Ex Parte Slayton et al

Patent Trial and Appeal BoardMar 12, 2018

13136538 (P.T.A.B. Mar. 12, 2018)

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. 13/136,538 08/02/2011 Michael H. Slayton 148534.00093.GTS063USNP 7205 26287 7590 03/14/2018 Quarles & Brady LLP/Guided Therapy Systems, LLC Attn: IP Docket 41 IE. WISCONSIN AVE SUITE 2350 MILWAUKEE, WI 53202-4426 EXAMINER HOFFA, ANGELA MARIE ART UNIT PAPER NUMBER 3768 NOTIFICATION DATE DELIVERY MODE 03/14/2018 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): pat-dept@quarles.com l.ruggiero@guidedtherapy.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MICHAEL H. SLAYTON and PETER G. BARTHE1 Appeal 2017-002208 Application 13/136,538 Technology Center 3700 Before DONALD E. ADAMS, JOHN E. SCHNEIDER, and DAVID COTTA, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method for treating damaged soft tissue which have been rejected for failure to comply with the written description requirement, as indefinite, as obvious and for non-statutory obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify the Real Party in Interest as Guided Therapy Systems LLC. Br. 1. Appeal 2017-002208 Application 13/136,538 STATEMENT OF THE CASE Subcutaneous tissues such as, muscles, tendons, ligaments and cartilage, are prone to wear and injury due to participation in sports or other daily activities which put stress on these tissues. Spec. 12. Injury to the tissue results in inflammation which is “characterized by increased blood flow to the tissue causing increased temperature, redness, swelling, and pain.” Spec. 13. The Specification describes a method for treating fibrous soft tissue using ultrasound. Spec. 1 5. Claims 1—5, 7—14, 34-40, 42-45, and 47 are on appeal. Claim 1 is representative and reads as follows: 1. A method of treating fibrous soft tissue, the method comprising: targeting injured fibrous soft tissue located in at least one of at and adjacent to a location of an injury, the location comprising a portion of fibrous soft tissue; directing therapeutic ultrasound energy to the targeted injured fibrous soft tissue and adjacent tissue; creating, with the therapeutic ultrasound energy, a conformal region of elevated temperature in the injured fibrous soft tissue and adjacent tissue; creating, with the therapeutic ultrasound energy in the conformal region, a plurality of micro lesions in the portion of the injured fibrous soft tissue; and applying a therapeutically effective amount of the therapeutic ultrasound energy to the conformal region to accelerate a healing cascade in the injured fibrous soft tissue by peaking inflammation in the injured fibrous soft tissue within the conformal region, the inflammation occurring in an inflammatory phase of the injury that is shortened by the peaking. 2 Appeal 2017-002208 Application 13/136,538 The claims stand rejected2 as follows: Claims 1—5, 7—14, 34-40, 42 45, and 47 have been rejected under 35 U.S.C. § 112, first paragraph, for failing to comply with the written description requirement. Claims 1—5, 7—14, 34-40, 42-45, and 47 have been rejected under 35 U.S.C. § 112, second paragraph, as indefinite. Claims 1—5, 8—14, 34-40, 43—45, and 47 have been rejected under 35 U.S.C. § 103(a) as unpatentable over Muratore3 in view of Barthe.4 Claims 7 and 42 have been rejected under 35 U.S.C. § 103(a) as unpatentable over Muratore in view of Barthe in further view of Babaev.5 Claims 1—5, 7—14, 34-40, 42-45, and 47 have been provisionally rejected for non-statutory obviousness-type double patenting over claims 1— 8 and 15—20 of co-pending application USSN 13/136,5416 in view of Kaufman.7 2 Claims 1—5, 7—14, 34-40, 42 45, and 47 were provisionally rejected for non-statutory obviousness-type double patenting over claims 1—10 of co pending application USSN 13/545,945. That application went abandoned on June 4, 2015, rendering this rejection moot. 3 Muratore et al., High-Intensity Focused Ultrasound Ablation of Ex Vivo Bovine Achilles Tendon, 34 Ultrasound in Med. & Biol. 2043 (2008) (“Muratore”). 4 Barthe et al., US 2008/0071255 Al, published Mar. 20, 2008 (“Barthe”). 5 Babaev et al., US 2009/0254006 Al, published Oct. 8, 2009 (“Babaev”). 6 This application is the subject of Appeal No. 2018-001898. 7 Kaufman et al., US 6,251,088 Bl, issued June 26, 2001 (“Kaufman”). 3 Appeal 2017-002208 Application 13/136,538 OBVIOUSNESS-TYPE DOUBLE PATENTING Appellants have not argued this rejection. We, therefore, summarily affirm the provisional obviousness-type double patenting rejections. See 37 C.F.R. § 41.37(c)(l)(iv) (Appeal Brief must contain “[t]he arguments of appellant with respect to each ground of rejection.”); Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (“When the appellant fails to contest a ground of rejection to the Board, ... the Board may treat any argument with respect to that ground of rejection as waived.”). See also, MANUAL OF PATENT EXAMINING PROCEDURE $ 1205.02 (“If a ground of rejection stated by the examiner is not addressed in the appellant’s brief appellant has waived any challenge to that ground of rejection and the Board may summarily sustain it”). WRITTEN DESCRIPTION Issue The issue with respect to this rejection is whether substantial evidence supports the Examiner’s conclusion that the claims fail to satisfy the written description requirement. The Examiner finds that the limitations of “to accelerate a healing cascade” and “the inflammation occurring in an inflammatory phase of the injury that is shortened by the peaking” are not supported by the present disclosure. Final Act. 2—3. The Examiner finds that the Specification recites several different definitions for peaking and that the Specification does not show that the “peaking” step shortens the inflammatory phase. Id. 4 Appeal 2017-002208 Application 13/136,538 Appellants contend that the Specification clearly defines peaking as pushing the inflammation to its peak. Br. 7. Appellants argue that one skilled in the art would understand that pushing inflammation to its peak sooner than it would normally occur would shorten the inflammatory period and thus shorten the healing process. Br. 8. Appellants contend that one skilled in the art would understand this to be the same as “to accelerate a healing cascade.” Analysis We find that Appellants have the better argument. The Specification teaches that wound healing involves a cascade of events starting with inflammation. Spec. 1204. The Specification also teaches that one of the therapeutic effects that can occur from the application of ultrasound energy is the increasing of “the ‘wound healing’ response through the liberation of cytokines and [this] may produce reactive changes within the tendon and muscle itself, helping to limit surrounding tissue edema and decrease the inflammatory response.” Spec. 1101. In addition, as demonstrated by Calderhead8, one skilled in the art would understand that by peaking the inflammation response, one can shorten the inflammation period, and thereby shorten the wound healing process. Calderhead Abstract. We agree with Appellants that the limitation does not represent new matter. 8 Calderhead et al., One Mechanism Behind LED Photo-Therapy for Wound Healing and Skin Rejuvenation: Key Role of Mast the Cell, 17 Laser Therapy 141 (2008). 5 Appeal 2017-002208 Application 13/136,538 We conclude that substantial evidence does not support the Examiner’s rejection for failing to comply with the written description requirement. INDEFINITENESS Issue The issue with respect to this rejection is whether substantial evidence supports the Examiner’s conclusion that the claims are indefinite. The Examiner finds that “peaking” is not a true step in the method and that the metes and bounds of peaking cannot be determined. Final Act. 4. Appellants contend that the claims term is not indefinite. Br. 9. Appellants argue that the Examiner has interpreted the claims too narrowly by finding that peaking inflammation is result-specific to the creation of micro-lesions or elevated temperature. Id. Appellants contend that the Specification makes it clear that the creation of the micro-lesions and heating are not required to cause peaking. Br. 9-10. Appellants point out that other factors can lead to peaking. Br. 10. Analysis Again, we find that Appellants have the better argument. The claims and Specification make it clear that formation of micro-lesions is separate from peaking inflammation. See claim 1 above, Spec. H 101, 104, and 205. For example, the Specification lists peaking inflammation and forming micro-lesions as two separate “therapeutic effects” resulting from application of ultrasound. Spec. 1101. Similarly, the Specification lists peaking as a biological effect caused without referencing the formation of micro-lesions. Spec. 1104. We agree with Appellants that this 6 Appeal 2017-002208 Application 13/136,538 demonstrates that peaking is a separate step in the claimed method and is not associated with the formation of micro-lesions. Br. 9—10. We conclude that substantial evidence does not support the Examiner’s conclusion that the claims are indefinite. OBVIOUNSESS MURATORE COMBINED WITHBARTHE Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that claims 1—5, 8—14, 34— 40, 43—45, and 47 would have been obvious over Muratore combined with Barthe. The Examiner finds that Muratore teaches the use of ultrasound to treat fibrous soft tissue using the same steps as recited in claim 1. Final Act. 5—6. The Examiner finds, however, that Muratore only discloses ex vivo application of ultrasound and not in vivo. Final Act. 6. The Examiner finds that Barthe discloses a method for treating fibrous soft tissue including creating micro-lesions using ultrasound. Final Act. 6. The Examiner concludes One of ordinary skill in the art at the time of the invention would have found it obvious that the method of Muratore performed in vivo would have produced the healing effects of peaking inflammation and thereby shortening of an inflammatory phase of an injury since similar healing effects are taught by Barthe with the application of HIFU micro lesions. As evidenced by these references, one of ordinary skill in the art at the time of the invention would have expected similar healing results with the application of HIFU microlesions as that of a needle tenotomy, for example. It is 7 Appeal 2017-002208 Application 13/136,538 known that a needle tenotomy produces a shortening of an inflammatory phase of an injury by peaking inflammation, as discussed by Muratore. Final Act. 7. Appellants contend that the references do not teach or suggest forming micro-lesions in injured fibrous soft tissue. Br. 11—12. Appellants argue that Muratore is limited to teaching formation of lesions ex vivo and that Barthe is directed to using ultrasound for cosmetic treatments, not treatment of injured tissue. Id. Appellants also argue that the references do not teach or suggest accelerating the healing cascade by peaking inflammation. Br. 12. With respect to claims 9, 44, 45, and 47, Appellants contend that the references do not teach or suggest stimulating healing of micro-tears or the formation of a three dimensional matrix of micro-lesions. Br. 14. Analysis We adopt the Examiner’s findings of fact, reasoning on scope and content of the prior art, and conclusions set out in the Final Action and Answer regarding this rejection. We find the Examiner has established that the subject matter of the claims would have been obvious to one of ordinary skill in the art at the time the invention was made over Muratore combined with Barthe. Appellants have not produced evidence showing, or persuasively argued, that the Examiner’s determinations on obviousness are incorrect. Only those arguments made by Appellants in the Briefs have been considered in this Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). We have identified claim 1 as representative; therefore, all claims, except claims 9, 44, 45, and 47, 8 Appeal 2017-002208 Application 13/136,538 which have been argued separately, fall with claim 1. We address Appellants’ arguments below. Appellants contend that the combination of references do not teach or suggest creating micro-lesions in injured fibrous soft tissue. Appellants contend that the teachings of Muratore are limited to ex vivo application of ultrasound and would not lead one skilled in the art to use ultrasound to create lesions in vivo. Br. 11. Appellants argue that Barthe is limited to cosmetic use of ultrasound and does not teach its application to injured tissue. Br. 12. We have considered Appellants’ arguments and find them unpersuasive. Muratore discloses the use of ultrasound to create micro lesions and postulates that the method can be used to accelerate a healing cascade. Muratore 2044-45. Barthe discloses in vivo use of ultrasound to treat fibrous soft tissue. Barthe 122. The tissues treated by Barthe include muscles and tendons. Id. The treatment method of Barthe includes the creation of micro-lesions. Barthe 174. We agree with the Examiner that one skilled in the art would be motivated by Muratore to adapt the teachings of Barthe “to predictably optimize the parameters for successful in vivo applications for treating injured soft tissue.” Ans. 14. Appellants next argue that the references do not teach or suggest accelerating the healing cascade by peaking the inflammatory process. Br. 12—14. Appellants contend that Muratore only refers to stimulating collagen growth not peaking inflammation. Br. 13. Appellants also argue that Muratore’s discussion regarding treating tennis elbow is not relevant as it 9 Appeal 2017-002208 Application 13/136,538 does not include inflammation of a chronic injury. Id. Again we are not persuaded. As the Examiner points out, the stimulation of collagen growth requires an inflammatory phase which inherently contains a peak. Ans. 14. As both references teach stimulating growth/healing, the methods inherently cause peaking of inflammation as part of the healing process. Ans. 14—15. With respect to Appellants’ argument regarding treating tendinosis versus tendinitis, as the Examiner points out, both Muratore and the instant Specification discuss treating tennis elbow, which is a form of tendinosis. Ans. 15. Spec. 236—238, Muratore 2043^44. Both the Specification and Muratore teach that tennis elbow involves inflamed tendons in the elbow. Thus, the teachings regarding tendinosis, specifically tennis elbow, are relevant to the instant claims. Regarding claims 9, 44, 45, and 47 Appellants contend that the references do not teach treating micro-tears nor do they teach forming the lesions in an array or matrix. Br. 14—15. Appellants’ arguments are not persuasive. Muratore specifically teaches treating an injury comprising micro-tears. Muratore Abstract. In addition, Muratore and Barthe both teach creation of a plurality of micro-lesions in a pattern which can be considered an array or matrix. Muratore FIG. 2, Barthe 1227 and FIG. 21. We conclude that a preponderance of the evidence supports the Examiner’s conclusion that claims 1, 9, 44, 45, and 47 would have been obvious over Muratore combined with Barthe. Muratore combined with Barthe and Babaev 10 Appeal 2017-002208 Application 13/136,538 Appellants’ sole argument regarding this rejection is that Babaev does not cure the deficiencies of Muratore and Barthe. Br. 15. As discussed above, the combination of Muratore and Barthe is not deficient. We therefore affirm this rejection. SUMMARY We affirm the obviousness rejections on this record. We reverse the rejection under 35 U.S.C. § 112, first paragraph. We reverse the rejection under 35 U.S.C. § 112, second paragraph. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 11