Ex Parte Ruan et alDownload PDFPatent Trial and Appeal BoardMay 10, 201713058649 (P.T.A.B. May. 10, 2017) 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. 13/058,649 03/15/2011 Tieming Ruan P-08139 (066810-01288) 2873 47058 7590 05/12/2017 David W. Highet, VP & Chief IP Counsel Becton, Dickinson and Company (Dickinson Wright PLLC) 1 Becton Drive, MC 110 Franklin Lakes, NJ 07417-1880 EXAMINER CARPENTER, WILLIAM R ART UNIT PAPER NUMBER 3763 NOTIFICATION DATE DELIVERY MODE 05/12/2017 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): lorraine_kow alchuk @ bd .com ip_docket @bd.com DWPatents @ dickinson wright. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TIEMING RUAN, ROBERT BANK, ELIOT Z AIKEN, MICHAEL VINCENT QUINN, and GARY SEARLE Appeal 2015-007366 Application 13/058,649 Technology Center 3700 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and TIMOTHY G. MAJORS, Administrative Patent Judges. PER CURIAM. DECISION ON APPEAL This is an appeal1 under 35U.S.C. § 134 involving claims to a safety pen needle assembly. The Examiner rejected the claims on the ground of anticipation. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Statement of the Case Background Appellants’ invention relates to “[sjafety pen needle assemblies ... for providing shielding to a used pen needle to prevent inadvertent ‘needle sticks’ therewith” (Spec. 11). 1 Appellants identify the Real Party in Interest as Becton, Dickinson and Company (see App. Br. 2). Appeal 2015-007366 Application 13/058,649 The Claims Claims 1—3, 5, and 7—102 are on appeal. Independent claim 1 is representative and reads as follows (emphasis added): 1. A safety pen needle assembly comprising: a hub; a needle fixed to said hub, said needle having a distal end, formed for insertion into a patient, and a proximal end; a shield; and, a biasing means disposed between said hub and said shield configured to urge said shield distally, wherein, a protrusion extends from at least one of said hub and said shield, a channel and locking aperture are formed in at least the other of said hub and said shield, said channel formed to accommodate said protrusion, said locking aperture being formed to receive said protrusion, a ridge separating said locking aperture and said channel, wherein said shield is movable from a first position to a second position, wherein, with said shield in said first position and prior to said needle being inserted into a patient, said protrusion is seated in a first location of said channel to retain said shield spaced from said distal end of said needle such that said distal end of said needle is exposed, wherein, with said shield in said second position, said protrusion being received by said locking aperture with said shield covering said distal end of said needle, said protrusion being received in said locking aperture at a location more distal than said first location, and, wherein, said channel guides said protrusion as said shield moves from said first position to said second position; whereby, when said shield is in said first position, a user may visually confirm proper priming and needle placement during use. 2 Claims 6 and 11—21 are withdrawn (see Final Act. 1). 2 Appeal 2015-007366 Application 13/058,649 The Issue The Examiner rejected claims 1—3, 5, and 7—10 under 35 U.S.C. § 102(b) as being anticipated Berthier3 (Final Act. 2—5). The Examiner finds that: Berthier discloses a safety pen needle assembly (1) comprising a hub (2) having a needle (6) fixed thereto, said needle having a distal end formed for insertion into a patient and a proximal end (Fig. 1). Berthier discloses a shield (8). Berthier discloses a biasing means (20) disposed between the hub and the shield configured to urge the shield distally (Fig. 1). Berthier discloses a protrusion (26) that extends from at least one of the hub and the shield, a channel (22) and a locking aperture (29) are formed in at least the other of the hub and the shield, the channel being formed to accommodate the protrusion, said locking aperture being formed to receive the protrusion, a ridge (generally 28) separating said locking aperture and the channel (See Fig. 2 or Fig. 3; note that the bottom 28 slopes upward until it sharply drops off at recess 29 thereby forming the ridge). Berthier discloses that the shield is moveable from a first position (not shown) to a second position (Fig. 1), wherein in the first position, the protrusion is seated in a first location of the channel (i.e. at the proximal end) to retain the shield spaced from the distal end of the needle such that the distal end of the needle is exposed. Berthier discloses that in the second position, the protrusion is received by the locking aperture with shield covering the distal end of the needle (Fig. 1), the protrusion being received in the locking aperture at a location more distal than the first location (see Fig. 2, note that the aperture 29 is more distal than sections 3 Berthier, US 5,429,612, issued July 4, 1995. 3 Appeal 2015-007366 Application 13/058,649 24, 25, and the majority of 23). Berthier discloses that the channel guides the protrusion as the shield moves from the first position to the second position, by following the shape of the channel, whereby when the shield is in the first position, i.e. the needle is exposed, a user may visually confirm proper priming and needle placement during use, i.e. since the needle is exposed a user can visualize it. (Final Act. 2—3.) The Examiner determines that the phrase “prior to said needle being inserted into a patient” constitutes functional language directed toward the intended use of the claimed device. Examiner notes that a recitation of intended use only limits the claims inasmuch as the claimed invention need only be capable of performing the specified function. In the instant case Examiner submits that when the shield of Berthier can be induced to the first position without insertion of the needle into a patient. (Final Act. 3—4.) The issue with respect to this rejection is: Does the evidence of record support the Examiner’s findings that Berthier teaches the claimed invention? Findings of Fact 1. Figure 1 of Berthier is reproduced below: 18 20 f 3 17 « f2 7 2 15 16 19 13 FIG-1 4 Appeal 2015-007366 Application 13/058,649 Figure 1 shows [a] device for an injection syringe including a cylindrical body (2) closed at one of its ends by a transverse wall in which the needle (6) is implanted, is such that the end of the cylindrical body is fitted with a slideway (7) for a needle protector (8) that includes a first tubular portion (9) of large diameter suitable for sliding along the slideway (7) between two positions that are axially separate from each other, and a small diameter portion (10) that extends the large diameter portion longitudinally, forming a moving protective sheath for the end of the needle (6), guiding and indexing elements (11, 12, 14, 16, 22, 26) being provided in inaccessible manner between the slideway (7) and the large diameter portion (9) of the protector so as to allow the needle to be uncovered and then recovered in succession once only. (Berthier Abstract; see also Final Act. 2—3.) 2. Figure 2 of Berthier is reproduced below: Figure 2 shows that the guidance and indexing means between the protector and the slideway (which in this case is the body or needle support 2 itself of the syringe) are constituted on the slideway by a U-shaped groove 22 whose two branches 23 and 24 extend along two different generator lines of the slideway and are interconnected by a circumferential groove 25 that connects them together transversely, and on the protector by a resilient tongue 26 that projects inside the 5 Appeal 2015-007366 Application 13/058,649 protector into the branch 23 of the groove 22. Within this branch, there is no hindrance to sliding in the needle uncovering direction. Advantageously, particularly when a spring such as 20 is used, the end of the branch 23 is fitted with ratchets 27 that co-operate with the tongue 26 in a pawl-like manner so as to prevent the protector returning towards the needle, while leaving the tongue free to retract and pass over the ratchets during movement in the opposite direction. In the other branch, the bottom 28 slopes slightly upwards towards the needle and is subsequently terminated by a recess 29 from which the pawl cannot be extracted. Movement of the protector is then finally prevented. To achieve such prevention of movement, it is appropriate to push the protector 8 towards the circumferential portion 25 of the groove 22 and to rotate it to place the tongue 26 in the branch 24, thereby enabling the needle to be covered again under assistance from the spring. (Berthier 4:32—58; see also Final Act. 2—3.) 3. Berthier teaches that [i]n a variant of this embodiment, the branch that does not include the recess includes a plurality of ratchets each constituting an abutment co-operating with the resilient tongue to cause it to be retracted in the needle uncovering direction while preventing the protector from sliding in the needle-covering direction. This variant makes it possible to adjust the length of the needle to be uncovered as a function of the depth to which it is to penetrate into tissue during injection. (Berthier 2:48—56; see also Ans. 5.) Principles of Law A prior art reference can only anticipate a claim if it discloses all the claimed limitations “arranged or combined in the same way as in the claim.” Wm. Wrigley Jr. Co. v. Cadbury Adams USALLC, 683 F.3d 1356, 1361 (Fed. Cir. 2012). 6 Appeal 2015-007366 Application 13/058,649 Analysis We adopt the Examiner’s findings concerning the scope and content of the prior art (Final Act. 2—5; Ans. 2—14; FF 1—3), and agree that the claims are anticipated by Berthier. We address Appellants’ arguments. Appellants contend that as stated at the end of claim 1, “when said shield is in said first position, a user may visually confirm proper priming and needle placement during use.” This is not at all provided in Berthier. The subject invention allows for a user to see the exposed distal end of the needle with the shield being retained to allow for such exposure. This permits visual confirmation of priming and needle placement for an injection. With Berthier, the needle is fully covered in an initial state, thus, both: 1. preventing visual confirmation of needle priming; and, 2. obstructing a view of needle placement for an injection. (App. Br. 5; see also Reply Br. 3.) We are not persuaded. We recognize claim 1 requires that the shield and protrusion are movable from one position to another such that in each position, the shield or protrusion is either retained or received by a locking aperture and that the needle is exposed in one of the positions. Berthier teaches “a needle protector (8) that includes a first tubular portion (9) of large diameter suitable for sliding along the slideway (7) between two positions that are axially separate from each other” (FF 1). Berthier teaches the protector may “be retracted in the needle uncovering direction while preventing the protector from sliding in the needle-covering direction. This variant makes it possible to adjust the length of the needle to be uncovered as a function of the depth to which it is to penetrate into tissue during injection” (FF 3). Thus, Berthier teaches a needle assembly having a shield that can be moved to multiple positions that are at least retained or 7 Appeal 2015-007366 Application 13/058,649 locked from movement, and in at least one position, the needle is exposed from the shield. As the Examiner explains, “[w]hen the projection of Berthier is disposed in such a position the shield is fully retracted and the distal end of the needle (6) is exposed for visual confirmation and inspection by the user” (Ans. 3; see also id. at 3—4, 8—10, 13, in which the Examiner rendered depictions of the movement of Berthier’s needle assembly along different positions.) “[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). “A patent applicant is free to recite features of an apparatus either structurally or functionally .... Yet, choosing to define an element functionally, i.e., by what it does, carries with it a risk.” In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). As the Examiner explains, such recitation of providing the device in the first position, prior to the needle penetrating a user’s skin, constitutes a mere intended use recitation. A recitation of intended use only limits the claims inasmuch as the device need only be capable of performing the specified function. Specifically, Examiner submits that the device of Berthier, regardless of the author’s intent, is CAPABLE of and CONFIGURED FOR being assembled and provided to a user in a pre-use state in the “first” position. The practitioner can then visually confirm proper priming and needle placement during use with the shield in the “first position”. The mere fact that the device in intended by Berthier to be provided to a practitioner with the needle shield extended is immaterial. (Ans. 5.) 8 Appeal 2015-007366 Application 13/058,649 The Examiner further noted that Berthier in fact appears to contemplate providing the needle at least partially extended prior to insertion of the needle into the patient. For example, Berthier recites “[t]his variant [i.e. ratchets 27] makes it possible to adjust the length of the needle to be uncovered as a function of the depth to which it is to penetrate into tissue during injection” (Col. 2, Ln. Ln. 48-56). {Id.-, FF 3.) We agree with the Examiner that the limitation “prior to said needle being inserted into a patient” is intended use. When a user determines to insert the needle into the patient is a choice that is not determinative of the structure of the claimed needle assembly. For example, whether the user has the needle exposed or retracted, prior to injection, is an intended use. Here, the order of steps are not limited by the structural limitations of claim 1. Appellants contend “[i]t is clear that the needle must be covered in its initial state. As the subject rejection is an anticipation rejection, it is clear that Berthier fails to disclose all of the limitations of the subject invention” (App. Br. 6). We do not find this argument persuasive because Appellants do not define in the claims which part of these two sequences of steps constitutes “an initial state” (see App. Br. 5 and further discussions below). More importantly, Berthier teaches a shield structure that may move between a needle-exposed state and a needle-protected state (FF 23). Even if there is an additional needle-protected state prior to the needle-exposed state, that functional use of Berthier is not excluded by apparatus claim 1 based both on the “comprising” language that is open to additional elements and because the term “first position” represents intended use, and does not 9 Appeal 2015-007366 Application 13/058,649 impose any structural limitations on the claims as already discussed. As long as Berthier allows exposure of the needle and the needle has not punctured the skin, visual confirmation of priming is possible. We recognize, but are not persuaded by, Appellants’ contention that Berthier does not teach the shield being retained in a first location and spaced so that the needle is exposed (see App. Br. 7). As discussed above, Berthier teaches that the needle can be exposed, and that the needle or shield movement is prevented based on the recess 29, the ratchets 27 interacting with the tongue 26, or the tongue being at position 25 (see Ans. 7; see also Ans. 8-17; FF 2-3). Appellants argue that [t]he retaining of the shield to be spaced from the distal end of the needle such that the distal end of the needle is exposed with the shield in the first position is an affirmative structural limitation of claim 1. Relative arrangement of elements, particularly in a retained state as claimed, does not constitute mere method of use. Modifying Berthier to have a distal end of the needle exposed in a retained, pre-use state requires modification from the device as disclosed. (App. Br. 7.) These arguments are unpersuasive. The Examiner recognizes that the retention of the shield at a first location is an affirmative structural claim limitation and finds that Berthier teaches this limitation (see Ans. 10—11). We further agree with the Examiner that “contrary to Appellant’s allegations, NO MODIFCATION of the structure of Berthier is necessary because the inventors of Berthier CLEARLY disclose the shield of the disclosed device to transition by a DELIBERATE user action, i.e. ‘pushing’ and ‘rotation’ (Col. 4, Ln. 43—58)” (id. at 11). 10 Appeal 2015-007366 Application 13/058,649 Appellants contend that “the Examiner has failed to take into account Applicant’s full disclosure, as well as the perspective of those skilled in the pen needle art” because “[t]he specification neither discloses nor suggests any intermediate positions for the shield” (Reply Br. 1—2). We are not persuaded. Claim 1 does not exclude intermediate positions or require more than two positions for the shield. “[L]imitations are not to be read into the claims from the specification.” In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). See also In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (“[Ajppellanf s arguments fail from the outset because ... they are not based on limitations appearing in the claims.”). Appellants argue that ‘Tflhe Examiner Proffers New Evidence That Should Be Ignored” in regard to the Examiner’s drawings provided in the Examiner’s Answer (see Reply Br. 3). This argument is unpersuasive because the Examiner’s drawings are a rendition of the movement of parts of Berthier’s pen assembly and merely help illustrate how the pen assembly operates for comparison to the claimed invention. Appellants present new arguments in regard to claims 8 and 9 in the Reply Brief and contend that “[f]or reasons unknown to present counsel, the arguments addressed in this section were not raised by prior counsel in the Appeal Brief. Applicant respectfully requests that these circumstances be considered ‘good cause’ under 37 C.F.R. §41.41(b)(2) to excuse the omission, and that the arguments be considered now” (Reply Br. 4) Appellants are reminded that if the Examiner has not introduced new grounds of rejection and Appellants’ later arguments are not responsive to arguments raised by Examiner’s Answer and are without good cause, they should not be considered. 11 Appeal 2015-007366 Application 13/058,649 Any argument raised in the reply brief which was not raised in the appeal brief, or is not responsive to an argument raised in the examiner’s answer, including any designated new ground of rejection, will not be considered by the Board for purposes of the present appeal, unless good cause is shown. (37 C.F.R. § 41.41(b)(2).) See also Ex Parte Borden, 93 USPQ2d 1473, 1473—74 (BPAI 2010) (informative opinion) (absent a showing of good cause, the Board is not required to address an argument newly presented in the reply brief that could have been presented in the principal brief on appeal). Here, we do not consider arguments not raised before by a prior counsel or a change in counsel as “good cause.” Conclusion of Law The evidence of record supports the Examiner’s findings that Berthier anticipates the claimed invention. SUMMARY In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 102(b) as being anticipated by Berthier. Claims 2, 3, 5, and 7—10 fall with claim 1. 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 12 Copy with citationCopy as parenthetical citation