Ex Parte 6447485 et alDownload PDFBoard of Patent Appeals and InterferencesJul 18, 201295000271 (B.P.A.I. Jul. 18, 2012) 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. 95/000,271 06/25/2007 6447485 VINTL.26FCPDIRX 2227 20995 7590 07/18/2012 KNOBBE MARTENS OLSON & BEAR LLP 2040 MAIN STREET FOURTEENTH FLOOR IRVINE, CA 92614 EXAMINER FLANAGAN, BEVERLY MEINDL ART UNIT PAPER NUMBER 3993 MAIL DATE DELIVERY MODE 07/18/2012 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________ NEXUS MEDICAL LLC Requester1 v. Patent of VENETEC INTERNATIONAL, INC. (a subsidiary of C.R. BARD, INC.) Patent Owner and Appellant ____________ Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 Technology Center 3900 ____________ Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON, and RAE LYNN P. GUEST, Administrative Patent Judges. ROBERTSON, Administrative Patent Judge. DECISION ON APPEAL 1 Nexus Medical did not participate in this appeal. Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 2 Patent Owner Venetec International Inc. (a subsidiary of C.R. Bard, Inc.) (“Patent Owner”) appeals under 35 U.S.C. §§ 134(b) and 315(a) the Examiner’s decision to reject claims 1-33.2 We have jurisdiction under 35 U.S.C. §§ 134(b) and 315(a). We heard oral arguments from Patent Owner on June 6, 2012, a written transcript of which will be entered into the electronic record in due course. We affirm-in-part and enter a new ground of rejection pursuant to our authority under 37 C.F.R. § 41.77(b). STATEMENT OF THE CASE United States Patent 6,447,485 B2 (hereinafter the “‘485 Patent”), which is the subject of the current inter partes reexamination, issued to Steven F. Bierman on September 10, 2002. The ‘485 patent is one of three related patents that were the subject of a civil case captioned Venetec International, Inc. v. Nexus Medical LLC, Civil Action 1:07-cv-0057-MPT (D. Del.), which Patent Owner informs us has been settled. (App. Br. 1.) We previously affirmed the Examiner’s rejections of the claims subject to reexamination in the two other related patents, namely 6,213,979 B1 (reexamination control. No. 90/010,167, 2010-007376, from which the ‘485 Patent claims divisional status), and 7,247,150 B2 (reexamination control. 2 See Patent Owner’s Appeal Brief 1 (filed April 4, 2011) (hereinafter “PO App. Br.”) Examiner’s Answer (mailed September 27, 2011) (hereinafter “Ans.”); Right of Appeal Notice (mailed April 13, 2010) (hereinafter “RAN.”). Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 3 No. 90/010,211, 2010-007390, which is a continuation of the ‘485 Patent via United States Patent 6,213,979 B1.) As previously mentioned, Third-Party Requester Nexus Medical, LLC3 (hereinafter “Requester”) did not file a Respondent Brief in this appeal. The ‘975 Patent relates to anchoring systems for anchoring medical lines to patients. (Col. 1, ll. 10-11.) Claims 1, 12, and 22, which are illustrative of the appealed subject matter, read as follows (with underlining showing added text relative to the original patent claims): 1. A method of securing a medical device to the body of a patient, the method comprising the steps of: providing a retainer including a base that defines a receiving area for receiving a portion of the medical device, a cover permanently coupled to the base, the cover being movable between a closed position, in which at least a portion of the cover extends over at least a portion of the receiving area, and an open position, in which the receiving area is at least partially open, a latching mechanism operating between the base and the cover to releasably latch the cover to the base with the cover in the closed position, and interacting structure which is adapted to engage the medical device in a non-occlusive manner and to limit longitudinal movement of the medical device through the retainer when the medical device is placed within the receiving area; positioning the retainer on the body of the patient; attaching the retainer to the body of the patient with an adhesive layer; securing a portion of the medical device in the receiving area of the base; moving the cover over the base so that the cover is located over at least a portion of the interacting structure; and securing the cover in position upon the base using the latching mechanism. 3 See Request for Inter Partes Reexamination filed June 25, 2007. Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 4 12. A method of securing a medical line to the body of a patient, the medical line having an irregularly shaped portion, the method comprising the steps of: providing a retainer attachable to a medical line, including a base, a cover permanently coupled to the base, a latching mechanism, a channel, and an adhesive layer attached to the retainer, the cover being movable between an open position and a closed position, the latching mechanism releasably latching the cover to the base in the closed position, the channel being disposed between the base and the cover when the cover is in the closed position, the channel having an irregular shape along its length that substantially corresponds in shape to the irregularly shaped portion of the medical line [being shaped] to retain the irregularly shaped portion of the medical line between the cover and the base with the cover in the closed position in order to inhibit movement of the irregularly shaped portion of the medical line in a direction generally parallel to the medical line's longitudinal axis; positioning the retainer on the body of the patient; attaching the adhesive layer to the body of the patient; placing a portion of the medical line into the channel; moving the cover over the base so that the medical line is retained within the channel; and securing the cover in position upon the base using the latching mechanism. 22. A method of securing a medical line to the body of a patient, the method comprising the steps of: providing a retainer, the retainer including a base that defines a receiving area for receiving a portion of the medical line and a cover coupled to the base, means for releasably latching the cover to the base, and means for limiting longitudinal movement of the medical line relative to the retainer; positioning the retainer on the body of the patient; Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 5 attaching the adhesive layer to the body of the patient; placing a portion of the medical line into the receiving area; moving the cover over the base so that the cover lies at least partially over the movement limiting means; and securing the cover in position upon the base using the latching mechanism. (PO App. Br. 34-37 Claims App’x.) Patent Owner contests the Examiner’s decision to reject the claims as follows (presented in a different order than in the Appeal Brief as noted in the parentheses): I. Claim 12 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement (Rejection 8, Ans. 17-18); II. Claims 1-3, 5-8, 11-13, 15-18, 21, and 22 under 35 U.S.C. § 102(b) as anticipated by Sorbonne4 (Rejection 1, Ans. 5-6); III. Claims 12, 22, and 29 under 35 U.S.C. § 102(b) as anticipated by Gordon ‘647 (Rejection 5, Ans. 13-14); 5 IV. Claims 22 and 30-33 under 35 U.S.C. § 102(b) as anticipated by Bierman ‘4356 (Rejection 6, Ans. 14-16); V. Claims 1, 12, and 23-29 under 35 U.S.C. § 103(a) as obvious over Bierman ‘435 in view of Sorbonne (Rejection 2, Ans. 7-8); 4 United States Patent No. 4,517,971, issued May 21, 1985. 5 United States Patent 4,397,647, issued August 9, 1983. 6 WO 96/10435, published April 11, 1996. Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 6 VI. Claims 2, 6, 16, and 22 under 35 U.S.C. § 103(a) as obvious over Sorbonne in view of Bierman ‘435 (Rejection 3, Ans. 9- 11); VII. Claims 1, 23, and 24 under 35 U.S.C. § 103(a) as obvious over Gordon ‘647 in view of Gordon ‘8807 (Rejection 4, Ans. 11- 13); and VIII. Claims 22, 30, and 33 under 35 U.S.C. § 103(a) as obvious over Gordon ‘647 in view of Bierman ‘435 (Rejection 7, Ans. 16- 17). The Patent Owner relies on the following rebuttal evidence: Amended Declaration of Paul Frankhauser executed December 21, 2007 (Ex. II, App. Br.; hereinafter “First Frankhauser Decl.”). Supplemental Declaration of Paul Frankhauser executed December 21, 2007 (Ex. III, App. Br.; hereinafter “Second Frankhauser Decl.”). Amended Declaration of Steven F. Bierman executed December 21, 2007 (Ex. V, App. Br.; hereinafter “First Bierman Decl.”). Supplemental Declaration of Steven F. Bierman executed December 21, 2007 (Ex. VI, App. Br.; hereinafter “Second Bierman Decl.”). Patent Owner also relies on evidence of secondary considerations presented in Exhibits VIII-XIII of the Appeal Brief. 7 United States Patent 4,250,880, issued February 17, 1981. Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 7 35 U.S.C. § 112 1st PARAGRAPH REJECTION Rejection I Discussion Regarding claim 12, the Examiner found that there was no written description support for the added limitations of a “medical line having an irregularly shaped portion” and a “channel having an irregular shape along its length.” (Ans. 18.) The Examiner found that Patent Owner’s reliance on mounting structure and channels as depicted in the figures are of a regular hour glass shape and not an irregular shape. (Ans. 18.) Patent Owner contends that Figures 10A-12 provide examples of a non-uniform channel and a medical line (with adaptor body 170) having a non-uniform, truncated shape, such that there is support for the term “irregularly shaped” as recited in the claims. (App. Br. 14.) We previously addressed the term “irregularly shaped” in our Decision in Appeal No. 2010-007390 (ex parte reexamination control No. 90/010,211 of U.S. Patent No. 7,247,150 B2) (“the ‘390 Decision” pages 19- 22). In the ‘390 Decision, we interpreted “irregularly shaped” as not being limited to the shapes disclosed in Figures 10A-12, and concluded that the term, which is not defined in the Specification, should be interpreted broadly. (The ‘390 Decision, pages 21-22.) Here, we agree with Patent Owner that Figures 10A-12, in depicting an adaptor body 170 and channels formed from box-like extensions 141 with inner faces 142 (see the ‘485 Patent, col. 17, ll. 48-66) provide support for the limitations “irregularly shaped” as related to the recited channel and portion of the medical line. Specifically, neither the channel created by the Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 8 box-like extensions nor the adaptor body is uniform or regular in shape. However, consistent with the ‘390 Decision, we do not impart any specific structure from Figures 10A-12 as being required for the claimed channel or portion of the medical line to be “irregularly shaped.” See Crown Packaging Tech., Inc. v. Ball Metal Beverage Container Corp., 635 F.3d 1373, 1381 (Fed. Cir. April 1, 2011) (citing Lampi Corp. v. Am. Power Prods., 228 F.3d 1365, 1378 (Fed. Cir. 2000) (concluding that the embodiment drawings did not compel a conclusion that the written description is so narrowly tailored to be limited to the embodiments depicted in the drawings). Accordingly, we reverse the Examiner’s rejection of claim 12 as failing to comply with 35 U.S.C. § 112, first paragraph. ANTICIPATION REJECTIONS Rejection II Issue The issue with respect to Rejection II is: Did the Examiner err in finding that Sorbonne discloses the interacting structure recited in claim 1, the medical line and channel configuration recited in claim 12, or the means for limiting longitudinal movement in claim 22 in view of the evidence of record? Findings of Fact Sorbonne discloses a catheter and intravenous tubing retainer (Col. 1, ll. 9-10.) Sorbonne discloses that the device disclosed therein is constructed Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 9 of a semi-soft flexible and clear synthetic resinous material that retains its shape. (Col. 2, ll. 7-9.) Figure 4 of Sorbonne is reproduced below: Figure 4 is a plan view of a venipuncture guard retainer in the installed position, with a portion of the lid broken away. (Col. 3, ll. 22-25.) Sorbonne discloses that the device 10 (ref. no. not shown) includes posts 42 and 44, where tubing 102 of a medical device is threaded around the post “while preventing crimping or occlusion of the tubing 102” to prevent catheter displacement. (Col. 6, ll. 10-26.) Analysis Claim 1 The Examiner found that Sorbonne discloses an interacting structure in the form of cylindrical posts secured to a base, where the tubing is threaded around the posts to prevent crimping or occlusion of the tubing inhibiting movement in the longitudinal direction. (Ans. 5-6.) Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 10 Patent Owner contends that Sorbonne fails to disclose an “interacting structure which is adapted to engage the medical device” as recited in the claims because there is no additional structure in Sorbonne besides the medical line and spools around which the medical line is threaded. (App. Br. 6.) Patent Owner also argues that the evidence of record demonstrates that the device of Sorbonne is not effective without substantially occluding flow. (App. Br. 7.) Specifically, Patent Owner contends that the contact between the medical line and spools necessarily results in some crimping, which would occlude flow. (App. Br. 8.) Initially, we are not persuaded by Patent Owner’s argument that the interacting structure recited in the claims requires “some additional structure” beyond the spools 42, 44 disclosed in Sorbonne in light of the embodiments disclosed in the Specification of the ‘485 Patent. (App. Br. 6- 7.) The claims do not recite any such structure. (See Ans. 19-20. )8 Sorbonne discloses that the medical line is threaded around (interacts with) the spools 42, 44 in order to prevent catheter displacement (longitudinal movement). (Sorbonne, col. 6, ll. 10-26.) Accordingly, Sorbonne discloses an interacting structure as recited in the claims. We are also not persuaded by Patent Owner’s argument that the evidence of record, namely the first and second Frankhauser Declarations, demonstrates that Sorbonne does not engage the medical device in a non- occlusive manner as recited in the claims. As the Examiner stated, Sorbonne expressly discloses that the medical lines are not occluded. (Ans. 22-23; 8 In the Answer, the Examiner specifically agreed with Requester’s comments submitted in the responses filed December 21, 2007 and January 22, 2008 and which are reproduced in the Answer, pages 18-55. Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 11 Sorbonne, col. 6, ll. 10-26.) We do not find the statements made in the First and Second Frankhauser Declarations to be sufficient to outweigh the express statements made in Sorbonne that the interaction between the medical line and the posts does not occlude the medical line. Specifically, the First Frankhauser declaration states that the device disclosed in Sorbonne would not retain catheters without occlusion of the tubing or without slippage of the tubing. (First Frankhauser Dec., para. 12.) However, the First Frankhauser Declaration does not direct our attention to sufficient supporting evidence to support the statements made therein. In addition, the First Frankhauser Declaration states that the diameter and material of the tubing “may” prevent the device disclosed in Sorbonne from retaining the tubing in a non-tension state, and that in the tension state, if the tubing had sufficient integrity to avoid occlusion against the spools, the tubing “would most likely” slip through the spools. (First Frankhauser Dec. para. 12.) Such unsupported qualified statements are insufficient to overcome the express disclosure in Sorbonne that the tubing would not be occluded. To the extent Patent Owner argues that the Second Frankhauser Declaration provides supporting evidence for the First Frankhauser Declaration, we are also not persuaded. In the Second Frankhauser Declaration, Mr. Frankhauser constructed a device that is said to have been a mock-up of the device described in Figures 3-9 of Sorbonne, in which two wooden dowels were used for spools. (Second Frankhauser Dec., para. 4 and 11.) Mr. Frankhauser acknowledged that the coefficient of friction would likely be different between tubing and other materials. Mr. Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 12 Frankhauser declared that due to the use of different sized spools, employing a material with a higher coefficient of friction would not change his analysis. (Second Frankhauser Dec. para. 11.) Mr. Frankhauser declared that when the tubing was held in the devices in a tension state, the tubing deformed causing occlusion. (Second Frankhauser Dec., para. 9.) We do not find the tests conducted to be sufficient to show that the device disclosed in Sorbonne would result in occlusion of the medical lines when subjected to longitudinal force. Sorbonne discloses that the device is constructed of a semi-soft flexible and clear synthetic resinous material that retains its shape (col. 2, ll. 7-9), whereas the tests described in Patent Owner’s evidence of record employ wooden dowels for the spools disclosed in Sorbonne. The materials are therefore not the same. Because the tested device does not replicate the Sorbonne device, the weight accorded to the statements regarding the amount of occlusion of the tube is diminished. In addition, we are not persuaded by the Declarant’s position that the larger spools of the test device provide a sufficient comparison with a material having a higher coefficient of friction. Sorbonne discloses that the material is “semi-soft and flexible” (col. 2, ll. 7-9), the effect of which on the occlusion of the tubing is not discussed in either the First or Second Frankhauser Declaration. Accordingly, the evidence presented by Patent Owner is not sufficient to outweigh the express statements made in Sorbonne that the device retains the medical line without crimping or occluding when subjected to external stress. As a result, we affirm the Examiner’s rejection of claim 1 as anticipated by Sorbonne. Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 13 Claim 12 Patent Owner contends that Sorbonne does not disclose an irregularly shaped channel that corresponds to a medical line having an irregularly shaped portion as recited in claim 12. (App. Br. 15.) We agree with Patent Owner that Sorbonne fails to anticipate claim 12. Claim 12 requires not only that the channel has an irregular shape along its length, but also that the medical line has an irregularly shaped portion that corresponds in shape to the irregularly shaped channel. Sorbonne discloses that the medical line is threaded around the two spools, but Sorbonne does not disclose an arrangement between the channel and the medical line where the interaction of an irregularly shaped portion of the medical line and the irregular shape of the channel inhibits movement in a direction generally parallel to the longitudinal axis of the medical line as recited in claim 12. (Col. 6, ll. 10-26; Fig. 4.) The Examiner does not appear to address this deficiency in formulating the rejection or in the response to arguments. (Ans. 6, 19-24.) Therefore, we reverse the Examiner’s rejection of claim 12 as anticipated by Sorbonne. Claim 22 In rejecting claim 22, the Examiner reiterated that the spools in Sorbonne are configured to engage the catheter tube in a non-occlusive manner, which satisfies the “means for limiting the longitudinal movement” limitation recited in claim 22. (Ans. 24.) Patent Owner contends that Sorbonne does not disclose any of the structures corresponding to the “means” recited in the claim as expressed in Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 14 the ‘485 Patent. (App. Br. 17.) Specifically, Patent Owner argues that the structure corresponding to the “means for limiting longitudinal movement of the medical line relative to the retainer” is either posts interacting with holes on a fitting of a medical line or walls defined by mounting structures that are shaped and arranged relative to each other to generally correspond or interact with a fitting on a medical line. (App. Br. 17.) We addressed similar arguments made by Patent Owner in our Decision in the ex parte reexamination of 6,213,979 B1 (reexamination control 90/010,167, Appeal 2010-007376, “the ‘376 Decision”), and which we hereby incorporate by reference. (See the ‘376 Decision, pages 5, 12- 13.) In the ‘376 Decision, we concluded that in light of the Specification of the ‘979 Patent, which is the same as the Specification of the ‘485 Patent, the unrestrictive broadening language of the Specification did not limit the “means” recited in the claims to the two structures identified by Patent Owner, but rather included equivalent structures that rely on the use of compressive or downward force forces directly on the medical line, including those with tolerable degrees of crimping or compression. (The ‘376 Decision, pages 12-13.) In view of this claim construction, which we adopt herein, we agree with Patent Owner that Sorbonne fails to disclose a means for limiting longitudinal movement as disclosed in the Specification of the ‘485 Patent or an equivalent thereof. That is, the means for retaining the medical line in place in Sorbonne does not rely on a compressive or downward force on the medical line. Rather the medical line is prevented from moving longitudinally by threading the medical line around spools to prevent Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 15 crimping or occlusion. (Sorbonne, col. 6, ll. 10-26.) Accordingly, the “means” disclosed in Sorbonne is not an equivalent of the means disclosed in the ‘485 Patent, as it does not perform the claimed function in substantially the same way as the structure described in the ‘485 Patent Specification. Therefore, we do not sustain the Examiner’s rejection of claim 22 as anticipated by Sorbonne. Rejection III The Rejection In rejecting claims 12, 22, and 29, the Examiner found that Gordon ‘647 discloses an interacting structure comprising ribs 21 and 28 positioned within a cradle, which hold a catheter within the cradle upon closing of a cover, such that the vertical spacing or height of the ribs provides a firm grip against longitudinal displacement of the tubing within the stabilizer. (Ans. 13-14.) The Examiner stated that the channel in Gordon ‘647 includes side walls 19, 20, rear walls 17, 18, bottom wall 22, and ribs 21. (Ans. 42.) As a result the Examiner found that the width of the channel varies due to the presence of the ribs, and is irregularly shaped. (Ans. 42.) The Examiner also found that Gordon ‘647 discloses a means for preventing longitudinal movement as recited in claim 22 in the form of projection 55, which engages the medical line in one embodiment of Gordon ‘647 or the channel with ribs 21 as in another embodiment of Gordon ‘647. (Ans. 46-47.) Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 16 Issues The issues with respect to Rejection III are: Did the Examiner err in finding that Gordon ‘647 discloses the medical line and channel configuration recited in claim 12? Did the Examiner err in finding that Gordon ‘647 discloses the means for limiting longitudinal movement recited in claim 22? Findings of Fact Gordon ’647 discloses a device for positionally stabilizing a catheter on the body of a patient. (Col. 1, ll. 23-24.) Figures 3 and 7 of Gordon ‘647 are reproduced below: Figures 3 and 7 are perspective views of catheter stabilizing devices according to Gordon ‘647. (Col. 3, ll. 16-30.) The device in Figure 3 includes a base member 11, a support member 14, a cradle 16 including a front wall 17, a rear wall 18 (not shown), side walls 19 and 20, bottom wall 22, gripping members (ribs) 21, and cover 25 with downward extending ribs 28. (Col. 3, l. 41 through col. 4, l. 39.) In use, the stabilizer depicted in Figure 3 is secured to the catheter tube, where the ribs 21 and 28 engage the catheter tube, and by virtue of a slight Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 17 crimping of the tube, provides firm engagement of the tube preventing longitudinal displacement of the tube. (Col. 4, l. 63 – col. 5, l. 25.) Figure 7 depicts a stabilizer 40 including base member 41, base portion 43, a pair of side walls 44 and 45 terminating in recesses 47 and 48 (not shown) which receive catheter tube 50. (Col. 6, ll. 15-51.) The stabilizer depicted in Figure 7 also includes a snap-over cover 46 that includes a gripping projection 55 to engage and slightly crimp the catheter tube 50 forcing the catheter tube 50 slightly downward into central opening 49. (Col. 7, ll. 32-49.) Analysis Claim 12 Patent Owner contends that the channel in Gordon ‘647 is defined by ribs 21 and 28, which are shaped to hold a medical tube with constant diameter. (App. Br. 16.) We agree with Patent Owner that Gordon ‘647 fails to anticipate claim 12. Specifically, the Examiner fails to identify where Gordon ‘647 discloses a “medical line having an irregularly shaped portion” as recited in claim 12. While Gordon ‘647 discloses a device for stabilizing a catheter containing an irregularly shaped channel (Fig. 3), Gordon ‘647 does not disclose a medical line having an irregularly shaped portion. Gordon ‘647 discloses catheter tubing, but does not disclose any particular shape that would include an “irregularly shaped portion” even when the term is accorded its broadest reasonable interpretation as discussed supra. Accordingly, we reverse the Examiner’s rejection of claim 12 and Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 18 claim 29, which depends indirectly from claim 12, as being anticipated by Gordon’647. Claim 22 Regarding claim 22, Patent Owner argues that Gordon ‘647 relies on compression or crimping to prevent longitudinal movement, which is not equivalent structure to the means recited in the claims as disclosed in the ‘485 Patent. (App. Br. 19.) However, as discussed supra with respect to Sorbonne, the “means for limiting longitudinal movement” recited in claim 22 does allow for tolerable amounts of compression or crimping. Gordon ‘647 discloses devices that prevent longitudinal displacement of the catheter tube via compressive or downward force, via the ribs 21 and 28 in the device depicted in Figure 3 or projection 55 in the device depicted in Figure 7. Thus, Gordon ‘647 discloses a “means for limiting longitudinal movement” as recited in claim 22. Accordingly, Patent Owner’s argument is unpersuasive. Therefore, we affirm the Examiner’s rejection of claim 22 as anticipated by Gordon ‘647. NEW GROUND OF REJECTION Claim 12 is Anticipated by Gordon ‘880 In the course of responding to Patent Owner’s arguments, the Examiner incorporated comments from the Requester’s response during prosecution, which advanced the position to the Examiner that in light of the amendments to claim 12, that claim 12 is anticipated by Gordon ‘880. (Ans. 41, 43-44.) Although the Examiner did not appear to adopt this rejection in Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 19 the subsequent Action Closing Prosecution (mailed November 9, 2009), we agree with the Requester’s position in Requester’s Comments to the Patent Owner’s Response to the Office Action Dated September 21, 2007, dated December 21, 2007, Pages 31-33) and incorporated by reference in the Examiner’s Answer. Thus, claim 12 is rejected under 35 U.S.C. § 102(b) as anticipated by Gordon ‘880 for the reasons expressed therein. This rejection is designated as a new ground of rejection pursuant to our authority under 37 C.F.R. § 41.77(b). Rejection IV Issue The dispositive issue in this rejection is whether Bierman ‘435 discloses a “cover coupled to the base” as recited in claim 22. The Examiner’s position is that Bierman ‘435 discloses that box clamp 14 is coupled to the retainer upon securement of the medical line to the retainer, where the box clamp constitutes the claimed cover and where the retainer constitutes the claimed base. (Ans. 51-52.) Patent Owner argues that Bierman ‘435 does not disclose a cover coupled to a base because box clamp 14 is not coupled to the retainer in the open position, and the claim requires the cover to be coupled both before and after the medical article is placed within the retainer. (App. Br. 23.) Findings of Fact Bierman ‘435 discloses an anchoring system for catheters. (Page 1, ll. 4-5.) Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 20 Figure 2 of Bierman ‘435 is reproduced below: Figure 2 depicts an exploded view of a central line catheter anchoring system. (Page 3, ll. 30-33.) The anchoring system 10 includes a retainer 20, box clamp 14, and wing clamp 18. (Page 4, ll. 22-35.) In use, the wing clamp 18 is stretched over the catheter 12, and the downwardly extending posts 17 of box clamp 14 are inserted through the holes 36, to form a combination wing clamp/box clamp. Posts 17 are further aligned with the slotted openings 42 in the top surface of the retainer 42 to engage the openings 42 and moved laterally to retain the box clamp 14 in place. (Page 7, ll. 4-20.) Analysis We cannot agree with the Examiner’s position that the cover recited in claim 22 need not be coupled prior to securement of the medical line to the retainer. Claim 22 recites “providing a retainer including a base . . . and a cover coupled to the base.” Thus, claim 22 plainly requires that the cover is Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 21 coupled to the base at the time the retainer is provided. Bierman ‘435, on the other hand, discloses that the box clamp 14 is not attached to the base until after the device is completely assembled. (Page 7, ll. 4-20; Fig. 2.) The Examiner did not dispute this fact, but rather argued that coupling occurred “upon securement” of the medical line (Answer 51-52.) As this interpretation is improper, we conclude that Bierman ‘435 does not disclose a cover coupled to the base as recited in claim 22. The Examiner relies on the position that the claims do not disclose the method in any particular order. (Ans. 53-54.) However, the order of method steps as it relates to placing a portion of the medical line into the receiving area and moving the cover over the base does not change the structural requirements of the retainer at the time of providing the retainer. Thus, because Bierman ‘435 does not disclose a cover coupled to the base at the time of providing the retainer, we reverse the Examiner’s rejection of claim 22 and 30-33 as being anticipated by Bierman ‘435. OBVIOUSNESS REJECTIONS Rejection V The Rejection The Examiner found that Bierman ‘435 discloses a device for engaging and securing a catheter in place through the combination of a box clamp having posts, a wing clamp which surrounds and engages a catheter, and a retainer. (Ans. 8.) The Examiner relied on Sorbonne for disclosing that a cover which overlies a device for securing a medical line is well- known, concluding that it would have been obvious to provide the device of Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 22 Bierman ‘435 with a cover as disclosed in Sorbonne. (Ans. 7.) The Examiner’s position is that Bierman ‘435 discloses the identical interacting structure that was disclosed in the ‘485 Patent, which does not occlude the catheter tube and limits the longitudinal movement of the medical device. (Ans. 25-28.) The Examiner also stated that modifying the cover of Sorbonne so that it would function in conjunction with the device in Bierman ‘435 would have been an obvious modification within the level of ordinary skill in the art. (Ans. 28-29.) Issues The issues for this rejection are: Does Bierman ‘435 disclose that the interacting structure limits longitudinal movement as recited in claim 1? Would it have been obvious to one of ordinary skill in the art to have added a cover to the device of Bierman ‘435 in view of Sorbonne? Does Bierman ‘435 disclose the medical line and channel configuration recited in claim 12? Findings of Fact Sorbonne discloses that the cover of the venipuncture site guard is adapted to conceal and enclose the venipuncture and retainer section to protect against inadvertent catheter displacement and contact. (Col. 5, ll. 7- 11, col. 6, ll. 18-25.) Sorbonne discloses and depicts covers that are attached via a hinge at the longitudinal axis of the base or at the side edge of the base. (Col. 3, ll. 56-57, col. 4, ll. 38-55, Fig. 5; col. 6, ll. 56-60; Fig. 9.) Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 23 Bierman ‘435 discloses a box clamp 14 that overlies the wing clamp 18 and conveniently and painlessly anchors a catheter to the patient’s skin. (Bierman ‘435, page 4, ll. 22-28.) Principles of Law In KSR, the Supreme Court explained, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). “A person of ordinary skill is also a person of ordinary creativity, not an automaton.” Id. at 421. “[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 417. Analysis Claim 1 We are unpersuaded by Patent Owner’s argument that (1) Bierman ‘435 discloses a friction fit between the wing clamp and the groove of the box clamp, and not between the wing clamp and the catheter and (2) Bierman ‘435 does not specifically describe “inhibiting longitudinal movement.” (App. Br. 9.) We addressed similar arguments made by Patent Owner in the ‘376 Decision. (See ‘376 Decision, pages 14-15, 18-20.) In the ‘376 Decision, we stated that Bierman ‘435 contained either the same or Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 24 substantially the same structures as disclosed in the ‘979 Patent, and thus would reasonably appear to limit the longitudinal movement of the catheter relative to the retainer. (Decision, p. 19.) We see no reason to disturb that analysis here where the disclosures of the ‘979 Patent and the ‘485 Patent are the same and no additional persuasive rebuttal evidence or arguments have been put forth. Therefore, we agree with the Examiner that there is sufficient evidence that Bierman ‘435 discloses limiting longitudinal movement as recited in claim 1. Additionally, we are not persuaded by Patent Owner’s arguments that one of ordinary skill in the art would not have combined Bierman ‘435 and Sorbonne to arrive at the cover arrangement recited in the claims. Specifically, Sorbonne discloses that the cover is adapted to conceal and enclose the venipuncture and retainer section to protect against inadvertent catheter displacement and contact. (Col. 5, ll. 7-11, col. 6, ll. 18-25.) Similarly, Bierman ‘435 discloses a box clamp 14, which the Examiner found corresponded to a cover (Ans. 8), that overlies the wing clamp 18 and conveniently and painlessly anchors the catheter to the patient’s skin. (Bierman ‘435, page 4, ll. 22-28.) Thus, both references disclose similar reasons for employing covers in catheter retaining devices. Patent Owner argues that combining Sorbonne with Bierman ‘435 would frustrate the purpose of Bierman ‘435 because the cover could not engage properly and the base and hinge structure of the cover would prevent the box clamp from moving in a lateral direction to slide posts through the holes as required for operation of the device in Bierman ‘435 by not Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 25 allowing for lateral movement of the box clamp. (App. Br. 10.) Patent Owner’s arguments are unavailing. Patent Owner focuses on the bodily incorporation of one embodiment disclosed in Sorbonne rather than what Sorbonne as a whole would convey to one of ordinary skill in the art. Sorbonne discloses that the covers are attached via a hinge either on the longitudinal axis of the base, or at the side edge of the base. (Col. 3, ll. 56-57, col. 4, ll. 38-55, Fig. 5; col. 6, ll. 56-60; Fig. 9.) Thus, Patent Owner’s arguments fail to take into account the full scope of Sorbonne as well as the knowledge of one of ordinary skill in the art. We agree with the Examiner, that as a result of the general disclosure in Sorbonne that retaining devices include covers that are attached to the base of the device, an obvious modification of Bierman’435 would have been to attach box clamp 14 to the retainer 20 via a hinge in a manner that would preserve the ability of the box clamp 14 to move laterally as required in the locking system of Bierman ‘435. (See Ans. 28.) Whether the modification would have been to use a hinge that allows for small lateral movement, or by attaching the box clamp at the side edge of the base, Patent Owner has not provided sufficient evidence that such modifications would have been beyond the capabilities of one of ordinary skill in the art. Therefore, the Examiner properly rejected claim 1 as obvious over Bierman ‘435 in view of Sorbonne. Claim 12 We agree with Patent Owner that Bierman ‘435 in view of Sorbonne fails to teach a channel having an irregular shape along its length that Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 26 substantially corresponds in shape to an irregularly shaped portion of the medical line as required in claim 12. (App. Br. 15-16.) That is, the channel in Bierman ‘435 is a straight, cylindrical channel, and thus is not of an irregular shape as required in claim 12. (Figure 2; see numeral 40.) As discussed above, Sorbonne also fails to disclose the required relationship between the channel and the medical line recited in claim 12. The Examiner does not account for this deficiency in formulating the rejection. (Ans. 7-8.) Therefore, we reverse the Examiner’s rejection of claim 12 as obvious over Bierman ‘435 in view of Sorbonne. Rejection VI Issue The Examiner concluded that it would have been obvious to provide the device of Sorbonne with the channel disclosed by Bierman ‘435 as a means to secure the medical device of Sorbonne in position. (Ans. 10-11.) Patent Owner contends that Bierman ‘435 does not disclose a means for limiting longitudinal movement as recited in claim 22. (App. Br. 18.) Patent Owner additionally contends that Sorbonne teaches away from clamping to the medical line as disclosed in Bierman ‘435 such that one of ordinary skill in the art would not have been led to incorporate the clamp disclosed in Bierman ‘435 into the Sorbonne device. (App. Br. 18.) Therefore, the dispositive issue is whether the Examiner erred in concluding it would have been obvious to have incorporated the clamp of Bierman ‘435 into the device of Sorbonne? Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 27 Discussion As to Patent Owner’s first argument, we are not persuaded that Bierman ‘435 fails to disclose a “means for limiting longitudinal movement” for similar reasons as discussed supra. Additionally, we do not agree with Patent Owner that Sorbonne teaches away from applying the clamp of Bierman ‘435 to the device of Sorbonne. Patent Owner relies on the statement in Sorbonne that prior art devices have failed to provide a venipuncture site guard that allows the cannula at the venipuncture site to move independently of the site guard while protecting the site as a teaching away from applying a clamp as disclosed in Bierman ‘435. (App. Br. 18; Sorbonne, col. 1, ll. 44-49.) However, as pointed out by the Examiner, Sorbonne itself is directed to secure engagement of the medical line, where unless the anchoring system as a whole moves, the medical line will also not move. (Ans. 22; see Sorbonne, col. 6, ll. 10-26, Fig. 4.) Thus, the securing system disclosed in Bierman ‘435 is an alternative to that disclosed in Sorbonne, such that the substitution of one for another would have been a predictable use of prior art elements. Therefore, we are not persuaded by Patent Owner’s arguments. Rejection VII The Rejection The Examiner found that Gordon ‘647 discloses a catheter stabilizer having a cradle that acts as a receiving area for the catheter tube. (Ans. 11.) The Examiner found that Gordon ‘880 discloses a similar cradle with longitudinal ridges 28 and hub boss 36a which limits the longitudinal Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 28 movement of the catheter by providing a surface that cannot move past ribs 60. (Ans. 12.) The Examiner concluded that it would have been obvious to provide the device of Gordon ‘647 with longitudinal ridges 28 to limit the longitudinal movement of the catheter. (Ans. 12.) Issue The dispositive issue with respect to this rejection is: Did the Examiner err in concluding that it would have been obvious to have incorporated the longitudinal ridges and hub boss configuration disclosed in Gordon ‘880 as a means for limiting longitudinal movement in the device disclosed in Gordon ‘647? Findings of Fact Gordon ‘880 discloses a fitting for securing an intravenous catheter in as stabilized manner to a patient’s skin. (Col. 1, ll. 11-13.) Figures 16 and 17 of Gordon ‘880 are reproduced below: Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 29 Figure 16 is a perspective view of a stabilizing fitting and Figure 17 is a perspective view of a stabilizing fitting showing a catheter hub in place. (Col. 2, ll. 54-57.) The stabilizing fitting includes a catheter boss 36a that is longitudinally located between a pair of ribs 60 in order to maintain the catheter hub 36 in position. (Col. 4, ll. 30-64.) Analysis Patent Owner’s first argument, that Gordon ‘647 does not disclose limiting longitudinal movement in a non-occlusive manner (App. Br. 11), is unpersuasive, as it fails to address the Examiner’s rejection, which does not rely on Gordon’647 for the manner of limiting longitudinal movement, but rather relies on Gordon ‘880 for that limitation. (See Ans. 37.) Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 30 We do not agree with Patent Owner that Gordon ‘880 fails to disclose the interacting structure of claim 1. (App. Br. 13.) Patent Owner does not substantively address the Examiner’s rejection or response to Patent Owner’s arguments, which address how Gordon ‘880 discloses the interacting structure of claim 1. (Ans. 11-12, 37.) We are also unpersuaded by Patent Owner’s argument that Gordon ‘647 and Gordon ‘880 teach away from the Examiner’s proposed combination. In this regard, Patent Owner contends that Gordon ‘880 discloses a device for releasably engaging a fitting, where the boss 36a is located outside the cover 66 (Fig. 17 supra), and Gordon ‘647 discloses a device for securing medical tubing, where the stabilizer disclosed in Gordon ‘647 is not capable of receiving the medical device in Gordon ‘880. (App. Br. 12.) Patent Owner argues that the ribs 60 and boss 36a of Gordon ‘880 would change the principle of operation in Gordon ‘647, where the positive engagement of the boss and ribs would defeat the purpose of achieving frictional engagement, prevent closure of the cover, and that the gripping members would have no purpose in the modified device of Gordon ‘647. (App. Br. 12-13; See Ans. 38-39.) We do not subscribe to Patent Owner’s view that one of ordinary skill in the art would not have incorporated the securing system of Gordon ‘880 into the device of Gordon ‘647 because Gordon ‘647 relies on frictional engagement of the ribs with the medical line. Rather, Gordon ‘880 provides an alternative mechanism for limiting longitudinal movement using the combination of ribs 60 and hub boss 36a. (Col. 1, ll. 11-13, col. 4, ll. 30-64; Fig. 16, 17.) Thus, we agree with the Examiner that rather than changing the Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 31 principle of operation, the proposed modification would contain additional features in order to retain the catheter in place. (See Ans. 40.) In addition, that Gordon ‘880 discloses a device for engaging a catheter fitting and Gordon ‘647 discloses a device for securing medical tubing, does not mean that one of ordinary skill in the art would not have considered each reference to be relevant to one another. Both are concerned with limiting movement of a catheter, and, as a result, one of ordinary skill in the art would have considered each together for that purpose. Moreover, Patent Owner has not provided sufficient evidence that one of ordinary skill in the art would have been incapable of modifying the cover in Gordon ‘647 to accommodate the rib and hub boss elements incorporated therein. As both patents establish that persons of ordinary skill in the art were familiar with the design and production of devices for securing and holding catheters and tubing in place, we agree with the Examiner that it would have been within the knowledge of one of ordinary skill in the art to extend the cover disclosed in Gordon ‘880 over the ribs 60 and to size the cover to accommodate the hub boss 36a of the catheter hub. (Ans. 38.) Therefore, we agree with the Examiner that Gordon ‘647 in view of Gordon ‘880 would have rendered claim 1 obvious to one of ordinary skill in the art. Rejection VIII Discussion The Examiner’s position is that Gordon ‘647 device in Figures 6-9 could receive the soft, pliable and flexible wing clamp disclosed in Bierman Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 32 ‘435. The Examiner’s position is also that Gordon ‘647 and Bierman ‘435 could have been combined because Gordon ‘647 expressly states that the securement device is for an intravenous catheter, which is the type disclosed in Bierman ‘435. (Ans. 55.) The Examiner also adopted the position that it would have been obvious to secure a catheter fitting as disclosed in Bierman ‘435 because the catheter fitting (wing clamp) is made of a soft, pliable flexible material that could easily be fit within the securement device disclosed in Gordon ‘647. (Ans. 55.) Patent Owner contends that neither Gordon ‘647 nor Bierman ‘435 discloses a means for limiting longitudinal movement that falls within the scope of claim 22, and further that there would be no reason to combine Gordon ‘647, which discloses a device for securing medical tubing directly, with Bierman ‘435, which discloses a device for securing a fitting attached to a medical line. (App. Br. 24.) Patent Owner’s first argument that Bierman ‘435 fails to disclose a means for limiting longitudinal movement as recited in claim 22 is not persuasive for the reasons discussed above. We are also not persuaded by Patent Owner’s argument that there would be no reason to combine Gordon ‘647, which discloses a device for securing medical tubing directly, with Bierman ‘435, which discloses securing a fitting attached to a medical line for similar reasons discussed supra with respect to the rejection of Gordon ‘647 in view of Gordon ‘880. Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 33 Secondary Considerations In light of the evidence of secondary considerations submitted by Patent Owner, it is necessary to re-weigh the evidence of obviousness in the rejections discussed above against Patent Owner’s evidence in order to determine whether, in light of the totality of evidence, the rejected claims would have been obvious. Patent Owner contends that the Examiner has not properly considered Appellants’ evidence of non-obviousness. (App. Br. 24-25.) Specifically, Patent Owner contends that there is sufficient evidence of commercial success, in the form of an increase in market share from 30% to 50% in five years for an embodiment, Statlock PICC Plus that falls within the scope of claims 1 and 22. (App. Br. 25-26.) Patent Owner further contends that packaging the securement device as part of a kit does not amount to forced consumption of the claimed articles. (App. Br. 26.) Patent Owner also contends that the reason for the commercial success was due to the claimed features, which resulted in a reduced amount of time to secure the PICC and eliminated the risk of needle stick injuries. (App. Br. 27.) Patent Owner argues that marketing efforts did not drive sales, as evidenced by the high sales account retention. Patent Owner contends that there is evidence of industry praise and initial skepticism as evidenced by several studies which suggested the use of the Statlock PICC Plus and CV Plus products. (Ans. 28-29.) In addition, Patent Owner argues that the Examiner’s position that medical professionals were typically reluctant to adopt new technology supports Patent Owner’s position that the devices were met with initial skepticism. (App. Br. 30-31.) Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 34 Patent Owner also argues that there was a long felt need for improved securement devices that reduce the risk of needle stick injury and infection, and that the health care industry has recognized the shortcomings of tape and sutures as securing methods. (App. Br. 31-32.) The Examiner also adopted the Requester’s comments regarding secondary considerations made in the response filed December 21, 2007. (Ans. 55.) Principles of Law Once a prima facie case of obviousness has been established, objective evidence of secondary considerations must be considered in making an obviousness decision. See Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538-39 (Fed. Cir. 1983). Any initial obviousness determination is reconsidered anew in view of the proffered evidence of nonobviousness. See In re Rinehart, 531 F.2d 1048, 1052 (CCPA 1976); In re Eli Lilly & Co., 902 F.2d 943, 945 (Fed. Cir. 1990) Discussion Considering the totality of the evidence, we are of the opinion that Patent Owner’s evidence of secondary considerations is insufficient to outweigh the evidence of obviousness of record for the reasons discussed infra. Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 35 Commercial Success While we acknowledge that the market share, units sold, and revenue data submitted by Patent Owner by way of the Supplemental Declaration of Steven F. Bierman are not insignificant (Third Bierman Dec. paras. 4-7), we nevertheless do not agree that the data constitutes sufficient evidence to provide a nexus between the alleged commercial success and the features of the claims. Specifically, there is insufficient evidence that the data for the product StatLock® PICC plus demonstrates that the alleged success is related to claimed features not already found in the prior art. See Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 (Fed. Cir. 2011) (“If commercial success is due to an element in the prior art, no nexus exists.”); Ormco Corp. v. Align Technology, Inc., 463 F.3d 1299, 1312 (Fed. Cir. 2006) (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”). In this regard, Patent Owner points to evidence that the success of the PICC Plus products was “due to their design” where the “inner structure . . . helps retain the catheter in the lateral and longitudinal directions [and] does not occlude the lumen of the catheter or tubing.” (First Frankhauser Dec. para. 5.) The evidence indicated that the attached cover has the advantage of “minimizing potential contamination during insertion, and reducing the likelihood of the cover being misplaced.” (Id.) The evidence also indicated that the advantages “included reduced application time, increased catheter securement without occluding the catheter, even when the catheter or attached medical tube was tugged or pulled, and the elimination of needle- stick injuries.” (First Bierman Dec., para. 10.) However, as discussed Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 36 above, the prior art already contained inner structures as recited in claims 1 and 22 for limiting longitudinal movement, for example in Bierman ‘435. In addition, the prior art also contained attached covers, as disclosed in Sorbonne, Gordon ‘647, and Gordon ‘880. Therefore, Patent Owner’s evidence of commercial success is not entitled to significant weight. Skepticism/Praise/Long Felt Need Patent Owner’s evidence of initial skepticism, industry praise, and long felt need are likewise unpersuasive. The studies pointed to by Patent Owner, only appear to consider the use of tape or sutures as alternative means of securing a medical line, and not the devices disclosed in the prior art applied to the claims. (First Bierman Decl., paras. 10, 11; First Frankhauser Decl. paras. 7-10; App. Br. Ex. IX-XIII.) Patent Owner’s statements only relate to the Sorbonne and Gordon references, and do not discuss the device disclosed in Bierman ‘435. (App. Br. 32.) Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008) ("While the evidence shows that the overall system drew praise as a solution to a felt need, there was no evidence that the success of the commercial embodiment . . . was attributable to the . . . only material difference between [the prior art] and the patented invention.") (citation omitted, emphasis added); In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) ("Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention"). Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 37 Thus, we have not been directed to sufficient evidence of industry praise, initial skepticism, and long felt need to outweigh the evidence supporting a conclusion of obviousness. Summary of Secondary Consideration Evidence After evaluating the evidence of obviousness as well as the evidence of secondary considerations, commercial success, industry praise, initial skepticism, and long felt need, we conclude that the evidence as a whole weighs in favor of obviousness in light of the strong evidence of obviousness discussed above, and the deficiencies in the secondary consideration evidence as discussed supra. Accordingly, we sustain the Examiner’s rejections of the claims as obviousness with the exception of those expressly reversed as discussed above. DECISION In sum, we affirm the Examiner’s decision to reject: Claims 1-3, 5-8, and 11 under 35 U.S.C. § 102(b) as anticipated by Sorbonne; Claim 22 under 35 U.S.C. § 102(b) as anticipated by Gordon ‘647; Claims 1 and 23-27 under 35 U.S.C. § 103(a) as obvious over Bierman ‘435 in view of Sorbonne; Claims 2, 6, and 22 under 35 U.S.C. § 103(a) as obvious over Sorbonne in view of Bierman ‘435; Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 38 Claims 1, 23, and 24 under 35 U.S.C. § 103(a) as obvious over Gordon ‘647 in view of Gordon ‘880, and Claims 22, 30, and 33 under 35 U.S.C. § 103(a) as obvious over Gordon ‘647 in view of Bierman ‘435. We reverse the following rejections: Claim 12 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement; Claims 12, 13, 15-18, and 21 under 35 U.S.C. § 102(b) as anticipated by Sorbonne; Claims 12 and 29 under 35 U.S.C. § 102(b) as anticipated by Gordon ‘647; Claims 22 and 30-33 under 35 U.S.C. § 102(b) as anticipated by Bierman ‘435; Claims 12, 28, and 29 under 35 U.S.C. § 103(a) as obvious over Bierman ‘435 in view of Sorbonne; and Claim 16 under U.S.C. § 103(a) as obvious over Sorbonne in view of Bierman ‘435. We enter the following new ground of rejection: Claim 12 is rejected under 35 U.S.C. § 102(b) as anticipated by Gordon ‘880. NEW GROUND OF REJECTION 37 C.F.R. § 41.77(b) states: (b) Should the Board reverse the examiner’s determination not to make a rejection proposed by a requester, the Board shall set Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 39 forth in the opinion in support of its decision a new ground of rejection; or should the Board have knowledge of any grounds not raised in the appeal for rejecting any pending claim, it may include in its opinion a statement to that effect with its reasons for so holding, which statement shall constitute a new ground of rejection of the claim. Any decision which includes a new ground of rejection pursuant to this paragraph shall not be considered final for judicial review. When the Board makes a new ground of rejection, the owner, within one month from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal proceeding as to the rejected claim: (1) Reopen prosecution. The owner may file a response requesting reopening of prosecution before the examiner. Such a response must be either an amendment of the claims so rejected or new evidence relating to the claims so rejected, or both. (2) Request rehearing. The owner may request that the proceeding be reheard under § 41.79 by the Board upon the same record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Requests for extensions of time in this inter partes reexamination proceeding are governed by 37 C.F.R. § 1.956. See 37 C.F.R. § 41.79. AFFIRMED-IN-PART; NEW GROUND OF REJECTION Appeal 2012-005323 Reexamination Control 95/000,271 Patent 6,447,485 B2 40 ack PATENT OWNER: KNOBBE MARTENS OLSON & BEAR LLP 2040 MAIN STREET FOURTEENTH FLOOR IRVINE, CA 92614 THIRD-PARTY REQUESTER: HOVEY WILLIAMS, LLP 2405 GRAND BLVD. SUITE 400 KANSAS CITY, MO 64108 Copy with citationCopy as parenthetical citation