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 .
Response to Arguments
Regarding the 102 and 103 rejections, applicant’s arguments 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. The examiner has found new prior art references to teach the amended limitations; see new 103 rejection below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
[Claim 7] The limitation “one or more of the plurality of optical fibers are located centrally along a longitudinal axis of the shaft” is indefinite, as it is unclear if/how this serves to further limit the independent claim which already requires “the bundle disposed along a central axis of the shaft”. Specifically, it’s unclear/confusing if these two locations/positions (“located centrally along a longitudinal axis of the shaft” vs “disposed along a central axis of the shaft”) for the fibers/bundle are referring to different locations/configurations for the fibers/bundle or if they refer to the exact same positioning. Similarly, it’s unclear if the “one or more optical fibers” is referring to the bundle, as a whole, or a subset of the fibers within the bundle. For examination purposes, the examiner interprets the limitation in claim 7 as a bundle disposed along a central axis of the shaft, as shown in Fig. 1B (bundle 132).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitation “one or more of the plurality of optical fibers are located centrally along a longitudinal axis of the shaft” fails to further limit the independent claim which already recites “the bundle disposed along a central axis of the shaft”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-7, 9, 10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 4,519,390 to Horne in view of US 5,394,492 to Hwang.
[Claims 1 and 7] Horne discloses a medical instrument (Figs. 1-3), comprising:
an elongate flexible shaft defining a length extending between a proximal end and a distal end (length of catheter tubing 34);
a plurality of optical fibers (10; Figs. 2-3) extending along the length of the shaft to define a bundle of the plurality of optical fibers (“many other sizes, types and configurations of optical fibers”; Col 3, lines 60-63. The examiner interprets the bolded limitation to be a plurality of optical fibers, specifically a bundle; see further explanation below), the bundle disposed along a central axis of the shaft (best seen in Fig. 3);
a fluid port coupled with the shaft (port 26);
a plurality of lumens (plurality of slots 40; Fig. 3) extending along the length of the shaft between the fluid port and the distal end, the plurality of lumens disposed radially outward with respect to the bundle and in fluid communication with the fluid port, the plurality of lumens configured to provide cooling to the plurality of optical fibers (Col 5, line 36 to Col 6, line 4);
a fiber optic connector disposed at the proximal end (proximal male fitting member 16; Col 4, line 25 to Col 5, line 35); and
a laser control module comprising a laser light source operatively coupled with the plurality of optical fibers (“The present invention is directed to a novel laser catheter assembly incorporating a novel connector for coupling an optical fiber with a laser. Although, for purposes of clarity, the discussion herein will be directed to use of the catheter assembly with an argon laser, it is to be understood that the invention is readily adaptable for use with other lasers”; Col 3, lines 42-48. The examiner takes the position that any/all laser sources, e.g. argon laser sources, inherently include a laser control module, e.g. on/off switch, in order to operate/function/emit a laser beam).
The limitation “wherein three or more of the plurality of optical fibers are disposed laterally adjacent one another to define bundle” is not explicitly taught by Horne. As discussed above, the examiner interprets the “many other sizes, types and configurations of optical fibers” to be a plurality of fibers, i.e. at least two, but the reference is silent to three or more. The examiner considers this a mere duplication of parts and it would be obvious to include as many optical fibers as desired, including three or more; MPEP 2144.04. To further support this position, Hwang explicitly teaches commonly known/used fiber configurations in laser surgery applications, including bundles of optical fibers with any suitable number of optical fibers, specifically 7, 19, 31 or 37 fibers (bundle 24, Fig. 3; Col 5, lines 24-32). Therefore, it would have been obvious to one of ordinary skill in the art to substitute (or modify) the optical fiber of Horne for an optical fiber bundle (or to include additional fibers), as taught by Hwang, as this is a simple substation of one know type of optical fiber (single/plurality of fibers) for another known type of optical fiber (bundle having at least 3 fibers) to obtain predictable results OR has a mere duplication of parts, i.e. including/arranging additional fibers to the single/plural fiber taught by Horne in order to make a bundle of at least 3 fibers, as taught by Hwang, as this bundle is a commonly known and used arrangement/configuration of optical fibers in laser surgical applications. Furthermore, Horne explicitly teaches “of course, many other sizes, types and configurations of optical fibers may be used in connection with the apparatus of the invention without departing from the inventive concept disclosed and claimed herein” which gives a POSITA explicit motivation to look to modify the device with other configurations of optical fibers, including the optical fiber bundle taught by Hwang.
[Claims 2-4] Horne discloses “although in some surgical procedures the laser catheter is merely grasped by the fingers of the physician at a position near the distal end of the catheter and wielded much like a light pen, in many cases it is necessary to actually insert the catheter within a body cavity, usually in connection with an endoscope” (Col 2, lines 35-41). The examiner interprets this as an instrument that is configured for insertion into a patient body via a working channel of an endoscope, specifically a ureteroscope. It is emphasized that the claims do not require an endoscope (or ureteroscope), but only a device configured to be inserted into one. The examiner contends that the catheter of Horne teaches all of the necessary structure, i.e. size/shape, to be capable of such a function, specifically the elongate flexible shaft (tubing 36) having an outside diameter of 0.095 inches (Col 5, lines 59-65) is inherently capable of being inserted in any/all endoscopes, including a ureteroscope (if this is the desired/intended application). This position is further bolstered by the fact that Horne explicitly teaches inserting a catheter with an endoscope. See MPEP 2114.
[Claims 5-6] The reference discloses the user of argon, Nd:YAG and CO2 lasers (Col 1, lines 12-47 and Col 3, lines 42-48), all of which are capable of ablating body tissue or a calculus. The reference further mentions vaporization of tissue, which is interpreted as ablation (“The primary effect of laser light on biological tissues is thermal energy caused by absorption. Laser beams from different types of lasers are typically absorbed by different tissues in the body. Depending upon the amount of energy in the laser beam, this thermal energy can act to vaporize the tissue, or merely to coagulate it”). See MPEP 2114.
[Claim 9] Hwang discloses that a fiber bundle with 31 optical fibers has a diameter of 1.510 mm (Col 5, line 64 to Col 6, line 18). Therefore, an optical fiber bundle with only 3 (or even 7 optical fibers) inherently have a diameter of less than 1 mm. Specifically, a 7-fiber bundle consists of 1 central fiber surrounded by 1 complete inner ring of 6 fibers (total of 2 layers across: center + 1 ring), spanning about 3 fiber diameters across, while a 31-fiber bundle consists of 1 central fiber surrounded by concentric rings (1 + 6 + 12 + 12 or similar hexagonal shells, totaling 4 layers deep), spanning about 7 fiber diameters across. Therefore, the diameter of a 7-fiber is bundle is more than half of the diameter of a 31-fiber bundle.
[Claim 10] As shown/understood in both Horne and Hwang, the fibers are front-facing, i.e. forward-firing, optical fibers that direct light distally away from the distal end of the shaft.
[Claim 21] Horne explicitly teaches “it is to be understood that the invention is readily adaptable for use with other lasers”, but fails to teach a laser diode. Hwang, in the same field of endeavor, makes it clear that laser diodes are known laser sources used for high-power laser surgical applications, e.g. vaporization of tissue. Therefore, it would have been obvious to substitute the laser source taught by Horne for the laser diode taught by Hwang, as a simple substitution of one know laser for another to obtain predictable results. The examiner contends that both of the systems taught by Horne and Hwang are fiber laser systems, as they both transmit a laser beam through a fiber, and therefore the laser control module is a component of such a fiber laser system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2003/0199860 to Loeb et al discloses a central optical fiber (1) with a plurality of fluid lumens (22 and 23) surrounding the central fiber for cooling the fiber (Figs. 4a-b; Par 0066).
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 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
