CARE + WEAR, INC.

Patent Trials and Appeals Board

Feb 2, 2022

2021003935 (P.T.A.B. Feb. 2, 2022)

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. 15/421,170 01/31/2017 Chaitenya RAZDAN 035929.00005 8390 4372 7590 02/02/2022 ARENT FOX LLP 1717 K STREET, NW WASHINGTON, DC 20006-5344 EXAMINER ALBERS, KEVIN S ART UNIT PAPER NUMBER 3786 NOTIFICATION DATE DELIVERY MODE 02/02/2022 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): patentdocket@arentfox.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex Parte CHAITENYA RAZDAN, CAROLINE SMITH, and SUSAN JONES ____________ Appeal 2021-003935 Application 15/421,170 Technology Center 3700 ____________ Before CHARLES N. GREENHUT, MICHAEL J. FITZPATRICK, and WILLIAM A. CAPP, Administrative Patent Judges. CAPP, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final rejection of claims 1, 3, 4, 6-9, 12-22, and 27. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies Careandwear II, Inc. as the Applicant and real party in interest. Appeal Br. 2. Appeal 2021-003935 Application 15/421,170 2 THE INVENTION Appellant’s invention relates to covers that protect an opening in a medical patient’s skin. Spec. ¶ 2. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. A protective cover for an affected area of a subject, comprising: a body portion comprising an aperture, the body portion comprising a cotton or equivalent material; and a window portion, wherein the body portion comprises an antimicrobial composition, wherein the body portion is formed from a material having a trapezoidal shape prior to assembly or application to the subject, wherein the material having the trapezoidal shape comprises a first end body edge having a first length and a second end body edge having a second length, wherein a distance between the first end body edge and the second end body edge is between about 4 and 10 inches, wherein a ratio of the first length to the second length is from about 0.84 to about 0.94, and wherein the window portion comprises a porous mesh material having pores from about 0.05 mm to 4.0 mm in diameter. Appeal 2021-003935 Application 15/421,170 3 THE REJECTIONS The Examiner relies upon the following as evidence in support of the rejections: NAME REFERENCE DATE Shesol US 5,897,519 Apr. 27, 1999 Dixon US 2007/0299407 A1 Dec. 27, 2007 Forsyth US 2008/0071224 A1 Mar. 20, 2008 Langen US 2010/0022928 A1 Jan. 28, 2010 Waters US 2010/0257654 A1 Oct. 14, 2010 Fitzgerald US 2013/0012883 A1 Jan. 10, 2013 Melendez US 2014/0090651 A1 Apr. 3, 2014 Simons US 2014/0188079 A1 July 3, 2014 The following rejections are before us for review: 1. Claims 1, 3, 4, 9, and 13-16 are rejected under 35 U.S.C. § 103 as unpatentable over Simons, Dixon, Fitzgerald, and Waters. 2. Claims 6-8 are rejected under 35 U.S.C. § 103 as unpatentable over Simons, Dixon, Fitzgerald, Waters, and Shesol. 3. Claim 12 is rejected under 35 U.S.C. § 103 as unpatentable over Simons, Dixon, Fitzgerald, and Waters. 4. Claims 17-19 are rejected under 35 U.S.C. § 103 as unpatentable over Simons, Dixon, Fitzgerald, Waters, and Langen. 5. Claim 20 is rejected under 35 U.S.C. § 103 as unpatentable over Simons, Dixon, Fitzgerald, Waters, and Melendez. 6. Claims 21 and 22 are rejected under 35 U.S.C. § 103 as unpatentable over Simons, Dixon, Langen, and Melendez. 7. Claim 27 is rejected under 35 U.S.C. § 103 as unpatentable over Simons, Dixon, Fitzgerald, Waters, and Forsyth. Appeal 2021-003935 Application 15/421,170 4 OPINION Unpatentability of Claims 1, 3, 4, 9, and 13-16 over Simons, Dixon, Fitzgerald, and Waters Appellant argues claim 1, but provides no separate arguments for the patentability of claims 3, 4, 9, and 13-16. Appeal Br. 5-11. We consider the arguments regarding claim 1, and claims 3, 4, 9, and 13-16 will stand or fall therewith. See 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Simons discloses the invention substantially as claimed. Final Act. 7. The Examiner combines embodiments 100 and 500 of Simons to arrive at a protective cover that includes an antimicrobial agent. Id. The Examiner relies on Dixon as disclosing a sleeve with a trapezoidal shape. Id. The Examiner concludes that it would have been obvious to modify Dixon’s trapezoidal shape to conform to the dimensional limits of claim 1. Id. at 8. The Examiner relies on Fitzgerald as disclosing a protective cover made of mesh material. Id. at 9. The Examiner relies on Waters as disclosing that it was known, in the prior art, to use mesh fabric with a hole/pore size of 1 mm diameter. Id. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art at the time the invention was made that combine the teachings of the prior art to achieve the claimed invention. Id. at 7-10. According to the Examiner, a person of ordinary skill in the art would have done this to prevent infection (p. 7); to have a close comfortable fit around the arm (p. 8); to keep the surrounding tissue healthy (p. 9); and provide an appropriate degree of breathability (p. 10). Appellant advances three arguments in traverse. First, Appellant essentially argues that Simons and Dixon are not combinable because their respective teachings regarding shapes are inconsistent and incompatible. Appeal 2021-003935 Application 15/421,170 5 Appeal Br. 6-9. Next, Appellant argues that a person of ordinary skill in the art would have not modified Simons by the mesh opening teachings of Waters because Waters’ fabric provides thermal insulation. Id. at 9. Third, Appellant argues that the Examiner failed to give appropriate weight to declaration testimony from Amy Gregory, a hospital nurse manager. Id. Regarding the shape issue, Appellant argues that Simons’ device is symmetrical about its longitudinal axis, which axis, according to Appellant, “follows the circumference of a body part when worn.” Appeal Br. 6. Appellant argues that modifying Simons so as to assume a trapezoidal shape would result in a device that is not symmetrical about the appropriate axis and would lose the benefits of useful life extension by being reversible. Id. In response, the Examiner finds that Dixon teaches a cover that assumes a trapezoidal shape. Ans. 3-7. The Examiner takes the position that Appellant’s shape argument is not directed to a legitimate issue in the case. Id. In this regard, we agree with the Examiner because, although the principal embodiment of Simons is a device 400 that wraps around the torso of the user (see e.g., Simons, ¶ 12, Fig. 4), the Examiner relies on the alternate embodiment 500 designed for arms or legs. Final Act. 7. Dixon expressly discloses the benefits of a trapezoidal device for being closely and comfortably worn on the forearm. Ans. 7 (citing Dixon ¶ 35); Dixon, ¶ 23, Figs. 1A, 8. Appellant’s device is similarly worn on the arm. Spec. ¶ 26. Simons discloses that its device applies to smaller, narrower appendages such as arms or legs for use with a PICC line. Simons ¶ 36. However, Simons is silent on the shape of the device for arms and legs. See generally Simons. Appellant’s argument that Simons’ rectangular shape feature would apply equally to embodiments used on arms/legs as well as Appeal 2021-003935 Application 15/421,170 6 the torso is an unwarranted assumption that lacks any sound factual basis in the record. See Reply Br. 6 (the torso embodiment shape “presumably applies” to embodiments for the arms and legs). In our opinion, a person of ordinary skill in the art would have no difficulty in adapting the teachings of either Simons or Dixon to accommodate placement of the protective cover on various and diverse portions of the body. A person of ordinary skill in the art understands that the human arm generally decreases in diameter as it nears the hand and wrist. Dixon discloses the benefit of using a trapezoidal shape that can be formed into a tubular member with a smaller diameter nearer the hand. Dixon ¶ 34. It is well settled that, if 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. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Here, Appellant presents neither evidence nor persuasive technical reasoning that improving the arm/leg embodiment of Simons with a trapezoidal shape would have required more than ordinary skill or produced unexpected results. In an obviousness analysis, “we do not ignore the modifications that one skilled in the art would make to a device borrowed from the prior art.” In re ICON Health & Fitness, Inc., 496 F.3d 1374, 1382 (Fed. Cir. 2007). The inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on the knowledge of the person of ordinary skill in the art. Koninklijke Philips N.V. v. Google LLC, 948 F.3d 1330, 1337 (Fed. Cir. 2020). We are cognizant that “[a] person of ordinary skill is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421. We agree with the Appeal 2021-003935 Application 15/421,170 7 Examiner that a person of ordinary skill in the art would have considered it obvious to so modify Simons and the Examiner has provided a sound reason for doing so. Final Act. 8 (close, comfortable fit). Appellant’s argument regarding fabric mesh focuses entirely on the Waters reference to the exclusion of Fitzgerald, which is the reference that the Examiner primarily relies on as disclosing a catheter protective device window composed of mesh material. See Appeal Br. 9, Final Act. 9. In the Answer, the Examiner reminds Appellant that Fitzgerald is relied on for teaching mesh fabric and that Waters is merely relied on as disclosing that it was known, in the prior art, to make mesh material with a 1 mm pore diameter. Ans. 8. In reply, Appellant argues that Waters is directed to mesh fabric that is designed to provide thermal insulation. Reply Br. 7. Fitzgerald is directed to a stretchable sleeve and wrap for securing catheter dressings and tubes on a patient. Fitzgerald, Abstract. Figure 2 of Fitzgerald depicts a wrap that is worn over the elbow portion of an arm. Id. Fig. 2. Fitzgerald’s cover features a transparent or semi-transport window that is disposed over a PICC line insertion point. Id. ¶ 66, Fig. 2. Fitzgerald teaches that such window is composed of mesh material. Id. However, Fitzgerald is silent with regard to the hole or pore size of the mesh material. See generally Fitzgerald. Appellant’s argument regarding mesh pore size is not persuasive. The textile industry is well developed and features a wide variety of fabrics. Appellant attempts to inextricably connect Waters’ pore size with its thermal insulating properties. However, a person of ordinary skill in the art would understand that the properties of a fabric, such as the degree of thermal insulation it provides, is a product of more than just pore size and is effected Appeal 2021-003935 Application 15/421,170 8 by variables such as thickness and type of material used. According to the Supreme Court, common sense dictates that familiar items may have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007). Furthermore, an artisan is presumed to know something about the art apart from what the references disclose. In re Jacoby, 309 F.2d 513, 516 (CCPA 1962). We infer from the silence of Fitzgerald that a person of ordinary skill in the art would know to select a mesh material with an appropriate pore size. See In re Fox, 471 F.2d 1405, 1407 (CCPA 1973) (explaining that elements that are not described in detail are presumed to be known to those of ordinary skill in the art). The mere fact that Appellant specifies a particular pore size while Fitzgerald is silent on the matter is not indicative of invention. Appellant claims a range of mesh pores from 0.05 mm to 4.0 mm in diameter. Claims App. Appellant does not provide us with any reason to believe that a person of ordinary skill in the art practicing Fitzgerald would likely select a pore size that is smaller than 0.05 mm or larger than 4.0 mm. A claim to a product does not become nonobvious simply because the patent specification provides a more comprehensive explication of the known relationships between the variables and the affected properties. In re Applied Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012). We view Waters as little more than one example of use of a mesh material. “A reference may be read for all that it teaches, including uses beyond its primary purpose.” In re Mouttet, 686 F.3d 1322, 1331 (Fed. Cir. 2012), citing KSR, 550 U.S. at 418-421. Although Waters is primarily directed to an infant garment, it is Appeal 2021-003935 Application 15/421,170 9 useful in demonstrating that it was known, in the prior art, to make mesh fabric with pores in the claimed range. Fitzgerald already teaches the use of transparent mesh fabric for the window of PICC line protective cover. We agree with the Examiner that a person of ordinary skill in the art would have found it obvious to use a pore size from Waters in the fabric of Fitzgerald Lastly, Appellant argues that the Examiner failed to properly consider the declaration testimony of Amy Gregory. Appeal Br. 10. Appellant characterizes the Gregory declaration as evidencing that the features of the claimed invention are “surprisingly effective.” Id. at 11. Appellant further argues that such testimony evidences that patients have experienced “surprising awareness” of the effectiveness of the claimed product. Id. Appellant further argues that patients have expressed a “preference” for its product. Id. Appellant argues that Gregory’s declaration is “expert opinion” that should be considered “evidence of non-obviousness.” Id. In response, the Examiner characterizes the declaration as failing to constitute “hard evidence.” Ans. 9. According to the Examiner, “the declaration by Amy Gregory holds no form of factual support.” Ans. 9-10. Although Gregory’s declaration and Appellant’s Appeal Brief are less than entirely clear on the matter, it appears that the declaration is offered as purported evidence of secondary considerations of non-obviousness, which is one of the four Graham factors in an obviousness analysis. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). Secondary considerations are essential components of the obviousness determination In re Rouffet, 149 F.3d 1350, 1355 (Fed. Cir. 1998). Objective evidence of nonobviousness includes copying, long felt but unsolved need, failure of others, commercial success, unexpected results created by the claimed invention, licenses Appeal 2021-003935 Application 15/421,170 10 showing industry respect for the invention, and skepticism of skilled artisans before the invention. Id. Such evidence may establish that an invention appearing to have been obvious in light of the prior art was not. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir. 1983). We have reviewed the Gregory declaration and confess that it is not clear to us which, if any, of the secondary considerations of obviousness is purportedly demonstrated by such declaration testimony. If it is offered as commercial success of the invention, it is woefully inadequate to such purpose. A patentee demonstrates commercial success by showing significant sales of the patented product in a relevant market. J. T. Eaton & Co. v. Atlantic Paste & Glue Co., 106 F.3d 1563 (Fed. Cir. 1997). The Gregory declaration contains no evidence of any amount of sales or any market share. See generally Gregory Decl. If the declaration is offered as evidence of unexpected results, it is likewise inadequate to such purpose. An unexpected results analysis requires consideration of what an artisan would have expected. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). Neither the Gregory Declaration nor Appellant’s briefing provides the necessary analysis. Ms. Gregory’s testimony about Appellant’s device providing “superior effects” and being preferred by patients is of little probative value. We are provided no underlying baseline data from which a proper comparison can be made to determine in what manner it is “superior” or “preferred.” Nor are we provided with evidence demonstrating that Gregory’s opinions reflect that of the industry generally. Gregory’s anecdotal observations are not sufficient to outweigh the Examiner’s determination of unpatentability as obvious. Appeal 2021-003935 Application 15/421,170 11 In view thereof, we sustain the Examiner’s unpatentability rejection of claims 1, 3, 4, 9, and 13-16 over Simons, Dixon, Fitzgerald, and Waters. Unpatentability of Claims 6-8, 12, 17-22, and 27 over Combinations based on Simons and Dixon These claims are rejected over Simons and Dixon and are not separately argued apart from arguments advanced against the rejection of claim 1 which we have previously considered. Appeal Br. 11. We sustain the Examiner’s rejection of claims 6-8, 12-22, and 27. See 37 C.F.R. § 41.37(c)(1)(iv) (failure to separately argue claims constitutes a waiver of arguments for separate patentability). CONCLUSION Claims Rejected 35 U.S.C. § References Affirmed Reversed 1, 3, 4, 9, 13-16 103 Simons, Dixon, Fitzgerald, Waters 1, 3, 4, 9, 13-16 6-8 103 Simons, Dixon, Fitzgerald, Waters, Shesol 6-8 12 103 Simons, Dixon, Fitzgerald, Waters 12 17-19 103 Simons, Dixon, Fitzgerald, Waters, Langen 17-19 21, 22 103 Simons, Dixon, Langen, Melendez 21, 22 20 Simons, Dixon, Fitzgerald, Waters, Melendez 20 27 103 Simons, Dixon, Fitzgerald, Waters, Forsyth 27 Overall Outcome 1,3, 4, 6- 9, 12-22, 27 Appeal 2021-003935 Application 15/421,170 12 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED