Ex Parte GardnerDownload PDFPatent Trial and Appeal BoardApr 19, 201312230132 (P.T.A.B. Apr. 19, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE 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. 12/230,132 08/25/2008 Richurd Gardner 0100/0206 8818 21395 7590 04/19/2013 LOUIS WOO LAW OFFICE OF LOUIS WOO 717 NORTH FAYETTE STREET ALEXANDRIA, VA 22314 EXAMINER LEE, BRANDY SCOTT ART UNIT PAPER NUMBER 3767 MAIL DATE DELIVERY MODE 04/19/2013 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 RICHURD GARDNER ____________ Appeal 2011-009761 Application 12/230,132 Technology Center 3700 ____________ Before ERIC GRIMES, MELANIE L. McCOLLUM, and ULRIKE W. JENKS, Administrative Patent Judges. JENKS, Administrative Patent Judge DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims directed to a needle sheath removal device. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. Appeal 2011-009761 Application 12/230,132 2 STATEMENT OF THE CASE The Specification is directed to “needle devices such as syringes that have . . . a sheath removal mechanism that enables a user to remove the sheath that covers the needle of such a needle device prior to its use without using both hands.” (Spec. ¶ 001.) Claims 1, 3-14, 17-19, 21, and 22 are on appeal, and can be found in the Claims Appendix of the Appeal Brief (App. Br. 17-23). Claims 1, 3, 4, 14, 17, 19, and 21 are independent claims. Claim 1 is illustrative of the claims on appeal, and reads as follows (emphasis added): 1. Apparatus comprising: a base with a needle end to which a needle extends, a needle protective housing having a back wall and two side walls each extending from the back wall pivotably connected to said base, a sheath non-fixedly mated to said base to cover the needle extending therefrom prior to use thereof, said sheath having an open end that frictionally contacts said base so as not to be removable from said base without a predetermined force applied thereto longitudinally along the axis of said base or needle to remove it from said base, said sheath having a circumferential lip at its open end, wherein said housing comprises finger means that are positioned below the lip of said sheath with said housing being in a first position in relative proximity to said sheath when said sheath is mated to said base and covers the needle, wherein said finger means comprises two cams each extending from a corresponding one of the side walls of said housing, each of said cams having a finger positioned below the lip of said sheath when said housing is at said first position, the finger of each of said cams pushing against the lip of said sheath to remove said sheath from said base when said housing is pivotally moved from said first position in a direction away from the longitudinal axis of said base or needle toward a second position. Appeal 2011-009761 Application 12/230,132 3 The Examiner has rejected the claims as follows: I. claims 1, 4-7, 9-12, 14, 17-19, and 21-22 as unpatentable under 35 U.S.C. § 103(a) as being unpatentable over Peters1 in view of Takaoki;2 II. claim 3 as unpatentable under 35 U.S.C. § 103(a) as being unpatentable over Peters in view of Levenson;3 III. claim 8 as unpatentable under 35 U.S.C. § 103(a) as being unpatentable over Peters and Takaoki in view of Hollister;4 and IV. claim 13 under 35 U.S.C. § 103(a) as unpatentable over Peters and Takaoki in view of Farrar.5 I. Obviousness over Peters and Takaoki The Examiner’s position is that Peters disclosed an apparatus with a base, a needle, a needle protective housing that is pivotably connected to the base, and a sheath that is mated to the base and covers the needle. (Ans. 4.) The Examiner found that Peters did not disclose “finger means comprising two cams each extending from a corresponding one of the side walls of said housing, each of said cams having a finger positioned below the lip of said sheath when said housing is at said first position.” (Id.) The Examiner found that Takaoki disclosed “a device with finger means comprising two cams having a finger that pushes against the lip of the sheath to remove the sheath from the base (Figures 6 and 7).” (Id.) According to the Examiner, 1 David Blake Peters III, US 2002/0091360 Al, published Jul. 11, 2002. 2 Takaoki Muneo, JP 06-121836, published May 6, 1994. 3 Myron F. Levenson, U.S. Pat. No. 4,915,698, issued Apr. 10, 1990. 4 William H. Hollister, U.S. Pat. No. 4,982,842, issued Jan. 8, 1991. 5 Quinton Farrar et al., US 2005/0148941 Al, published July 7, 2005. Appeal 2011-009761 Application 12/230,132 4 “it would have been obvious to a person of ordinary skill in the art to modify the housing of Peters with the cam/finger means of Takaoki to optimize the effectiveness of the sheath removal system.” (Id.) “In particular, [the] Examiner was referring to adding the wedge member of Figures 6 and 7 [Takaoki] to edge of housing (84) of Peters where pushing member (90) is located.” (Id. at 15.) Appellant contends that adding the wedge-portion of Takaoki’s device to the needle protective housing at position 90, as suggested by the Examiner, would prevent the housing 84 from pivoting toward the needle housing and getting under the flange at 88 in order to remove the needle housing when the housing 84 is pivoted in the direction disclosed in figure 8c. (Reply Br. 2) The issue is: Has the Examiner set forth a prima facie case of obviousness based on the preponderance of the evidence of record? Findings of Fact FF 1. Peters disclosed a needle protective device with a protective cap ejector. Figures 8A-C of Peters are reproduced below: App App (Pete shea (Pete annu eal 2011-0 lication 12 rs, Fig. 8A th remova rs ¶¶ 0030 lar housin Once the position behind t member flange 8 09761 /230,132 -C) Fig. l means in -0032.) F g by a piv leg 84 is shown in he annular 90 is then 8 and eject 8A-C illus corporated ig. 8A sho ot hinge 86 pivoted ab FIG. 8B, t flange 88 located to the sheath 5 trate a dia with the n ws a leg 8 (id. at ¶ 0 out 45 deg he pushing . Once thi exert a lev 42 from grammatic eedle prot 4 that is c 062). rees or so member s occurs, t er action the needle side view ective hou onnected t , to the 90"snaps" he pushing on the ann 32 upon t of a sing. o the ular he App App (Id. a are r (Tak attac The desc tip o need that 6 In c eal 2011-0 lication 12 leg 84 b 8A. t ¶ 0063.) FF 2. Ta eproduced aoki, Fig. hment and front view ription of d f lever L c le coverin the coverin iting to th 09761 /230,132 eing return kaoki6 dis below: 6, 7) Draw detachme and side v rawings ( an be inse g by pushi g can be l is referenc ed back to closed a s ing 6 is “ nt of hypo iew of hy brackets in rted betwe ng the wed oosened (i e, we refe 6 its initial heath remo [t]he expla dermic ne podermic n original) en the flan ge-like le d. at ¶ 001 r to the ma position s val devic natory vie edle cover eedle cov .) The dra ge M and ver in tow 5). chine tran hown in F e. Figures w showin ing . . . . [ ering.” (I wings sho the hypod ards the ne slation of IG. 6 and 7 g general Drawing 7 d. w that the ermic edle so record. ] Appeal 2011-009761 Application 12/230,132 7 FF 3. The Specification provides that “the cam may be a separate molded clip piece retrofitted to the needle protective housing.” (Spec. ¶ 0007.) Principles of Law “[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited with approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Analysis We conclude that the Examiner has not met the burden of setting out a prima facie case based on the combination of Peters and Takaoki because the Examiner has not adequately explained why one of ordinary skill in the art would have included Takaoki’s “wedge member . . . on the edge of housing (84) of Peters where pushing member (90) is located” (Ans. 15). We find that the Examiner has not adequately articulated how the addition of the wedge provides a function that is not already present in Peters, let alone, explained how the combination would “optimize the effectiveness of the sheath removal system” (Ans. 4). In other words, the Examiner has not articulated what useful purpose the addition of the wedge would have on the function of Peters device, and thereby has not provided a sound rationale that would lead the ordinary artisan to arrive at the claimed invention. KSR, 550 U.S. at 418. Appeal 2011-009761 Application 12/230,132 8 The KSR Court noted that a combination of old elements has been held to be obvious when “[t]he two [elements] in combination did no more than they would in separate, sequential operation.” KSR, 550 U.S. at 417 (citing Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57 (1969)). Here, the Examiner combines Peters and Takaoki each of which is directed to the removal of a sheath from a needle, however, each device achieves this by a different mode of operation. Takaoki inserts a wedge in- between the needle and sheath and dislodges the sheath by pushing the wedge closer to the needle (FF 2). As noted by Appellant: Peters discloses that housing 84 has to be first moved in the direction indicated by the directional arrow in Fig. 8B, so that the notch 90 at housing 84 catches the flange 88 of the needle cover. Thereafter, housing 84 is moved in the direction indicated by the directional arrow in Fig. 8C so that the notch 90 would push against the flange 88 to thereby remove needle cover 42 from the needle. (Reply Br. 3; FF 1.) We conclude that the Examiner has not sufficiently articulated how the addition of the wedges to the housing of Peters provides functionality that is not already present in Peters and at the same time maintains the same functionality of Takaoki’s wedge. Here, both sheath removal systems have a different mode of operation (App. Br. 11), thus, more is required to explain why the combination is obvious. Accordingly, we reverse the rejection of claim 1, 4-7, 9-12, 14, 17-19, and 21-22, all of which require either “a finger positioned below the lip of said sheath,” “a finger positioned below a lip at the open end of said sheath,” or “a cam positioned below a lip that forms the open end of said sheath.” As the same issue is also dispositive for the obviousness rejection of claim 8 Appeal 2011-009761 Application 12/230,132 9 based on Peters in view of Takaoki further in view of Hollister (III), and claim 13 based on Peters in view of Takaoki further in view of Farrar (IV), we reverse the rejections as to those claims as well. II. Obviousness over Peters and Levenson The Examiner’s position is that “Peters does not disclose finger means comprising at least one cam extending from the bottom edge of the back wall of the housing, said cam push[ing] against the lip of said sheath to remove said sheath from said base.” (Ans. 13.) The Examiner, however, finds that Levenson disclosed a cam “extending from the bottom edge of the back wall of the housing, said cam push[ing] against the lip of said sheath to remove said sheath from said base.” (Id.) The Examiner concludes that “it would have been obvious to a person of ordinary skill in the art to modify the device of Peters with the cam (32) of Levenson to optimize the effectiveness of removing the sheath from the base.” (Id.) The issue is: Has the Examiner set forth a prima facie case of obviousness based on the preponderance of the evidence of record? Finding of Fact FF 4. Peters disclosed that [t]he sheath 42 is equipped with an annular flange 88 while the leg 84 of the appendage 54 is equipped with an internal mating pushing notch, rib flange or some other member 90. . . the pushing member 90 engages with the annular flange 88 and commences exertion of a biasing force on the sheath 42 tending to force the sheath in the direction of arrow R along the longitudinal axis A . . . the pushing member 90 "snaps" behind the annular flange 88 . . . to exert a lever action on the annular flange 88 and eject the sheath 42. App App (Pete prote show (Lev cove The defin or lip end 2 42, t shou remo eal 2011-0 lication 12 rs ¶ 0063. FF 5. Le ctive cove s such a d enson Fig r (in phant figure sho e a cylind 32 exten 6.” (Id. a he needle lder 48 on FF 6. Th ving a nee 09761 /230,132 ) venson di r of a hyp evice and . 4) Figure om) being ws a cross rical cavity ding inwar t col. 3, ll. and cover the cover e Specific dle sheath sclosed “[ odermic n is reprodu 4 shows removed section of 30 of pre dly from c 49-53.) I are inserte 42. (Id. a ation show . Figure 2 10 a] device f eedle.” (L ced below the section from the s “[c]ylindr determine ylindrical n order to d into cav t col. 4, ll. s a finger is reprodu or removi evenson A : view show yringe. (I ical wall 2 d length a wall 22 is remove th ity 30 and 45-59; An and cam a ced below ng and rep bstract.) ing the n d. at col 3, 2 and end nd diamete provided e cover of tab 32 eng s. 13) ssembly f : lacing a Fig. 4 eedle ll. 11-13) wall 28 r. A tab at open a needle ages the or App App (Spe ¶001 porti [nee Anal 14 th wall has n exten requ spec Spec 6.) T a fin is no eal 2011-0 lication 12 c. Fig. 2B) 5.) Shown on 20a tha dle protect ysis Appellan at has a ta 22 at its o othing to ding from ired by cla This arg ific definit ification in he figure ger protrud t clear wh 09761 /230,132 Fig. 2B i “is a fing t extends ive] housi t contend b or lip 32 pen end 26 do with ha the botto im 3.” (Id ument is n ion of a fin Fig. 2B d shows the ing from at the struc s an enlarg er means from the lo ng 10.” (S s that Leve that exten .” (App. ving ‘fing m edge fro . ) ot persuas ger mean epicts an cam attac the cam. ( ture of a c 11 ed view o in the shap wer edge pec. ¶ 003 nson’s “[d ds inward Br. 14.) A er means c m the bac ive. The S s or, for th example o hed to the Id.) How am encom f the need e of a cam of the low 2.) ]evice 10 ly from its ppellant a ompris[in k wall of s pecificatio at matter, f a finger m needle pro ever, from passes. le assemb 20 havin er portion has a tubu upper cyl sserts that g] at least aid housin n has not a cam. Th eans asse tective ho the Specif ly. (Spec. g a finger 10b of lar portion indrical “Levenso one cam g,’ as provided e mbly. (F using and ication, it n a F Appeal 2011-009761 Application 12/230,132 12 “[D]uring examination proceedings, claims are given their broadest reasonable interpretation consistent with the specification.” In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000). The Examiner interprets that the lip 32 of Levenson’s disclosed device (10) to be a finger means comprising at least one cam. (Ans. 13.) We do not find the Examiner’s interpretation of a cam unreasonable given the lack of a limiting definition in the Specification. Appellant also argues: [A] person skilled in art would not have combined the teachings of Peters with Levenson insofar as Levenson focuses to the removal of the needle sheath from the needle assembly of the syringe before the needle is to be used by the user, and in particular to the manipulation of the syringe to the tilt angles per shown in Figs. 3 and 4 to insert the sheathed needle into the cavity 30 and to remove the syringe from the device while leaving the removed needle sheath in the cavity 30, respectively. (App. Br. 15.) We are not persuaded by Appellant’s argument. Peters functions to remove the sheath by placing pushing member 90 underneath the annular flange 88 and removing the sheath by applying a pushing lever action against the flange (FF 4). Levenson functions to remove the sheath of the needle by inserting the needle and sheath into cavity 30 and then engaging the shoulder of the sheath with the lip 32 (FF 5) and using pushing action against the lip in order to loosen the sheath (Ans. 13). However, we do not agree that Appellant has adequately explained why Levenson’s lip 32 would not serve a similar purpose in the context of Peters’ device. In this regard, we note that Peters specifically disclosed that the leg member 84 could encompass some other constructions for member 90 that functions by snapping behind the annular flange 88 in order to eject the sheath (FF 4). Appeal 2011-009761 Application 12/230,132 13 We agree with the Examiner’s conclusion that based on the combination of references it would have been obvious to “modify the housing (84) of Peters with the projection (32, Figure 3) of Levenson for optimizing the removal of the sheath” (Ans. 17). We thus affirm the rejection of claim 3 under 35 U.S.C. § 103(a) as being obvious. SUMMARY We reverse the rejection of claims 1, 4-7, 9-12, 14, 17-19, and 21-22 under 35 U.S.C. § 103(a) over Peters in view of Takaoki. We affirm the rejection of claim 3 under 35 U.S.C. § 103(a) over Peters in view of Levenson; We reverse the rejection of claim 8 under 35 U.S.C. § 103(a) over Peters and Takaoki in view of Hollister. We reverse the rejection of claim 13 under 35 U.S.C. § 103(a) over Peters and Takaoki in view of Farrar. 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 dm Copy with citationCopy as parenthetical citation