Ex Parte Ting et alDownload PDFPatent Trial and Appeal BoardSep 25, 201813616497 (P.T.A.B. Sep. 25, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/616,497 09/14/2012 Joseph Ting 68981 7590 09/27/2018 Zeltiq Aesthetics, Inc. Perkins Coie LLP P.O. BOX 1247 SEATTLE, WA 98111-1247 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 579688001US2 4428 EXAMINER SMITH, KAITLYN ELIZABETH ART UNIT PAPER NUMBER 3739 NOTIFICATION DATE DELIVERY MODE 09/27/2018 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): patentprocurement@perkinscoie.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOSEPH TING, SAMUEL W. TOLKOFF, TIMOTHY ROBINSON, and RICHARD WISDOM Appeal2017-006211 Application 13/616,497 Technology Center 3700 Before JEFFREY N. FRED MAN, ULRIKE W. JENKS, and TA WEN CHANG, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellants 1 appeals from the Examiner's decision to reject claims directed to a cooling system for affecting subcutaneous lipid rich cells. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify the real party in interest as Zeltiq Aesthetics, Inc. Appeal Br. 2. Appeal 2017-006211 Application 13/616,497 STATEMENT OF THE CASE According to the Specification, lipid-rich cells can be affected at low temperatures that do not affect non-lipid-rich cells. As a result, lipid-rich cells, such as those forming the cellulite, can be affected while other cells in the same region are generally not damaged even though the non- lipid-rich cells at the surface are subject to even lower temperatures. Spec. ,r 35. Subcutaneous tissue contains lipid-rich cells, "[t]he term 'subcutaneous tissue' means tissue lying underneath the dermis and includes adipocytes (fat cells) and subcutaneous fat." Spec. ,r 16. Claims 42-77 are on appeal2 and can be found in the Claims Appendix of the Appeal Brief. Claim 42 is representative of the claims on appeal, and reads as follows: 42. A cooling system for affecting subcutaneous lipid-rich cells in tissue of a subject, the cooling system comprising: a first cooling element having a first heat exchanging surface, wherein the first cooling element is configured to remove heat from the lipid-rich cells to affect the lipid-rich cells while non-lipid rich cells in skin of the tissue are not substantially affected; a second cooling element spaced apart from the first cooling element, the second cooling element having a second heat exchanging surface, wherein the second cooling element is configured to remove heat from the lipid-rich cells to affect the lipid-rich cells while non-lipid rich cells in the skin of the tissue are not substantially affected; and a holder assembly coupled to the first cooling element and the second cooling element such that the first cooling element is rotatable about a first axis along the holder assembly and the second cooling element is rotatable about a second axis along the holder assembly to adjust a relative position between the first and second heat exchanging surfaces to 2 Claims 1--41 are canceled. Appeal Br. 2. 2 Appeal 2017-006211 Application 13/616,497 accommodate the tissue located between the first and second cooling elements. Appellants request review of the following rejections made by Examiner: I. Claims 42-69 and 72-76 under 35 U.S.C. § I03(a) as unpatentable over Anderson 3 in view of Beeuwkes. 4 II. Claims 70 and 71 under 35 U.S.C. § I03(a) as unpatentable over Anderson and Beeuwkes further in view of Halvorson. 5 III. Claim 77 under 35 U.S.C. § I03(a) as unpatentable over Anderson and Beeuwkes and further in view of Pira. 6 We consider rejections 1.-111. together, because the same issue is dispositive for all three rejections each relying on the teachings of Anderson and Beeuwkes. See Appeal Br. 23 ("Halvorson fails to teach or suggest the deficiencies of Anderson and Beeuwkes" or "Pira fails to teach or suggest the deficiencies of Anderson and Beeuwkes"). The issue is: Does the preponderance of evidence of record support Examiner's conclusion that the combination of Anderson and Beeuwkes teaches a cooling system containing cooling elements that are rotatable about a fixed axis? 3 Richard R. Anderson et al., US 2005/0251120 Al, published Nov. 10, 2005 ("Anderson"). 4 Reinier Beeuwkes, III, US 5,456,703, issued Oct. 10, 1995 ("Beeuwkes"). 5 Kaia A. Halvorson, US 2003/0220594 Al, published Nov. 27, 2003 ("Halvorson"). 6 Luc Pira, US 6,017,337, issued January 25, 2000 ("Pira"). 3 Appeal 2017-006211 Application 13/616,497 Findings of Fact FF 1. Anderson teaches a treatment system for cooling lipid-rich cells within a skinfold. Figure 2, is reproduced below, and shows such a coo ling system: CONTROL UNIH POINfR SUPPLY ' 105 fA! i,,r.:::::'.::======~-160 165 i70 120 ·-·-·---·""""""""""""""""""""""""" _____ ......., FOUlfR APPtlCA mm ~ FIG. 2A Figure 2, reproduced above, shows a treatment system for cooling fat cells. See Anderson ,r 178; see Final Act. 4. The system includes control units 105 and treatment units 107 as well as a detector 120 that can measure temperature change in the tissue. See Anderson ,r 178. "Compression unit 205 may be adapted to pull treatment units 107 together, thereby folding (or 'pinching') target tissue (epidermis 160, dermis 165 and fat cells 170) up between treatment units 107." Id. FF2. Anderson teaches that "compression unit 205 may vary the force with which treatment units 107 are pulled together around the target tissue ( epidermis 160, dermis 165 and fat cells 170). For example, compression unit 205 can apply a pulsing force for alternately 4 Appeal 2017-006211 Application 13/616,497 tightening and loosening the fold (or 'pinch') of the target tissue." Anderson ,r 179. FF3. Anderson teaches that the cooling unit can also be applied to tissue as a flat system that does not pinch the tissue. During the cold exposure the cooling device was applied to the skin with minor to moderate pressure that did not cause significant mechanical compression of blood flow. The cooling element was applied to the skin without any manipulation of the surface profile. Anderson ,r 185 (Example 1 ). Loss of subcutaneous adipose tissue was observed using the flat cooling device. See id. ,r 187 (Table 1 ), see id. ,r 188 (Table 2). FF4. Anderson teaches using the cooling device with or without decreasing blood flow. Compare Anderson claims 1, 38, and 39 with claims 109 and 110. FF5. Beeuwkes teaches a device for applying hot/cold therapy to target regions. Beeuwkes, Abstract. Beeuwkes system has "substantially omnidirectional movement of the thermal cells relative to the support structure, i.e. rotation, pivoting etc. to enable the thermal cells to achieve intimate heat/cold transmitting relation with the target region." Beeuwkes 3: 1-5, see also id. at 5:25-29 ("This retention apparatus may conveniently take the form of a support band structure such as a headband, for example, from which the compliant cells are pivotally, rotatably and adjustably supported"). FF6. Beeuwkes teaches that "[t]he apparatus also incorporates means for releasably securing or positioning the compliant cell or cells in intimate low mechanical pressure per unit area surface conforming 5 Appeal 2017-006211 Application 13/616,497 contact with selected target regions of the selected anatomical region." Beeuwkes 5:20-25, see id. at 9:40-59. Beeuwkes teaches that "application of only minimal mechanical force against facial surfaces ... permit the patient to undergo efficient heat or cold therapy in such manner as to be free from the pain or discomfort that might be caused if the mechanical force that is necessary if heat transfer were localized." Beeuwkes 2: 18-23. Principle of Law "If the claim extends to what is obvious, it is invalid under§ 103." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007). Analysis Examiner finds that Anderson teaches a cooling system that removes heat from lipid-rich cells. See Final Act. 4. Examiner acknowledges that Anderson does not teach that the cooling elements are rotatable about the axis in the holder assembly. See id. Examiner looks to Beeuwkes for teaching an apparatus that applies heat/cold to "target regions of the human anatomy (title) including a holder assembly ( 14) and treatment units ( 12 and 13) and a yoke device (92) that allows for omnidirectional movement." Id. at 5. Examiner concludes that based on the combined teachings of Beeuwkes and Anderson Id. it would have been obvious to one having ordinary skill in the art at the time of the invention to have included the omnidirectional movement of the thermal cells of Beeuwkes in the apparatus of Anderson so as to enable the thermal cells to achieve intimate heat/cold transmitting relation with the target region. 6 Appeal 2017-006211 Application 13/616,497 We generally agree with and adopt the findings concerning the scope and content of the prior art as well as the conclusions as set forth in the Examiner's Answer and the Final Office Action. The findings of fact reproduced above are referenced to highlight certain pertinent evidence. We address Appellants' arguments below: Appellants contend that Examiner relies on impermissible hindsight. Appeal Br. 18. We are not persuaded. Any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper. In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Appellants have not directed us to what aspects of Appellants' Specification Examiner relies on in reaching the conclusion of obviousness. See Ans. 3. Here, Anderson teaches the application of a flat cooling element onto the skin that applies only minor to moderate pressure. FF3. Anderson also teaches that the cooling element that pinches skinfold can vary the pressure. FF1-FF2. Additionally, Anderson also teaches that either apparatus can be used with or without blood flow restriction. FF4. These combined teachings of Anderson reasonably convey that Anderson's device can be used in such a way that does not require the application of pressure onto the tissue to the point of restricting blood flow. Beeuwkes similarly teaches an apparatus for heating or cooling the skin. FF5. Beeuwkes explains that it's desirable to apply only minimal pressure in order minimize a patient's discomfort while applying treatment. FF6. A teaching that suggests minimizing a patient's discomfort does not 7 Appeal 2017-006211 Application 13/616,497 indicate no pressure may applied to the tissue while applying the treatment. Beeuwkes reasonably teaches that when pressure is applied to the device, it should not cause patient discomfort. FF6. Examiner relies on Beeuwkes's teaching of a cooling device that can be adjusted to bring the thermal cell into intimate contact with the patient's skin. See FF5-FF6. In other words, Beeuwkes's heating and/or cooling surfaces can be adjusted to most closely fit the anatomical contours of a patient's skin. This reasonably ensures that the device surface makes as close a contact as possible over the entire heat transfer surface. Here, Examiner's rejection relies on adding Beeuwkes's omnidirectional hinge into Anderson's device "to enable the thermal cells to achieve intimate heat/cold transmitting relation with the target region." Final Act. 5. Based on the cited evidence, we find no error with Examiner's rationale. Appellants have not directed us to any knowledge that was outside of the level of the ordinary artisan and only available from the Specification to arrive at the claimed invention. Accordingly, we are not persuaded by the hindsight argument. Appellants contend that one of ordinary skill in the art would not be motivated to "lock[] the treatment units because Beeuwkes fails to disclose locking or other suitable means for achieving functionality needed to perform Anderson's procedures." Reply Br. 3. We are not persuaded. Examiner explains that no rejection of adding a lock was made because the claims do not require such a feature. See Ans. 3. As Examiner further explains "[t]he modification of Anderson with the omnidirectional rotation capability of Beeuwkes has not changed the degree to which Anderson pulls the treatment units together." Ans. 2, see id. 8 Appeal 2017-006211 Application 13/616,497 at 4. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. KSR, 550 U.S. at 417. It is proper to "take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418. See also id. at 421 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton."). Examiner's rejection is not relying on adding a locking mechanism to Beeuwkes hinges inserted into Anderson's apparatus to arrive at the claimed invention. See Ans. 3. But even if the rejection required the application of such a mechanism, Beeuwkes reasonably suggests securing the device against the anatomical region. Specifically, Beeuwkes teaches that "[t]he apparatus also incorporates means for releasably securing or positioning the compliant cell[ s ]" against the selected anatomical region. FF6; see also Ans. 4 ("Beeuwkes then goes on to teach that it is desirable to support the treatment units in substantially immovable relation with the selected anatomical region and that the treatment units are also sufficiently adjustable relative to the support structure"). We agree with Examiner's conclusion that one of ordinary skill in the art would know how to secure the omnidirectional hinge of Beeuwkes for use in Anderson's apparatus. See Ans. 4. ("modifying Anderson with the omnidirectional rotation components of Beeuwkes would not necessarily result in low applied mechanical force as the degree to which Anderson pulls the treatment units together has not been modified"). Beeuwkes teaches the apparatus "incorporates means for releasably securing or positioning the compliant cell" or that these compliant cells can be "adjustably supported." See FF5-FF6. These teachings in Beeuwkes sufficiently support the Examiner's conclusion that an ordinary 9 Appeal 2017-006211 Application 13/616,497 artisan would know how to make the hinges of Beeuwkes work in Anderson's apparatus. Appellants contend that Anderson requires high compressive forces. Appellants rely on paragraph 153 of Anderson that explains "high compressive forces are applied such that the locally applied pressure limits or eliminates cutaneous warm blood flow into the target region to allow sufficient cooling of targeted subcutaneous tissue within the fold." Reply Br. 3. "The fundamental differences between Anderson's limiting cutaneous blood flow at the base of the fold of skin and Beeuwkes's apparatus designed to maintain cutaneous blood flow supports non-obviousness." Appeal Br. 19. We are not persuaded. It is well settled that "in a section 103 inquiry, 'the fact that a specific [embodiment] is taught to be preferred is not controlling, since all disclosures of the prior art, including unpreferred embodiments, must be considered."' Merck & Co. v. Biocraft Laboratories, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (quoting In re Lamberti, 545 F.2d 747, 750 (CCPA 1976)); see also In re Mills, 470 F.2d 649,651 (CCPA 1972) ("All the disclosures in a reference must be evaluated, including nonpreferred embodiments, and a reference is not limited to the disclosure of specific working examples." ( Citations omitted).) "[ A Jpparatus claims cover what a device is, not what a device does. An invention need not operate differently than the prior art to be patentable, but need only be different." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990). Here, Anderson teaches that the application of force is not required in order for the cold treatment to work. See FF3-FF4. Specifically, Anderson 10 Appeal 2017-006211 Application 13/616,497 teaches that the compression unit may be pulsed, applying tightening and loosening cycles to the target tissue. FF2. This reasonably suggests that the application of continuous force and blood flow restriction, as argued by Appellants, is not required in order to achieve tissue cooling using Anderson's apparatus. Here, Anderson reasonably suggests that the apparatus can be utilized in such a way that does not require restriction of blood flow. FF2-FF4. Anderson teaches applying a cooling device using only minor to moderate pressure, i.e., one that does not compress blood flow, while the device is applied to the skin and this application also works to disrupt subcutaneous fat. FF3. Therefore, Appellants' contention that Anderson requires high compressive forces is not persuasive. Furthermore, Beeuwkes teaching of applying only minimal force to the surface in order to minimize discomfort to the patient does not mean that no pressure can be applied. See FF6. Beeuwkes's teaching of minimizing comfort would reasonably suggest to the one of ordinary skill in the art that pressure may be applied to the apparatus making contact with the skin as long as the patient is comfortable. Because Anderson teaches that blood flow restriction is not required for the apparatus to function (see FF2-FF4) and Beeuwkes reasonably allows some pressure to be applied to the skin (see FF5-FF6) we are not persuaded by Appellants' contention that Anderson's apparatus is fundamentally different from the cooling apparatus disclosed in Beeuwkes. We conclude that the evidence cited by Examiner supports a prima facie case of obviousness with respect to claim 42, and Appellants have not provided sufficient rebuttal evidence that outweighs the evidence supporting the Examiner's conclusion of obviousness. As Appellants do not argue the 11 Appeal 2017-006211 Application 13/616,497 claims separately, claims 43-77 fall with claim 42. 37 C.F.R. § 41.37 ( C )(1 )(iv). SUMMARY We affirm the rejection of claim 42 under 35 U.S.C. § 103(a) over Anderson in view ofBeeuwkes. Claims 43---69 and 72-76 were not separately argued and fall with claim 42. We affirm the rejection of claims 70 and 71 under 35 U.S.C. § 103(a) over Anderson and Beeuwkes further in view of Halvorson. We affirm the rejection of claim 77 under 35 U.S.C. § 103(a) over Anderson and Beeuwkes and further in view of Pira. 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 12 Copy with citationCopy as parenthetical citation