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 A3 (multiplexer 400, Fig. 4) and Species B1 (catheter 800, Figs. 8A-B) in the reply filed on 6/10/2026 is acknowledged.
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 1-12 and 18-20 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 system controller that (i) controls at least one of a pulse frequency, a pulse energy level and a pulse width of each of the plurality of pulses of energy from the energy source, and (ii) controls a firing sequence of the plurality of pulses of energy from the energy source such that the plurality of pulses of energy from the energy source are sequentially directed to each of the plurality of energy guides, so that an advancing wavefront is generated within the balloon interior that moves toward the treatment site in a first direction from near the balloon first end toward the balloon second end” lacks sufficient written description support.
First and foremost, it’s clear from the specification and the dependent claims that the “at least one of a pulse frequency, a pulse energy level and a pulse width of each of the plurality of pulses of energy from the energy source” have no effect on the direction of the wavefront. Specifically, claims 2-7 and Figs. 14A-H (and the related disclosure of these figures) make it clear that the pulse frequency can increase, decrease or stay constant, the pulse energy level can similarly increase, decrease or stay constant, and the pulse width can also increase, decrease or stay constant and all of these options result in an advancing wavefront. It is emphasized that these are the only possible options for each laser parameter (increase, decrease or constant), therefore control/adjustment of these laser parameters has not effect on the direction of the wavefront, as every possible option results in the claimed advancing wavefront.
Therefore, according to applicant’s own specification and claims, the only laser parameter that actually determines/effects the direction of the wavefront is seemingly the firing sequence. However, the current breadth of the independent claim is broad enough to encompass any number of optical fibers and any firing sequence, as “sequentially” does not require any specific order. While applicant has support for specific firing sequences related to a specific number of optical fibers, e.g. claims 13-17, the independent claim is much broader than what is properly supported. MPEP 2163.03 states “An original claim may lack written description support when… a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc).” The examiner takes the position that current breadth of the independent claim is not sufficiently described/supported by applicant’s original specification. Specifically, applicant does not have support for every firing sequence for any number of optical fibers that produces the claimed advancing wavefront (genus), as this has not been sufficiently described in the specification as to how this achieved with any sequence and any number of fibers, instead applicant has support for a very specific firing sequence for a specific number of optical fibers (species, as recited in claims 13-17; which are not rejected under 112a written description).
[Claim 18] The limitation “wherein the system controller controls the energy source such that a second plurality of pulses of energy from the energy source are sequentially directed to the fifth energy guide, then the fourth energy guide, and then the third energy guide so that a second advancing wavefront is generated within the balloon interior that moves toward the treatment site in a second direction from near the balloon second end toward the balloon first end” lacks sufficient written description support. Specifically, this is the exact opposite sequence/direction than the previous sequence, but still somehow results in an advancing wavefront, i.e. “that moves toward the treatment site in the first direction from near the balloon first end toward the balloon second end” (as defined by applicant’s own claims). As discussed above, and in applicant’s specification, that an advancing wavefront is generated when the laser emission starts at the proximal-most fiber (first) and proceeds forwards/distally along the catheter shaft until reaching the distal-most fiber (third, fourth or fifth; depending on the number of fibers present). The current claim recites that the exact opposite direction, i.e. starting at the distal-most fiber (fifth) and working backwards/proximally along the catheter shaft, i.e. proximally, but somehow also results in an advancing wavefront. Based on the details/explanation from applicant’s own specification and the knowledge of a POSITA, it’s unclear HOW such an advancing wavefront is created. Seemingly this should generate a retreating wavefront. Specifically, applicant’s own specification states “the pressure waves will advance in the direction of activation” (Pars 0056 and 0214 of applicant’s specification) which is the opposite of what is being claimed. This conflict/contradiction is not explained in sufficient detail as to why/how the result of this activation sequence is the exact opposite of what is expected to happen, i.e. a retreating wavefront is expected while the claims require an advancing wavefront.
[Claim 19] The limitation “the advancing wavefront is spherical-shaped and impinges at an angle relative to the balloon wall to create a shearing force at the balloon wall substantially adjacent to the treatment site” is not sufficiently supported as to HOW a spherical-shaped advancing wavefront is created or HOW the angle relative to the balloon is adjusted/controlled. Par 0214 of applicant’s specification discusses this shearing force, but never discusses how the shape and angle of the wavefront is controlled. In fact, the specification says “in such applications, as individual guide beams 124B are directed to specific energy guides 822A1-822A8 in a specific sequence, the pressure waves will advance in the direction of activation”, but never discloses what this specific sequence is or what these specific energy guides are. Therefore, it’s unclear how this spherical-shaped wavefront is created/generated and/or how the angle at which this wavefront impinges the balloon is controlled/adjusted produce the claimed advancing wavefront with shearing forces.
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 18 and 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 18] Based on the conflict/contradiction between the specification and the claims, as discussed above in relation to the 112a written description rejection, the claim is indefinite. Specifically, based on the explanation in the specification that “pressure waves will advance in the direction of activation” the claimed sequence of the fifth energy guide and then the fourth energy guide should create a retreating wavefront (not an advancing wavefront, as claimed). MPEP 2173/03 states “A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty.” For examination purposes, the examiner interprets the second “advancing” wavefront as a second retreating wavefront.
[Claim 19] Based on the lack of explanation/details in the specification (see 112a written description, above), it is unclear what is structurally required in order to generate/create the claimed advancing wavefront having shearing forces. This is seemingly controlled by laser parameters, including firing sequence, but it’s unclear what specific laser parameters or firing sequence is necessary in order to achieve 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”. Stated differently, it’s unclear how the examiner can apply prior art to read on such a limitation when it’s unclear what is structurally required in order to provide the claimed effect/result. For example, if the examiner knew (based on applicant’s specification) what laser parameters and/or firing sequence resulted in such an advancing wavefront, then the examiner could apply art based on the prior art teaching the same/similar parameter or firing sequence. However, since applicant’s specification is completely silent on how this result is achieved, the scope of the claim is indefinite. For prior art purposes, if a prior art references teaches a controller that can control any of the pulse energy, pulse width or pulse frequency and a firing sequence, then the examiner contends that the prior art is capable of achieving the claimed wavefront; see MPEP 2114 “Functional claim language that is not limited to a specific structure covers all devices that are capable of performing the recited function. Therefore, if the prior art discloses a device that can inherently perform the claimed function, a rejection under 35 U.S.C. 102 and/or 35 U.S.C. 103 may be appropriate.”
Claim Rejections - 35 USC § 102 or 35 USC § 103
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.
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 1-11 and 13-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US 2017/026592 to Grace et al.
[Claims 1, 13 and 20] Grace discloses a catheter system (best seen in Figs. 1, 2, 3A and 3C) for treating a treatment site within or adjacent to a vessel wall of a blood vessel, the catheter system comprising:
a catheter shaft (100);
a balloon (150/350) that is coupled to the catheter shaft, the balloon includes a balloon first end, a balloon second end (proximal and distal ends of balloon), and a balloon wall that defines a balloon interior, the balloon wall being configured to be positioned adjacent to the treatment site (210, Fig. 2; Par 0278);
an energy source that generates a plurality of pulses of energy (laser 230);
a plurality of energy guides (300, 310 and 320, i.e. optical fibers; Par 304) that are each configured to selectively receive at least one of the plurality of pulses of energy from the energy source (this is considered intended use that any/all optical fiber is capable of achieving), each of the plurality of energy guides being disposed along the catheter shaft and at least partially within the balloon interior (“Each of the concentric proximal laser emitters 300, 310, 320 is the termination point of an optical fiber layer that lies within a balloon catheter” Par 0304; See also Pars 0305-306. Figs 1, 2 and 3A-C all show the fibers disposed along the catheter shaft and at least partially with the balloon interior), the plurality of energy guides each including a corresponding guide distal end, each of the guide distal ends (e.g. first 300, second 310 and third 320) being positioned within the balloon interior at a different longitudinal position from one another along a length of the balloon (Fig. 3A clearly shows each of the optical fibers distal ends terminating at a different longitudinal location; “the distal end a catheter having multiple, telescopically extending, concentric proximal laser emitters 300, 310, 320 coupled to one or more laser catheters. Each of the concentric proximal laser emitters 300, 310, 320 is the termination point of an optical fiber layer that lies within a balloon catheter” Pars 0304-0306); and
a system controller (laser controller 950, Fig. 9) that (i) controls at least one of a pulse frequency, a pulse energy level and a pulse width of each of the plurality of pulses of energy from the energy source (“Controller 950 includes one or more computing devices programmed to control laser 230” Par 0279; See also Par 0282. Par 0294 discusses controlling the pulse frequency; Par 0291 discusses controlling the pulse energy level; Par 0293 discusses controlling the pulse width; See Pars 0291-296. A POSITA would readily/necessarily recognize that a controller that is programmed to control the laser inherently controls the laser parameters, e.g. pulse frequency, pulse energy level and pulse width, especially considering the fact that Grace explicitly discloses different values/ranges for these parameters. If applicant disagrees, see alternative 103 below), and (ii) controls a firing sequence of the plurality of pulses of energy from the energy source such that the plurality of pulses of energy from the energy source are sequentially directed to each of the plurality of energy guides (“The multiple proximal laser emitters in FIGS. 3A and 3B can be activated in any sequence during a procedure, including individually or simultaneously with each other, thereby providing a greater range of treatment options” Par 0306. It is noted that “sequentially” does not refer to any specific order/sequence, i.e. any sequence is interpreted as sequentially), so that an advancing wavefront is generated within the balloon interior that moves toward the treatment site in a first direction from near the balloon first end toward the balloon second end (“The forces generated by the pressure waves 240 can propagate radially, including in forward (such as, parallel to the vessel)… directions” Par 0284; Fig. 2).
Regarding the claimed advancing wavefront, the examiner contends that Grace explicitly teaches a sequence that creates/generates and advancing wavefront, i.e. pressure waves 240 that advance in a forward direction. For example, while Grace discloses that the controller can achieve any activation sequence and separately discloses an advancing wavefront, i.e. propagating waves in a forward direction, it fails to explicitly disclose a controller configured to control the energy source so that an advancing wavefront is generated. As made clear from applicant’s specification and claim 13, such an advancing wavefront is generated when energy from the energy source is sequentially directed to the first guide, then the second guide, then the third guide. It is emphasized that there are only 13 sequence options for activating 3 different guides either individually or simultaneously; this is considered a finite and very small amount of options/possibilities. According to MPEP 2131.02, the examiner contends that a POSITA would at once envisage such a sequence (first, second then third). Specifically, the examiner contends that logically the first sequence (or one of the very first sequences) that a POSITA (or anyone) would immediately recognize/envision/think of is first, second then third, as a consecutive series of numbers is readily apparent to anyone (especially a POSITA) when considering a specific sequence. If applicant disagrees, then such a sequence would be obvious to try, as this is merely choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success or as mere routine optimization; See MPEP 2144.05. Additionally, this seems like the mostly logical sequence to try, i.e. the proximal-most fiber to the distal-most fiber, especially when considering a wavefront that propagates in a forward direction.
Furthermore, the examiner contends that the specific order of first guide, then second guide then third guide inherently results in an advancing wavefront that moves toward the treatment site in a direction from near the balloon first/proximal end toward the balloon second/distal end, especially considering the relative spacing/positioning of the first, second and third guides at different longitudinal locations within the balloon, with the first guide (300) being closest to the proximal end of the balloon and the third guide (320) being closest to the distal end of the balloon, as explicitly described/detailed above. In fact, applicant’s specification seems to support this position of inherency, as it states “the pressure waves will advance in the direction of activation”.
Regarding the controller configured to control specific laser parameters, if applicant disagrees that Grace explicitly or inherently fails to teach such a controller, the examiner takes the position that such a laser controller is obvious. Specifically, Grace discloses that the laser controller (950) is programmed to control the laser and also goes on to describe various values/ranges for laser parameters (including pulse frequency, pulse energy level and pulse width). The examiner contends that a POSITA would recognize that these laser parameters are controlled by the laser controller, but if not, such a laser controller would be extremely obvious as this is ubiquitous within laser surgery devices. The examiner takes official notice of such a fact, i.e. laser controllers are commonly known and used to control laser parameters emitted by the laser.
[Claims 2-11] As discussed above, the laser controller controls all the disclosed laser parameters (or would be obvious to control all the laser parameters), including all three of pulse frequency, pulse energy level and pulse width.
Regarding the increasing or decreasing of the pulse frequency and pulse energy levels during the firing sequence, the examiner contends that based on the different values/ranges for the pulse frequency and pulse energy levels, disclosed by Grace. Clearly, Grace encompasses different values for these parameters and a controller that controls them, but is silent to specifically increasing or decreasing these parameters during the firing sequence. However, the examiner contends that either 1. Grace teaches a controller that is inherently capable of such control (MPEP 2114) or 2. Such a controller is obvious. Regarding the inherency, the examiner takes the position that the laser controller is inherently capable of either increasing or decreasing both the pulse frequency or pulse energy level. If applicant disagrees, then the examiner takes the position that there are only 3 options for these laser parameters during the firing sequence, i.e. increasing, decreasing or constant. The examiner contends that it would be obvious to try any/all of these options, i.e. increasing or decreasing the pulse frequency and/or increasing or decreasing the pulse energy level as this is merely choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success or is merely routine optimization; MPEP 2144.05. It is emphasized that applicant has no criticality or unexpected result to any of these options; This is even more apparent when it’s clear that every option/combination of options is disclosed (or claimed). Specifically, it’s hard to appreciate that any of these options is critical when every single option and combination of options are disclosed (and most are claimed). Stated differently, this seemingly amounts to trial and error by applicant, and this same trial and error, i.e. routine experimentation, by a POSITA would be obvious.
[Claims 14-17] The examiner contends that adding a fourth and fifth energy guide at staggered longitudinal positions (similar to the staggered positions already explicitly disclosed for the first, second and third guides) is an obvious duplication of parts. Furthermore, Pars 0277 and Par 0306 make it clear that the number and location of emitters/energy guides, i.e. rows, can be adjusted as desired. Therefore, it would have been obvious to add a fourth and fifth energy guide a as a mere duplication of parts, as Grace specifically envisioned any number of emitters. Furthermore, the examiner continues to take the position that it would be obvious to try any order/sequence of activation, even when adding a fourth and fifth emitter/guide, and especially the specific order/sequence that starts at the proximal-most fiber and proceeds longitudinally down the catheter shaft until it ends at the distal-most fiber, i.e. first, second, third, fourth and then fifth fibers (as defined by the claims), as explained above.
[Claim 18] As discussed above, Grace explicitly teaches “the multiple proximal laser emitters in FIGS. 3A and 3B can be activated in any sequence during a procedure, including individually or simultaneously with each other, thereby providing a greater range of treatment options” (Par 0306), as well as explicitly teaching both advancing wavefronts (waves 240 propagating in a forward direction) and retreating wavefronts (waves 240 propagating in a backwards direction); Par 0284. Similarly, to claims 1 and 14-17 above, the examiner contends that it would be obvious to try any/all firing sequences, including the sequence claimed, as a matter of routine optimization or choosing among a finite amount of predictable solutions in order to achieve the desired results, i.e. advancing and retreating wavefronts.
[Claim 19] As discussed above, in relation to the 112b rejection, the examiner takes the position that Grace teaches the necessary structure, i.e. a laser controller that control the laser parameters and the firing sequence, that is inherently capable of providing the claimed result/effect, i.e. an advancing wavefront that is spherical-shaped and impinges at an angle relative to the balloon wall to create a shearing force at the balloon wall.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Grace (Grace ‘592) as applied to claim 1 above, and further in view of US 2014/0276689 to Grace (Grace ‘689).
Grace ‘592 is discussed above, but fails to explicitly teaches a multiplexer that is responsible for the firing sequence. However, in the same field of endeavor, Grace ‘689 discloses a multiplexer that receives laser pulses to sequentially direct the pulses into each of the fibers (Figs. 4, 5 and/or 8, e.g. fiber selector 808; Pars 0056-58). Therefore, it would have been obvious to one of ordinary skill to modify the device taught by Grace ‘592 to include the multiplexer taught by Grace ‘689, as multiplexers (like those taught by Grace ‘689) are known mechanisms to selectively direct laser pulses into individual optical fibers of a plurality of fibers in order such that a desired firing sequence is achieved.
Conclusion
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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