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 Embodiment C (Guide Sleeve 1257; Figs 12A-D) in the reply filed on 6/8/2026 is acknowledged. Claims 7, 8, 17 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 1-6, 9-16, 19 and 20 are pending examination.
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.
Claims 1-6, 9-16, 19 and 20 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.
[Claims 1, 10 and 20] The independent claims all recite the same preamble: “An energy director for a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve within a body of a patient, the catheter system including (i) an energy source that generates energy, (ii) a balloon having a balloon distal region that has a varying diameter, and a balloon proximal region having a substantially constant diameter, and (iii) an energy guide including a guide distal end, the energy guide being configured to receive the energy from the energy source, the energy director comprising”, making it clear (in the preamble) that the catheter system is NOT part of the claimed scope. Specifically, the claimed invention is directed solely to the energy director FOR a catheter system. MPEP 2111.02 “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”. However, the body contradicts/conflicts with this position of purely intended use by seemingly requiring components of the catheter system in the body of the claim, e.g. “a guide sleeve that is secured to the energy guide” (seemingly requires the energy guide), “the guide sleeve at least partially encircling the guide distal end of the energy guide” (seemingly requires the guide distal end of the energy guide), “the guide sleeve extending distally from the guide distal end in a direction toward the balloon distal region” (seemingly requires the balloon), “the guide sleeve directing the energy received by the energy guide so that the energy generates a plasma in the direction toward the balloon distal region” (seemingly requires the energy source), etc. Therefore, this contradiction/conflict between the purely intended use recited in the preamble and the seemingly positive recitation of structural components in the body of the claim creates confusion as to what the breadth/scope of the claimed invention actually encompasses/entails.
Therefore, the scope/breadth of the claims is unclear, specifically it’s unclear if the claims require the catheter system, as a whole including the components of an energy source, a balloon and an energy guide, or just the energy director that is functionally capable of cooperating with an imaginary/hypothetical/unclaimed catheter system having those components. To address this issues, it is recommended that applicant amend the claims to 1. Positively recite/require the catheter system and components thereof to make it clear that the claims require/include the entire catheter system OR 2. Make it clear that the catheter system and components thereof are purely functional limitations, i.e. using phrases like “configured to secure”, “configured to partially encircle”, “configured to extend distally”, and “configured to direct”, etc. For examination purposes, the examiner interprets the claim language to be directed solely to the energy director that is configured or adapted to function with an energy source, a balloon and an energy guide of a catheter system, but in no way requires an energy source, balloon, energy guide or even a catheter. Therefore, the prior art does not have to teach an energy source, a balloon, an energy guide or even a catheter to read on the current claim language. As long as the prior art teaches an energy guide that is capable of functioning/cooperating with hypothetical/imaginary/unclaimed components of the catheter system, then the claim language is met. 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. It is emphasized that applicant’s claimed energy director (guide sleeve 1257, Figs. 12A-D) is merely a tube/sleeve/sheath that surrounds an optical fiber and extends past the distal end of the fiber; Therefore, that is all that is structurally required to meet the claims; see 102 rejections below.
The dependent claims have the same issues, as identified above with respect to the independent claims.
[Claims 9-16, 19 and 20] These claims recite the limitation of a sleeve distal end “being positioned” or “that is positioned” in the balloon proximal region. This claim language is unclear as to whether or not this is a permanent configuration, i.e. always true, or if this is a functional limitation that only has to be true in certain circumstances or configurations, e.g. an adjustable position that CAN be positioned in the proximal region. It is emphasized this issue is further complicated/confused by the fact that a balloon is not actually required by the claims. For examination purposes, this is considered a functional limitation that is met if/when the sleeve distal end is capable of being positioned in the balloon proximal end, i.e. the sleeve distal end does not always have to be positioned in the balloon’s proximal region to meet this claim language.
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 1-6, 9-16, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 2019/0321104 to Brown or US 9,678,275 to Griffin.
Brown (Fig. 4) clearly anticipates the claimed energy director; see comparison below of applicant’s energy director (guide sleeve 1257) surrounding an energy guide/optical fiber (1222A) and Brown’s energy guide (sleeve 2) surrounding an optical fiber (4). These are structurally equivalent elements, as can be seen in the comparison below. Brown discloses that the energy guide (2) made be made of ceramic or metal (Pars 0023 and 0035; Claim 10). Similarly, Griffin (Fig. 3) clearly anticipates applicant’s claimed energy director (ferrule 105 including/especially the setback portion 145 that surrounds optical fiber 125); see comparison below. Griffin discloses “FIG. 3 depicts a simple embodiment of a solution to this problem: a ceramic, glass, polymer or metal ferrule 105 is mounted on the fiber tip at the fluoroacrylate coating 110 with adhesive 115”.
As discussed above, in relation to the 112b rejection, it is emphasized that the claims do not require an energy source, a balloon, an energy guide or catheter system. The examiner contends that Brown’s sleeve (2) is structurally equivalent to applicant’s claimed/disclosed energy guide (sleeve 1257); see comparison above. Therefore, Brown teaches all of the necessary structural elements/configurations to be capable of functioning/operating in the claimed manner, e.g. when an imaginary or hypothetical balloon of a catheter system is used, when an imaginary or hypothetical energy source that produces plasma is used, etc. See MPEP 2114.
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Brown’s energy director: light guide tube 2
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Griffin’s energy director: ferrule 105/ setback145
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Applicant’s energy director: guide sleeve 1257
Claims 1-6, 9-16, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by WO 2015/056662 to Miyagawa*
*It is noted that while the WIPO is being used for the actual rejection, the application US 2020/0289202 is being used for translation/citations purposes in the explanation of the rejection, below.
Furthermore, it is emphasized, as made clear in the 112b above, the claims do NOT require a catheter system including an energy source, a balloon and an energy guide. While some/all of these elements may be mapped/taught by the current rejection, this is purely to provide compact prosecution.
[Claims 1 and 4] Miyagawa discloses an energy director (light guide tube 134; Figs. 6-8) for a catheter system (ablation system 110; Figs. 6-8) for treating a treatment site within or adjacent to a vessel wall or heart valve within a body of a patient, the catheter system including (i) an energy source (laser light generating unit 112) that generates energy, (ii) a balloon (balloon 121) having a balloon distal region that has a varying diameter, and a balloon proximal region having a substantially constant diameter (see balloon 121 in Fig. 7 with a tapered distal end 125 and a proximal region having a substantially constant diameter, i.e. the majority of the balloon is shown as parallel lines having a constant diameter; see annotated Fig. 7 below for further explanation/details), and (iii) an energy guide (optical fiber 129) including a guide distal end (132), the energy guide being configured to receive the energy from the energy source (Par 0141), the energy director comprising:
a guide sleeve (light guide tube 134, including opening 135 and reflector 133) that is secured to the energy guide (“The inner diameter of the internal space of the light guide tube 134 is equal to the outer diameter of the optical fiber 129”, Par 0137; Par 0139 makes it clear that once inserted the fiber 129 and guide sleeve 134 move integrally together. This is considered a guide sleeve “secured” to the energy guide), the guide sleeve at least partially encircling the guide distal end (132) of the energy guide (best seen in Fig. 7), the guide sleeve extending distally from the guide distal end in a direction toward the balloon distal region (specifically the distal end of the light guide tube 134, including the reflector 133, extends past the distal end of the energy guide 132 towards the distal end of the balloon 125; See Figs. 6-7 and annotated Fig. 7 below), the guide sleeve directing the energy received by the energy guide so that the energy generates a plasma in the direction toward the balloon distal region (intended use/functional language; The energy guide taught by Miyagawa is structurally capable of functioning in the claimed manner, i.e. providing the claimed effect depending on the intensity and emission time, i.e. pulse duration, provided by the energy; see Par 0094 and MPEP 2114.
Annotated Fig. 7 for claim interpretation of claim 1:
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[Claim 2] As discussed above, the guide sleeve includes (reflector 133 and reflective surface 137). Par 0138 teaches that the reflector is made of resin, i.e. polymer, and the reflective surface is made of metal. Therefore, the guide sleeve is made at least partially of a polymer or metal.
[Claim 3] As seen in Figs. 6-7, the guide sleeve has a sleeve inner diameter that is substantially constant, i.e. a tube with constant diameter represented by parallel lines.
[Claim 5] The guide sleeve taught by Miyagawa includes a sleeve inner diameter that defines that defines a sleeve interior (including the inside/lumen of the light guide tube 134 through which the optical fiber 129 is passed and the opening 135). Regarding the limitation “the energy guide being configured to guide the energy so that the energy diverges within the sleeve interior of the guide sleeve and contacts the guide sleeve so that the plasma is initiated within the sleeve interior of the guide sleeve”, it is emphasized that an energy guide is not required by the current claim language. However, Miyagawa discloses all of the necessary structure/configuration to function in the claimed manner, i.e. provide the claimed effect; see MPEP 2114.
[Claim 6] Miyagawa discloses a sleeve opening (135) that is in fluid communication with a balloon interior of the balloon (121), e.g. via openings 130 and 131 (at least Par 0134).
[Claim 9] While the annotated Fig. 7 above shows the guide sleeve being positioned in the balloon distal region, Par 0139 makes it clear that the guide sleeve is slidable within in-side tube (127) and therefore the sleeve distal end is capable of being positioned in the balloon proximal region; see 112b rejection above.
[Claims 10-16, 19 and 20] See explanation for claims 1-6 and 9 above, as the current claim limitations are just various combinations of these previously rejected claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2019/0083177 to Brown discloses the claimed energy director (at least Figs. 1-3)
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.
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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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