Ex Parte Field et alDownload PDFPatent Trial and Appeal BoardMar 11, 201310803882 (P.T.A.B. Mar. 11, 2013) 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. 10/803,882 03/19/2004 Stephen James Field 0119/0034 7153 21395 7590 03/11/2013 LOUIS WOO LAW OFFICE OF LOUIS WOO 717 NORTH FAYETTE STREET ALEXANDRIA, VA 22314 EXAMINER ROY, BAISAKHI ART UNIT PAPER NUMBER 3777 MAIL DATE DELIVERY MODE 03/11/2013 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 PATENT TRIAL AND APPEAL BOARD __________ Ex parte STEPHEN JAMES FIELD, RICHARD HINGLEY, STEPHEN JAMES LODGE, and THOMAS CUTHBERT MILLS __________ Appeal 2011-013229 Application 10/803,882 Technology Center 3700 __________ Before DONALD E. ADAMS, ERIC GRIMES, and RICHARD M. LEBOVITZ, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a medical device or catheter, which have been rejected for anticipation and obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm in part. STATEMENT OF THE CASE Claims 1 and 3-18 are on appeal. Claims 1, 13, and 15 are representative and read as follows: Appeal 2011-013229 Application 10/803,882 2 1. A medical device comprising an elongate portion of plastics material, the portion being extruded with at least a first, inner layer of a plastics material and a second layer of a plastics material on an outside of the inner layer, wherein one of said layers is substantially free of gas bubbles, wherein the other of said layers of the device is coextruded with the one of the layers to include gas bubbles dispersed within the material of said other layer to increase the visibility of the device under ultrasound imaging, and wherein said layer substantially free of gas bubbles is thinner than said other layer such that the layer containing gas bubbles is covered at a surface by the thinner of the layers. 13. A device according to Claim 1, wherein the device is a catheter having a bore extending along its length. 15. A device according to Claim 13, wherein said plastics material is transparent to the eye, and wherein the density of bubbles is such as to permit material within the catheter to be viewed by the eye. The claims stand rejected as follows: • Claims 1, 3-8, 12-14, and 16-18 under 35 U.S.C. § 102(b) as anticipated by Arterburn 1 (Answer 4); • Claims 9-11 under 35 U.S.C. § 103(a) as obvious based on Arterburn and Bland 2 (Answer 6); and • Claim 15 under 35 U.S.C. § 103(a) as obvious based on Arterburn and Smith 3 (Answer 7). I. The Examiner has rejected claims 1, 3-8, 12-14, and 16-18 as anticipated by Arterburn (Answer 4). The Examiner finds that “Arterburn 1 Arterburn, US 4,644,977, issued Feb. 24, 1987. 2 Bland et al., US 6,071,580, issued June 6, 2000. 3 Smith, US 6,840,090 B2, issued Jan. 11, 2005. Appeal 2011-013229 Application 10/803,882 3 discloses a device which includes [an] inner layer of plastic and a second layer of plastic wherein one of the layers or the inner layer 18 is free of gas bubbles and the other layer or second layer 20 includes gas bubbles” (id. at 5). The Examiner also found that Arterburn described foam layers 14 and 20 (id.). The Examiner reasons that the foamed layer in Arterburn‟s device would inherently increase visibility under ultrasound imaging (id.), and that the “term „medical device‟ in the preamble does not limit the device. Even if it did, the tube in the reference could be used in a medical environment if necessary.” (Id. at 6.) We agree with the Examiner that claim 1 encompasses Arterburn‟s device. Arterburn discloses a lightweight, abrasion- and stain-resistant hose (Arterburn, col. 1, ll. 35-39) that comprises inner and outer cover layers with a foamed layer in between (id. at col. 1, ll. 48-52). Arterburn exemplifies a hose in which the inner, nonfoamed layer has a thickness of 0.015 inch and the foamed layer has a thickness of 0.04 to 0.06 inch (id. at col. 4, ll. 8-11) and the layers are coextruded (id. at col. 4, l. 14). Arterburn thus describes a product meeting all of the structural limitations of claim 1. Appellants argue, however, that the requirement in claim 1 of increased visibility under ultrasound imaging is a proper functional limitation (Appeal Br. 14), and “Arterburn fails to disclose anything remotely having to do with ultrasound imaging” (id. at 14-15). This argument is unpersuasive. Claim 1 is directed to a product, not a method of using a product in conjunction with ultrasound imaging. The Examiner concluded that Arterburn‟s product would necessarily have increased visibility under ultrasound imaging because it has the same Appeal 2011-013229 Application 10/803,882 4 structure as claimed (Answer 5-6), which is consistent with the Specification‟s description of known plastic devices that have increased ultrasound visibility because they incorporate bubbles (Spec. 1-2). Appellants have provided no persuasive basis for concluding that the Examiner‟s reasoning is faulty. Appellants also argue that claim 1 is directed to a “medical device,” which means “devices that are meant to be inserted into the human body and accordingly have to have an elastic property so that the devices can follow the contours of the interior organs of the patient into which the devices are to be inserted” (Appeal Br. 15). Appellants argue that “no person skilled in the art could have construed the hose disclosed by Arterburn to be a medical device” (id.). We disagree. The broadest reasonable interpretation of a “medical device” is a device with a medical application. Appellants have not pointed to an express definition in the Specification that would limit the claimed device to one that is meant to be inserted into the human body, or to one with particular elastic properties. The Specification states, for example, that medical devices include cables (Spec. 8). In any case, Arterburn discloses a hose that has “an inner diameter of 5/8 inch or less” (Arterburn, col. 4, ll. 7), which is reasonably interpreted as a size capable of insertion into the human body. Finally, with respect to claim 1, Appellants argue that Arterburn‟s hose differs from the product of claim 1 because “the Arterburn hose requires (1) a reinforcement layer, and (2) an outer layer that does not have foams” (Appeal Br. 17). Claim 1, however, uses the transition term Appeal 2011-013229 Application 10/803,882 5 “comprising,” and therefore encompasses products that include the recited elements together with other elements such as a reinforcement layer and an outer, unfoamed layer. See CIAS, Inc. v. Alliance Gaming Corp., 504 F.3d 1356, 1360 (Fed. Cir. 2007) (“In the patent claim context, the term „comprising‟ is well understood to mean „including but not limited to‟.”). With regard to claim 4, 4 Appellants point out that the claim requires “that the second layer provides an outer surface of the device” (Appeal Br. 19). Appellants argue that Arterburn does not disclose any embodiments with an outer surface having gas bubbles (id.), and that “even though acknowledging that all layers may be foamed to minimize the cost, Arterburn nonetheless teaches against the foaming of the inner and outer surfaces as such foaming would make the outer layer permeable to fluids” (id.). This argument is not persuasive. Claim 1 does not require the “second layer” to be the layer containing gas bubbles. The claim recites an “inner layer,” and a “second layer” on the outside of the inner layer, “wherein one of said layers is substantially free of gas bubbles” and the layers are coextruded “such that the layer containing gas bubbles is covered at a surface by the thinner,” bubble-free layer. Claim 1 thus reads on an embodiment in which the inner layer is the bubble-containing layer and is covered on its outer surface by the bubble-free layer. Cf. Arterburn, col. 4, ll. 14-16 (“foamed layer 14 . . . coextruded with the nonfoamed outer cover 16”). Although Appellants argue that Arterburn‟s embodiments have more 4 Appellants actually present this argument with respect to claim 3 but the relevant limitation is in claim 4, not claim 3. Appeal 2011-013229 Application 10/803,882 6 than two layers (Appeal Br. 19), claim 4 encompasses such embodiments for the reason discussed above with respect to claim 1. With regard to claim 13, Appellants point out that the claim recites a catheter (Appeal Br. 19). Similarly, Appellants point out that claims 16-18 recite a catheter or an embryo transfer catheter (id. at 13). Appellants argue that “the examiner has failed to take into account the preamble of the claims in evaluating the claims” (id. at 15). Appellants argue that “no person skilled in the art could have construed the hose disclosed by Arterburn to be . . . a catheter” (id.) because catheters are “meant to be inserted into the human body and accordingly have to have an elastic property so that the devices can follow the contours of the interior organs of the patient into which the devices are to be inserted” (id.). We agree with Appellants that the preambles of claims 13 and 16-18 are entitled to some weight in the interpretation of the claims; that is, the claims should not be read to encompass all products comprising an elongate shaft having the recited layers. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999) (“If the claim preamble, when read in the context of the entire claim, recites limitations of the claim, or, if the claim preamble is „necessary to give life, meaning, and vitality‟ to the claim, then the claim preamble should be construed as if in the balance of the claim.”). A catheter is “a tubular medical device for insertion into canals, vessels, passageways, or body cavities for diagnostic or therapeutic purposes Appeal 2011-013229 Application 10/803,882 7 (as to permit injection or withdrawal of fluids or to keep a passage open).” 5 Appellants have not argued that an “embryo transfer catheter” (see claim 17) differs structurally from a “catheter.” Thus, claims 13 and 16-18 are directed to devices that are capable of insertion into, e.g., a body cavity, for a diagnostic or therapeutic purpose. As discussed above with respect to claim 1, Arterburn discloses a hose having “an inner diameter of 5/8 inch or less” (Arterburn, col. 4, ll. 7), which is reasonably interpreted as a size capable of insertion into a body cavity. Appellants have not provided evidence or any persuasive technical reason for concluding that Arterburn‟s hose is incapable of being used for any diagnostic or therapeutic purpose. Therefore, we conclude that the broadest reasonable interpretation of claims 13 and 16-18 encompasses the hose disclosed by Arterburn. With regard to claim 15, the Examiner finds that “Arterburn does not teach of a transparent tube . . . [but] Smith teaches a plumbing system that incorporates a transparent hose 38 so that the plumber can determine visually whether there is water in the hose (col. 2 lines 30-34)” (Answer 7). The Examiner concludes that it would have been obvious to make Arterburn‟s hose transparent “for maintenance purpose and ensuring that undesired material does not penetrate inside the hose and ensure proper drainage through the hose” (id.). We agree with the Examiner‟s fact-finding and conclusion. Appellants argue that “[g]iven the multiple layers of the Arterburn hose, and the fact that each of the Arterburn hoses requires a reinforcement 5 www.merriam-webster.com/medlineplus/catheter, accessed Mar. 8, 2013. Appeal 2011-013229 Application 10/803,882 8 layer, it is highly unlikely that the material within the Arterburn hose could be viewed by the eye” (Appeal Br. 19). However, each of the layers of Arterburn‟s hose, except for the reinforcement layer, are made of a “[t]hermoplastic materials such as polyvinyl chloride, polyethylene,” etc. (Arterburn, col. 4, ll. 44-47). Appellants have not persuasively explained why the number of layers would affect overall transparency if each of the layers was made of a transparent thermoplastic material. Arterburn states that the “reinforcement 12 can be of any desired configuration such as knit, spiral, or braid; and made of nylon, polyester, or any textile material” (id. at col. 2, ll. 65-67). Here again, Appellants have not persuasively explained why the reinforcement layer would necessarily prevent the contents of the hose from being visible through the wall of the hose. Appellants also argue that “common sense suggests that since it is water that traverses through the Arterburn hose, there really is no need to look at what is passing through the bore of the hose” and there is no evidence supporting the motivation to combine Arterburn and Smith as posited by the Examiner (Appeal Br. 19-20). This argument is also unpersuasive. Smith discloses that “[i]n a preferred embodiment of the present invention, the hose is transparent, so that the plumber can determine visually whether there is water in the hose” to ensure that drainage is complete (Smith, col. 2, ll. 30-32). Appellants have not persuasively explained why this property would not have provided a reason to make Arterburn‟s hose transparent. Appeal 2011-013229 Application 10/803,882 9 II. The Examiner has rejected claims 9-11 as obvious based on Arterburn and Bland (Answer 6). These claims depend from claim 1 and require that the gas bubbles have a size of 0.1µ to 300µ (claim 9), 1µ to 50µ (claim 10), or 5µ to 10µ (claim 11). The Examiner finds that Bland discloses an “open cell thermoplastic foam with pores sized of about 5 micrometers or more (col. 4 lines 15-22)” (Answer 6), and concludes that it would have been obvious “to use the foam structure with pores of particular dimension of Bland et al. such that the Arterburn tube or hose device has the desired thickness, density and porosity” (id.). Appellants argue that “Bland is directed to an absorbent open cell thermoplastic foam that has a high liquid absorption rate and capacity” (Appeal Br. 20). Appellants argue that “it is highly questionable that a person skilled in the art would use the Bland foam with the Arterburn hose. . . . There simply is no suggestion of motivation in either of the references that Bland can be combined with Arterburn as alleged by the examiner.” (Id.) We agree with Appellants that the Examiner has not provided adequate reasoning to support the conclusion that it would have been obvious to use Bland‟s foam in the hose disclosed by Arterburn. As Appellants point out, Bland discloses that its “open-cell thermoplastic foams . . . exhibit excellent and unexpected absorptive properties and characteristics” (Bland, col. 3, ll. 13-15), specifically, high absorption rate and capacity (id. at col. 3, ll. 60-62). Bland discloses that its foams are Appeal 2011-013229 Application 10/803,882 10 useful in applications such as an insert for a meat tray or a diaper (id. at col. 2, ll. 24-31). The Examiner has not provided evidence or persuasive technical reasoning to show that a person of ordinary skill in the art would have considered Bland‟s foams to have “the desired thickness, density and porosity” (Answer 6) for use in Arterburn‟s hose. The Examiner also reasoned that the “references are combined such that the gas bubbles of Arterburn are of a certain dimension to provide the desired volume to the foamed layer such that the foamed layer is of a certain thickness and provides better visibility under ultrasound imaging” (id. at 12). This reasoning is also unpersuasive because the Examiner has not pointed to any disclosure in either Arterburn or Bland of using their products in conjunction with ultrasound imaging. SUMMARY We affirm the rejection of claims 1, 4, 13, and 16-18 as anticipated by Arterburn, and the rejection of claim 15 as obvious based on Arterburn and Smith. Claims 3, 5-8, 12, and 14 fall with claims 1, 4, and 13 because they were not argued separately. 37 C.F.R. § 41.37(c)(1)(vii). We reverse the rejection of claims 9-11 as obvious based on Arterburn and Bland. Appeal 2011-013229 Application 10/803,882 11 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-IN-PART cdc Copy with citationCopy as parenthetical citation