Lumenis Ltd.Download PDFPatent Trials and Appeals BoardApr 2, 202014242449 - (D) (P.T.A.B. Apr. 2, 2020) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/242,449 04/01/2014 Yoni IGER 35678-930001 7078 122004 7590 04/02/2020 ISUS Intellectual Property PLLC A. Jason Mirabito 1300 I Street, NW Suite 400 Washington, DC 20005 EXAMINER STEINBERG, AMANDA L ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 04/02/2020 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): admin@isusip.com jason@isusip.com officeus@isusip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte YONI IGER __________ Appeal 2019-004295 Application 14/242,449 Technology Center 3700 __________ Before MICHAEL L. HOELTER, ANNETTE R. REIMERS, and LISA M. GUIJT, Administrative Patent Judges. GUIJT, Administrative Patent Judge. DECISION ON APPEAL Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s rejection of claims 1–7, 10–19, 21, 22, 27–34, 37, and 38. Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Lumenis, Ltd. Appeal Br. 3. Appeal 2019-004295 Application 14/242,449 2 STATEMENT OF THE CASE Appellant’s invention relates to “a medical laser apparatus” particularly, for the “cosmetic treatment of skin.” Spec. ¶ 1. Claims 1, 12, and 37 are the independent claims on appeal. Claim 1, reproduced below with disputed limitations italicized for emphasis, is exemplary of the subject matter on appeal. 1. A medical apparatus for treatment of skin tissue for collagen synthesis and skin regeneration comprising: a first non- ablative laser source that is configured by a controller to apply a first laser light beam at a first wavelength to the skin tissue, and a second, different laser source that is configured to apply a second laser light beam at a second wavelength to the skin tissue, the first laser light beam having a first, long pulse duration[2] wherein the apparatus further comprises a treatment head and wherein the first laser light beam is configured to be supplied to the treatment head, the treatment head comprising a scanning device, the scanning device being configured to direct the first laser light beam to a plurality of locations within a first treatment area having a first diameter to create a plurality of fractional coagulated areas within the first treatment area which extend into the skin tissue, the second laser light beam being configured to be pulsed with a second, short pulse duration[3] directed to a 2 Notably, the claim term “long pulse duration” is a term of degree. Cf. Spec. ¶ 36 (disclosing, with reference to the first laser source, that “a relatively long pulse length” is a pulse length “of up to 0.5 s”). We decline to exercise the discretion afforded to us in 37 C.F.R. § 41.50(b) to impose a new ground of rejection under 35 U.S.C. § 112(b) directed to claims 1–7, 10–19, 21, 22, 27–34, 37, and 38; rather, we leave to the Examiner the determination of whether such a new ground is appropriate. Although the Board is authorized to reject claims under 37 C.F.R. § 41.50(b), no inference should be drawn when the Board elects not to do so. See MPEP 1213.02. 3 Notably, the claim term “short pulse duration” is a term of degree. Cf. Spec. ¶ 36 (disclosing, with reference to the second laser source, that “a very short, high-power pulse” may be “in the range [of] 1 to 100 ns”). We Appeal 2019-004295 Application 14/242,449 3 second treatment area, the second treatment area having a second diameter overlapping the plurality of the fractional coagulated areas in the first treatment area, the second treatment area being larger than the plurality of the coagulated areas formed in the first treatment area, the second treatment4 being configured to cause one or more of photomechanical or photoacoustic effects in the plurality of fractional coagulated areas of the first treatment area, the controller being configured to cause the apparatus to apply the first laser light beam and subsequently the second laser light beam; wherein the first wavelength is 1565 nm and the second wavelength is 1064 nm. THE REJECTIONS I. Claims 1–7, 10–19, 21, 22, 27–34, 37, and 38 stand rejected under 35 U.S.C. § 103 as being unpatentable over Tankovich (US 2011/0313408 decline to exercise the discretion afforded to us in 37 C.F.R. § 41.50(b) to impose a new ground of rejection under 35 U.S.C. § 112(b) directed to claims 1–7, 10–19, 21, 22, 27–34, 37, and 38; rather, we leave to the Examiner the determination of whether such a new ground is appropriate. Although the Board is authorized to reject claims under 37 C.F.R. § 41.50(b), no inference should be drawn when the Board elects not to do so. See MPEP 1213.02. 4 The claim term “the second treatment” lacks antecedent basis. We decline to exercise the discretion afforded to us in 37 C.F.R. § 41.50(b) to impose a new ground of rejection under 35 U.S.C. § 112(b) directed to claims 1–7, 10, 11, 27–30, 32, 37, and 38; rather, we leave to the Examiner the determination of whether such a new ground is appropriate. Although the Board is authorized to reject claims under 37 C.F.R. § 41.50(b), no inference should be drawn when the Board elects not to do so. See MPEP 1213.02. Appeal 2019-004295 Application 14/242,449 4 A1; published Dec. 22, 2011) and Stumpp (US 2008/0255639 A1; published Oct. 16, 2008), as evidenced Jansen.5 II. Claims 30 and 34 stand rejected under 35 U.S.C. § 103 as being unpatentable over Tankovich, Stumpp, and Altshuler (US 2008/0172047 A1; published July 17, 2008), as evidenced by Jansen. ANALYSIS Interpretation of the claims Independent claims 1 and 37 require, in relevant part, a medical apparatus for treatment of skin tissue, comprising (i) a first laser source configured to apply a first laser light beam to the skin tissue; and (ii) a second laser source configured to apply a second laser light beam to the skin tissue. Claims 1 and 37 also require, in relevant part, a scanning device “configured to direct the first laser light beam to a plurality of locations within a first treatment area having a first diameter to create a plurality of fractional coagulated areas within the first treatment area which extend into the skin tissue” and also that “the second laser light beam being configured to be . . . directed to a second treatment area.” Thus, there are three “areas” recited in claims 1 and 37: (i) the first treatment area with at least a diameter; (ii) the second treatment area with at least a diameter; and (iii) a plurality of fractional coagulated areas which extend into the skin within the first treatment area. Claims 1 and 37 further require, in relevant part, that (i) “the second treatment area ha[s] a second diameter overlapping the 5 Jansen et al., Effect of Pulse Duration on Bubble Formation and Laser- Induced Pressure Waves During Holmium Laser Ablation, LASER IN SURGERY AND MEDICINE 18:278–293 (1996). Appeal 2019-004295 Application 14/242,449 5 plurality of the fractional coagulated areas in the first treatment area”; and (ii) “the second treatment area being larger than the plurality of the coagulated areas formed in the first treatment area” (emphasis added). Claims 1 and 37 do not expressly recite any boundaries (i.e., diameters) for the first and second treatment areas, other than to require that the first and second laser light beams are directed to the first and second treatment areas, respectively. We look to the Specification to determine whether boundaries, and specifically, diameters (i.e., transverse measurements of something, widths, or thicknesses) of the first and second treatment areas can be ascertained. Regarding the first treatment area, the Specification discloses that “beam 23 is directed at the skin 20, where a local fractional volume of the skin is heated to coagulative level,” such that “[t]he treated areas have a width which depends on the width of the first beam 23” and wherein “the regions of skin 20 between the areas 24 are substantially unharmed and unaffected.” Spec. ¶ 38. The Specification also discloses that “first laser light beam 23 may be directed to form an array of areas 24 in any suitable manner as required, depending on the area and condition to be treated,” wherein “[s]uitable patterns are illustrated in [Figure] 3, including hexagonal, annular, circular, square, rectangular and linear arrangements of areas 24.” Id.; see also Spec. ¶¶ 29, 30, Fig. 3 (depicting a plurality of alternative beam locations during a first irradiation step). The Specification further discloses that “a second laser light beam is generated from the second laser source 12 and directed to the treated area of skin 20” is shown in Figure 4, reproduced below, wherein “second laser light beam 25 has a much larger diameter than the first laser light beam 23” Appeal 2019-004295 Application 14/242,449 6 and “as such will be able to cover a portion of the array of areas 24 illustrated in Fig. 3, thus irradiating a plurality of areas 24 simultaneously.” Spec. ¶ 39. Figure 4 depicts the subsequent irradiation step of directing second light beam 25 to a second treatment area. We decline to read into the claims a limitation that the first treatment area has a diameter that is defined by a transverse measurement of the boundaries of pattern formed by scanning the first laser light beam, because the claims require the first laser light beam to create a plurality of locations within a first treatment area having a first diameter, not to define the first treatment area on the skin tissue. Similarly, we decline to read into the claims a limitation that the second treatment area has a diameter that is defined by the width of the second laser light beam, because the claims require the second light beam to be directed to a second treatment area, not to define the second treatment area on the skin tissue. Cf. Spec. ¶ 15 (disclosing directing the first and second laser light beams to “irradiation area[s]”); id. ¶ 37 (disclosing directing the first laser light beam to a plurality Appeal 2019-004295 Application 14/242,449 7 of locations over “a desired area for treatment”). In other words, as written, the claims do not allow for a construction that the first and second treatment areas are identifiable only after irradiation by the first and second laser light beams and by the beams (i.e., beam pattern widths, beam widths themselves). Independent claim 12 recites, in relevant part, a method of directing laser light to a skin tissue surface for skin tissue treatment, comprising the steps of (i) generating and directing a first laser light beam to a plurality of first irradiation areas on the skin tissue to create a plurality of fractional coagulated areas in a first treatment area having a first diameter of the skin tissue; and (ii) subsequently generating and directing a second laser light beam to a second treatment area on the skin tissue having a second diameter overlapping the first diameter and being larger than the plurality of coagulated areas formed in the first treatment areas. Similar to claims 1 and 37 supra, claim 12 does not specify that the fractional coagulated areas define the first treatment area, or more particularly, that a diameter of the pattern of the fractional coagulated areas defines the first treatment area; nor does claim 12 specify that second treatment area is defined by the width of the second laser light beam. None of dependent claims 2–7, 10, 11, 13–19, 21, 22, 27–34, and 38 recite boundaries for the first and second treatment areas. In sum, we interpret the first and second treatment areas to mean predetermined areas on the skin that are desirable for treatment. Notably, construing claims broadly during prosecution is not unfair to the applicant, because the applicant has the opportunity to amend the claims to obtain Appeal 2019-004295 Application 14/242,449 8 more precise claim coverage. In re Am. Acad. of Sci. Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2012). Rejection I Independent claim 1 and dependent claims 2, 3, 6, 7, 10, 11, 27, 28, and 30 Appellant argues claims 1–3, 6, 7, 10, 11, 27, 28, and 30 as a group. Appeal Br. 8–11, 13. We select independent claim 1 as representative, and claims 2, 3, 6, 7, 10, 11, 27, 28, and 30 standing or falling with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv). Regarding independent claim 1, the Examiner finds, inter alia, that Tankovich discloses a medical apparatus for treatment of skin tissue for collagen synthesis and skin regeneration comprising first and second laser sources configured to apply first and second laser light beams to the skin, the first laser light beam being directed to create a coagulated area in a first treatment area having a first diameter and the second laser light beam being directed to a second treatment area having a diameter that overlaps the coagulated area in the first treatment area, as claimed. Final Act. 3–4 (citing Tankovich ¶¶ 27, 68, Figs. 3, 5C). The Examiner also finds that Tankovich’s second laser light beam is configured to cause one or more of photomechanical or photoacoustic effects in the coagulated area of the first treatment area, as claimed. Id. (citing Tankovich ¶¶ 68–72). The Examiner determines that Tankovich does not teach a scanning device for directing the first laser light beam to a plurality of locations within the first treatment area to create a plurality of fractional coagulated areas within the first treatment area, and the Examiner relies on Stumpp for disclosing directing a laser light beam to a first treatment area to create a Appeal 2019-004295 Application 14/242,449 9 plurality of fractional coagulated areas within the first treatment area, as claimed. Final Act. 4–5 (citing Stumpp ¶ 40). The Examiner reasons that it would have been obvious to modify Tankovich’s “dual laser device” to include a scanning head that directs the first laser light beam to a plurality of locations within the first treatment area to create a plurality of fractional coagulated areas within the first treatment area, as taught in Stumpp, for example, “‘to penetrate as deeply as needed . . . without causing unwanted side effects.’” Id. at 5 (citing Stumpp ¶¶ 3, 13, 15, 16). The Examiner further finds that although Tankovich discloses that the second laser light beam has a wavelength of 1064 nm, Tankovich fails to disclose that the first laser light beam may have a wavelength of 1565 nm, as claimed. Final Act. 4 (see, e.g., Tankovich, Table II). The Examiner relies on Stumpp for teaching that laser light beams having wavelengths between about 1500 and about 1620 nm (i.e., including 1565 nm, as claimed) “can be used depending on ‘the desired size and depth of the coagulation zones’” for treating skin tissue. Id. at 5 (citing, e.g., Stumpp ¶ 29). The Examiner reasons that selecting a wavelength of 1565 nm for a first laser light beam is “routine optimization,” because the choice of wavelengths for the first and second laser light beams “‘can be optimized based on factors, such as, for example, the desired diameter and depth of the coagulated zone, the desired diameter and depth of the treatment zone, the type(s) of tissue being treated, the type(s) of condition(s) being treated, the light scattering properties of the wavelength(s), etc.’” Id. (quoting Stumpp ¶ 30) (citing In re Aller, 220 F. 2d 454, 456 (CCPA 1955)). In other words, the Examiner finds that Stumpp discloses the general conditions of the claim and also that wavelength is variable and that it is recognized in the prior art as result-effective, and Appeal 2019-004295 Application 14/242,449 10 specifically, a variable that effects the diameter and depth of the coagulated and treatment zones and that is selected based on the tissue and the conditions of the tissue being treated. Id. First, Appellant argues that Tankovich’s method is “the exact opposite” of the subject matter claimed, because, in Tankovich, a thermal cavity is created (or a single coagulated area) to pre-heat the tissue followed by the creation of droplets (or a plurality of fractional coagulated areas) for a cumulative thermal effect—as compared to the claims, which require the first laser light beam to create a plurality of fractional coagulated areas followed by the second laser beam. Appeal Br. 9; see also id. 10 (“[t]here is no suggestion in Tankovich to use the sequence of the events recited in the claims”); Reply Br. 2–3. The Examiner responds correctly that Tankovich alone is not relied on for teaching Appellant’s claimed sequence of irradiation, but rather, Tankovich as modified by Stumpp, results in the claimed sequence of irradiation. Ans. 7. Indeed, Tankovich discloses: (i) first, heating a volume of skin to create tissue damage, namely, a single thermal cavity (as compared to mechanically damaging tissue by ablation), for example, using a first non-ablative laser light beam characterized by a long pulse duration, as claimed (i.e., longer than 1 microsecond as compared to a shorter pulse duration intended to cause mechanical effects, such as ablation or tissue disruption), wherein the wavelength for creating the thermal cavity “should be chosen for low skin and blood absorption” (Tankovich ¶¶ 9, 11, 13); and (ii) second, creating a plurality of tiny, precise, mechanically damaged tissue areas (by ablation or disruption), or energy droplets, within the thermal cavity, by applying a second laser light beam characterized by a short pulse Appeal 2019-004295 Application 14/242,449 11 duration in comparison to the first laser light beam which produces skin damage through photodisruption and photoablation with minimal or no thermal damage and by a wavelength of, for example, 1560 nm, where absorption in the skin and blood is relatively high (id. ¶¶ 9, 11, 14, 15). Tankovich discloses that [s]uch specific distribution of energy is essential to a number of medical and aesthetic applications of lasers and other sources of radiation. Radiation that forms the thermal cavity does not damage the tissue, but increase overall energy deposition close to the damage threshold. In this case energy droplets provide more accurate energy delivery which is just needed for specific therapeutic effects due to supra threshold effects and spatial modulation of those effects across thermal cavity area. Id. ¶ 44. Stumpp discloses “using a first fractional optical energy treatment to coagulate a plurality of zones” in the tissue, and next, “directing a subsequent fractional optical energy treatment through the coagulated zones to the underlying portion in order to produce an effective treatment in the underlying portion of a region of tissue.” Stumpp, Abstract. Stumpp explains that [b]y using the method of applying a first optical energy treatment to create coagulated zones which act as beam paths, subsequent optical energy treatments that either cannot [] reach the underlying portion or that can damage an untreated overlying layer can be applied through the beam paths directly to the underlying portion, allowing the underlying portion to be treated using an optimal subsequent optical energy treatment. . . . [T]he aim of the first optical energy treatment is to produce a zone of coagulated tissue with reduced light scattering . . . .” Appeal 2019-004295 Application 14/242,449 12 Stumpp ¶¶ 18, 21. Stumpp also discloses that the first treatment may be ablative or non-ablative, in addition to creating a plurality of coagulated zones in the tissue. Id. ¶ 19. Thus, according to the Examiner’s proposed modification, rather than creating Tankovich’s single thermal cavity in a first step, a first non-ablative laser source is used to create a plurality of fractional coagulated areas, as taught in Stumpp, followed by Tankovich’s second step of creating energy droplets, which is consistent also with Stumpp’s second step of applying a second fractional optical energy treatment. In other words, the Examiner does not modify Tankovich’s second irradiation step to be a single, thermal cavity, but rather, includes Tankovich’s second irradiation step of applying energy droplets, consistent with Stumpp’s teaching of two, or subsequent, fractional optical energy treatments through the coagulated zones. In sum, Appellant’s argument does not address the Examiner’s rejection. In the Reply Brief, Appellant addresses the Examiner’s rejection as articulated in the Final Office Action supra, acknowledging that the Examiner is “substituting” Stumpp’s fractional laser treatment for Tankovich’s first treatment, such that Tankovich’s first step would result in an area of fractional coagulated zones, rather than a thermal cavity, and next, forming Tankovich’s fractionated plurality of energy droplets. Reply Br. 3. Appellant argues “[t]his is not what is recited in Appellant’s claims.” Reply Br. 3. However, such a conclusory statement does not apprise us of why claim 1 fails to read on the Examiner’s proposed modification of Tankovich, in view of Stumpp. Second, Appellant argues that “there is no suggestion in Tankovich or the other cited references to implement the specific wavelengths now recited Appeal 2019-004295 Application 14/242,449 13 in claim 1.” Appeal Br. 10; see also id. at 11 (arguing that the Examiner’s reliance on Tankovich’s Hair Removal and Skin Rejuvenation examples for disclosing specific wavelengths are improper). However, Appellant’s argument does not address the Examiner’s finding that the selection of wavelengths for subsequent laser light beam treatments is a result-effective variable, as set forth supra. Indeed, Tankovich and Stumpp involve the thermal and/or mechanical treatment of skin tissue using a laser, recognizing that wavelength selection is a critical parameter. See Tankovich ¶ 6 (discussing the selection of wavelengths based on tissue to achieve “selective thermolysis”); Stumpp, Abstract (“[t]he treatment parameters used to deliver the first and subsequent treatments, including wavelength, can be optimized in order to provide a first optical treatment that effectively coagulates the overlying portion and a subsequent one or more optical treatments that effectively treat the underlying portion”), ¶ 30 (as relied on by the Examiner supra). Appellant’s argument does not apprise us of error in the Examiner’s finding that wavelength, in the context of skin treatment, is recognized in the prior art as a result-effective variable. “[W]ere 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.” In re Aller, 220 F.2d 454, 456 (CCPA 1955); In re Applied Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012) (a recognition in the prior art that a property is affected by a variable is sufficient to find the variable result-effective). Alternatively, Appellant argues that the Examiner’s findings “overlook[] the specific choice of [the claimed] wavelengths as producing ‘unexpected improvements in the efficacy of the process.’” Appeal Br. 11 Appeal 2019-004295 Application 14/242,449 14 (citing Spec. ¶ 40). However, the Examiner responds correctly that paragraph 40 of the Specification does not provide evidentiary support that the claimed wavelengths provide unexpected results. Ans. 4. Paragraph 40 of the Specification discloses that [c]onsequently, by subsequently illuminating an area previously treated in a non-ablative manner, with a pulsed laser source, collagen synthesis and skin regeneration over the entire skin area is increased, not simply within or just around the zones 24, leading to an unexpected improvement in the efficacy of the process. Spec. ¶ 40. This passage does not discuss the selection of wavelengths or provide evidence that the claimed wavelengths provide unexpected results. See also In re Scherl, 156 F.2d 72, 74–75 (CCPA 1946) (applicant has the burden of establishing criticality by a proper showing of the facts upon which applicant relies). Accordingly, we sustain the Examiner’s rejection of independent claim 1, and claims 2, 3, 6, 7, 10, 11, 27, 28, and 30 which fall therewith. Independent claims 12 and 37, and dependent claims 4, 5, 13–19, 21, 22, 31–34, and 38 Appellant chose not to present arguments for the patentability of independent claims 12 and 37, and claims 4, 5, 13–19, 21, 22, 31–34, and 38 depending therefrom, apart from the arguments presented for independent claim 1 supra. Appeal Br. 12, 13. Accordingly, for essentially the same reasons stated supra, we also sustain the Examiner’s rejection of claims 4, 5, 13–19, 21, 22, 31–34, and 38. Appeal 2019-004295 Application 14/242,449 15 Rejection II Appellant chose not to present arguments for the patentability of claims 30 and 34 apart from the arguments presented for independent claim 1 supra. Appeal Br. 13. Accordingly, for essentially the same reasons stated supra, we also sustain the Examiner’s rejection of claims 30 and 34. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–7, 10–19, 21, 22, 27– 34, 37, 38 103 Tankovich, Stumpp, as evidenced by Jansen 1–7, 10– 19, 21, 22, 27–34, 37, 38 30, 34 103 Tankovich, Stumpp, Altshuler, as evidenced by Jansen 30, 34 Overall Outcome 1–7, 10– 19, 21, 22, 27–34, 37, 38 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation