Ex Parte Tomes et alDownload PDFPatent Trial and Appeal BoardJan 18, 201812647515 (P.T.A.B. Jan. 18, 2018) 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. 12/647,515 12/27/2009 Jennifer E. Tomes BPMDL0005JT.P 1 2088 (10055UC1 27939 7590 01/19/2018 Philip H. Burrus, IV Burrus Intellectual Property Law Group LLC 222 12th Street NE Suite 1803 Atlanta, GA 30309 EXAMINER POON, ROBERT ART UNIT PAPER NUMBER 3788 MAIL DATE DELIVERY MODE 01/19/2018 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 JENNIFER E. TOMES, DEBORAH B. ADLER, KENNETH S. CHUA, JACK E. MAZE, ALBERTO C. SAVAGE, and ARLENE SIAVELIS Appeal 2016-003 8731 Application 12/647,5152 Technology Center 3700 Before ANTON W. FETTING, BRADLEY B. BAYAT, and AMEE A. SHAH, Administrative Patent Judges. SHAH, Administrative Patent Judge. 1 Throughout this Opinion, we refer to the Appellants’ Appeal Brief (“Br.,” filed July 7, 2015) and Specification (“Spec.,” filed Dec. 27, 2009), and to the Examiner’s Answer (“Ans.,” mailed Dec. 2, 2015) and Final Office Action (“Final Act.,” mailed Apr. 7, 2015). 2 We note related appeals 2014-007096 (App. 13/374,509), 2014-005013 (App. 13/153,265), and 2014-007582 (App. 13/153,300). Br. 2. Related patents U.S. 8,448,786 B2, U.S. 8,631,935 B2, andU.S. 8,678,190 B2 have also been subject to Inter Partes Review (IPR). Review of U.S. 8,448,786 B2 was not granted (IPR2015-00509, Paper 11, July 15, 2015), and reviews of U.S. 8,631,935 B2 and U.S. 8,678,190 B2 were terminated in response to cancellation of the contested claims by Patent Owner (IPR2015-00513, Paper 12, Aug. 11, 2015, IPR2015-00514, Paper 15, July 24, 2015) Appeal 2016-003873 Application 12/647,515 DECISION ON APPEAL The Appellants3 appeal under 35 U.S.C. § 134(a) from the Examiner’s final decision rejecting claims 24—37.4 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. STATEMENT OF THE CASE The Appellants’ invention “relates generally to storage containers for medical devices, and more particularly to a storage container for a long, flexible medical implement, such as a catheter, and related medical devices, as well as an instruction manual included therewith.” Spec. 12. Claims 24 and 28 are the independent claims on appeal. Claim 24 (Br. 26 (Claims App.)) is exemplary of the subject matter on appeal and is reproduced below (with added paragraphing and bracketing): 24. A catheter package assembly with instructions, comprising: [(a)] a tray having at least a first compartment having at least one syringe disposed therein and a second compartment having a catheter assembly disposed therein, wherein the tray is sealed with a wrap; [(b)] an instruction manual comprising a health care services portion and a detachably coupled a patient portion; and [(c)] a thermally sealed bag disposed about the tray, wherein the instruction manual is disposed outside the wrap and within the thermally sealed bag; 3 According to the Appellants, the real party in interest is Medline Industries, Inc. Br. 2. 4 Claims 38 and 39 have been withdrawn from consideration. Final Act. 1. 2 Appeal 2016-003873 Application 12/647,515 [(d)] wherein the patient portion comprises instructions printed thereon for reducing a chance of contracting an infection from using the catheter assembly. REJECTIONS AT ISSUE ON APPEAL Claim 24 stands rejected under 35 U.S.C. § 101 on the ground of non- statutory double patenting as being unpatentable over claim 1 of Tomes (US 8,631,935 B2, iss. Jan. 21, 2014), Morelli (US 2010/0274205 Al, pub. Oct. 28, 2010), and Primer (US 2008/0283426 Al, pub. Nov. 20, 2008). Final Act. 4. Claims 24—36 stand rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Busch (US 2004/0004019 Al, pub. Jan. 8, 2004), Morelli, and Primer. Id. at 5. Claim 37 stands rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Busch, Morelli, Primer, and Hedge (US 5,487,566, iss. Jan. 30, 1996). Id. at 7. PRELIMINARY MATTER The Appellants request clarification on the Restriction Requirement mailed May 23, 2012. Br. 22—23. The Examiner responds that the Requirement was not withdrawn. Ans. 9. We note that matters regarding restriction requirements are to be resolved via petition to the technology center Director. See 37 C.F.R. § 1.144, MPEP 1002.02(c). We consider claims 38 and 39 as withdrawn and not pending on appeal. 3 Appeal 2016-003873 Application 12/647,515 ANALYSIS Double Patenting The Appellants do not provide any arguments against the Examiner’s double patenting rejection of claim 24. Thus, we summarily affirm the rejection. Obviousness — Claims 24—27 The Appellants contend that the Examiner’s rejection of independent claims 24 is in error. After careful consideration of the arguments presented in the Appeal Brief at pages 11—17, we are not persuaded of Examiner error. Unsuitable for its intended purpose The Appellants do not contest the Examiner’s findings, but argue that the Examiner’s rejection is in error because “one of ordinary skill in the art would not be motivated to combine Primer with Busch and Morelli, as doing so would render Primer’s label unsuitable for its intended purpose.” Br. 11; see also id. at 12—14. We find this argument unpersuasive because the Examiner’s rejection is not based upon a bodily incorporation of Primer’s manual into the manual of Busch as modified by Morelli. We also find this argument unpersuasive because modifying the manual of Busch and Morelli with the features of Primer would not render Primer’s label unsuitable for its intended purpose of providing information in an efficient manner. See Primer 112. The Examiner finds that Busch teaches the packaged catheter assembly of claim 24 comprising a tray as recited in limitation (a), and that Morelli teaches a medical device kit with an instruction manual, as partially recited in limitation (b) and a thermally sealed bag with the manual disposed 4 Appeal 2016-003873 Application 12/647,515 outside a wrap on the tray as recited in limitation (c). See Final Act. 5— 6. The Examiner relies on Primer for teaching the instruction manual comprising a health care services portion and a detachable patient portion, as partially recited in limitation (b), wherein the patient portion comprises instructions as recited in limitation (d), determining that one of ordinary skill in the art would have “replace[d] the single[-]sheet label” (Ans. 7) of Busch and Morelli to have the portions of Primer to “incorporate additional information” (Final Act. 6; see also Ans. 7). Claim 24 recites that the manual comprises instructions and is “disposed outside the wrap” that seals the individual tray. Br. 26 (Claims App.). As the Appellants point out (see Br. 12), Primer discloses that its booklet-type label is attached to an exterior of an individual product. See Primer, e.g., 45, 56, 60, 64, 68, 72, 76. The booklet-type label provides instructions as an “efficient means for correlating relevant medical care information to a respective patient.” Id. ^ 12. A plurality of the individual products can be packaged together in one container of any material that includes a label with the same information as provided on the booklet-type label. Id. H 41, 47. The individual product can be a sterile procedure tray (“STP”) comprising a “standardized package of a plurality of [] medical instruments and medical care products used when performing a medical procedure.” Id. 1 63, Fig. 10. The STP is packaged in a bag-type pouch, that can be shrink-wrap, and that has a booklet-type label attached to the exterior surface of the pouch/wrap. Id. ]Hf 63, 64. The Appellants do not show where, or how, Primer discloses that the individual item, such as the STP, cannot be further within an enclosure, such as a sealed bag container, such that the individual item label is still seen, or 5 Appeal 2016-003873 Application 12/647,515 that Primer’s container label cannot be a booklet-type label. In other words, the Appellants do not show why, or how, having the manual of Busch and Morelli as modified by Primer would render Primer inoperable for its intended purpose of providing medical care information on the outside of an individual item. Secondary considerations The Appellants further argue that the Examiner’s rejection is in error because “secondary evidence demonstrates non-obviousness over the combination.” Br. 11; see also id. at 14—17. The Appellants present the Declaration of Jennifer Tomes, dated December 10, 2012 (“Declaration”) and non-patent literature in the form of articles as evidence of commercial success and unexpected results. Id. at 15—16. The Appellants also present the Declaration and non-patent literature in the form of manuals as evidence of copying. Id. at 16-17. We have fully considered the Declaration and evidence provided in support of secondary considerations and, weighing all evidence of obviousness against all evidence of non-obviousness, we find the secondary considerations unpersuasive of Examiner error. Evidence of secondary considerations must be relevant to and reasonably commensurate with the scope of the claim, and, therefore, we must determine whether there is a nexus between the merits of the claimed invention and the evidence of secondary considerations. See In re Huai- Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011); Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 305 n.42 (Fed. Cir. 1985), cert, denied, 475 U.S. 1017 (1986). 6 Appeal 2016-003873 Application 12/647,515 Here, inventor Jennifer Tomes’s Declaration is directed to references that are not the subject of the rejection on appeal. In the Declaration, Tomes states that claims 11, 18, and 21—27 are rejected as obvious over the prior art Busch, Roshdy (US 6,793,078 B2), and Paikoff (US 4,523,679) and that “the information below includes such secondary considerations sufficient to rebut obviousness in view of the cited references.” The article from Infection Control Today (“Infection Control’) discusses that the Arkansas Methodist Medical Center “has seen a 21 percent reduction on catheterizations and catheter-associated urinary tract infections.” The Infection Control article states that the Foley catheter management system helped in the reduction with its “one-layer tray design is labeled in a specific sequence that helps guide . . . [the] nurses during the catheterization process to adhere to current CDC recommendations, including aseptic technique,” “checklist to help the nurse make a decision on whether catheterization is appropriate for the patient and assure that the education transfers into everyday clinical practice,” “Foley InserTag and checklist sticker placed on the patient's chart,” and “patient education care card that looks like an actual get well card . . . [and] is a more effective way to educate patients about the procedure, including the risks and complications associated with closed system Foley catheters.” However, the article also states that, to help reduce catheterizations and, thus, infections, nursing staff are required “to take the program education on the alternatives to catheterization,” and it was newly recommend to remove catheters within 24 to 48 hours post-operatively. The iStockAnalyst article discuses that the “catheter management system, featuring a revolutionary one-layer tray design, is helping hospitals” 7 Appeal 2016-003873 Application 12/647,515 reduce infections through improved education. Almost duplicative of the Infection Control article, the iStockAnalyst article discusses the Arkansas Methodist Medical Center’s reduction in catheterizations resulting from the catheter management system’s “one-layer tray design [that] is labeled in a specific sequence that helps guide . . . [the] nurses during the catheterization process to adhere to current CDC recommendations, including aseptic technique,” “checklist to help the nurse make a decision on whether catheterization is appropriate for the patient and assure that the education transfers into everyday clinical practice,” “Foley InserTag and checklist sticker placed on the patient's chart,” and “patient education care card that looks like an actual get well card.” Also similar to the Infection Control article, the iStockAnalyst article further states that, to help reduce catheterizations and, thus, infections, nursing staff are required “to take the program education on the alternatives to catheterization,” and it was newly recommend to remove catheters within 24 to 48 hours post-operatively. The Morningstar article discusses Floyd Medical Center’s 83 percent reduction in catheter associated urinary tract infections (CAUTI) and 23 percent decline in catheterizations due to a comprehensive improvement initiative featuring the catheter management system that “helps providers by combining evidence-based principles and training with a revolutionary one- layer tray design.” The Center utilizes the tray “along with facility-wide physician and nurse education . . . [of] the appropriate use of catheters and the importance of avoiding catheters when not medically necessary to reduce its CAUTI rates.” The Center’s Medical Director cited the “kit’s larger sterile barrier . . . [flap] and one-layer tray design (versus the industry standard two-layer tray) as important factors to helping the nursing staff 8 Appeal 2016-003873 Application 12/647,515 maintain aseptic technique,” the “tray’s checklists” that help “document a valid clinical reason for inserting a catheter and another that reviews the proper steps to catheter insertion” that are “then adhered to the patient’s chart for proper documentation of insertion,” and the InserTag yellow sticker around drain tubing to indicate the date and time of the catheter insertion. However, all of the evidence for commercial success and unexpected results make clear that use of the tray in combination with training and timely removal resulted in reductions in catheterizations and infections. The Appellants have not adequately shown that the tray itself caused unexpected results or that “the commercial success was caused by the merits of the invention as distinct from the prior art.” In re Huai-Hung Kao, 639 F.3d at 1069. Further, the features of the tray that were considered most helpful are not recited in the claim; the secondary considerations are not reasonably commensurate with the scope of the claim. Claim 24 does not recite or require the tray of one-layer labeled in a specific sequence, the instructions as checklists, an InserTag sticker that goes around drain tubing, a sterile barrier flap, or a greeting card. As such, the Declaration and articles are not probative of commercial success and unexpected results because they do not deal with the specific prior art that was the subject of the rejections (see In re Beattie, 974 F.2d 1309, 1313 (Fed. Cir. 1992)), and because there is not a nexus between the merits of the claimed invention and the evidence of secondary considerations. The manuals from Bard indicate the differences between an older label and a newer one that contains more information and in a booklet style. “Copying requires duplication of features of the . . . [Appellants’] work based on access to that work, lest all infringement be mistakenly treated as 9 Appeal 2016-003873 Application 12/647,515 copying.” Institut Pasteur & Universite Pierre et Marie Curie v. Focarino, 738 F.3d 1337, 1347-48 (Fed. Cir. 2013). The Appellants have not shown that the newer label resulted directly from the Appellants’ claim or access thereto. The Appellants further do not provide adequate evidence that Bard copied the Appellants’ invention and instructions. Cf. Apple Inc. v. Samsung Flees. Co., 839 F.3d 1034, 1054 (Fed. Cir. 2016), cert, denied, 138 S. Ct. 420 (2017) (record containing “multiple internal Samsung presentations given by different Samsung groups at different times stating that the iPhone’s slide to unlock feature is better than the various Samsung alternatives” was substantial evidence of copying). Thus, we are not persuaded the Examiner erred in the rejection of claim 24. We sustain the Examiner’s rejection of independent claim 24 and dependent claims 25—27, which were not argued separately (Br. 11). Obviousness — Claims 28—37 The Appellants contend that the Examiner’s rejection of independent claims 28 is in error. After careful consideration of the arguments presented in the Appeal Brief at pages 17—21, we are not persuaded of Examiner error. The Examiner finds that, similar to claim 24, Busch, Morelli, and Primer teach the manual configured for inclusion with a tray, the manual comprising a health care services portion with information and a detachably coupled patient portion with information. See Final Act. 6, Ans. 8—9. The Examiner finds that the prior art does not teach the information comprises instruction for using the catheter assembly and devices, i.e., the contents of the information. See Final Act. 7, Ans. 9. But the Examiner determines that the type of information provided, i.e., the instructions, is non-functional 10 Appeal 2016-003873 Application 12/647,515 descriptive material that would not distinguish the invention from the prior art in terms of patentability. Final Act. 7, Ans. 8—9. We agree. The Appellants do not contest the Examiner’s findings, but argue that the specific type of information is functional and should be given patentable weight. See Br. 17—21. We note that non-functional descriptive material cannot render patentable an invention that is otherwise not patentable over the prior art. See In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983) (when descriptive material is not functionally related to the substrate, the descriptive material will not distinguish the invention from the prior art in terms of patentability). Although we will not disregard any claim limitations and will assess the claimed invention as a whole, we will follow the Federal Circuit’s guidance as in the Gulack decision and will “not give patentable weight to printed matter absent a new and unobvious functional relationship between the printed matter and the substrate.” In re Lowry, 32 F.3d 1579, 1582-83 (Fed. Cir. 1994). Claim 28 is directed to a manual comprising a portion with instructions for using the assembly and devices and a detachably coupled patient portion. Primer discloses a label with usage instructions for a product to treat a medical condition. Primer 114. The only difference between the claim limitations and Primer lies in the instructions, i.e., that the usage instructions are for using a catheter assembly and devices on a patient. Thus, the relevant question is whether the specific instructions have a “new and unobvious functional relationship” with the aid. We disagree that In re Ngai, 367 F.3d 1336 (Fed. Cir. 2004) does not apply here. Br. 17—19. There is no objective evidence of record that there is such a functional distinction between the instructions. Although the specific instructions may change 11 Appeal 2016-003873 Application 12/647,515 based on the devices or items in the assembly, the function of usage instructions for a product and instructions for using the catheter assembly and devices would be same. As such, the specific type of instructions constitutes non-functional descriptive that may not be relied upon for patentability. See In re Ngai, 367 F.3d at 1339; see also Ans. 8—9. Concluding otherwise would result not only in the Appellants’ descriptive appearance distinguishing over the prior art, but equally would distinguish every other type of appearance of matter printed on a card or label. To give effect to the Appellants’ arguments, we would need to ignore our reviewing court’s concerns with repeated patenting. See, e.g., AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1064—65 (Fed. Cir. 2010) (“As explained in Ngai, if this court concluded otherwise ‘anyone could continue patenting a product indefinitely provided that ‘they add a new instruction sheet to the product.’ 367 F.3d at 1339. Neither the Patent Act nor our precedent countenances such an outcome”); King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1279 (Fed. Cir. 2010) (“The rationale behind this line of cases is preventing the indefinite patenting of known products by the simple inclusion of novel, yet functionally unrelated limitations”). Contrary to the Appellants’ assertion, the Board did not hold in related IPR2015-00514 that the instructions were functional. Rather, the Board held, as the Appellants cite, that the detachability of the two portions appears to be a functional feature. Br. 21. Thus, we are not persuaded the Examiner erred in the rejection of claim 28. We sustain the Examiner’s rejections of independent claim 28 and dependent claims 29—37, which were not argued separately (Br. 11). 12 Appeal 2016-003873 Application 12/647,515 DECISION The Examiner’s rejection of claim 24 under 35 U.S.C. § 101 on the ground of non-statutory double patenting is AFFIRMED. The Examiner’s rejections of claims 24—37 under pre-AIA 35 U.S.C. § 103(a) are AFFIRMED. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 13 Copy with citationCopy as parenthetical citation