Ex Parte Schraga

Patent Trial and Appeal BoardJun 13, 2016

12951925 (P.T.A.B. Jun. 13, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/951,925 11/22/2010 7055 7590 06/15/2016 GREENBLUM & BERNSTEIN, PLC 1950 ROLAND CLARKE PLACE RESTON, VA 20191 FIRST NAMED INVENTOR Steven SCHRAGA 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. P39093 1633 EXAMINER SCHMIDT, EMILY LOUISE ART UNIT PAPER NUMBER 3763 NOTIFICATION DATE DELIVERY MODE 06/15/2016 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): gbpatent@gbpatent.com greenblum.bernsteinplc@gmail.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEVEN SCHRAGA Appeal2014-004857 Application 12/951,925 Technology Center 3700 Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and ERIC C. JESCHKE, Administrative Patent Judges. HOELTER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE This is a decision on appeal, under 35 U.S.C. Â§ 134(a), from the Examiner's Final rejection of claims 1-9, 11, and 14--28. App. Br. 1, 3. Claims 10, 12, and 13 have been canceled. App. Br. 3. We have jurisdiction under 35 U.S.C. Â§ 6(b). We AFFIRM. THE CLAIMED SUBJECT MATTER The disclosed subject matter "relates generally to syringes, e.g., hypodermic syringes, such [as] are utilized for injection of medicament into the body tissues of human and animal patients." Spec. i-f 2. Claims 1, 21, Appeal2014-004857 Application 12/951,925 23, 24, and 27 are independent. Claim 1 is illustrative of the claims on appeal and is reproduced below: 1. A single-use injection device comprising: a barrel; a plunger having a proximal end and a portion structured and arranged to move within the barrel; a needle unit movable between an initial position and a post-use position located within the plunger; at least one releasable retaining member which releasably retains the needle unit in the initial position and that is movable to a position arranged outside an outer surface of the proximal end of the plunger; and a safety system that one of: after the proximal end of the plunger receives therein a distal end of the needle unit, automatically causes the needle unit to retract into the plunger when the plunger reaches a substantially fully depressed position; and utilizes a frangible or breakable seal arranged within the plunger and being axially spaced from the proximal end of the plunger. REFERENCES RELIED ON BY THE EXAMINER Tsao Botich Tenhuisen US 5,019,044 May 28, 1991 US 6,179,812 Bl Jan. 30, 2001 US 2003/0004491 Al Jan. 2, 2003 THE REJECTIONS ON APPEAL Claims 1---6, 8, 11, and 14--26 are rejected under 35 U.S.C. Â§ 102(b) as anticipated by Tsao. Claims 7 and 9 are rejected under 35 U.S.C. Â§ 103(a) as unpatentable over Tsao and Tenhuisen. Claims 27 and 28 are rejected under 35 U.S.C. Â§ 103(a) as unpatentable over Tsao and Botich. 2 Appeal2014-004857 Application 12/951,925 ANALYSIS The rejection of claims 1-6, 8, 11, and 14-26 as anticipated by Tsao Appellant presents separate arguments for each of independent claims 1, 21, 23, and 24. App. Br. 8-16. Appellant also presents separate arguments for each of dependent claims 2 and 15. App. Br. 16-17. We address each with the remaining claims standing or falling therewith. See 3 7 C.F.R. Â§ 41.37(c)(l)(iv). Claim 1 Independent claim 1 is directed to a syringe comprising a barrel, a plunger, and a needle unit. The needle unit is movable between an initial or useable position and a post-use or non-useable position. App. Br. 21. Claim 1 specifically recites a safety system such that "after the proximal end [i.e., needle end] of the plunger receives therein a distal end of the needle unit," the needle unit is automatically caused to move to the post-use or non- useable position. Emphasis added. Regarding this safety system, the Examiner particularly relies on Tsao's "transition from Fig. 3 to Fig. 4" for disclosing a proximal end of plunger 50 receiving therein a distal end of needle unit 30, and that thereafter, the needle unit is automatically caused to retract into the plunger as claimed. Final Act. 3; see also Ans. 2. Tsao teaches a two-step activation process before the needle is retracted into the plunger. As shown in Figure 3 of Tsao, "the bottom surface 35 of the holder plate 34 will be firstly in contact with the rubber plug" 56 and thereafter, "the rubber plug [56] is pushed to break away from the [plunger's] front opening 54." Tsao 3:65--4:2. Tsao's Figure 4 illustrates that, after plug 56 "is squeezed out of the front opening 54," the 3 Appeal2014-004857 Application 12/951,925 plunger presses against "bottom surface 29 of the two L-shaped clamping elements 24 and 26," which causes compressed spring 38 to be released. Tsao 4:3-11. Consequently, "[b ]ecause the rubber plug 56 has been squeezed out of the front opening 54, the hypodermic needle 30 will be pushed by the spring 38 into the inner chamber 52 of the plunger 50 to become totally received therein." Tsao 4:20-24. Hence, Figure 3 of Tsao discloses the first step (i.e., breaking the plug free from the plunger) in the operation of Tsao's syringe while Figure 4 discloses the second or final step (i.e., releasing the compressed spring to push the needle into the plunger's inner chamber) occurring after the plunger has been fully depressed. Appellant contends that no portion of Tsao's plunger 50 receives therein any portion of the needle unit "before the device is activated." App. Br. 9; see also Reply Br. 3, 4. Appellant's contention is not persuasive in view of the Examiner's reliance on Tsao' s "transition from Fig. 3 to Fig. 4" that occurs during use. Final Act. 3; Ans. 2; Tsao 3:62--4:24. These figures illustrate the limitation that "after the proximal end of the plunger receives therein a distal end of the needle unit" (see Tsao Fig. 3), the needle unit is automatically caused "to retract into the plunger when the plunger reaches a substantially fully depressed position" due to the subsequent release of the compressed spring (see Tsao Fig. 4). 1 Hence, in view of these teachings in Tsao, Appellant's contention that Tsao lacks a needle unit received within the plunger, and that such receipt within the plunger does not occur "before the device is activated," is not persuasive of Examiner error. App. Br. 9. 1 As indicated in Tsao, this retraction into the plunger occurs "[b ]ecause the rubber plug 56 has been squeezed out of the front opening 54" beforehand. Tsao 4:20-24. 4 Appeal2014-004857 Application 12/951,925 Appellant also contends that the position shown in Tsao' s Figure 3 "is not an actual position as much as it is a momentary (or fraction of a second) snap shot of how the seal 56 disengages from the plunger during activation of the device." App. Br. 9; see also Reply Br. 2-3. In other words, Appellant contends that Tsao's activation "is at best fleeting," and as such, the Examiner's reliance on Tsao's Figure 3 is improper. App. Br. 9. We are instructed by our reviewing court that an intermediate product or article can anticipate a claimed article even if the intermediate product is merely a stage in the final product. See In re Mullin, 481F.2d1333, 1335- 36 (CCPA 1973) (an article that is intended and appreciated is no less anticipatory be it an intermediate structure rather than an end use item (citing In re Herbert, 461 F.2d 1390, 1394 (CCPA 1972))). Here, it is clear from Tsao that the configuration illustrated in Figure 3 is an intermediate stage in the operation of Tsao's device. Tsao describes this configuration (Tsao 3 :62--4:2) and hence, Appellant does not explain how this configuration is not intended and/or appreciated by Tsao. Accordingly, we are not persuaded by Appellant's argument that the transitory nature of Tsao's disclosure precludes the Examiner from relying on such teachings. Appellant also addresses the limitation reciting a spring retention member "that is movable to a position arranged outside an outer surface of the proximal end of the plunger." App. Br. 10. Appellant contends that this is not taught by Tsao's corresponding clamping element 24 (Final Act. 3) because this member (and its companion clamping element 26) are "not moved to a position arranged outside an outer surface of the proximal end of the plunger." App. Br. 10. Instead, as per Appellant, each member "remains in contact with surface 51 [of the plunger] and is not moved to a position 5 Appeal2014-004857 Application 12/951,925 outside the surface 51."2 App. Br. 10. However, claim 1 is silent as to any contact (or lack thereof) between the claimed "retaining member" and the plunger. Furthermore, the Examiner states that this matter of contact/no contact "does not negate the fact that [Tsao's members 24, 26] are movable into a position outside the plunger." Ans. 2. As stated by our reviewing court, "the name of the game is the claim," and unclaimed features cannot impart patentability. In re Hiniker Co., 150 F.3d 1362, 1369 (Fed. Cir. 1998). Accordingly, we agree with the Examiner that Appellant is arguing a distinction (contact/no contact) that is not claimed, and as such, Appellant's contention is not persuasive of Examiner error. Thus, based on the record presented, we sustain the Examiner's rejection of independent claim 1, and dependent claims 3, 11, 14, 25, and 26. Claim 21 Independent claim 21 includes the limitation directed to a "user installable" needle hub assembly. Appellant contends that in Tsao, "the needle unit 30/34/38 is not user installable" because "these elements are already mounted within the barrel 12 prior to use." App. Br. 11; see also Reply Br. 4--5. The Examiner states, "the device of Tsao has separable parts which are capable of being installed by a user." Ans. 3. Indeed, Tsao illustrates the needle hub assembly being threaded onto the barrel. See Tsao Figs. 1--4; see also id. at 2:55-57. In addition, the Examiner states, "a member of a hospital staff as discussed by Appellant is also capable of such 2 Appellant does not dispute that Tsao's members 24, 26 are outside Tsao's plunger 50, only that they remain "in contact with" the plunger. App. Br. 10. 6 Appeal2014-004857 Application 12/951,925 installation." Ans. 3. Appellant does not address or explain how the Examiner might be mistaken on this point, or otherwise explain how hospital staff is not capable of threading the needle assembly onto Tsao' s barrel. Accordingly, Appellant's contention is not persuasive of Examiner error. Appellant also contends that "for reasons similar to those noted above regarding claim 1," Tsao fails to teach the limitation, "after a proximal end of the plunger receives therein a distal end of the needle unit," the needle is automatically retracted into the plunger. App. Br. 12-13. Appellant's contention is not persuasive for the reasons discussed supra. In view of the record presented, we sustain the Examiner's rejection of independent claim 21 and dependent claim 22. Claim 23 Appellant repeats the argument that in Tsao, the needle unit is not "user installable" as recited. App. Br. 13. Appellant's argument is not persuasive for the same reasons previously expressed. Appellant also contends, "claim 23 specifically recites a single-use syringe which upon use is rendered unusable" but Appellant does not explain how Tsao does not also disclose such a syringe. App. Br. 13. Appellant further repeats the contact/no contact argument discussed above (App. Br. 13-14), but as indicated supra, this argument is based on an unclaimed feature and hence is not persuasive of Examiner error. Accordingly, and based on the record presented, we sustain the Examiner's rejection of independent claim 23. 7 Appeal2014-004857 Application 12/951,925 Claim 24 Appellant again repeats the contact/no contact argument. App. Br. 15. This contention is not persuasive for the reasons previously expressed. See also Ans. 3. We sustain the Examiner's rejection of independent claim 24. Claim 2 Claim 2 depends from claim 1 and includes the additional limitation that the needle unit "is arranged within a needle assembly installable on the barrel." Appellant contends that in Tsao, "the needle unit 34 is mounted in the barrel" whereas claim 2 recites that the needle assembly is "installable on the barrel." App. Br. 16. The Examiner references Tsao "Figs. 1 and 2" for disclosing this limitation. Final Act. 4. These figures disclose a needle assembly threaded to barrel 12. Appellant does not otherwise indicate how Tsao's needle assembly, threaded to barrel 12, is not a disclosure of a needle assembly "installable on the barrel" as recited. We are not persuaded the Examiner erred in relying on Tsao's Figures 1 and 2 for disclosing this limitation. We sustain the Examiner's rejection of claim 2 and claims 4---6, 8 and 16-20 that further depend therefrom. Claim 15 Claim 15 depends from claim 1 and includes the additional limitation of "a locking arrangement selectively locking a portion of the plunger to the barrel upon the plunger reaching a substantially fully depressed position." The Examiner relies on Figure 4 of Tsao for disclosing this limitation, and particularly "members 11 and 59." Final Act. 4; see also Ans. 3. Appellant does not address these items 11 and 59 (located at the base of Tsao' s plunger/barrel), but instead contends, "there is no locking whatsoever between unit 34 and member 56 (located at the needle end of Tsao's 8 Appeal2014-004857 Application 12/951,925 plunger/barrel). As best understood, Appellant is seeking a disclosure of this locking arrangement at a particular end region of the syringe when claim 15 is silent as to where this locking arrangement is to be located. In short, Appellant does not explain how Tsao's "members 11 and 59" fail to teach this locking arrangement as illustrated in Tsao, and as such, we sustain the Examiner's rejection of claim 15. The rejection of claims 7 and 9 as unpatentable over Tsao and Tenhuisen Appellant contends that these two claims "are believed to be allowable based at least on their dependence to" independent claim 1. App. Br. 18. As indicated supra, we are not persuaded that claim 1 is allowable, and Appellant does not provide any additional arguments as to why dependent claim 7 and 9 might be allowable other than that they depend from claim 1. Appellant's contention is not persuasive. We sustain the Examiner's rejection of claims 7 and 9. The rejection of claims 27 and 28 as unpatentable over Tsao and Botich Independent claim 27 (and hence dependent claim 28) includes the limitation of "installing a selected needle assembly on the injection device." The Examiner acknowledges that Tsao "does not specifically teach selecting one of a plurality of needle assemblies for installation" and relies on Botich for "selecting between different needle gauges for insertion on to the barrel." Final Act. 8. Appellant repeats the argument that in Tsao, the Examiner is relying "on the momentary and fleeting position shown in Fig. 3" and contends that such reliance is "an unreasonably broad interpretation" of Tsao. App. Br. 19. Appellant does not explain how the Examiner's reliance on a stage of operation in Tsao that is explicitly shown and discussed renders the 9 Appeal2014-004857 Application 12/951,925 Examiner's reliance thereon to be "unreasonably broad" just because such stage of operation may only be "momentary and fleeting." Id. Appellant's contention is not persuasive for the reasons previously expressed. Appellant also contends, "although TSAO teaches to provide contact between surface 51 and element 26, TSAO fails to teach or suggest" a certain limitation in claim 27 directed to a portion of the plunger extending over a portion of the needle unit. App. Br. 19. Appellant's contention focusing on the contact/no contact between the retaining members and the plunger is not indicative of Examiner error with respect to this limitation. Appellant's contention is not persuasive for the reasons previously addressed. See also Ans. 3. Appellant further addresses Botich contending that Botich "does not cure the deficiencies" of Tsao. App. Br. 19. The Examiner did not rely on Botich to cure any deficiencies in Tsao, but instead to show that it is known to select "between different needle gauges." Final Act. 8. Appellant does not identify any error by the Examiner when relying on Botich for this reason. Accordingly, and based on the record presented, we sustain the Examiner's rejection of claims 27 and 28. DECISION The Examiner's rejections of claims 1-9, 11, and 14--28 are affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED 10