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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 30MAR2026 has been entered.
Status of Claims
The amendments and remarks filed on 30MAR2026 have been entered and considered.
Claims 1-19 are currently pending.
Claims 1 & 16 have been amended.
No claims have been withdrawn.
Claim 15 has been canceled.
Claims 40-44 have been added.
Claims 1-14, 16-19, & 40-44 are under examination.
Response to Arguments
Applicant's arguments filed 30MAR2026 regarding the rejections under 35 U.S.C 103 have been fully considered but are not persuasive. Parts deemed not persuasive discussed below:
Applicant argues (Pages 8-9 of the Remarks):
Welches and Altshuler do not teach or suggest a technique for consistently achieving material ejection.
However, the examiner disagrees. Applicant's arguments amount to 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. Therefore, the rejections are maintained.
Applicant argues (Page 10 of the Remarks):
Welches does not disclose performing a low-temperature, defect-inducing step that is functionally distinct from bubble generation, nor does it disclose separating these functions between different lasers.
However, the examiner disagrees. Applicant's arguments amount to 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. Therefore, the rejections are maintained.
Applicants submit Welches does not teach or suggest using lasers that would be unacceptable for or not sufficient for generating a bubble.
However, the examiner disagrees as the combination of references have been shown to teach the claim limitations, and applicants should not argue the references separately. It would have been obvious to one having ordinary skill in the art that it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Altshuler does not remedy the defects of Welches. Altshuler relates to dermatological and cosmetic treatment devices (e.g., scar removal), not surgical tissue destruction or material "ejection." Applicants submit that the method of Welches would be unacceptable for use in Altshuler, because Altschuler relates to cosmetic procedures such as scar removal, and the bubble technique in Welches would do precisely the opposite of the goal in Altshuler, i.e., destroying tissue with a laser ablation/ejection of tissue would generate scars and damage to tissue, not reduce scars. Because Altshuler relates to cosmetic procedures such as scar removal, it teaches away from Applicant's cavitation-driven blow-off process, which a person of ordinary skill in the art would recognize as potentially painful due to its reliance on localized mechanical failure and tissue ejection.
However, the examiner disagrees. Altshuler’s device is applicable to cosmetic procedures along with ablation procedures (see Altshuler ¶0223 “The creation of lattices of damage islets can be used in order to damage or destroy internal epithelia to treat conditions such a benign prostatic hyperplasia or hypertrophy, or restenosis. The methods can also be used to weld tissues together by creating damage areas at tissue interfaces.”). The applicant is focusing on only one aspect of Altshuler’s disclosure where it has been shown to have multiple applications for the device. As such, Altshuler’s device have similar components and functional operations to achieve a similar goal of ablation as Welches, and therefore would be obvious to combine.
Applicant argues (Page 12 of the Remarks):
Altshuler teaches away from the idea of using higher intensity lasers that would cause large increases in heat in a tissue.
The examiner disagrees as Altshuler ¶0022 shows that the desired temperature ranges have a large scale in both the temperature values and the ranges of temperature change.
Applicant submits that the instant application provides "surprising and unexpected" results that should be considered as secondary evidence of nonobviousness. MPEP §2145. Applicant submits that benefits of the methods as claimed include cleaner cuts, sharper boundaries, and more consistent material ejection, which arise specifically from deliberately separating the defect-inducing step from the bubble-generation step so as to transiently reduce shear modulus and mechanically precondition the material before cavitation occurs. For example, see paragraphs [0008]-[0010], [0092]. As described in the instant specification, controlled preconditioning can direct micro-crack formation and fracture propagation toward the material surface, enabling reliable blow-off and high-aspect-ratio removal - that was not achievable using bubble generation alone. See specification at paragraphs [0052]-[0053], [0091]-[0094], and FIG. 18. Neither Welches nor Altshuler suggest that such surprising
However, the examiner is not persuaded. The combination of references has been shown to already teach the claim limitations as they are claimed regardless of the intended results. Further, the advantages claimed are logical results of process parameter optimization and therefore would be obvious based on the prior art. Further, the applicant is arguing unexpected results. MPEP 716.02(e) states that “an affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness”. The applicant is relying on their disclosure that there is “unexpected result” but no direct comparison between their claimed invention and the primary reference conditions has been provided. MPEP 716.02(d) further states that the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. The cited sections of the specification only provides description of tissue removal rate using specific laser and spot size, which is not in scope with the claimed invention as recited in claim 1.
Applicants note that Welches does not teach a method for ejection of tissue; rather, Welches relates to a process for bubble formation and subsequent vaporization. See, e.g., Welches paragraphs [0052]-[0053].
However, the examiner disagrees because material ejection has not been described further for its intended meaning or claimed further. Therefore, under the broadest reasonable interpretation the material ejection is encompassed in vaporization as both tissue ejection and tissue vaporization removes the tissue in a targeted area (Welches ¶0051 “At least a portion of the tissue within rapidly expanding bubble (e.g., the cavitation bubble) is near-instantaneously vaporized providing an ablation volume.).
Applicant argues (Page 14 of the Remarks):
Ben Oren does not cure the deficiencies of Welches and Altshuler. Ben Oren relates to methods of blocking neural activity, not causing tissue ablation/ejection. Ben Oren is cited for describing a cooling system or Ho: YAG laser. Applicants submit that Ben Oren is unrelated to the methods and use of lasers as instantly claimed. Lasers used in Ben Oren for inhibiting neural activity are unrelated to lasers and methods for tissue ablation. Restated, inhibiting neurons is very different than destroying tissue, and one of skill would presumably not want to destroy or cause tissue ejection if inhibition of neurons is the goal.
However, the examiner disagrees because Ben Oren relates to blocking neural activity by the means of methods such as tissue ablation. Additionally, the examiner maintains that Ben Oren further is related to tissue ablation in which tissue is damaged for the purpose of blocking neural activity. (see Ben Oren ¶0013 “According to a non-limiting example, pulsed laser radiation may be used and ablation may occur only within the target area on which the laser radiation is focused. According to some embodiments, the laser radiation is focused on a target area such that only neurons within the target area are damaged, while non-neural tissues within the target area maintain functional activity.”). Therefore, the use of Ben Oren for the claim limitations, as combined with the other references, is maintained by the examiner
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 41-44 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 41-44 are directed to “The apparatus of claim 1” in the preamble. However, claim 1 is a method claim. As such, the antecedent basis of the limitation “The apparatus of claim 1” is indefinite as there is no apparatus of claim 1.
Claims 41-44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. Claims 41-44 fails to clearly define elements of apparatus since a transitional phrase is lacking for the structural elements of apparatus. Only transitional phrase is from the parent claim 1, which defines the method steps, not structural elements. As such, it is unclear which structural elements, first and second lasers, are part of the apparatus as recited in claims 41-44. This claim is an omnibus type claim.
For the purpose of prior art rejection below, claims 41-44 have been interpreted as being directed to “The method of claim 1”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 41-44 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 41-44 are directed to “The apparatus of claim 1” in the preamble. However, claim 1 is a method claim. As set forth above in the 35 U.S.C. 112(b) rejection, claims fail to clearly define elements of apparatus. Under the broadest reasonable interpretation, claims 41-44 does not include any method steps recited in claim 1 and further fails to recite any structural elements for the apparatus as recited in claims 41-44. As written, claims 41-44 are in improper dependent form for failing to further limit the subject matter of claim 1 and for not including every limitation of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 5-14, & 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Welches (US Publication No. 20160128777; Previously Cited) in view of Bragagna et al. (US Publication No. 20080208104), and Altshuler et al. (US Publication No. 20060004347; Previously Cited).
Regarding claim 1, Welches discloses a method for subtractive material processing (Welches ¶0051 “At least a portion of the tissue within rapidly expanding bubble (e.g., the cavitation bubble) is near-instantaneously vaporized providing an ablation volume.”; Abstract “Systems and methods for treating mucosal tissue by concentrating a laser emission to at least one depth at a fluence sufficient to create an ablation volume in at least a portion of the mucosal tissue”), the method comprising: a defect-inducing step (Welches ¶0067 “As discussed previously, shock waves and pressure waves of varying intensity propagate through the tissue as a result of a picosecond LIOB injury being imparted on the tissue. The propagation of these intense waves through biologic tissues manifests as mechanical stress and strain in the tissue cells.”; ¶0118); and a bubble-generation step (Welches ¶0053 “At least a portion of the cavitation bubble 101 is ablated (e.g., vaporized) and in this pressure bubble 101 the photo thermal effect (e.g., temperature rise) of the picosecond laser on the tissue is largely confined.”), wherein: the defect-inducing step comprises a first laser emitting radiation from an environment onto a material to create a spatially confined region with reduced mechanical modulus in the material between a bubble-generation site and an interface between the environment and the material (Welches ¶0053 “FIG. 1B depicts a tissue injury 100 caused by the picosecond laser. At least a portion of the cavitation bubble 101 is ablated (e.g., vaporized) and in this pressure bubble 101 the photo thermal effect (e.g., temperature rise) of the picosecond laser on the tissue is largely confined.” Showing the confined region as a result of the applied pressure waves from paragraph 52”; ¶0067 “As discussed previously, shock waves and pressure waves of varying intensity propagate through the tissue as a result of a picosecond LIOB injury being imparted on the tissue. The propagation of these intense waves through biologic tissues manifests as mechanical stress and strain in the tissue cells.”; ¶0118 “Onion-like mechanical injuries 306A, 306B, and 306 (e.g., shockwave and pressure wave injuries) are disposed around an ablation/cavitation bubble cavity 301A, 301B, and 301 that is within their center.” Showing the area between the bubble and interface has been damaged); the bubble-generation step comprises a laser emitting pulsed radiation from the environment onto the material to create a subsurface bubble below the environment-material interface (Welches Figure 3B as described in ¶0113 showing the application of energy to generate a bubble below the surface at the lens 315A/315B which serves as the environment/material interface.; ¶0174 “In various embodiments, a picosecond laser (e.g., a 532 nm, a 755 nm, and/or a 1064 nm picosecond laser) is equipped with a microlens array. The purpose of the microlens array is to create LIOB micro injuries in a plurality of micro focal zones within the target tissue. The microlens array creates micro injuries below the tissue surface such that the micro injury remains surrounded by healthy tissue. This promotes healing by allowing blood flow from healthy tissue to treat the subsurface mechanical injury.”); wherein the pulsed radiation has a wavelength between 0.4 - 2.3 pm (Welches ¶0200 “While wavelengths including 532 nm, 755 nm, or 1064 nm can all be made in picosecond durations sufficient to allow for LIOB formation, the 755 nm wavelength is expected to provide a preferred depth of treatment.”) and material failure due to bubble expansion occurs in the material region with reduced mechanical modulus created by the defect-inducing step and results in material ejection (Welches ¶0051 “At least a portion of the tissue within rapidly expanding bubble (e.g., the cavitation bubble) is near-instantaneously vaporized providing an ablation volume. Adjacent the vaporized volume are a roughly spherical injury where the most intense pressure waves called shock waves are concentrated.”; ¶0059 “More specifically, pulse widths from about 190 picoseconds to about 900 picoseconds, from about 200 picoseconds to about 500 picoseconds, or from about 260 to about 300 picoseconds can be employed to induce micro injuries that are mediated by plasma explosion initiated cavitation bubbles and the resulting shock waves and pressure waves.”).
Welches does not disclose using multiple laser sources. Bragagna in a similar field of endeavor of laser ablation teaches using multiple laser sources (Bragagna ¶010”4 “FIG. 2c shows a further embodiment of a laser micro-porator 10 comprising a plurality of individual laser sources 7, preferably laser diodes, each individually driven by a motor 8g, so that the beam 4 of each laser source 7 can individually be directed onto the surface of the skin to create a plurality of individual pores 2.). Before the effective filing date, it would have been obvious to one of ordinary skill I the art to combine the laser system disclosed by Welches with the use of multiple laser sources, as taught in Bragagna for the purposes of creating a laser system that can have reduced cell damage in non-targeted areas as well as creating a system that is capable of more treatments due to increased control options.
Welches in view of Bragagna does not disclose causing a defect-inducing temperature increase between 30-50°C to reduce a mechanical shear modulus of the material. Altshuler in a similar field of endeavor of laser-induced tissue ablation teaches causing a defect-inducing temperature increase between 30-50°C to reduce a mechanical shear modulus of the material (Altshuler ¶0022 “In the various embodiments of the invention, the lattices of EMR-treated islets can be heated to temperatures of 35-40.degree. C., 40-50.degree. C., 50-100.degree. C., 100-200.degree. C., or greater than 200.degree. C.” Showing the temperature range increasing by 30-50 degrees C when starting at normal temperatures (i.e. 29-37.degree. C.) as disclosed in ¶0174 which discussed reversible treatments; ¶0326 “ The threshold light fluence was evaluated incident on the skin, which heated the tissue by 30.degree. C. at the characteristic depth of 0.25 mm (curve 1), 0.5 mm (curve 2) and 0.75 mm (curve 3), respectively, and coagulated tissue up to this depth”). Before the effective filing date, it would have been obvious to one of ordinary skill I the art to combine the laser system disclosed by Welches in view of Bragagna with causing a defect-inducing temperature increase between 30-50°C to reduce a mechanical shear modulus of the material, as taught in Altshuler for the purposes of increasing the device’s treatment capability and parameter controls by using a large range of temperature variation (Altshuler ¶0144).
Regarding claim 5 Welches in view of Bragagna and Altshuler teaches the limitations of claim 1. Welches additionally discloses wherein the material is a biological tissue. (Welches Abstract “Systems and methods for treating mucosal tissue by concentrating a laser emission to at least one depth at a fluence sufficient to create an ablation volume in at least a portion of the mucosal tissue”; ¶0050 “controlled to provide systems and methods for controlled damage of cells and tissues (e.g., organs) that leads to improvement in the cells and tissues, improvements including tissue rejuvenation.”).
Regarding claim 6, Welches in view of Bragagna and Altshuler teaches the limitations of claims 1 & 5. Welches additionally discloses wherein the biological tissue contains a structural inhomogeneity (Welches ¶0195 “In tissue, scattering and inhomogeneity of the medium (tissue constituents) prevents long distance stable channel formation unlike in air or homogenous mediums. The collimated beam can be directed to form channels or filaments of light energy that ablate tissue or cause pressure waves over short distances in the tissue.”; Figures 7A (As described in ¶0025 and ¶0156) and 7B (As described in ¶0026 and ¶0156) showing the tissue structures.).
Regarding claim 7 Welches in view of Bragagna and Altshuler teaches the limitations of claims 1 & 5-6. Welches additionally discloses wherein the structural inhomogeneity is an epithelial tissue layer (Welches ¶0185 “In other words, LIOB deposited approximately 50 microns deep in the epidermis initiate elastin changes in the dermis to depths as great as 400 microns. In part, the process of treating or illuminating a first layer with light can induce bubble or pressure waves in one or more layers or regions below the first layer to treat other layers, tissues, regions, or structures below the first layer.”; Figure 7A (As described in ¶0025 and ¶0156)& Figure 8A (As described in ¶0027 and ¶0157) showing the tissue structure epidermis 732,832).
Regarding claim 8 Welches in view of Bragagna and Altshuler teaches the limitations of claim 1. Welches additionally discloses wherein the bubble-generation step creates a plasma (Welches ¶0051 “This LIOB injury features plasma initiated rapidly expanding bubbles.”; ¶0091; ¶0095).
Regarding claim 9 Welches in view of Bragagna and Altshuler teaches the limitations of claims 1 & 8. Welches additionally discloses wherein radiation emitted by an ultrafast laser creates the bubble in a material. (Welches ¶0011 “FIG. 1B illustrates a tissue injury caused by a picosecond laser including an ablation volume of a cavitation bubble with a layer of tissue adjacent the cavitation bubble being subjected to relatively intense pressure and the next progressively outer layer(s) of tissue being subjected to relatively less intense pressure”).
Regarding claim 10 Welches in view of Bragagna and Altshuler teaches the limitations of claim 1. Welches additionally discloses wherein the region of reduced mechanical modulus is conically shaped with least modulus reduction along the cone axis. (Welches Figure 3A as described in ¶0113 showing the conical focus. Additionally shown in in Figures 1B & 3B, 3C, 3E where the beams have reduced damging effects until they converge at the targeted deep ablation site at the tip of the cone of treatment that is formed by the crossing beams.).
Regarding claim 11 Welches in view of Bragagna and Altshuler teaches the limitations of claim 1. Welches additionally discloses wherein radiation for the defect inducing step is derived from the radiation source for the bubble generating step. (Welches ¶0034 “The system optionally includes a wavelength-shifting resonator 72 for receiving the picosecond pulses generated by the pump radiation source 71 and emitting radiation at a second wavelength in response thereto to the treatment beam delivery system 73 “; ¶0035 “Additionally, it will be appreciated by a person skilled in the art in light of the present teachings that the pump radiation source 71 can be operated so as to generate pulses at various energies, depending for example, on the amount of energy required to stimulate emission by the wavelength-shifting resonator 72 and the amount of energy required to perform a particular treatment in light of the efficiency of the system 70 as a whole.”).
Regarding claim 12 Welches in view of Bragagna and Altshuler teaches the limitations of claims 1 & 11. Welches additionally discloses wherein radiation for the defect-inducing step is derived from pump-radiation for the radiation source for the bubble-generating step. (Welches ¶0035 “Additionally, it will be appreciated by a person skilled in the art in light of the present teachings that the pump radiation source 71 can be operated so as to generate pulses at various energies, depending for example, on the amount of energy required to stimulate emission by the wavelength-shifting resonator 72 and the amount of energy required to perform a particular treatment in light of the efficiency of the system 70 as a whole.”; ¶0033; ¶0037; ¶0039).
Regarding claim 13 Welches in view of Bragagna and Altshuler teaches the limitations of claims 1 & 11-12. Welches additionally discloses wherein radiation for the defect-inducing step is derived from the radiation source for the bubble-generating step through a non-linear conversion process. (Welches ¶0103 “Selective photothermolysis is a thermal approach to creating tissue injuries, by thermal means. In the picosecond and nanosecond domains, linear absorption and thus photothermolysis describe the initiation of ionization and consequent non-linear absorption, resulting in an expanding plasma bubble.”; ¶0126 “A sequential one two pulse technique can provide an enhanced lesion. For example, a sequential one two pulse technique can optimize the shockwave effect by delivering a 2.sup.nd laser pulse to the target (LIOB expanded bubble) before ionization and non-linear absorption has discontinued. The technique initiates a second expanding shockwave to increase lesion size.”).
Regarding claim 14, Welches in view of Bragagna and Altshuler teaches the limitations of claims 1 & 5. Welches additionally discloses wherein the defect-inducing step utilizes radiation between 0.8 - 2.3um. (Welches ¶0190 “Further, one or more LIOBs may also be formed in the lamina propia based upon the design of the micro-lens array such that the focal zone is aimed to purposely generate lesions in the deeper tissue. Additionally, alternate wavelengths may be applied to adjust the depth of the targeted high fluence focal zone.”; ¶0022 “While wavelengths including 532 nm, 755 nm, or 1064 nm can all be made in picosecond durations sufficient to allow for LIOB formation, the 755 nm wavelength is expected to provide a preferred depth of treatment.”).
Regarding claim 16, Welches in view of Bragagna and Altshuler teaches the limitations of claims 1 & 5. Altshuler further teaches wherein the defect-inducing step utilizes a ytterbium fiber laser. (Altshuler ¶0241 “In other embodiments, other laser sources, such as chromium (Cr), Ytterbium (Yt) or diode lasers, or broadband sources, e.g., lamps, can be employed for generating the treatment radiation.”). Before the effective filing date, one of ordinary skill in the art would think to combine the laser system disclosed by Welches and Altshuler with the ytterbium fiber laser taught in Altshuler since it allows for operation over multiple wavelengths.
Regarding claim 17 Welches in view of Bragagna and Altshuler teaches the limitations of claims 1 & 5. Welches additionally discloses wherein the defect-inducing step utilizes an erbium (Er):Glass laser. (Welches ¶0037 “In an exemplary embodiment, the pump radiation source 71 comprises a solid state lasing medium and an optical pumping device. Exemplary solid state lasers include an alexandrite or a titanium doped sapphire (TIS) crystal, Nd:YAG lasers, Nd:YAP, Nd:YAlO.sub.3 lasers, Nd:YAF lasers, and other rare earth and transition metal ion dopants (e.g., erbium, chromium, and titanium) and other crystal and glass media hosts (e.g., vanadate crystals such as YVO.sub.4, fluoride glasses such as ZBLN, silica glasses, and other minerals such as ruby).”).
Claims 2-4, 18-19, & 40-44 are rejected under 35 U.S.C. 103 as being unpatentable over Welches (US Publication No. 20160128777; Previously Cited) in view of Bragagna et al. (US Publication No. 20080208104), Altshuler et al. (US Publication No. 20060004347; Previously Cited) as applied to claims 1 and 5 above, and further in view of Ben Oren et al. (US Publication No. 20170027645; Previously Cited).
Regarding claim 2, Welches combined with Bragagna and Altshuler discloses the limitations of claim 1, but does not disclose wherein the material is cooled before, during or after the bubble generation step. Ben Oren in a similar field of endeavor of laser-induced tissue ablation teaches wherein the material is cooled before, during or after the bubble generation step (Ben Oren ¶0033 “optical element is used to focus the laser beam on the surface of the lumen that is actively cooled”; ¶0013 “According to some embodiments minimal thermal damage to the surrounding tissues is achieved by cooling the surrounding tissues, tissue in the path of the energy transfer and/or shielding it from the effects of the thermal damage induced to the target tissue.”). Before the effective filing date, one of ordinary skill in art would think to combine the laser system disclosed by Welches combined with Bragagna and Altshuler, with the methods where the material is cooled before, during or after the bubble generation step, as taught in Ben Oren for the purposes of minimizing thermal damage (Ben Oren Column 2 Lines 20-25).
Regarding claim 3, Welches combined with Bragagna and Altshuler discloses the limitations of claims 1-2, but does not disclose wherein the cooling is convective cooling. Ben Oren in a similar field of endeavor of laser-induced tissue ablation teaches wherein the cooling is convective cooling (Ben Oren ¶0364 “Non limiting examples include infusion pumps of chilled coolants to induce local hypothermia as known in the art.” This citation shows the disclosure of examples of convective cooling being used, which utilizes the coolant flowing to cool an area. ). Before the effective filing date, one of ordinary skill in the art would think to combine the laser system disclosed by Welches combined with Bragagna and Altshuler with the convective cooling techniques as taught in Ben Oren for the purposes of minimizing thermal damage (Ben Oren Column 2 Lines 20-25).
Regarding claim 4, Welches combined with Bragagna and Altshuler discloses the limitations of claims 1-3, but does not disclose wherein the cooling is evaporative cooling. Ben Oren in a similar field of endeavor of laser-induced tissue ablation teaches wherein the cooling is evaporative cooling (Ben Oren ¶0364 “According to some embodiment cold gases are used that can be delivered through the catheter or generated on the spot such as, but not limited to, liquid nitrogen that evaporated close enough to the target that requires cooling.”). Before the effective filing date, one of ordinary skill in the art would think to combine the laser system disclosed by Welches combined with Bragagna and Altshuler with the evaporative cooling techniques as taught in Ben Oren for the purposes of minimizing thermal damage (Ben Oren Column 2 Lines 20-25).
Regarding claim 18, Welches combined with Bragagna and Altshuler discloses the limitations of claims 1 and 5, but does not disclose wherein the bubble-generation step utilizes a thulium (Tm) laser. Ben Oren in a similar field of endeavor of laser-induced tissue ablation teaches wherein the bubble-generation step utilizes a thulium (Tm) laser. (Ben Oren ¶0265 “According to non-limiting examples, the laser radiation is produced by a laser selected from the group consisting of: a double YAG laser emitting radiation at a wavelength of 532 nm, a laser diode emitting radiation at a wavelength of 808 nm-980 nm, a laser diode emitting radiation at a wavelength of 1500 nm, a 2 microns Holmium Thuliium and a combination thereof.”; ¶0269 “In yet another embodiment, a 2.9 laser with free running pulses ranging from micro-hundreds of seconds to micro-seconds (such as 3 Mikron Er:YAG lasers) or a pico-sec (such as PIRL manufactured by Attodyne Lasers) or nano-sec laser can be used to generate very thin controlled cuts in the duodenal wall by ablation. Controlled cuts may be performed with other lasers such as, but not limited to, Thulmium or 355 nm. According to some embodiments, a second laser may be used in conjunction with the laser source producing the disclosed laser radiation in order to facilitate coagulation.”). Before the effective filing date, one of ordinary skill in the art would think to combine the picosecond-laser system disclosed by Welches combined with Bragagna and Altshuler with the thulium (Tm) laser taught in Ben Oren for the purposes of being compact and adding the ability to use small spots to obtain a high enough peak power to cause damage (Ben Oren ¶0253), and the addition of the secondary laser facilitates coagulation (Ben Oren ¶0269).
Regarding claim 19, Welches combined with Bragagna and Altshuler discloses the limitations of claims 1 and 5, but does not disclose wherein the bubble-generation step utilizes an holmium (Ho):YAG laser. Ben Oren in a similar field of endeavor of laser-induced tissue ablation teaches wherein the bubble-generation step utilizes an holmium (Ho):YAG laser (Ben Oren ¶0265 “According to non-limiting examples, the laser radiation is produced by a laser selected from the group consisting of: a double YAG laser emitting radiation at a wavelength of 532 nm, a laser diode emitting radiation at a wavelength of 808 nm-980 nm, a laser diode emitting radiation at a wavelength of 1500 nm, a 2 microns Holmium Thuliium and a combination thereof.”; ¶0269 “In yet another embodiment, a 2.9 laser with free running pulses ranging from micro-hundreds of seconds to micro-seconds (such as 3 Mikron Er:YAG lasers) or a pico-sec (such as PIRL manufactured by Attodyne Lasers) or nano-sec laser can be used to generate very thin controlled cuts in the duodenal wall by ablation. Controlled cuts may be performed with other lasers such as, but not limited to, Thulmium or 355 nm. According to some embodiments, a second laser may be used in conjunction with the laser source producing the disclosed laser radiation in order to facilitate coagulation.”). Before the effective filing date, one of ordinary skill in the art would think to combine picosecond-laser system disclosed by Welches combined with Bragagna and Altshuler with the (Ho):YAG laser taught in Ben Oren for the purposes of being compact and adding the ability to use small spots to obtain a high enough peak power to cause damage (Ben Oren ¶0253), and the addition of the secondary laser facilitates coagulation (Ben Oren ¶0269).
Regarding Claim 40, Welches combined with Bragagna and Altshuler teaches the limitations of claim 1. Welches nor Bragagna disclose wherein the first laser comprises an ytterbium fiber laser and the second laser comprises a thulium fiber laser. Altshuler teaches wherein the first laser comprises an ytterbium fiber laser (Altshuler ¶0241 “In other embodiments, other laser sources, such as chromium (Cr), Ytterbium (Yt) or diode lasers, or broadband sources, e.g., lamps, can be employed for generating the treatment radiation.”). Before the effective filing date, it would have been obvious to one of ordinary skill I the art to combine the laser system disclosed by Welches in view of Bragagna, and Altshuler, with wherein the first laser comprises an ytterbium fiber laser, as taught in Altshuler, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Neither Welches, Bragagna, nor Altshuler teach the second laser comprises a thulium fiber laser. Ben Oren further teaches the second laser comprises a thulium fiber laser (Ben Oren ¶0265 “According to non-limiting examples, the laser radiation is produced by a laser selected from the group consisting of: a double YAG laser emitting radiation at a wavelength of 532 nm, a laser diode emitting radiation at a wavelength of 808 nm-980 nm, a laser diode emitting radiation at a wavelength of 1500 nm, a 2 microns Holmium Thuliium and a combination thereof.”; ¶0269 “In yet another embodiment, a 2.9 laser with free running pulses ranging from micro-hundreds of seconds to micro-seconds (such as 3 Mikron Er:YAG lasers) or a pico-sec (such as PIRL manufactured by Attodyne Lasers) or nano-sec laser can be used to generate very thin controlled cuts in the duodenal wall by ablation. Controlled cuts may be performed with other lasers such as, but not limited to, Thulmium or 355 nm. According to some embodiments, a second laser may be used in conjunction with the laser source producing the disclosed laser radiation in order to facilitate coagulation.”). Before the effective filing date, it would have been obvious to one of ordinary skill I the art to combine the laser system disclosed by Welches in view of Bragagna, and Altshuler with wherein the second laser comprises a thulium fiber laser, as taught in Ben Oren, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 41, Welches combined with Bragagna and Altshuler teaches the limitations of claim 1. Neither Welches or Bragagna teach wherein the first laser comprises an ytterbium fiber laser. Altshuler further teaches wherein the first laser comprises an ytterbium fiber laser (Altshuler ¶0241 “In other embodiments, other laser sources, such as chromium (Cr), Ytterbium (Yt) or diode lasers, or broadband sources, e.g., lamps, can be employed for generating the treatment radiation.”). Before the effective filing date, it would have been obvious to one of ordinary skill I the art to combine the laser system disclosed by Welches in view of Bragagna, and Altshule with wherein the first laser comprises an ytterbium fiber laser, as taught in Altshuler, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Neither Welches, Bragagna, or Altshuler teach the second laser comprises a holmium laser. Ben Oren further teaches the second laser comprises a holmium laser (Ben Oren ¶0265 “According to non-limiting examples, the laser radiation is produced by a laser selected from the group consisting of: a double YAG laser emitting radiation at a wavelength of 532 nm, a laser diode emitting radiation at a wavelength of 808 nm-980 nm, a laser diode emitting radiation at a wavelength of 1500 nm, a 2 microns Holmium Thuliium and a combination thereof.”; ¶0269 “In yet another embodiment, a 2.9 laser with free running pulses ranging from micro-hundreds of seconds to micro-seconds (such as 3 Mikron Er:YAG lasers) or a pico-sec (such as PIRL manufactured by Attodyne Lasers) or nano-sec laser can be used to generate very thin controlled cuts in the duodenal wall by ablation. Controlled cuts may be performed with other lasers such as, but not limited to, Thulmium or 355 nm. According to some embodiments, a second laser may be used in conjunction with the laser source producing the disclosed laser radiation in order to facilitate coagulation.”). Before the effective filing date, it would have been obvious to one of ordinary skill I the art to combine the laser system disclosed by Welches in view of Bragagna, and Altshuler with wherein the second laser comprises a holmium laser, as taught in Ben Oren, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 42, Welches combined with Bragagna and Altshuler teaches the limitations of claim 1. Welches further discloses wherein the first laser comprises an erbium glass laser (Welches ¶0037 “n an exemplary embodiment, the lasing or gain medium of the pump radiation source 71 can be pumped by any conventional pumping device such as an optical pumping device (e.g., a flash lamp) or an electrical or injection pumping device. In an exemplary embodiment, the pump radiation source 71 comprises a solid state lasing medium and an optical pumping device. Exemplary solid state lasers include an alexandrite or a titanium doped sapphire (TIS) crystal, Nd:YAG lasers, Nd:YAP, Nd:YAlO.sub.3 lasers, Nd:YAF lasers, and other rare earth and transition metal ion dopants (e.g., erbium, chromium, and titanium) and other crystal and glass media hosts (e.g., vanadate crystals such as YVO.sub.4, fluoride glasses such as ZBLN, silica glasses, and other minerals such as ruby).”).
Neither Welches or Bragagna teach the second laser comprises a thulium laser. Ben Oren further teaches the second laser comprises a thulium laser (Ben Oren ¶0265 “According to non-limiting examples, the laser radiation is produced by a laser selected from the group consisting of: a double YAG laser emitting radiation at a wavelength of 532 nm, a laser diode emitting radiation at a wavelength of 808 nm-980 nm, a laser diode emitting radiation at a wavelength of 1500 nm, a 2 microns Holmium Thuliium and a combination thereof.”; ¶0269 “In yet another embodiment, a 2.9 laser with free running pulses ranging from micro-hundreds of seconds to micro-seconds (such as 3 Mikron Er:YAG lasers) or a pico-sec (such as PIRL manufactured by Attodyne Lasers) or nano-sec laser can be used to generate very thin controlled cuts in the duodenal wall by ablation. Controlled cuts may be performed with other lasers such as, but not limited to, Thulmium or 355 nm. According to some embodiments, a second laser may be used in conjunction with the laser source producing the disclosed laser radiation in order to facilitate coagulation.”). Before the effective filing date, it would have been obvious to one of ordinary skill I the art to combine the laser system disclosed by Welches in view of Bragagna, and Altshuler with the second laser comprises a thulium laser, as taught in Ben Oren, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 43, Welches combined with Bragagna and Altshuler teaches the limitations of claim 1. Welches further discloses wherein the first laser comprises an erbium glass laser (Welches ¶0037 “n an exemplary embodiment, the lasing or gain medium of the pump radiation source 71 can be pumped by any conventional pumping device such as an optical pumping device (e.g., a flash lamp) or an electrical or injection pumping device. In an exemplary embodiment, the pump radiation source 71 comprises a solid state lasing medium and an optical pumping device. Exemplary solid state lasers include an alexandrite or a titanium doped sapphire (TIS) crystal, Nd:YAG lasers, Nd:YAP, Nd:YAlO.sub.3 lasers, Nd:YAF lasers, and other rare earth and transition metal ion dopants (e.g., erbium, chromium, and titanium) and other crystal and glass media hosts (e.g., vanadate crystals such as YVO.sub.4, fluoride glasses such as ZBLN, silica glasses, and other minerals such as ruby).”)
Neither Welches, Bragagna, or Altshuler teach the second laser comprises a holmium laser. Ben Oren further teaches the second laser comprises a holmium laser (Ben Oren ¶0265 “According to non-limiting examples, the laser radiation is produced by a laser selected from the group consisting of: a double YAG laser emitting radiation at a wavelength of 532 nm, a laser diode emitting radiation at a wavelength of 808 nm-980 nm, a laser diode emitting radiation at a wavelength of 1500 nm, a 2 microns Holmium Thuliium and a combination thereof.”; ¶0269 “In yet another embodiment, a 2.9 laser with free running pulses ranging from micro-hundreds of seconds to micro-seconds (such as 3 Mikron Er:YAG lasers) or a pico-sec (such as PIRL manufactured by Attodyne Lasers) or nano-sec laser can be used to generate very thin controlled cuts in the duodenal wall by ablation. Controlled cuts may be performed with other lasers such as, but not limited to, Thulmium or 355 nm. According to some embodiments, a second laser may be used in conjunction with the laser source producing the disclosed laser radiation in order to facilitate coagulation.”). Before the effective filing date, it would have been obvious to one of ordinary skill I the art to combine the laser system disclosed by Welches in view of Bragagna, and Altshuler with wherein the second laser comprises a holmium laser, as taught in Ben Oren, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 44, Welches combined with Bragagna and Altshuler teaches the limitations of claim 1. Neither Welches, Bragagna, or Altshuler teach wherein the first laser comprises a thulium laser and the second laser comprises a holmium laser. Ben Oren teaches wherein the first laser comprises a thulium laser (Ben Oren ¶0265 “According to non-limiting examples, the laser radiation is produced by a laser selected from the group consisting of: a double YAG laser emitting radiation at a wavelength of 532 nm, a laser diode emitting radiation at a wavelength of 808 nm-980 nm, a laser diode emitting radiation at a wavelength of 1500 nm, a 2 microns Holmium Thuliium and a combination thereof.”; ¶0269 “In yet another embodiment, a 2.9 laser with free running pulses ranging from micro-hundreds of seconds to micro-seconds (such as 3 Mikron Er:YAG lasers) or a pico-sec (such as PIRL manufactured by Attodyne Lasers) or nano-sec laser can be used to generate very thin controlled cuts in the duodenal wall by ablation. Controlled cuts may be performed with other lasers such as, but not limited to, Thulmium or 355 nm. According to some embodiments, a second laser may be used in conjunction with the laser source producing the disclosed laser radiation in order to facilitate coagulation.”) and the second laser comprises a holmium laser (Ben Oren ¶0265 “According to non-limiting examples, the laser radiation is produced by a laser selected from the group consisting of: a double YAG laser emitting radiation at a wavelength of 532 nm, a laser diode emitting radiation at a wavelength of 808 nm-980 nm, a laser diode emitting radiation at a wavelength of 1500 nm, a 2 microns Holmium Thuliium and a combination thereof.”; ¶0269 “In yet another embodiment, a 2.9 laser with free running pulses ranging from micro-hundreds of seconds to micro-seconds (such as 3 Mikron Er:YAG lasers) or a pico-sec (such as PIRL manufactured by Attodyne Lasers) or nano-sec laser can be used to generate very thin controlled cuts in the duodenal wall by ablation. Controlled cuts may be performed with other lasers such as, but not limited to, Thulmium or 355 nm. According to some embodiments, a second laser may be used in conjunction with the laser source producing the disclosed laser radiation in order to facilitate coagulation.”). Before the effective filing date, it would have been obvious to one of ordinary skill I the art to combine the laser system disclosed by Welches in view of Bragagna, and Altshuler with wherein the first laser comprises a thulium laser and the second laser comprises a holmium laser, as taught in Ben Oren, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Conclusion
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/MEGAN T FEDORKY/Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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