Ex Parte Marron et alDownload PDFPatent Trial and Appeal BoardJul 14, 201612839949 (P.T.A.B. Jul. 14, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/839,949 07/20/2010 121974 7590 07118/2016 KACVINSKY DAISAK BLUNI PLLC America's Cup Building 50 Doaks Lane Marblehead, MA 01945 FIRST NAMED INVENTOR Thomas Mark Marron UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. S63 .2P- l 467 4-US02 9209 EXAMINER BOWMAN, ANDREW J ART UNIT PAPER NUMBER 1717 NOTIFICATION DATE DELIVERY MODE 07/18/2016 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): kddocketing@cpaglobal.com Docketing@kdbfirm.com bbonneville@kdbfirm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte THOMAS MARK MARRON, MICHAEL SEAN OWENS, MARK STEVEN SMITH, JAMES EDWARD LASCH, AMOD SHRIDHAR MOD AK, and ANDY DUBEL1 Appeal2015-000923 Application 12/839,949 Technology Center 1700 Before GEORGE C. BEST, A VEL YN M. ROSS, and LILAN REN, Administrative Patent Judges. REN, Administrative Patent Judge. DECISION ON APPEAL Appellants appeal under 35 U.S.C. § 134(a) from a Rejection2 of claims 1-12. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 The Real Party in Interest is identified as Boston Scientific Scimed, Inc. (Appeal Brief, filed May 8, 2014 ("App. Br."), 3.) 2 Non-Final Office Action mailed January 21, 2014 ("Non-Final Rejection"; cited as "NFR"). The Examiner has previously issued multiple actions including a Final Rejection dated August 2, 2013, a Non-Final Rejection dated February 8, 2013, a Final Action dated November 5, 2012, and a Non- Final Rejection dated July 18, 2012. Appeal2015-000923 Application 12/839,949 A. Introduction3 OPINION The subject matter on appeal relates to a system "for coating a medical device such as a catheter, balloon or implantable prosthesis such as a stent." (Spec. 2, 11. 31-33.) Figure 1 of the '949 Specification, providing a frontal view of the system, is reproduced below: Figure 1 of the '949 Specification Figure 1 illustrates "coating system 1 O" which "comprises a transfer web 20 and a metering web 30 .... " (Spec. 4, 11. 29-30.) As illustrated, "transfer web 20 includes outside surface 21 and inside surface 23; metering web 30 includes outside surface 31 and inside surface 33." (Id. at 7, 1. 33-8, 1. 1.) Figure 1 also illustrates "a medical device retaining mechanism 80 ... suitable for mounting a medical device [] such as a stent, balloon, catheter or 3 Application 12/839,949, Medical Device Coating System, filed July 20 2010, claims the benefit of U.S. Provisional Patent Application No. 61/226,782, filed July 20, 2009 and the benefit of U.S. Provisional Application No. 61/247,829, filed October 1, 2009. We refer to the '"949 Specification," which we cite as "Spec." 2 Appeal2015-000923 Application 12/839,949 catheter component, etc. thereon." (Id. at 17, 11. 13-16.) "[S]ource mechanisms 22 and 32 are spools or rollers which have a predetermined length of web contained thereon and the end mechanisms 24 and 34 are, at least initially empty spools or rollers which receive the appropriate web 20 or 30." (Id. at 6, 11. 16-19.) Upon actuating the rollers, "the webs along the respective transfer web pathway 25 and metering web pathway 35" may be advanced. (Id. at 6, 11. 31-32.) The '949 Specification states that "[b ]efore advancement of the webs, or during a point when at least the transfer web 20 is not moving (stopped) by a control mechanism (not shown), an initial quantity of coating solution 50 is deposited from an applicator onto an outside surface 21 of the transfer web 20[.]" (Id. at 8, 11. 16-19.) "[T]he applicator 61 is a syringe. Once the initial quantity of coating solution 50 is applied, the transfer web 20 is advanced in order to move the solution 50 from the staging area to a metering gap 54. The initial quantity of coating solution 50 is then passed through the metering gap 54." (Id. at 9, 11. 5-8.) "The coating solution that remains on the transfer web 20 after passing through the gap 54 defines a coating patch 50a that will have a substantially uniform thickness across its relevant working area 57." (Id. at 8, 11. 28-30.) "The working area 57 is the area of the patch which will be subsequently brought into contact with a medical device." (Id. at 8, 11. 30-31.) 3 Appeal2015-000923 Application 12/839,949 Figure 6 is reproduced below: Figure 6 of the '949 Specification Figure 6 "is a detailed depiction of the gap [ 54] defined by the metering web (via the blade) and the transfer web (via the base) shown in FI Gs. 1-4 through which a quantity of coating solution is passed before application onto a medical device." (Id. at 4, 11. 3-5.) The '949 Specification states: As illustrated in FIG. 6, the metering gap 54 is a restriction wherein an outside surface 31 of the metering web 30 is brought into close proximity with the outside surface 21 of the transfer web 20, such that when the initial quantity of coating solution 50 is passed through the gap 54 at least some amount of excess coating solution 50b will adhere to the outside surface 31 of the advancing metering web 30 and be transported away. (Id. at 8, 11. 23-28.) Representative claim 1 reads: 1. A system for applying a coating solution to a medical device, the system comprising: 4 Appeal2015-000923 Application 12/839,949 a transfer web, the transfer web defining an inside surface and an outside surface, the transfer web extending along a transfer web pathway, the transfer web being moveable in an upstream and downstream direction along the transfer web pathway; a metering web, the metering web defining an inside surface and an outside surface, the metering web extending along a metering web pathway, the metering web separate and distinct from the transfer web; a coating deposition mechanism, the coating deposition mechanism constructed and arranged to deposit a quantity of coating solution onto a staging area, the staging area comprising a region of the outside surface of the transfer web, a metering gap, the metering gap being defined by the outside surface of the transfer web and the outside surface of the metering web, the metering gap being positioned downstream from the staging area; and a medical device support, the medical device support positioned at a coating application region being defined by the outside surface of the transfer web downstream from the metering gap. (Claims Appendix, App. Br. 29 (emphases added).) The Examiner maintains the following grounds of rejection:4 A. Claims 1-3, 5, 6, 10, and 12 stand rejected under 35 U.S.C § 103(a) as being unpatentable over Voelker.5 Al. Claim 4 (dependent from claim 1) stands rejected under 35 U.S.C § 103(a) as being unpatentable over Voelker and Allenberg. 6 4 Examiner's Answer mailed August 29, 2014 ("Ans."). 5 Walter D. Voelker, Polyurethane Foam Under Textile Fabric, U.S. Patent No. 3,240,655 (issued March 15, 1966). 6 Kurt Allenberg, et al., Soft Orthopedic Casting Article With Reinforcement System, U.S. Patent No. 5,913,840 (issued June 22, 1999). 5 Appeal2015-000923 Application 12/839,949 A2. Claims 7-9 (dependent from claim 1) stand rejected under 3 5 U.S.C § 103(a) as being unpatentable over Voelker and TMI. 7 A3. Claim 11 (dependent from claim 1) stands rejected under 3 5 U.S.C § 103(a) as being unpatentable over Voelker and Richard.8 B. Discussion Findings of fact throughout this Opinion are supported by a preponderance of the evidence of record. Claim 19 With regard to the obviousness rejection of claim 1 based on Voelker, the dispositive issue is whether the Examiner has shown that a system having "a transfer web" and "a metering web" is present in or would have been obvious in view of the applied prior art. The reference Voelker "relates to the process and apparatus for continuous production of a thin sheet of plastic foam adhered to sheet material." (Voelker col. 1, 11. 11-14.) In particular, Voelker teaches: [an] apparatus and method for applying a layer of plastic foam forming materials whose thickness is precisely controlled to one surface of a non-porous or impermeable sheet material, the impermeable sheet is advanced through a foam thickness controlling zone, and only after the foam has a predetermined thickness and significant adhesiveness, placing in contact with 7 The TMI Group of Companies, K Paint Applicator, Copyright 2002 ("TMI"). 8 Robert E. Richard, Medical Devices Based on Modified Polyols, U.S. Patent Application Publication No. 2008/0160062 Al (published July 3, 2008). 9 Claims 2, 6, and 12 stand or fall with claim 1. (See, e.g., App Br.) 6 Appeal2015-000923 Application 12/839,949 the surface of the foam under controlled light pressure an upper sheet material, whereby adhesion of the upper sheet material to the foam is obtained. If such upper sheet material is a textile fabric or other porous material, the penetration by the foam of the porous surfaces of the sheet material may be precisely controlled by this delayed laydown of the upper sheet material. (Id. at col. 1, 11. 23-33.) Voelker's Figure 1 is reproduced below: Figure 1 of Voelker Figure 1 depicts a portion of an apparatus for securing foam to the bottom of a sheet material. (Voelker col. 1, 11. 38-43.) In this apparatus, "an impermeable sheet material 10 is power drawn through a series of zones including a coating zone 11." (Id. at col. 2, 11. 1-3.) "The impermeable sheet passes between metering rolls 12 and 13 and then through a loop 14, including passage over rolls 15, 16, 17 and 18 before reentering the coating zone 11." (Id. at col. 2, 11. 3-6.) The Examiner finds that the upper portion of the "impermeable sheet material 1 O" in Voelker teaches or suggests the claimed "metering web" and that the lower portion of the sheet material 10 teaches or suggests the claimed "transfer web." (NFR 3.) The Examiner finds that a skilled artisan would have found the claimed structure obvious based on the teaching or 7 Appeal2015-000923 Application 12/839,949 suggestion that Voelker' s sheet material 10 may function both as a transfer and a metering web. (Ans. 4.) Appellants, however, argue that there is no teaching or suggestion in Voelker of an apparatus that includes both a transfer web and a metering web. (App. Br. 17.) Appellants additionally argue the Examiner erred in relying on Ex parte Rubin, 128 USPQ 440 (BPAI 1959) in finding obviousness. (App. Br. 16.) Although the Examiner's obviousness analysis does not include citations to MPEP 2144.04 or In re Dulberg, 289 F.2d 522 (CCPA 1961), Appellants assert that the rejection is in error also because the Examiner misapplied "the theory of separating parts" under the MPEP and Dulberg. (App. Br. 16.) Appellants further argue that "the legal theory of duplication of parts also is not applicable" here. (Id. (citing Appeal Brief submitted October 1, 2013 at 18-19 ("First Appeal").) 10 In the First Appeal (which was not reviewed by us), Appellants argued that "the function disclosed in Voelker for the impermeable sheet material 10 is a moveable substrate for the formation, and transfer of, a foam material" which should be distinguished from the function of "metering the amount of foam forming chemicals on the impermeable sheet material 10." (First Appeal at 19.) "[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious," the answer depends on "whether the improvement is more than the 10 In response to the Appeal Brief filed October 1, 2013, a Non-Final Rejection was issued on January 21, 2014. 8 Appeal2015-000923 Application 12/839,949 predictable use of prior art elements according to their established functions." Id. at 417. In this case, Appellants distinguish cases such as Rubin and Dulberg based on the facts but do not apply these cases to show why claim 1 is patentable over Voelker. Appellants acknowledge that the apparatus in Voelker includes a "sheet material 1 O" which may "pass[] between metering rolls 12 and 13" and that "the thickness of the deposited film of chemicals is further regulated by adjusting space between the metering rolls 12 and 13." (App. Br. 14 (citing Voelker col. 2, 11. 9-15).) Appellants do not argue that the Examiner erred in finding that "Voelker essentially runs his web upside down during the first portion of the coating operation so as to use a portion of the web to meter the coating thickness that is applied to the web further downstream as an alternative to supply a completely different web system for the metering that is separate from the web that [is] to be coated." (NFR 4; App. Br. 17.) Appellants do not argue that the Examiner erred in finding that using Voelker' s sheet material 10 as both a transfer web and a metering web would have been a "predictable use of prior art elements according to their established functions." (See NFR 4; see also KSR, 550 U.S. at 417.) Thus, claiming a mere plurality of prior art elements is not an unobvious distinction over the prior art of record, because using plural elements would have produced a predictable result under section 103. 11 11 Appellants also argue in passing that Voelker is not related to a medical device. (Appeal Br. 15.) Appellants, however, do not argue that the preamble statement that the system is "for applying a coating solution to a medical device" is more than a purpose or intended use. Such a statement of intended use does not impart patentability to apparatus claims when it does not recite, as is the case here, structure or functional features that distinguish 9 Appeal2015-000923 Application 12/839,949 In the Reply Brief (Reply Br. 2--4 ), 12 Appellants argue that the claimed apparatus should be distinguished from that of Voelker because the claimed apparatus may "regulate coating thickness" so that the claimed apparatus may "coat a medical device with a coating of uniform thickness." (Id. at 3.) Appellants' argument is flawed for at least two reasons. First, Appellants' principal brief provides that Voelker' s apparatus may also be used for "the thickness of the deposited film of chemicals [to be] ... regulated[.]" (App. Br. 14 (citing Voelker col. 2, 11. 9-15).) Second, claim 1 does not recite the purported function of coating thickness control, and we decline to import into the claim limitations that are not recited. Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005). To the extent that Appellants advance new arguments in the Reply Brief (Reply Br. 2--4) not in response to a shift in the Examiner's position in the Answer, we note that "[a ]ny bases for asserting error, whether factual or legal, that are not raised in the principal brief are waived." In re Hyatt, 211 F.3d 1367, 1373 (Fed. Cir. 2000) (noting that an argument not first raised in the Brief to the Board is waived on appeal); Ex parte Nakashima, 93 USPQ2d 1834 (BP AI 2010) (informative) (explaining that arguments and evidence not timely presented in the principal Brief will not be considered when filed in a Reply Brief, absent a showing of good cause explaining why the argument could not have been presented in the Principal Brief); Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative). over the prior art. See Catalina Mktg. Int'!, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). 12 Reply Brief filed October 22, 2014 ("Reply Br."). 10 Appeal2015-000923 Application 12/839,949 Claim 3 Claim 3 depends from claim 1 and additionally recites "a blade, the blade comprising an edge, the metering web pathway extending around at least a portion of the edge, the inside surface of the metering web contacting the at least a portion of the edge along an edge line." Based on the figures in the '949 Specification, the Examiner construes the term "blade" to include a "doctor blade" which may have a "rounded edge." (NFR 5; Ans. 5.) Under this claim construction, the Examiner finds that a skilled artisan would have found claim 3 obvious in view of the "rounded roller of the prior art Voelker" which includes an outer edge and an edge line. (NFR 5; see also Ans. 5 (citing Figure 1 of Voelker and roller 12).) Appellants do not dispute the Examiner's construction of the term "blade" but faults the Examiner for failing to "provide[] extrinsic evidence" in support of the claim construction. (App. Br. 18; see also Reply Br. 4.) Appellants also argue that the Examiner erred by relying "on function rather than recited structure in the rejection of claim 3." (App. Br. 18 (emphasis in original).) When claim terminology is construed during prosecution, claims are given their broadest reasonable interpretation consistent with the specification, reading claim language in light of the specification as it would be interpreted by one of ordinary skill in the art. In re Am. A cad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). In this case, the Examiner has construed the term "blade" based on the '949 Specification including the drawings. (See NFR 5 (citing to figures of the '949 Specification); Ans. 5 (citing Figure 6 of the '949 Specification).) While the Examiner has set 11 Appeal2015-000923 Application 12/839,949 forth a broad but reasonable interpretation of the claim language, Appellants have not pointed to any definitions or disavowals in the specification or otherwise clearly explained why the Examiner's interpretation is unreasonable or inconsistent with the '949 Specification. Appellants have not provided an explanation, supported by evidence in the record, why claim 3 should be patentably distinguished from the apparatus in Voelker either based on the Examiner's claim construction or Appellants own construction. No harmful error has therefore been shown with regard to the rejection of claim 3. Claim 5 Claim 5 depends from claim 1 and additionally recites that the "initial quantity of coating solution applied to the transfer web defines a barbell-like shape." The Examiner finds that a skilled artisan, based on the chemical solution applied by roller 12 in Voelker, would have found claim 5 obvious because a change in shape is generally considered obvious and the prior art teaches or suggests "the same coating shape" formed by roller 12. (NFR 5; Ans. 5-6.) Appellants does not address the Examiner's conclusion that a change in shape alone is insufficient to show patentablity. (See App. Br. 19-20; Reply Br. 5-6.) Appellants instead cite Figure 1 of Voelker and argue that the figure shows that "Voelker does not teach or suggest that the mixing head 19 applies the foam forming chemicals to the sheet material 10 in a barbell shape." (App. Br. 20; see also Reply Br. 6.) A change of shape does not make a product nonobvious where the claimed shape is not of functional significance and accomplishes the same 12 Appeal2015-000923 Application 12/839,949 purpose as the prior art shape. See Jn re Dailey, 357 F.2d 669, 672-73 (CCPA 1966). Appellants' argument in this case, solely based on the fact that the prior art reference Voelker does not explicitly describe the coating as "barbell" shaped, has not pointed us to harmful errors in the Examiner's conclusion that a skilled artisan would have found a change in shape obvious. Claim 10 Claim 10 depends from claim 1 and additionally recites that "the medical device support includes a medical device rotatably disposed thereon, the medical device being positioned immediately adjacent to the transfer web." Appellants argue that the Examiner erred by failing to use the FDA definition of "medical device." (App. Br. 22; see Reply Br. 7.) Appellants also argue that the Examiner erred in finding that take up roll 30 illustrated in Figure 2 of Voelker (reproduced below) as "a medical device support" recited in claim 10. (App. Br. 23.) Figure 2 of Voelker 13 Appeal2015-000923 Application 12/839,949 Voelker' s Figure 2 depicts a portion of an apparatus for securing foam to the bottom of a sheet material. (Voelker col. 1, 11. 3 8--43.) Appellants reason that because "take up roll 30 is not positioned at a claimed 'coating application region,"' Figure 2 of Voelker does not teach or suggest a "medical device support [that is] positioned at a coating application region being defined by the outside surface of the transfer web downstream from the metering gap ... the medical device being positioned immediately adjacent to the transfer web" as recited in claim 10. (App. Br. at 24; see Reply Br. 8.) The '949 Specification does not provide a definition of "medical device." (See Ans. 6.) During examination, claim terms are given their broadest reasonable construction consistent with the specification. In general, words used in a claim are accorded their ordinary and customary meaning. Honeywell Int 'l Inc. v. Universal Avionics Sys. Corp., 488 F.3d 982, 992 (Fed. Cir. 2007). In this case, Appellants cite to no evidence in the record or legal authority to restrict the construction of "medical device" to those particular devices regulated by the FDA. (See App. Br. 22.) We therefore decline to adopt Appellant's narrow claim construction in this case. See In re Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997) ("Absent an express definition in their specification, the fact that appellants can point to definitions or usages that conform to their interpretation does not make the PTO's definition unreasonable when the PTO can point to other sources that support its interpretation."). We are not persuaded that the Examiner committed harmful error in finding obviousness based on the Examiner's construction of the term "medical device." It is undisputed that Voelker shows "a coating zone 11" 14 Appeal2015-000923 Application 12/839,949 in which "sheet material 10 is power drawn through." (See Voelker col. 2, 11. 1-3.) It is undisputed that Voelker shows that the sheet material 10 "passes between metering rolls 12 and 13 ... including passage over rolls 15, 16, 17, and 18 before reentering the coating zone 11." (See id. at col. 2, 11. 3-6.) It is also undisputed that Voelker shows that after sheet material 10 is coated in coating zone 11, the "coated impermeable sheet" may move forward "through power driven rolls 31 and 32" to be "collected on a product reel 30." (See id. at col. 2, 11. 36-39, 49-63.) Appellants do not dispute the Examiner's finding that the claimed apparatus is not a medical device but a device that may be used to coat a medical device. (See Ans. 6; see also App. Br. 21-23.) Based on Voelker's device "for applying a layer of ... materials whose thickness is precisely controlled to a ... sheet material" (Voelker col. 1, 11. 23-26) and Voelker's "product removal zone" for collection of a coated sheet "on a product reel 30" (id. at col. 2, 11. 64, 72), "a person of ordinary skill can implement a predictable variation" to arrive at the device recited in claim 10. (See Ans. 6-7 (finding, among others, that a skilled artisan may find claim 10 obvious based on teaching of "roll (item 30)" and "the rod (which is ... not labeled")); see also KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).) We are not persuaded that harmful error has been shown in the Examiner's fact findings here. 15 Appeal2015-000923 Application 12/839,949 Claim 813 Claim 8 depends from claim 1 and additionally recites a particular "uniform thickness of [a] coating patch" which "is about half of the height of the metering gap." (App. Br. 30.) Appellants do not dispute the Examiner's finding that the TMI reference discloses a "Bird applicator" that "produces a wet film thickness equal to half of the gap size." (See App. Br. 26; see also NFR 6 (citing TMI at 1 ).) Appellants, however, argue that the rejection of claim 8 should be reversed because the cited art TMI brochure shows a "gap applicator" instead of a "web" as recited. (App. Br. 26.) Appellants argue that "[t]here is no teaching or suggestion in Voelker or the TMI brochure that the impermeable sheet 10 of Voelker could be modified so that the thickness of the foam forming chemicals would be less than the height of the gap." (Id; Reply Br. 9.) It is well-established that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements. In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012); see In re Keller, 642 F.2d 413, 425 (CCPA 1981) ("The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference .... "). Moreover, Appellants do not disagree with the Examiner's rationale that a skilled artisan "would be motivated to set the dimensions of the gap coating device of Voelker to the dimensions of TMI because TMI shows that those are desirable settings for gap coating applications in general[.]" (See App. Br. 25-26; NFR 6); see also KSR, 550 U.S. at 416-17 (holding that a 13 Claims 7 and 9 stand or fall with claim 8. (App. Br. 25.) 16 Appeal2015-000923 Application 12/839,949 combination of familiar elements according to known methods yielding no more than predictable results that is likely to render a claim obvious).) No harmful error has been shown in this aspect of the obviousness findings. Claims 4 and 11 Appellants argue that the rejection of claim 4 should be reversed because the cited art Allenberg "does nothing to address the failure of Voelker to teach or suggest each and every element of independent claim 1." (App. Br. 25.) Appellants also argue that the rejection of claim 11 should be reversed because the cited art "Richard does nothing to address the failure of Voelker." (Id. at 27.) For the reasons provided with regard to the rejection of claim 1 based on Voelker, we affirm the rejections of claims 4 and 11. C. Order It is ORDERED that the rejections of claims 1-12 are affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § l.136(a). AFFIRMED 17 Copy with citationCopy as parenthetical citation