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 claim objections of claims 3, 11 and 23, applicant’s cancellation of these claims has rendered this objection moot.
Regarding the 112a written description rejection, applicant’s amendments and arguments fail to address this rejection. Therefore, the rejection is substantially maintained; see below.
Regarding the 112b indefiniteness rejections of claims 1, 21 and 28, applicant generally alleges that the amendments overcome the rejections without any sort of explanation. The examiner contends that all applicant has done is changed the term “conditioning” to “first” and “energizing” to “second”, but the exact same issues remain, as it remains unclear what makes the first/conditioning pulse a pulse that provides the effect of “conditioning”; merely changing the word “conditioning” to “first” does not resolve any of the previous-identified issues.
Regarding the 112b indefiniteness rejections of claims 6 and 26 applicant’s amendments and related arguments fail to address this rejection. Therefore, the rejection is maintained; see below.
Regarding the 102 or 103 rejection of Massimini, applicant’s arguments generally allege that Massimini does not teach the amended claim limitations, but provides no explanation or details as to why or how. As made clear in the current claim language, an energy guide or plasma generator is inherently/implicitly conditioned when a first, lower-energy pulse (as compared to a next/second higher-energy pulse) is transmitted through the energy guide; see cited portion of MPEP 2112 below. The examiner maintains that Massimini teaches or suggests transmitting a first pulse having a lower energy than a second pulse, and the second pulse generates a plasma bubble, as detailed/explained in the previous office action. See new 102/103 rejection below with the updated claim mapping to address applicant’s amendments.
MPEP 2112:
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.
Applicant is reminded that 37 CFR 1.111(b) states:
In order to be entitled to reconsideration or further examination, the applicant or patent owner must reply to the Office action. The reply by the applicant or patent owner must be reduced to a writing which distinctly and specifically points out the supposed errors in the examiner’s action and must reply to every ground of objection and rejection in the prior Office action. The reply must present arguments pointing out the specific distinctions believed to render the claims, including any newly presented claims, patentable over any applied references. If the reply is with respect to an application, a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated. The applicant’s or patent owner’s reply must appear throughout to be a bona fide attempt to advance the application or the reexamination proceeding to final action. A general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references does not comply with the requirements of this section.
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, 2, 4-10, 12, 21, 22 and 24-30 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.
[Claims 1, 21 and 28] The specification fails to provide sufficient explanation/details as to what is encompassed by the limitation “conditioning one or both of (i) the proximal end of the energy guide and (ii) the plasma generator by delivering the first pulse to the proximal end of the energy guide” as recited in claim 1. Similar language exists in claims 21 and 28, particularly “alternately delivering the first pulse and the second pulse to the proximal end of the energy guide to condition one of (i) the proximal end of the energy guide, and (ii) the plasma generator, to generate a plasma within the inflatable balloon”. While the specification provides guidance that a conditioning pulse has an energy level that is less than the energizing pulse, it’s unclear exactly what makes a pulse capable of providing the effect of “conditioning”, as this is an incredibly broad term that relates to a desired effect. However, the specification is silent as to the breadth of everything encompassed by this claimed effect of conditioning and HOW exactly all of the claimed effects that are encompassed by “conditioning” are accomplished. Stated differently, the specification lacks guidance/explanation on what the breadth/scope of “conditioning” entails and to the defining characteristics of a condition pulse, i.e. a pulse that results in conditioning. What specific characteristics/properties of a pulse make it a conditioning pulse (other than the fact that it has less energy that an energizing/plasma-inducing pulse). Therefore, it’s unclear how a proximal end of the energy guide or plasma generator can be conditioned, if it’s unclear exactly what effects/results are encompassed by the broad term “conditioning” and how a pulse provides such an effect.
MPEP 2163.03 states “an original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated.”
MPEP 2161.01 states “similarly, 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.”
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, 2, 4-10, 12, 21, 22 and 24-30 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 “conditioning one or both of (i) the proximal end of the energy guide and (ii) the plasma generator by delivering the first pulse to the proximal end of the energy guide” is indefinite. As discussed above, the specification fails to provide any details/explanation as to exactly what constitutes a pulse that can provide the effect of “conditioning”, i.e. a pulse that results in conditioning. It is noted that “conditioning” and more specifically a pulse that provides conditioning is not a term of the art and applicant has failed to provide an explicit definition of what exactly is meant/encompassed by conditioning and how a pulse specifically achieves such an effect. Is any pulse that has less energy than a second, plasma-generating pulse capable of achieving the claimed effect of “conditioning”.
For examination purposes, any first pulse that has lower energy than a second, plasma-generating pulse will be interpreted as a first pulse that inherently/implicitly provides (or results in) conditioning.
[Claims 21 and 28] The limitation “alternately delivering the first pulse and the second pulse to the proximal end of the energy guide to condition one of (i) the proximal end of the energy guide, and (ii) the plasma generator, to generate a plasma within the inflatable balloon” is indefinite. For the same reasons explained above, in relation to claim 1, this claim limitation is indefinite. For examination purposes, as long as the prior art teaches delivering a first pulse having less energy than the second pulse, the claim limitation is met.
[Claims 6 and 26] These claims recite “a respective spaced-apart plasma generator”, however a plasma generator has already been recited in the claims. It’s unclear if this limitation refers to the previously recited plasma generator or a new/different plasma generator.
Claim Rejections - 35 USC § 102 or 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.
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, 2, 4, 10, 21, 22, 24, 29 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under U.S.C 103 as obvious over US 2021/0275249 to Massimini et al., as evidenced by US 2021/0128241 to Schultheis
[Claim 1] A method for conditioning one of an energy guide and a plasma generator in a catheter (Title/Abstract; Fig. 1), the method comprising the steps of:
positioning the plasma generator (interpreted as either the distal end of the “one or more light guides” 122 or the balloon fluid 132; Fig. 1. Schultheis discloses “the catheter systems and related methods utilize an energy source, i.e. a light source such as a laser source or another suitable energy source, which provides energy that is guided by one or more energy guides, e.g., light guides such as optical fibers, which are disposed along the catheter shaft and within the balloon interior of the balloon to create a localized plasma in the balloon fluid that is retained within the balloon interior of the balloon. As such, the energy guide can sometimes be referred to as, or can be said to incorporate a “plasma generator” at or near a guide distal end of the energy guide that is positioned within the balloon interior of the balloon located at the treatment site” Par 0025. Therefore, at least the distal end of the energy guide is a plasma generator, as evidenced by Schultheis) within an inflatable balloon (104) near a distal end of the energy guide (at least Par 0073; Fig. 1 which shows the distal end of light guide 122 located within the balloon where the plasma 134 is generated);
coupling a proximal end of the energy guide to an energy source (power source 124; at least Pars 0069, 0072 and 0101-102. As can be seen in Fig. 1, the energy source 124 is coupled to the proximal end of light guide 122);
positioning the inflatable balloon adjacent to a treatment site (106, Fig. 1; Pars 0067-68);
adjusting the energy source with a source adjuster (controller 123 and/or amplifier 128; Pars 0071-72) to generate (a) a first pulse having a first energy level, and (b) a second pulse having a second energy level, the first energy level being lower than the second energy level (Any of pulses 242A, 242B, 342A or 342B of Figs. 2A, 2B, 3A or 3B, respectively, are considered the claimed pulses. At least Pars 0078-82 discloses that the pulses, specifically the amplitude, i.e. energy level, of each pulse is customized/tailored, i.e. different from one pulse to the next, in order to create a specific pre-bubble and plasma bubble. Therefore, inherently one pulse, i.e. the first pulse, has a lower energy level than the next/subsequent/second pulse; See also Par 0084-93 and Figs. 4-5. If applicant disagrees; see alternative 103 below); and
conditioning one or both of (i) the proximal end of the energy guide, and (ii) the plasma generator by delivering the first pulse to the proximal end of the energy guide (The examiner contends that the first pulse having lower energy than the second pulse inherently/implicitly provides the claimed effect of “conditioning”; See 112 rejections above and MPEP 2112 and 2114. For example, the pre-bubble discussed by Massimini can be interpreted as “conditioning”.); and
generating a plasma within the inflatable balloon by applying the second pulse to the plasma generator (plasma pulse 246B or 346B, Figs. 2B or 3B; at least Par 0080)
As discussed above, the examiner contends that by teaching that the amplitude, i.e. pulse energy, of the multiple pulses “can be different from energy pulse to energy pulse”, a POSITA would “at once envisage” a first pulse having a lower energy than a second pulse. However, if applicant disagrees, it is clear that there are only two options after every pulse: 1 the next pulse is higher or 2. The next pulse is lower. Therefore, it would be obvious to try either option, and specifically a first/lower pulse followed by a second/higher pulse, as this is choosing between a from a finite number of identified, predictable solutions, with a reasonable expectation of success and/or as optimization of a result effective variable, specifically in order to customize/tailor the pulses, as explicitly taught by Massimini
[Claims 2 and 10] Massimini discloses a light guide (122), specifically an optical fiber, and the energy source is a laser (at least Par 0069).
[Claim 4] The examiner interprets the controller (123) as a controller that automatically controls/adjusts the energy source in order to generate the desired, i.e. customized/tailored, pulses (at least Pars 0030 and 0071). If applicant disagrees, see alternative 103 below.
[Claim 21] The majority of the limitations have been detailed above, in relation to claim 1. Regarding the limitation “the energizing energy level representing a 100% energy level and the first conditioning energy representing greater than 0.001% of the energizing energy level and less than 99.999% of the energizing energy level” (which is the only limitation not present in claim 1), the examiner contends that this is just what “lower” means. Specifically, if the energizing level is defined as 100% energy level, then any energy level below this 100% energy level is a percentage of 100%. If applicant disagrees; see alternative 103 below.
Massimini inherently discloses a pulse energy level that is lower than the next pulse, as “one or more of the shape, amplitude and/or duration pulse width can be different from energy pulse 242A to energy pulse 242A” requires that one pulse be less energy than the next. While the examiner contends that a lower pulse energy implicitly/inherently requires a pulse energy of 0.001% to 99.999% of the higher energy level pulse. If applicant disagrees, then this is considered overlapping, approaching and similar ranges which is a prima facie case of obviousness. Additionally or alternatively, this is considered optimization of a result effective variable, specifically different/lower pulse energies for each pulse, as established by Massimini, and it would be obvious to one of ordinary skill in the art to choose/try the desired lower energy level as a matter of routine optimization. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."; MPEP 2144.05.
Regarding “alternately” delivering a lower-energy conditioning pulse and a higher-energy energizing pulse, since one pulse of a different amplitude necessarily follows the next, the examiner contends that this alternately delivering step is taught. If applicant disagrees, the examiner contends that such an alternating manner would be obvious to try as optimization of a result effective variable, specifically in order to customize/tailor the pulses, as explicitly taught by Massimini. Specifically, there are only two options after every pulse: 1 the next pulse is higher or 2. The next pulse is lower. It would be obvious to try alternating lower and higher energy level for each pulse, as this is choosing between a from a finite number of identified, predictable solutions, with a reasonable expectation of success. Furthermore, applicant has provided no criticality or unexpected results to this alternating manner.
[Claims 22 and 24] See explanation for claims 2 and 4, above.
[Claims 29 and 30] These claims recite contingent limitations of a microbubble coupled to a surface of the proximal end of the energy guide and a contaminate positioned on a surface of the plasma generator. The examiner takes the position that the delivery of the first pulse will inherent/implicitly displace or clear such a microbubble or contaminate (if such a microbubble or contaminate exists); see MPEP 2112 and 2111.04
Claims 4, 5, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Massimini as applied to claims 1 and 21 above, and further in view of Schultheis.
[Claims 4 and 24] As discussed above, the examiner contends that Massimini inherently discloses an automatic controller to adjust the energy source to generate the desired pulses. However, if applicant disagrees, such automation is obvious. Specifically, “the court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art” MPEP 2144.04. This position is further supported by Schultheis, which discloses “the system controller 126 can include one or more processors or circuits for purposes of controlling the operation of at least the energy source 124 and the GUI 127. For example, the system controller 126 can control the energy source 124 for generating pulses of energy as desired and/or at any desired firing rate” Par 0071. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the controller taught by Massimini for the automatic controller taught by Schultheis, as a simple substitution of one known controller for another to obtain predictable results, i.e. automatically adjust/control the laser source to generate the desired energy and timing of laser pulses.
[Claims 5 and 25] Massimini explicitly discloses “one or more of the shape, amplitude and/or duration pulse width can be different from energy pulse 242A to energy pulse 242A. With this design, the composite energy pulse can be customized in a manner that is advantageous to generating one or more plasma pulses 246A having the desired characteristics.” Therefore, Massimini clearly defines the difference in energy level/amplitude from one pulse to the next a result effective variable. Therefore, it would have been obvious to choose/try as many “conditioning”, i.e. lower energy-level, pulses before an “energizing”, i.e. higher energy level, pulse, as routine optimization or as choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success
Claims 6-9, 12 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Massimini ‘249, as evidenced by Schultheis, as applied to claims 1 and 21 above, and further in view of US 2020/0397230 to Massimini et al (‘230).
[Claims 6 and 26] Massimini ‘249 discloses a plurality of energy guides (“one or more light guides 122”; Par 0069) and implicitly/inherently when a plurality of energy guides exist, the adjusting and alternately delivering are implemented for each of the plurality of light guides. If applicant disagrees, then this is considered an obvious duplication and it would be obvious to try/choose operating the multiple optical fibers in the same manner as the single optical fiber.
Massimini ‘249 fails to explicitly disclose a spaced-apart plasma generator, however in the same field of endeavor, Massimini ‘230 discloses a laser balloon catheter (e.g. Fig. 2) that generates plasma having an energy guide (light guide 222) and a spaced-apart plasma generator (plasma target 242). Therefore, it would have been obvious to substitute the energy guide and plasma generator configuration taught by Massimini ‘249 for the spaced-apart configuration taught Massimini ‘230, as one know configuration of an energy guide/plasma generator for another to obtain the predictable results of generating plasma within a balloon catheter for treatment of vascular lesions
[Claims 7 and 27] While Massimini ‘249 explicitly teaches that the amplitude, i.e. energy level, of each pulse is different, inherently meaning one pulse has a lower pulse energy than the other. It fails to explicitly teach that the lower energy pulse is before the higher energy pulse. However, it an alternating pattern, a lower pulse will always be before a higher pulse. If applicant disagrees, the examiner takes the position that it would have been obvious to try/choose either the lower or the higher pulse first as this is choosing from a finite number of identified, predictable solutions (2 options: higher before lower or lower before higher), with a reasonable expectation of success or alternatively as an optimization of a result effective variable.
[Claim 8] As discussed above, the alternating pulses are delivered to the proximal end of the fiber from the laser source (at least Pars 0070 and 0072).
[Claim 9] See explanation for claim 5 and 25, above.
[Claim 12] Massimini ‘230 discloses that the plasma generator (242) is made of metal (at least Par 0075)
[Claim 28] See explanation for claims 1, 21 and 12, as all of the claimed limitations have been previously addressed.
Potentially Allowable Subject Matter
Claim 31 currently has no applicable prior art rejection, but is not indicated as allowable, based on the 112a and 112b rejections of claim 1. If applicant were to overcome these 112 rejections, claim 31 could be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, depending on the amendments to fix the 112 issues. Any amendments to address the 112 rejections would require further search/consideration, and a prior art rejection may be applicable at that time.
Conclusion
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.
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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