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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/27/26 has been entered. Claims 1-20 are pending, while Claims 15-20 remain withdrawn.
Response to Arguments
Applicant's arguments filed 3/27/26 have been fully considered but they are not persuasive.
Visuri teaches various firing pattern and firing sequence examples (8:35—9:10). The teachings of Visuri in combination with the teachings of Cook for selective, simultaneous, sequential and/or alternating firing of each of the light channels in any desired combination, order/sequence and/or pattern, given the multiplexer (e.g. ¶¶ 72, 97, 100, 227), would have made it obvious to phosita to arrive at the claimed firing patterns.
The amendments overcome the remaining Double Patenting Rejections.
Specification
The disclosure is objected to because of the following informalities:
On page 44, the remark in bold “[Should we provide more specific examples of particular sequences as established through use of the multiplexing algorithms?]” appears to be in error.
Appropriate correction is required.
The abstract of the disclosure is objected to because: The parentheses and characters therein should be omitted. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This section is presented to clarify the interpretation of certain terms that under different context may have invoked 112f, but do not invoke 112f in the instant claims:
a) the terms “energy source” and “energy guide” are commonly used in conjunction, and understood in the art to describe the transmission of wave energy from a source through a waveguide (see e.g. US 5,019,040; US 6,579,311). In addition, see point b, regarding the special definition of “plasma generator”, which relates to the “energy source” and “energy guide”.
b) the term “emitter” in Claim 1 does not invoke 112f, as it is further defined in the claim by the guide distal end and the “plasma generator”, which has a special definition in the instant specification. On page 7, paragraph 2, the specification informs us that: “Each emitter 135 includes at least a guide distal end 122D of one of the energy guides 122A and a corresponding plasma generating structure 133 (also referred to herein as a "plasma generator") that cooperate to generate plasma within the balloon 104. The plasma generation, in turn, causes bubble formation that generates a pressure wave that imparts pressure adjacent to the vascular lesions 106A at the treatment site 106.” Thus, “plasma generator” is interpreted as plasma generating material 133 of emitter 135 that is spaced apart and in front of the guide distal end 122D and generates plasma when irradiated with appropriate laser light. The “plasma generator” doesn’t generate plasma on its own. It is in essence the material of “the emitter” (used as a more generic term in the specification), and it is this material in combination with the laser energy impinging thereon that plasma is generated.
Thus, the “emitter” is a generic term encompassing the distal ends of fibers emitting laser and the plasma generating materials positioned in front of the fiber distal ends.
d) the term “station” in the “emitter stations” of Claims 6-8 do not invoke 112f, because the plain and ordinary meaning of “station” includes “place” or “position” (see definition by Oxford English Dictionary, 1989). Thus, “station” is interpreted as a term indicating position under the broadest reasonable interpretation (ie. “emitter positions/places”).
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 1-2, 5, 7, and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210186613 by Cook, in view of US 6,368,318 by Visuri.
Regarding Claim 1, Cook teaches a catheter system for treating a treatment site within or adjacent to a vessel wall (e.g. title, abstract, ¶6: laser catheter system for intravascular lithotripsy), the catheter system comprising:
an energy source that generates energy (e.g. ¶9,60, Fig. 1: laser energy source 124);
a catheter shaft (e.g. ¶60, Fig. 1: catheter 102);
a balloon that is coupled to the catheter shaft, the balloon including a balloon wall that defines a balloon interior, the balloon being configured to retain a catheter fluid within the balloon interior (e.g. ¶10-11,54,62, Fig. 1: balloon 103 carries fluid wherein plasma can be generated);
a plurality of energy guides that are each configured to selectively receive the energy from the energy source, each of the plurality of energy guides including a guide distal end (e.g. ¶16,60: multiple light guides 122, each provided with a different beam; ¶199, Fig. 18A: optical fibers 1822A through 1822D; ¶97: controller used to selectively direct light beam to each fiber as desired);
a plurality of emitters that are positioned within the balloon interior, each emitter including the guide distal end of one of the plurality of energy guides and a corresponding plasma generator that is spaced apart from the guide distal end (¶54: “the light guide … can be said to incorporate a “plasma generator” at or near the guide distal end of the light guide that is positioned within the balloon interior of the balloon located at the treatment site”; ¶83: “the light energy is diverted within the light guide 122A to one or more of a plasma generator 133 and the photoacoustic transducer 154 that is in optical communication with a side surface of the light guide 122A”; ¶89: “Such pulses of light energy are then directed and/or guided along the light guides 122A to a location within the balloon interior 146 of the balloon 104, thereby inducing plasma formation in the balloon fluid 132 within the balloon interior 146 of the balloon 104, e.g., via the plasma generator 133 that can be located at the guide distal end 122D of the light guide 122A. In particular, the light emitted at the guide distal end 122D of the light guide 122A energizes the plasma generator 133 to form the plasma within the balloon fluid 132 within the balloon interior 146. The plasma formation causes rapid bubble formation, and imparts pressure waves upon the treatment site 106.”; Thus, the distal ends of the fibers, along with the plasma generators 133 meet the claimed emitters), the energy that is received by each of the plurality of energy guides being emitted from the guide distal end and impinging on the corresponding plasma generator so that plasma is generated in the catheter fluid retained within the balloon interior (¶54,83,89: plasma is created by the laser beams impinging on the plasma generators); and
a system controller including a processor that controls the energy source so that the energy from the energy source is alternatively directed to each of the plurality of energy guides in a first pattern of firing and a second pattern of firing that is different than the first pattern of firing (e.g. ¶96-98: “The system controller 126 can include one or more processors or circuits for purposes of controlling the operation of at least the light source 124, the GUI 127 and the multiplexer 128. For example, the system controller 126 can control the light source 124 for generating pulses of light energy as desired and/or at any desired firing rate. Subsequently, the system controller 126 can then control the multiplexer 128 so that the light energy from the light source 124, i.e. the source beam 124A, can be effectively and accurately multiplexed so as to be selectively and/or alternatively directed to each of the light guides 122A in the form of individual guide beams 124B in a desired manner.”; ¶100-101: “ the multiplexer 128 is configured to selectively and/or alternatively direct light energy from the light source 124 to each of the light guides 122A in the light guide bundle 122. More particularly, the multiplexer 128 is configured to receive light energy from a single light source 124, such as a single source beam 124A from a single laser source, and selectively and/or alternatively direct such light energy in the form of individual guide beams 124B to each of the light guides 122A in the light guide bundle 122 in any desired combination (i.e. simultaneously direct light energy through multiple light guides 122A), sequence, order and/or pattern. As such, the multiplexer 128 enables a single light source 124 to be channeled simultaneously and/or sequentially through a plurality of light guides 122A such that the catheter system 100 is able to impart pressure onto and induce fractures in vascular lesions at the treatment site 106 within or adjacent to the vessel wall 108A of the blood vessel 108 in a desired manner.”; Thus, clearly, more than one pattern of light activation and direction is disclosed to be controlled via controller 126, in Cook).
Cook does not explicitly disclose the combination of the processor controlling the energy source so that the energy from the energy source is first directed to each of the plurality of energy guides in a first pattern of firing and subsequently directed to each of the plurality of energy guides in a second pattern of firing that is different than the first pattern of firing, wherein the first pattern of firing has a first sequence of firing at least some of the plurality of emitters and the second pattern of firing has a second sequence of firing of at least some of the plurality of emitters that is different than the first sequence of firing at least some of the plurality of emitters.
However, Cook teaches selective, simultaneous, sequential and/or alternating firing of each of the light channels in any desired combination, order/sequence and/or pattern, given the multiplexer (e.g. ¶¶ 72, 97, 100, 227). In other words, the teachings of Cook would, at the very least, provide phosita with a system ready for improvement and the ability to select and optimize the firing patterns of each of the channels as desired.
Visuri teaches an analogous multifiber laser treatment catheter (e.g. abstract), which includes multiple different firing sequences of each of the optical channels/fibers (e.g. 8:35—9:10). As one firing pattern, the individual channels are pulsed in a spaced apart sequence (e.g. 8:47-51, Fig. 3A). As another firing pattern, a pattern where adjacent fibers are fired one after another (e.g. 8:51-56, Fig. 3B). In addition, Visuri teaches using different patterns, one pattern after another (e.g. 9:1-10). In one example, Visuri teaches alternating a first sequence where the fibers are fired in a clockwise order, with a second sequence, where the reverse occurs in a counter-clockwise firing order “similar to a washing machine” (e.g. 9:1-10). Visuri teaches the benefits of preventing heat concentration (8:51-56), consecutively impacting adjacent areas (9:1-10), promoting agitation (9:1-10), respectively, for the disclosed patterns.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate any combination and sequence of firing patterns from the examples taught by Visuri, including a clockwise firing sequence and a subsequent counterclockwise, and/or sequences based on any of the non-adjacent, adjacent, clockwise, counterclockwise firing patterns, in a catheter system according to the teachings of Cook, as: a) this would amount to a selection among known and limited options that would have been obvious to try, b) this would be a matter of routine experimentation within the skill in the art, c) this would “promote agitation” as suggested by Visuri (9:1-10), and d) this would allow the user to promote or avoid heat concentration, promote agitation, consecutively impact adjacent areas (as suggested by Visuri, 8:51-56, 9:1-10), as desired during a procedure.
Regarding Claim 2, Cook as modified in Claim 1 teaches the catheter system of claim 1 wherein the plasma generation causes bubble formation that generates a pressure wave that imparts pressure adjacent to the vessel wall (¶11: “the plasma generation causing rapid bubble formation and imparting pressure waves upon the balloon wall adjacent to the vascular lesion”).
Regarding Claim 5, Cook discloses the catheter system of claim 1 further comprising a plurality of emitter stations that are positioned within the balloon interior, each emitter station being positioned at a different longitudinal position within the balloon interior relative to a length of the balloon than each of the other emitter stations, each emitter station including one of the plurality of emitters (e.g. ¶78: “each of the light guides 122A can be disposed at any suitable longitudinal position relative to the length of the balloon 104 and/or relative to the length of the guidewire lumen 118 to more effectively and precisely impart pressure waves for purposes of disrupting the vascular lesions 106A at the treatment site 106”; As noted in the claim interpretation section, “station” merely indicates the place of the emitters, and ¶78 makes it clear that at least some emitters are positioned at different lengths of the catheter, something which is sufficient to meet Claim 5).
Regarding Claims 7, Cook as modified in Claim 1 teaches the catheter system of claim 5, wherein the system controller controls the energy source so that the energy from the energy source is alternatively directed to each of the plurality of emitters in the first pattern of firing and the second pattern of firing (e.g. as discussed in Claim 1 for the clockwise and counter clockwise sequences, which alternate).
Regarding Claims 9-10, Cook as modified in Claim 1 teaches the catheter system of claim 8 wherein the system controller controls each of the rate of firing of the energy source and the sequence of firing of each of the plurality of emitters (e.g. ¶97,100: both rate and sequence are controlled as desired).
Regarding Claim 11, Cook as modified in Claim 1 teaches the catheter system of claim 1 further comprising a multiplexer that receives the energy from the energy source and directs the energy from the energy source in the form of individual guide beams to each of the plurality of energy guides (e.g. ¶97: multiplexer 128 is used to control the firing patterns).
Regarding Claims 12-13, Cook as modified in Claim 1 teaches the catheter system of claim 1, wherein the energy source is a light source that generates pulses of light energy, wherein the light source is a laser source (e.g. ¶9,60,72, Fig. 1: laser energy source 124).
Regarding Claim 14, Cook as modified in Claim 1 teaches the catheter system of claim 1, wherein each of the plurality of energy guides includes an optical fiber (e.g. ¶72: fibers 122).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Cook/Visuri, as applied to Claim 1, and further in view of US 20200397230 by Massimini.
Regarding Claim 3, Cook as modified in Claim 1 teaches the catheter system of claim 1, yet does not explicitly disclose wherein each plasma generator includes an angled face that redirects the energy emitted from the guide distal end so that the plasma is generated in the catheter fluid retained within the balloon interior. However, Massimini teaches an analogous laser catheter system for intravascular lithotripsy (title, abstract), with optical fibers having plasma generators at their end, wherein each plasma generator includes an angled face that redirects the energy emitted from the guide distal end so that the plasma is generated in the catheter fluid retained within the balloon interior (e.g. abstract, ¶14-15,61,76, Fig. 3A,16,19: plasma generating faces 342/1642/1972 are angled to direct the waves toward the vessel wall). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate angled faces on the plasma generators of a system according to the teachings of Cook, as taught by Massimini, in order to: a) predictably redirect the energy toward the target obstructions at the vessel walls, as suggested by Massimini (¶61), and b) maintain the fibers closer to the shaft, thus lowering the profile of the deflated balloon and reducing the vulnerability of the fiber ends being mechanically damaged.
Regarding Claim 4, Cook as modified in Claim 3 teaches the catheter system of claim 3, yet does not explicitly teach wherein the angled face is formed from stainless steel. However, Massimini teaches an analogous laser catheter system for intravascular lithotripsy (title, abstract), wherein each plasma generator includes an angled face that includes stainless steel and its variants, tungsten, tantalum, platinum, molybdenum niobium, and iridium (¶17,75). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate stainless steel in the angled faces on the plasma generators of a system according to the teachings of Cook, as taught by Massimini, as: a) this would predictably generate plasma at the faces of the plasma generators, b) it has a high melting temperature (Cook, ¶75), c) and the selection of a known material based upon its suitability for the intended use is a design consideration within the skill of the art (In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); Also See MPEP 2144.04)
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Cook/Visuri, as applied to Claim 5, and further in view of US 2016/0184023 by Grace.
Regarding Claim 6, Cook discloses the catheter system of claim 5, yet does not disclose wherein the plurality of emitter stations includes a first emitter station including a first plurality of emitters that are each positioned at a first longitudinal position within the balloon interior, and a second emitter station that includes a second plurality of emitters that are each positioned at a second longitudinal position within the balloon interior that is different than the first longitudinal position. Cook does teach multiple fibers leading to different emitters at different longitudinal locations (e.g. ¶78). Grace teaches an analogous laser catheter system for intravascular lithotripsy (e.g. abstract), wherein a plurality of emitter stations includes a first emitter station including a first plurality of emitters that are each positioned at a first longitudinal position within the balloon interior, and a second emitter station that includes a second plurality of emitters that are each positioned at a second longitudinal position within the balloon interior that is different than the first longitudinal position (e.g. ¶224, Fig. 1, Fig. 1A: “Referring to FIG. 1, the distal end of catheter 100 of the present disclosure includes one or more layers of optical fibers arranged circumferentially around or adjacent to an inner lumen 110. The proximal end of the catheter 100 is coupled to a laser generator, which is not shown. The one or more layers of optical fibers are housed in a flexible tubular catheter and terminate at different points of emission (such as, emitters), where the laser light energy is released and directed towards a desired target. The inner layer of optical fibers 115 terminates at the distal emitter 120 at the distal tip 130 of the catheter, while the outer layer of optical fibers 135 terminates at the proximal emitter 140 of the catheter. The proximal laser emitter 140 is disposed proximate of the distal tip and contained within the balloon assembly 150, which is circumferentially arranged around a portion of the distal end of the catheter excluding the distal tip 130 of the catheter and the distal emitter 140.”; ¶255, Fig. 3C: concentric emitters 300,310,320 at different longitudinal lengths; ¶228: multiple emitters in each station/row). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate multiple emitters at each emitter longitudinal station in a system according to the teachings of Cook, at taught by Grace, as: a) at the most fundamental level, it would only amount to either duplication or separation of parts (emitters/generators), each having long been held as within the skill in the art (See St. Regis Paper Co. v. Bemis Co., 193 USPQ 8); Nerwin v. Erlicnrnan, 168 USPQ 177, 179; MPEP 2144.04), b) this would predictably provide emission of energy (pressure wave) toward the target tissue, c) it would enhance the reliability and lifespan of the device, and d) this would cover a larger area of target tissue, and in the event that the concentric arrangement suggested by Grace is adopted, it would treat vessel obstructions faster and with less rotational or axial movement of the catheter.
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Cook does not teach Claim 8, which depends on Claims 7, 5 and 1, as a whole.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796
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