MEGAGEN IMPLANT CO., LTD.

Patent Trials and Appeals Board

Mar 1, 2022

2021005093 (P.T.A.B. Mar. 1, 2022)

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. 15/035,220 05/06/2016 Kwang Bum PARK 1842-042 1021 83219 7590 03/01/2022 Renaissance IP Law Group LLP (PIP) 17933 NW Evergreen Place, Suite 121 Beaverton, OR 97006 EXAMINER FREHE, WILLIAM R ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 03/01/2022 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): dkt@renaissanceiplaw.com eofficeaction@appcoll.com pto@renaissanceiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KWANG BUM PARK Appeal 2021-005093 Application 15/035,220 Technology Center 3700 Before CARL M. DEFRANCO, MICHAEL L. WOODS, and LEE L. STEPINA, Administrative Patent Judges. WOODS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 2-7, 10, 12-17, and 19. Appeal Br. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE and enter new grounds of rejection. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a) (2022). Appellant identifies Megagen Implant Co., Ltd., as the real party in interest. Appeal Br. 3. Appeal 2021-005093 Application 15/035,220 2 CLAIMED SUBJECT MATTER The application is titled “DRUG INJECTION DEVICE.” Spec. 1. Claim 2 is the sole independent claim pending. See Appeal Br. 12-16 (“Claims App.”). We reproduce claim 2 below, with emphasis added to a particular limitation addressed in our decision: 2. A drug injection device, comprising: an injection unit which is provided with an ampoule accommodation portion for accommodating an ampoule that contains an injectable solution, and injects the injectable solution into a person being operated on; an injection speed adjustment unit which is connected to the injection unit, applies pressure to the injectable solution, and adjusts an injection speed of the injectable solution, being injected into the body of the person being operated on, by selectively adjusting a speed of the pressure applied to the injectable solution; a chargeable battery which is provided in the injection speed adjustment unit and supplies power to a driving motor; a first coil which is provided in the injection speed adjustment unit and charges the chargeable battery; and a non-contact charging cradle which is non-contacted to the first coil and provided with a second coil supplying electric energy to the first coil, wherein the injection speed adjustment unit comprises: an injection unit attachment portion to which the ampoule accommodation portion is detachably attached; a pressurizing plunger which is connected to the ampoule accommodated in the ampoule accommodation portion and applies pressure to the injectable solution; a pressurizing plunger up/down driving module which is provided on the same axis as the pressurizing plunger and drives the pressurizing plunger up or down; and a waterproof portion through which the pressurizing plunger passes and that prevents a liquid from penetrating to the inside of the injection speed adjustment unit, wherein the injection unit attachment portion comprises: Appeal 2021-005093 Application 15/035,220 3 a body portion for injection unit attachment provided in an insertion groove to which an end region of the ampoule accommodation portion is inserted; and a locking jaw portion provided at the body portion for injection unit attachment and locked to a projection member projecting in a lateral direction from an outer wall of the ampoule accommodation portion when the ampoule accommodation portion rotates, wherein the locking jaw portion comprises: an upper locking jaw supporting an upper end of the projection member; and a lower locking jaw supporting a lower end of the projection member and elastically biasing the lower end of the projection member toward the upper locking jaw, wherein the pressurizing plunger up/down driving module comprises: a lead screw engaging with the pressurizing plunger; the driving motor, wherein the driving motor is adapted to rotate the lead screw; and a guide portion that guides movement of the pressurizing plunger, wherein the guide portion includes an exposure hole through which the pressurizing plunger is exposable when driven up or down; and a detection sensor adjacent to the exposure hole and configured to detect whether the pressurizing plunger is exposed by the exposure hole. Claims App. 12-13. (emphasis added). Appeal 2021-005093 Application 15/035,220 4 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Sano US 4,942,352 July 17, 1990 Ford US 5,720,728 Feb. 24, 1998 Herbst US 6,022,337 Feb. 8, 2000 Patrick US 8,022,736 B2 Aug. 23, 2011 Kronestedt US 2009/0308386 A1 Dec. 17, 2009 Bruce US 2012/0035472 A1 Feb. 9, 2012 Cowan US 2013/0126559 A1 May 23, 2013 Whalley US 2013/0310756 A1 Nov. 21. 2013 REJECTIONS The following rejections are before us on appeal: Claims Rejected 35 U.S.C. § Reference(s)/Basis 2-7, 10, 12-15 103 Herbst, Sano, Cowan, Bruce, Whalley, Kronestedt 16, 17 103 Herbst, Sano, Cowan, Bruce, Whalley, Kronestedt, Patrick 19 103 Herbst, Sano, Cowan, Bruce, Whalley, Kronestedt, Ford See Final Act. 2-14. I. Herbst, Sano, Cowan, Bruce, Whalley, Kronestedt The Examiner rejects claims 2-7, 10, and 12-15 as unpatentable over Herbst, Sano, Cowan, Bruce, Whalley, and Kronestedt. See Final Act. 2. For the reasons that follow, we reverse this rejection. a. Rejection In rejecting sole independent claim 2, the Examiner finds that Herbst discloses a drug injection device having several of the claimed features, Appeal 2021-005093 Application 15/035,220 5 including “a pressurizing plunger (23) which is connected to the ampoule (21) . . . and applies pressure to the injectable solution.” Final Act. 2-3 (citing in part Herbst, 4:61-5:18). The Examiner further finds that Herbst discloses “a pressurizing plunger up/down driving module (39) which is provided on the same axis as the pressurizing plunger (23) and drives the pressurizing plunger (23) up or down.” Id. at 3 (citing Herbst, 5:5-18). The Examiner acknowledges, however, that “Herbst does not disclose wherein the pressurizing plunger up/down driving module comprises[] a lead screw engaging with the pressurizing plunger.” Id. at 5 (emphasis added). To address this shortcoming, the Examiner relies on Bruce’s and Kronestedt’s teachings, finding that Bruce discloses “a lead screw (66) engaging with a pressurizing plunger (74).” Id. at 5-6. The Examiner further finds that “Kronestedt discloses a threaded lead screw (84) engaging with a pressurizing plunger (piston) wherein threaded components provide for a higher degree of accuracy.” Id. at 6 (citing Kronestedt ¶¶ 23, 51) (emphasis added). Based on the teachings of Bruce and Kronestedt, the Examiner reasons that [I]it would have been obvious before the effective filing date of the present application to one of ordinary skill in the art to have modified the pressurizing plunger up/down driving module of Herbst in view of Sano, Cowan and Bruce to comprise a lead screw engaging with the pressurizing plunger; a driving motor which rotates the lead screw and a guide portion that guides movement of the pressurizing plunger as disclosed by Bruce wherein threaded components provide for a higher degree of accuracy as disclosed by Kronestedt. Final Act. 6-7 (emphasis added). Appeal 2021-005093 Application 15/035,220 6 b. Appellant’s Argument Appellant’s argument focuses on one issue-whether Kronestedt teaches a threaded driver as more accurate than other drivers. See Appeal Br. 7-10. Specifically, Appellant argues that Nothing in the cited references teaches or suggests that the threaded components of Bruce and Kronestedt, when incorporated into Herbst so as to be combined with the drive unit of Herbst, enables the injection device of Herbst to expel medicament with a higher degree of accuracy than is achievable by the drive unit of Herbst alone. Id. at 8. Appellant’s argument is persuasive. c. Analysis The Examiner erred in finding that Kronestedt discloses that “threaded components provide for a higher degree of accuracy.” See Final Act. 7 (“threaded components provide for a higher degree of accuracy as disclosed by Kronestedt.”). The Examiner reads too much into Kronestedt’s disclosures. The Examiner cites to Kronestedt’s paragraphs 23, 51, and 61 in support of a finding that threaded components are more accurate. Final Act. 6; Ans. 5. These paragraphs, however, do not support the Examiner’s position. Although Kronestedt teaches that “[t]he finer the pitch of grooving, or screw pitch, of the threaded components, the higher degree of accuracy will be achieved and lower the force acting on the piston” (Kronestedt ¶ 61) and that a “device using a plunger rod 84 having a very fine pitch of grooving, or screw pitch, to give a very accurate dose” (id. ¶ 59), this is not a teaching Appeal 2021-005093 Application 15/035,220 7 that a threaded driver, or “lead screw,” is more accurate than other drivers. Rather, Kronestedt simply teaches that for threaded drivers, smaller (or finer) screw pitches will be more accurate than threaded drivers with larger screw pitches. Accordingly, we reverse the rejection of independent claim 2, and its dependent claims 3-7, 10, and-15, which inherit the same rejection infirmity, as unpatentable over Herbst, Sano, Cowan, Bruce, Whalley, and Kronestedt. See Final Act. 7-12. II. Remaining Rejections In rejecting claims 16, 17, and 19 as unpatentable over Herbst, Sano, Cowan, Bruce, Whalley, Kronestedt, and either Patrick or Ford, the Examiner relies on the same flawed findings discussed above. See Final Act. 12-14. For the same reasons, we do not sustain the rejection of independent claim 2, we do not sustain the rejection of dependent claims 16, 17, and 19 as unpatentable over Herbst, Sano, Cowan, Bruce, Whalley, Kronestedt, and either Patrick or Ford. III. New Grounds of Rejections Other than the Examiner’s erroneous finding regarding Kronestedt, discussed above, we adopt the Examiner’s findings and reasonings as set forth in the Final Office Action. See Final Act. 2-14. These new grounds of rejections supplement the original rejections. We enter new grounds of rejection, as follows: Appeal 2021-005093 Application 15/035,220 8 Claims Rejected 35 U.S.C. § Reference(s)/Basis 2-7, 10, 12-15 103 Herbst, Sano, Cowan, Bruce, Whalley, Kronestedt, Spinello1, Spinello2 16, 17 103 Herbst, Sano, Cowan, Bruce, Whalley, Kronestedt, Patrick, Spinello1, Spinello2 19 103 Herbst, Sano, Cowan, Bruce, Whalley, Kronestedt, Ford, Spinello1, Spinello2 Although Kronestedt does not teach that the use of threaded lead screws is more accurate than other drive mechanisms, we find that a skilled artisan would have utilized a threaded lead screw with Herbst’s drug delivery system just the same. In particular, a skilled artisan would have looked to Spinello12 and Spinello23 to satisfy claim 2’s requirement of a “lead screw engaging with the pressurizing plunger” and a “driving motor, wherein the driving motor is adapted to rotate the lead screw.” See Claims App. 13. Herbst provides scant detail about how, exactly, its drive mechanism works. To illustrate, we reproduce below Herbst’s Figure 19 which we find to be the most helpful in describing Herbst’s drive mechanism: 2 U.S. Patent Number 4,747,824, issued May 31, 1988 (“Spinello1”). 3 U.S. Patent Number 5,180,371, issued Jan. 19, 1993 (“Spinello2”). Appeal 2021-005093 Application 15/035,220 9 Figure 19 “shows a block diagram for the various electrical elements of [Herbst’s] system.” Herbst, 3:19-20. Herbst discloses that its “motor activates a driver mechanism 158 used to reciprocate plunger 23.” Id. at 6:47-48. “[D]river mechanism” 158 is literally and figuratively a “black box.” See id. Rather than provide detail about the mechanical structure of driver mechanism 158, Herbst instead teaches that its “drive unit[] utilize[es] the technology described in [Spinello 1] and [Spinello 2].” Id. at 1:52-55. Based on Herbst’s express teaching, we find that a skilled artisan would have looked to Spinello1 and Spinello2 to understand Herbst’s drive mechanism. We reproduce a copy of Spinello1’s Figure 5, below: Appeal 2021-005093 Application 15/035,220 10 As described in Spinello1, Figure 5 “is a schematic diagram partly in cross section illustrating one form of apparatus in accordance with the invention.” Spinello1, 4:34-36. In particular, Figure 5 shows anesthetic glass vial 16 containing a movable rubber piston 16a for sealing 2 cc of a drug. Id. at 5:65-68. Piston rod 22 is “internally threaded to receive a drive screw 23 coupled to a reversible stepper motor 24.” Id. at 6:23-36. “The piston rod 22 is axially slidably mounted in the support wall 20 and is constrained against rotation by a key 20a on the support and received in a slot or key- way 22b so that it is driven in and out upon activation of the stepper motor 24 to pump or aspirate depending upon the direction of rotation of the drive screw.” Id. at 6:34-42. Appeal 2021-005093 Application 15/035,220 11 Spinello2 teaches similar structure. See, e.g., Spinello2, 7:18-39, Fig. 5. Based on these disclosures, we find that Spinello1 and Spinello2 teach “a lead screw” (Spinello1’s drive screw 23) “engaging with the pressurizing plunger” (Spinello1’s piston 16a) and a “driving motor” (Spinello1’s stepper motor 24), wherein the driving motor (24) “is adapted to rotate the lead screw” (23), as recited in independent claim 2. See Claims App. 13. We conclude that it would have been obvious before the effective filing date of the present application to one of ordinary skill in the art to have included with Herbst’s driver mechanism, in view of other cited art, including Spinello1 and Spinello2, a lead screw engaging with the pressurizing plunger and a driving motor which rotates the lead screw. Indeed, Herbst expressly discloses, teaches, and suggests use of Spinello1’s and Spinello2’s threaded drive mechanisms. See Herbst, 1:52-56. The proposed modification would improve Herbst’s “Dental Anesthetic and Delivery Injection Unit” (id. at code (54)) by providing a device that “is pleasant and easy to use and which affords the dentist extraordinarily acute tactile response characteristics,” as taught by Spinello1 (Spinello1, 1:53-56). IV. Conclusion We reverse the Examiner’s rejections of claims 2-7, 10, 12-17, and 19, but enter new grounds of rejection of these same claims. Appeal 2021-005093 Application 15/035,220 12 DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed New Ground 2-7, 10, 12-15 103 Herbst, Sano, Cowan, Bruce, Whalley, Kronestedt 2-7, 10, 12-15 16, 17 103 Herbst, Sano, Cowan, Bruce, Whalley, Kronestedt, Patrick 16, 17 19 103 Herbst, Sano, Cowan, Bruce, Whalley, Kronestedt, Ford 19 2-7, 10, 12-15 103 Herbst, Sano, Cowan, Bruce, Whalley, Kronestedt, Spinello1, Spinello2 2-7, 10, 12-15 16, 17 103 Herbst, Sano, Cowan, Bruce, Whalley, Kronestedt, Patrick, Spinello1, Spinello2 16, 17 19 103 Herbst, Sano, Cowan, Bruce, Whalley, Kronestedt, Ford, Spinello1, Spinello2 19 Overall Outcome 2-7, 10, 12-17, 19 2-7, 10, 12-17, 19 TIME PERIOD FOR RESPONSE For the reasons discussed above, we reverse and enter NEW GROUNDS OF REJECTION pursuant to 37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection pursuant to this Appeal 2021-005093 Application 15/035,220 13 paragraph shall not be considered final for judicial review.” Section 41.50(b) also provides that Appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. . . . (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. . . . 37 C.F.R. § 41.50(b)(1)-(2). Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure § 1214.01. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a) (2022). See 37 C.F.R. § 1.136(a)(1)(iv) (2022). REVERSED; 37 C.F.R. § 41.50(b) (2022)