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 .
Election/Restrictions
Applicant’s election without traverse of Species A (shaft 120; Fig. 1), specifically Species A1 (bundle 131, Fig. 1B) in the reply filed on 4/23/26 is acknowledged. Applicant states “The claims believed to encompass the elected species and sub-species are claims 1-9, 13-15, 18, and 21.” However, the examiner partially disagrees.
Regarding claim 10, which requires “the instrument of claim 8, wherein the optical fibers of the bundle are configured to direct light distally away from the distal end of the shaft.”, it’s clear from Fig. 1, specifically element 122/135 that the light is directed distally away from the distal end of the shaft. Therefore, claim 10 reads on the elected embodiment and is pending examination.
Regarding claim 15, which requires an “annular lumen”, it’s clear that the elected embodiment (Fig. 1B) shows three separate lumens (140), none of which are annular in shape. The only embodiment that shows this annular lumen is in Fig. 4A-C, where the annular lumen 440 is formed between the inner (420A) and outer shafts (420B). Therefore, claim 15 is withdrawn from consideration.
Regarding claim 18, which requires “a hollow outer shaft, wherein: the shaft is disposed within the outer shaft, the lumen is defined by annular space between the shaft and the outer shaft, the fluid port is attached to the outer shaft, and the outer shaft is longitudinally displaceable with respect to the shaft”, it’s clear that this claimed inner and outer shaft that are displaceable with respect to each other is only shown in Figs. 4A-C and 5A-B, which is an unelected embodiment. Therefore, claim 18 is withdrawn from consideration.
Therefore, claims 11, 12, 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected embodiment, there being no allowable generic or linking claim. Claims 1-10, 13, 14 and 21 are pending examination.
Claim Objections
Claims 11, 12, 15-20 are objected to because of the following informalities: The status identifier for these claims should be “withdrawn” (not “original” or “previously presented”). Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8, 10, 13 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5,470,330 to Goldenberg et al.
[Claim 1] Goldenberg discloses a medical instrument (Figs. 1, 4, 6-8, 17, 27-37), comprising:
an elongate flexible shaft (any of: protective flexible jacket 28, Fig. 1; catheter 80, Figs. 6-8; sheath 304, Fig. 27; catheter 118, Fig. 31; catheter 160, Fig. 33; catheter 174, Fig. 34; catheter 194, Fig. 36; catheter 316, Fig. 37) defining a length extending between a proximal end and a distal end;
a plurality of optical fibers (fibers 90, Fig. 7; small stranded optical fibers 240, Fig. 17; optical fibers 302, Fig. 27; fibers 120, Fig. 31; fibers 162, Fig. 33; fibers 180, Fig. 34; fibers 202, Fig. 36; fibers 322, Fig. 37) extending along the length, wherein one or more of the plurality of optical fibers is has a cross-sectional diameter within a range of 150 µm to 50 µm (“In the context of the present invention, the fiber can be a single fiber or a bundle of fibers having a total diameter in the range of 100-2,000 microns. A bundle of close-packed small-diameter fibers is preferred because they provide greater overall flexibility and thereby more easily accommodate the twists and tight turns that are required to feed the delivery system through body cavities” Col 7, line 54 to Col 8, line 6; “the fibers can be made as small as 50 microns in diameter” Col 8, lines 34-41; “The small optical fibers 240 are approximately 50 to 100 microns in diameter” Col 15, lines 1-10; “The optical fibers 120 may be 50-400 microns” Col 18, line 27; “The fibers 162 in the catheter preferably range from about 50 to 300 microns.” Col 19, lines 19-20; “The optical fibers 180 comprise a highly flexible array of fibers that may range in size from 50 to 400 microns in diameter” Col 19, lines 61-63 “a plurality of optical fibers that are approximately 50 microns in diameter.” Claim 11);
a fiber optic connector disposed at the proximal end (energy couplers shown/described in relations to Figs. 1-4; Col 8, line 42 to Col 11, line 10); and
a laser control module (excimer laser 2, Fig. 1; source 112, Fig. 4) comprising a laser light source (“high energy pulsed laser”, e.g. Excimer laser) operatively coupled with the plurality of optical fibers (the examiner contends that a laser control module is inherent/implicit to such laser sources, at the very least to turn them on/off. At least Col 10, lines 37-64 disclose control circuitry to adjust the pulse duration.)
[Claims 2-4] It’s clear from Figs. 31-37 that the device/catheter is configured for insertion into a patient body (blood vessel 114). While Goldenberg is technically silent to the device being inserted into an endoscope/ureteroscope, the examiner takes the position that the disclosed size/diameter of the device taught by Goldenberg makes it inherently capable of such a function; MPEP 2114. Specifically, based on the disclosed diameter of the overall fiber bundle (“a bundle of fibers having a total diameter in the range of 100-2,000 microns”) and catheter (“The outside diameter of the catheter is preferably between 1.0 mm to 2.0 mm”; Col 15, lines 9-10), the device taught by Goldenberg is capable of being inserted into an endoscope, and specifically a ureteroscope, as this is the same size/diameter disclosed as applicant for achieving this function.
[Claims 5 and 6] Throughout the reference Goldenberg teaches ablation of a lesion (e.g. 312, Fig. 30; 116, Fig. 31; 158, Fig. 33; 172, Fig. 34; 192, Fig. 36; 326, Fig. 37), as well as ablation of an obstruction or plaque (Background/Summary section) and specifically ablating calcified plaque (Col 8, lines 42-60). This calcified plaque is interpreted as a calculus. If applicant disagrees, the examiner contends that the laser parameters taught by Goldenberg (at least 50 mJ/mm2 and a duration in a range of 10-3000 nsec; claim 8) are at the very least capable of ablating a calculus, therefore making the device “configured for ablation of a calculus”; see MPEP 2114.
[Claims 7 and 8] See at least Figs. 17 and 27 which show fiber bundles having a fiber located centrally along a longitudinal axis of the bundle/catheter/shaft, i.e. center of the circle (e.g. central optical fiber 242; Fig. 17), and at least 3 laterally adjacent fibers (e.g. small optical fibers 240). Additionally, Figs. 7, 31 and 33-37 show at least 3 optical fibers laterally adjacent, i.e. next to, each other.
[Claim 10] As best illustrated in Figs. 30-37, the fibers of the bundle are configured to direct light distally away from the distal end of the shaft, i.e. to ablate the lesion located in front of the device, as shown in the figures.
[Claims 13 and 14] Figs. 7 (central lumen 82), Fig. 27 (lumen 306), and the guidewire lumens in Figs. 31, 33-37, specifically “guidewire and flushing lumen 178” in Fig. 34 d all teach/disclose a lumen extending along the length. Regarding Fig. 32, Goldenberg teaches “additional lumens may also be included at the center of the balloons 130 to accommodate other instruments to assist with illumination or flushing, for example” (Col 18, lines 45-55). It is inherent/implicit that any disclosed “flushing” or inflation of a balloon requires a fluid port coupled with the shaft, the fluid port in fluid communication with the lumen. Additionally or alternatively, Goldenberg teaches “the solution can be injected into the catheter through a suitable port 98 at the proximal end, and emerge through holes 100 in the side wall of the catheter at its distal end (see FIG. 8).”; Figs. 6-8.
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.
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Goldenberg.
While Goldenberg does not provide an explicit example where the diameter of the bundle has a diameter less than 1 millimeter, the reference provides examples of ranges that overlap and touch the claimed range. Specifically, Goldenberg teaches “a bundle of fibers having a total diameter in the range of 100-2,000 microns” (which is equivalent to 0.1 mm to 2mm). And in reference to Figs. 16-18 states “the outside diameter of the catheter is preferably between 1.0 mm to 2.0 mm”. Furthermore, as discussed above, Goldenberg teaches that the optical fiber diameter is 50 microns, with 3 such bundled fibers having a diameter of about 150 microns (or 0.15 mm). Therefore, it would have been obvious to one of ordinary skill in the art to try/choose a diameter for a fiber bundle of less than 1mm, as this is within the desired range of diameter values taught by Goldenberg. Furthermore, Goldenberg teaches “a bundle of close-packed small-diameter fibers is preferred because they provide greater overall flexibility and thereby more easily accommodate the twists and tight turns that are required to feed the delivery system through body cavities”. MPEP 2144.04 states… In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Goldenberg as applied to claim 1 above, and further in view of US 2003/0219202 to Loeb.
Goldenberg is discussed above, including disclosing a laser control module (source 112; Fig. 4) that is a component of a laser fiber system (102; Fig. 4), but fails to explicitly teach that the laser source is a laser diode. Specifically, the only type of laser source disclosed by Goldenberg is an Excimer laser. However, in the same field of endeavor, specifically a laser ablation device that treats plaque deposit in a blood vessel (Abstract of Loeb), Loeb discloses a variety of light sources that can be used including either an Excimer laser or a laser diode (Par 0036). Therefore, it would have been obvious to one of ordinary skill in the art to substitute the excimer laser taught by Goldenberg for the laser diode taught by Loeb as this is a simple substitution of one known laser source for another to ablate atherosclerotic plaque.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The concept of using closely packed, small diameter optical fiber bundles in laser surgical devices is known:
US 6,011,889 to Daneil et al. (Col 6, lines 5-20; Figs. 3 and 3A)
US 4,938,205 to Nudelman (Col 11, line 16 to Col 12, line 13)
US 4,718,406 to Bregman et al. (Col 2, lines 50-60 ;Fig. 2)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 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, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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