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 Group 1 (claims 1-6, 10 and 16-19) in the reply filed on 4/20/2026 is acknowledged. Claims 7-9, 11-15 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claims 1-6, 10 and 16-19 are objected to because of the following informalities: applicant is reminded to keep claim terms consistent throughout the entire claim set. While it is clear in the claims that the limitations “at least two optical fibers”, “the optical fibers”, “each optical fiber” and “the optical fibers of the sheath” all refer to the same fibers, it would be even clearer if applicant could use a single/consistent phrasing to refer to these fibers. It is also noted that the word “the” should precede “at least two optical fibers” in lines 7-8. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 10 and 16-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
[Claim 1] The limitation “a laser-beam control unit configured to control the system of laser sources so as to select the wavelength, the light power, the duration of the deposition of laser energy and the moment of emission of each of the laser beams guided and emitted by the optical fibers in the direction of the target region so as to dynamically generate and adjust a 3D thermal distribution having a geometric shape matching the geometric shape of the target region” is not properly described in the specification. This limitation is computer-implemented functional language, however the specification never discusses HOW this result/effect, i.e. bolded claim language, is achieved. Specifically, how does the control unit select the claimed parameters to “dynamically generate and adjust a 3D thermal distribution having a geometric shape matching the geometric shape of the target region”? While these same words are repeated in the specification, the specification is completely silent to the particular steps or algorithm that provides the claimed result/effect. Therefore, this claim language fails the written description requirement.
MPEP 2161.01 states “original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.”
MPEP 2163.03 states “The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. ‘Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.’ Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002)”
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.
Claims 1-6, 10 and 16-19 are 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 1] The limitation “a laser-beam control unit configured to control the system of laser sources so as to select the wavelength, the light power, the duration of the deposition of laser energy and the moment of emission of each of the laser beams guided and emitted by the optical fibers in the direction of the target region so as to dynamically generate and adjust a 3D thermal distribution having a geometric shape matching the geometric shape of the target region” is indefinite, as it is unclear what is structurally required, specifically in terms of the bolded limitation. Stated differently, it’s unclear what (if anything) the bolded limitation adds to the scope of the claim, specifically in terms of a structural configuration of the controller. Is the claimed result (in bold) merely an inherent result of a controller that is able/configured to control/select the claimed parameters or is an additional configuration/functionality of the controller required in order to achieve the claimed result? For examination purposes, any prior art that teaches a controller that is configured/able to control the claimed parameters is inherently/implicitly capable of achieving the claimed result.
MPEP 2173.05(g) states… the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear.
MPEP 2114 states… "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.
Claim Interpretation
For clarity, it is emphasized that the claimed heat treatment is merely functional language, i.e. intended use. In terms of the preamble, MPEP 2111.02 states “if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In terms of the limitation “each of the optical fibers being suitable for guiding a heat-treatment laser beam to the target region”, it is emphasized that the claims only require an optical fiber capable/suitable for guiding a heat-treatment laser beam, i.e. infrared light. It is emphasized that the claims fail to recite a laser source that emits infrared light (which is responsible for/provides the heat treatment). In terms of the limitation “thermal distribution”, the examiner contends that as long as the prior art is capable of emitting infrared laser beams, then the resulting pattern/distribution of light is inherently a thermal distribution, as it is inherent/implicit that infrared light produces heat, i.e. a thermal effect.
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 1-6, 10 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0100839 to Efremkin in view of US 2021/0038062 to Talbot et al.
[Claim 1] Efremkin discloses a laser device with multi-emitters of laser energy (laser catheter 300; Figs. 1 and 6-9), for heat-treating a target region of a biological tissue (intended use in the preamble; MPEP 2111.02. At the very least Efremkin is capable of such a treatment, specifically when infrared laser light is emitted), the laser device comprising:
- at least one sheath (“The laser catheter 10 is formed with an outer jacket or sleeve having the ability to resist user-applied forces such as torque, tension, and compression” Par 0034) having a longitudinal axis (central passageway 16; Fig. 1) and comprising a proximal end (14) and a distal end (16) intended to be placed facing the target region (334; Figs. 6 and 8);
- at least two optical fibers (20, Fig. 1 and/or 322, Figs. 6 and 8) extending, in the sheath, between the proximal end and the distal end (Par 0034), each of the optical fibers being suitable for guiding a heat-treatment laser beam to the target region and depositing laser energy in the target region, the distal ends of at least two optical fibers being configured so that each emits a laser beam in a different emission direction with respect to the longitudinal axis of the sheath (Figs. 6A-B and 8A-B show light being directed at different directions/angles; at least Par 0089);
- a laser source (115; Fig. 3) configured to generate at least two laser beams (each pulse can be considered a separate laser beam or each beam emitted from a single fiber can be considered a separate laser beam), the at least two laser beams having different or identical wavelengths with an adjustable light power (“Laser power source may also be able to generate different wavelength or pulse duration irradiation optimized for the most optimal effect on the targeted tissue” Par 0043; see also Pars 0037-40); and
- a laser-beam control unit (112; Pars 0037-40) configured to control the system of laser sources so as to select the wavelength (“wavelength” Par 0038), the light power (“optimum output level” Par 0038; “laser power characteristics” Par 0039)), the duration of the deposition of laser energy (“pulse duration” Par 0038) and the moment of emission of each of the laser beams guided (by determining the pulse duration and repetition rate of the pulses, the moment of emission is inherently/implicitly selected) and emitted by the optical fibers in the direction of the target region so as to dynamically generate and adjust a 3D thermal distribution (“the energy is laser energy with a wavelength that is highly absorbable in a water content medium” Par 0026; See further discussion below) having a geometric shape matching the geometric shape of the target region (“As illustrated in FIGS. 6A and 6B laser rays effectively and optimally cover the entire targeted area of the occlusion 334” Par 0089. It’s clear that the “entire targeted area” is a 3D shape, having a length, width and depth. This is also considered an inherent/implicit effect of the controller being configured to select the various parameters and the optical fibers emitting light at different directions.)
Regarding the “thermal distribution”, Efremkin is silent to the specific wavelengths used, but does teach that it should be “highly absorbable in water content medium”. As evidenced by the water absorption spectrum shown in Fig. 2A and Table 1 of Talbot, it’s clear that infrared wavelengths, e.g. 1900-3000 nm, are highly absorbable in water (Pars 0065-67 of Talbot). Therefore, the examiner takes the position that either Efremkin is inherently capable of generating/adjusting a 3D thermal distribution, i.e. three-dimensional pattern/distribution of infrared light, or it would be obvious to modify Efremkin to specifically choose/try infrared light, as it is known to be highly absorbable in water content medium, as taught by Talbot. It is emphasized that a 3D distribution of light is explicitly taught by Efremkin, and when infrared light is used/emitted, this 3D distribution becomes a 3D thermal distribution.
Regarding the “a system of laser sources configured to generate at least two laser beams”, Efremkin discloses a single laser that generates different wavelengths, but fails to teach a system of laser sources (plural). However, the concept of using a single laser source that emits different wavelengths or two laser sources that each emit a single/different wavelength is known in the art. Specifically, Talbot (Fig. 1) teaches this common concept of using a first laser source (106) connected to first optical fiber (108) and a second laser source (108) connected to a second optical fiber (118), where each source and wavelength emitted therefrom is chosen to provide a desired result in tissue; See Pars 0068-69 of Talbot. Therefore, it would have been obvious to one of ordinary skill in the art to modify Efremkin to substitute the single laser for a system of laser sources, as taught by Talbot, as this is a simple substitution of one laser for a plurality of laser sources that achieves the same result, i.e. providing different wavelengths to multiple optical fibers. This is also considered a mere duplication of parts; MPEP 2144.04.
[Claims 2-3 and 16] As seen in Figs. 6A-B and 8A-B, the distal end of at least two optical fibers (322) is positioned at a different distance from a surface of the distal end of the sheath (shown as a solid covering over the fibers) and they are configured to emit a laser beam in an emission direction oriented at an angle a between 0° and 180° with respect to the longitudinal axis of the sheath (see arrows extending from the distal end of fibers 322 that represent the light beams which are shown at different angles from about 0° and 45°)
[Claims 4 and 17] The laser sources taught by Efremkin, specifically solid state lasers, diode lasers, gas lasers and semiconductor lasers (Par 0026), i.e. all of the lasers except the broad band light source, are considered monochromatic laser sources as they only emit a single color/wavelength. Similarly, the laser sources taught by Talbot (Par 0067 and Table 1) are interpreted as monochromatic laser sources.
[Claims 5 and 18] As discussed above, both Efremkin and Talbot disclose using different wavelengths and Talbot explicitly teaches using a different wavelength for each optical fiber (“the second output 120 may extend over a second wavelength range, distinct from the first wavelength range” Par 0069; Fig. 1).
[Claims 6, 10 and 19] Efremkin discloses “Fiber couplers are commonly special optical fiber devices with one or more input fibers for distributing optical signals into two or more output fibers” (Par 0031). The input fibers are the claimed transmission fibers and the output fibers are the claimed at least two optical fibers located within sheath, where the coupler (22) connects the transmission fibers (from the source) to the optical fibers in the sheath (Pars 0034, 0079 and 0084). Similarly, Talbot discloses a fiber optic coupler/connector that connects transmission fibers (from each laser source; 1710A-N; Fig. 17) to the optical fibers in the sheath (delivery system 1701); See Par 0124. See also Figs. 22-23 and Pars 0156-159 of Talbot which discloses optical connectors that are used to connect optical fibers from a laser source to optical fibers located within a multi-fiber probe (2310/2312)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Laser devices with multi-emitters of laser energy that guide light in different directions are known in the art:
US 2019/0142544 to Horn et al (Figs. 5, 6, 8 and 10)
US 2011/0295347 to Wells et al. (Figs. 2C-H)
US 4,648,892 to Kittrell et al. (Fig. 4)
Transmission optical fibers that guide light from individual laser sources and optical fiber connectors/couplers that connect these transmission fibers to individual delivery optical fibers (within a catheter/sheath/probe, i.e. intended to be inserted into a body of a patient) are known in the art:
US 2013/0123648 to Stampoulidis (Figs. 5, 7 and 8)
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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