber 700 and allowing surface tension to pull the molten material into a substantially spherical shape” (Col. 16, lines 29-51). Dictionary.com defines blend as “to mix smoothly and inseparably together” (see attached). In view of Fig. 7, the optical component 758 (which is formed by melting the cladding layer 784 and fiber core 786) does not distinguishably show the cladding layer 784 and fiber core 786. Instead, optical component 758 simply shows a first coating 762 and a second coating 764 on the optical component 758 (Col. 16, lines 52-54). The Examiner maintains that these teachings imply that the cladding layer 784 and fiber core 786 are mixed/blended/combined together in an inseparable manner after they are together melted to form the optical component. If the cladding layer 784 and the fiber core 786 weren’t blended together, then Fig. 7 of Zerfas would not cease showing the cladding layer 784 or fiber core 786 in the optical component 758. Therefore, the 35 U.S.C. 103 rejection of claim 15 is maintained. It is emphasized that Zerfas was relied upon to teach these particular limitations, and not Bruce. Therefore, Applicant’s arguments regarding what Bruce teaches in reference to these particular limitations is currently irrelevant. In regards to the 35 U.S.C. 103 rejections of the remaining claims (e.g., claims 14 and 16), the Examiner notes these rejections are also maintained as the rejections of the claims from which they depend are also maintained. Please see 35 U.S.C. 103 rejections below.
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.
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.
Claims 11-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Zerfas, et al. (U.S. Patent No. 10,492,864) in view of Bruce, et al. (WO 91/02562).
Regarding claim 11, Zerfas teaches (Fig. 3) a method of making navigable surgical fibers (Col. 2, lines 21-29; Col. 5, line 54-Col. 6, line 3; Col. 11, lines 47-55 – method for producing a distal end portion of an optical fiber), comprising:
(Fig. 2A, # 200 – optical fiber, i.e. laser fiber, 210 – distal end portion, 252 – cladding layer, 254 – fiber core, 272 – jacket layer, i.e. coating layer) providing a laser fiber having a length, a diameter, a distal end, a core, a cladding surrounding the core, and at least one coating layer surrounding the cladding along the length of the laser fiber (Col. 8, lines 37-63);
(Fig. 3, # 300 and 310) removing the at least one coating layer from the distal end of the laser fiber in order to expose the cladding and the core of the laser fiber at the distal end thereof, thereby forming an exposed distal end that is free from the at least one coating layer (Col. 11, lines 47-62 – the optical fiber can include a fiber core and one or more cladding layers disposed around the fiber core. At least one layer (e.g., a jacket layer) (i.e., coating layer) is removed from a distal end portion of the optical fiber so that a portion (e.g., a cladding layer) of the distal end portion of the optical fiber is exposed. The coating can also be cleaved (i.e., the core will be exposed as well));
(Fig. 2A, # 28 and 210; Fig. 3, # 320) heating the exposed distal end of the laser fiber (Col. 2, lines 25-29; Col. 8, lines 20-36 – the distal end portion 210 is heated using a heating source 28; Col. 11, lines 63-66 – the exposed portion of the distal end portion of the optical fiber is placed in a heating zone associated with a heating source);
(Fig. 3, # 330; Fig. 6, # 658 – optical component with substantially spherical shape, i.e., bulbous shape; Fig. 7, # 758 – optical component with a substantially spherical shape, i.e., bulbous shape; Fig. 8, # 858 – optical component with a substantially spherical shape, i.e., bulbous shape; Please see Annotated Fig. 7 below) forming the heated distal end of the laser fiber into a lens having a bulbous-shaped region at a distal end of the lens adjacent to an elongated conical-shaped region at a proximal end of the lens; the bulbous-shaped region having a diameter that decreases in a distal direction from a maximum lens diameter that is greater than the diameter of the laser fiber; the elongated conical-shaped-region having a diameter that decreases in a proximal direction from the maximum lens diameter to a diameter equal to the diameter of the laser fiber (Col. 11, line 66 – Col. 12, line 2 – The exposed portion of the distal end portion of the optical fiber is heated based on a heating cycle so that at least a portion of a substantially spherical shape is formed; Col. 15, lines 36-46; Col. 16, lines 40-43; Col. 17, lines 32-38);
cooling the lens (Col. 10, lines 60-65 – a method for producing the substantially spherical shape at the distal end portion of the optical fiber can include a cooling cycle to plastically set the distal end portion of the optical fiber after the first heating cycle);
(Fig. 7, # 762 and 764; Fig. 8, #862, 864, 866) applying a symmetrical coating of a light absorbing material to an apex of the lens (Col. 16, lines 47-63 – one or more coatings may be applied on the exposed portion 710. One of the coating materials may be EFIRON polymer. It is noted that polymers are known to be able to absorb light.; Col. 17, lines 56-60 – Although the distal tip portion 866 may be formed in any manner, in some embodiments, after the first coating 862 and second coating 864 are formed, a laser may be fired through the optical fiber 800 to burn off the coatings at the distal tip portion 866. – It is noted that this action of burning off the coatings at distal tip portion 866 is representative of the coatings (762/764/862/864) being light absorbing materials. These coatings would not burn if they weren’t light absorbing materials.);
(Fig. 7, # 762 and 764) circumferentially coating the lens, the cladding, and a portion of the at least one coating layer adjacent to the exposed distal end of the fiber with a curable material (Col. 16, line 52 – Col. 17, line 11; Col. 17, lines 12-31 – curing the coated optical fiber);
(Fig. 7, # 762 and 764 – the curable material of the coating layers does form a substantially cylindrical surface extending from the at least one coating layer to the minor axis of the lens) forming the curable material into a substantially cylindrical surface extending from the at least one coating layer adjacent to the exposed distal end to the maximum lens diameter (Col. 16, line 52 – Col. 17, line 31);
curing the curable material (Col. 17, lines 12-31); and
(Fig. 8, # 866 – distal tip portion, i.e. representative of aperture) transmitting laser energy through the laser fiber to ablate the light absorbing material and a section of the curable material covering the light absorbing material at the apex of the lens to create an aperture (Col. 17, lines 32-60 – Although the distal tip portion 866 may be formed in any manner, in some embodiments, after the first coating 862 and second coating 864 are formed, a laser may be fired through the optical fiber 800 to burn off the coatings at the distal tip portion 866).
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Annotated Fig. 7
Zerfas does not explicitly teach the limitation of instant claim 11, that is wherein the distal end of the laser fiber is kept oriented vertically while heating the exposed distal end of the laser fiber. It is noted that Zerfas does teaches (Figs. 2A-2E) that the distal end portion 210 is heated using a heating source 28 until the distal end portion 210 softens (e.g., flows) and the substantially spherical shape is formed (Col. 8, lines 20-36). It is noted that Zerfas appears to teach the laser fiber being oriented horizontally according to Figs. 2A-2E. However, it is also noted that Zerfas teaches that while a process described with reference to FIGS. 2A-2E may be used to form the optical component 758, a different process may also be used to form the optical component 758 (Fig. 7; Col. 16, lines 29-51).
Bruce is directed to analogous art and teaches an integral end structure for a medical laser waveguide (Title, Abstract). Bruce explains that this invention relates to optical waveguides for medical use to transmit laser energy from a medical laser to tissue to be treated according to a medical procedure (Page 1, lines 7-15). Bruce also teaches the limitation of instant claim 11, that is wherein (Figs. 4A-4G) the distal end of the laser fiber is kept oriented vertically while heating the exposed distal end of the laser fiber (Page 22, line 30 – Page 23, line 14 – the end of an optical fiber is oriented in a generally vertical direction and rotated about the longitudinal axis thereof. A first portion of the length of the fiber adjacent to the end thereof is heated, thereby rendering it molten. The heated portion of the fiber core is permitted to assume a bulbous shape having smoothly flaring sides and a diameter that is greater than the diameter of the fiber. The bulbous shape is then cooled.; Page 52, lines 12-34)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Bruce’s method step of orienting the laser fiber oriented vertically while heating the exposed distal end into Zerfas’ method of making navigable surgical fibers because doing so permits the heated distal end to assume a bulbous shape having smoothly flaring sides and a maximum diameter taken normal to the longitudinal axis of the fiber core that is greater than the diameter of the fiber core itself (see Page 25, line 22-Page 26, line 5 of Bruce). One of ordinary skill in the art would have also been motivated to implement Bruce’s method step because Zerfas’ explains that different processes can be used to form the optical component (see Fig. 7, # 758 and Col. 16, lines 29-51 of Zerfas)
Therefore, claim 11 is unpatentable over Zerfas, et al. and Bruce, et al.
Regarding claim 12, Zerfas teaches (Fig. 8, # 800 – optical fiber, i.e. navigable surgical fiber) a navigable surgical fiber (Col. 17, lines 32-60). Zerfas, in view of Bruce, renders obvious the method of claim 11, as indicated hereinabove (please see rejection of claim 11 hereinabove).
Therefore, claim 12 is unpatentable over Zerfas, et al. and Bruce, et al.
Regarding claim 13, Zerfas, in view of Bruce, renders obvious the method of claim 11, as indicated hereinabove. Zerfas also teaches the limitation of instant claim 13, that is wherein the heating the exposed distal end of the laser fiber is performed using an arc plasma or laser finishing system (Col. 8, lines 20-36 – the heating source can be an electric arcing source, which is representative of an arc plasma system).
Therefore, claim 13 is unpatentable over Zerfas, et al. and Bruce, et al.
Regarding claim 15, Zerfas, in view of Bruce, renders obvious the method of claim 11, as indicated hereinabove. Zerfas also teaches the limitation of instant claim 15, that is wherein (Fig. 7) the heating of the exposed distal end of the fiber causes the core and the cladding to melt and bulge which blends the core and cladding circumferentially over the distal end of the lens (Col. 16, lines 29-51 – The optical component 758 (i.e., lens) of a substantially spherical shape may be formed at the distal end of the cleaved optical fiber 700 by melting the cladding layer 784 and the fiber core 786 at a distal portion of the optical fiber 700. The optical component 758 may be formed by melting a portion of the optical fiber 700 and allowing surface tension to pull the molten material into a substantially spherical shape).
Therefore, claim 15 is unpatentable over Zerfas, et al. and Bruce, et al.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Zerfas, et al. (U.S. Patent No. 10,492,864 – cited on IDS) and Bruce, et al. (WO 91/02562), further in view of Krishnamurthy, et al. (U.S. PGPub No. 2004/0176759).
Regarding claim 14, Zerfas, in view of Bruce, renders obvious the method of claim 11, as indicated hereinabove. Zerfas does not explicitly teach the limitation of instant claim 14, that is wherein a radiopaque marker is applied to a distal end of the at least one coating layer adjacent to the exposed distal end of the laser fiber before the circumferentially coating with the curable material.
Krishnamurthy teaches a radiopaque electrical needle (Title, Abstract). Krishnamurthy teaches wherein (Fig. 3, # 300) a radiopaque marker is applied to a distal end of the at least one coating layer adjacent to the exposed distal end of the laser fiber before the circumferentially coating with the curable material (Par. [0013] – the coating may cover the radiopaque marker; Par. [0024] – a radiopaque band 300 is located at the edge 204 of the coating).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented the radiopaque marker teaching of Krishnamurthy into Zerfas’ method because doing so would be an example of using a known technique to improve similar devices in the same way. One of ordinary skill in the art would have desired implementing the coating over the radiopaque marker in order to maintain the navigable surgical fiber’s true profile (see Par. [0013] of Krishnamurthy). One of ordinary skill in the art would have also desired applying a radiopaque marker to a distal end of the at least one coating layer in order to provide a clear demarcation between the coated and exposed regions of the device (see Par. [0024] of Krishnamurthy) and to be able to facilitate precise placement during fluoroscopy procedures (see Par. [0011] of Krishnamurthy). One of ordinary skill in the art would find such a feature to be desirable for Zerfas’ device which is used in ureteroscopy procedures because it would be beneficial to confirm location of the surgical fiber to ensure effective treatment (see Col. 1, lines 16-47 of Zerfas).
Therefore, claim 14 is unpatentable over Zerfas, et al., Bruce, et al., and Krishnamurthy, et al.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Zerfas, et al. (U.S. Patent No. 10,492,864 – cited on IDS) and Bruce, et al. (WO 91/02562), further in view of Marciante, et al. (U.S. PGPub No. 2004/0019266).
Regarding claim 16, Zerfas, in view of Bruce, renders obvious the method of claim 11, as indicated hereinabove. Zerfas does not explicitly teach the limitation of instant claim 16, that is wherein more than one radiopaque markers are applied to the at least one coating layer adjacent to the exposed distal end of the laser fiber.
Marciante teaches an apparatus and method for radiopaque coating for an ultrasonic medical device (Title, Abstract). Marciante teaches wherein (Fig. 2, # 3 and 7) more than one radiopaque markers are applied to the at least one coating layer adjacent to the exposed distal end of the laser fiber (Par. [0054] – elongated probe 1 with a radiopaque coating at a plurality of predetermined locations 3, 7).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented the radiopaque markers of Marciante’s medical device to the at least one coating layer of Zerfas because doing so would be an example of using a known technique to improve similar devices in the same way. One of ordinary skill in the art would have desired implementing radiopaque markers because of its benefit of allowing the medical device to absorb radiation and therefore increase visibility during a procedure such as fluoroscopy (see Par. [0054] of Marciante). One of ordinary skill in the art would find such a feature to be desirable for Zerfas’ device which is used in ureteroscopy procedures because it would be beneficial to confirm location of the surgical fiber to ensure effective treatment (see Col. 1, lines 16-47 of Zerfas).
Therefore, claim 16 is unpatentable over Zerfas, et al., Bruce, et al., and Marciante, et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
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