Details:
Ex parte Boucherie
Appeal 2010002109; Appl. 10/530,351; Tech. Center 1700
Decided May 2, 2011
The application on appeal related to a method for manufacturing plungers for medical syringes.
1. Method for manufacturing plungers for medical syringes,
said plunger comprising at least two parts including a longitudinal plunger body made of plastic and a piston body provided at a front end of the plunger body,
which piston body comprises a plastic which is softer than the plastic of the plunger body,
wherein said plunger, or at least a part of the plunger, is formed by first manufacturing the piston body and then the plunger body, or at least a part of the plunger body, by means of injection moulding, and
wherein the plunger body, or said part of the plunger body, is injected against the piston body,
said piston body having a front side and a side wall and being formed such that the front side and side wall thereof are free of any flash lines and/or gate points for the plastic.
(Emphasis added.)
The term "flash lines," also known as flashing, refers to the excess bits of plastic produced by the molding process. As explained in the specification, this excess plastic is especially undesirable for a medical syringe, since the material "may come off and thus end up in the reservoir of the syringe, and thus also in the medical liquid to be injected."
The Examiner rejected the independent claims as being anticipated by various references. One of the references was a Japanese patent publication, Chiba, which disclosed a method of manufacturing a syringe. The Examiner asserted that manufactured syringe was shown in Fig. 1 of Chiba as having no flash lines or gate points and thus met the claim limitation highlighted above.
On the final rejection, the Applicant appealed and argued (inter alia) the claim limitation highlighted above. In the Appeal Brief, the Applicant distinguished Chiba as follows:
As can be seen in Figs. 2(a)-(c) of the Chiba publication, the front side and the sidewalls of the gasket 6 include a gate point for the thermoplastic elastomer and flash lines, respectively. For clarification, the flash lines are formed on the side wall of the gasket 6 along the split between the molds 21a, 21b. This is due to the fact that some of the thermoplastic elastomer material injected to form the gasket 6 will fill in the gaps defined by the split between the two mold parts 21a, 21b, no matter how small the gaps are.In the annotated Fig. 2(c) below, the flash lines are drawn in red.
In the Answer, the Examiner explained that the manufactured product in Fig. 1 was relied on for teaching the contested limitation:
Figure 1 of Chiba clearly shows a gasket 6 (i.e. piston body) that is free from any flash lines and/or gate points for the plastic. Although Figures 2(a)-2(c) show a gasket 6 (i.e. piston body) having a gate point, this gate point is removed to the extent that the resulting gasket, shown in Figure 1, is free from any flash lines or gate points. Note that the claim does not require the piston to be free of any flash lines and/or gate points as it exits the die, for example, but the claim only requires the piston being free from flash lines and/or gate points. It is therefore interpreted that as long as the final form of the molded gasket 6 (i.e. piston body) is free from flash lines and/or gate points, Chiba's gasket 6, as shown in Figure 1, meets the claimed limitation. The claim does not preclude a finishing step that would remove any flash lines or gate points resulting from the molding process.The Applicant filed a Reply Brief to contest these findings. First, the Applicant repeated the explanation of how the manufacturing process discussed in the text of Chiba and illustrated in Figs. 2(a) - (c) of Chiba would produce flash lines and gate points. The Applicant then explained why it was inappropriate to rely on the final product shown in Chiba's Fig. 1 for the claimed process limitation:
(Emphasis added.)
While the flash lines and the gate point for the plastic may not actually appear to be shown in Fig. 1, this may be for a number of reasons that do not involve the steps according to the method as recited in claim 1. In particular, since the drawing of Fig. 1 is shown as a cross-sectional view, if the view is taken along any plane other than the plane that contains the flash lines, the flash lines would not appear in the drawing of Fig. 1. Alternatively, even if the cross-sectional view is taken along the plane that contains the flash lines, since there is a necessary compression of the gasket 6 at the interface between the gasket 6 and the walls 4a of the outer case 4 to ensure sealing therebetween, such flash lines would also be compressed, and not necessarily visible in the drawing of Fig. 1.
The Reply Brief also explained that while finishing steps in general were not excluded by the claim, those that eliminated flash lines and gate points were excluded, by the "formed free of" limitation:
While the examiner's answer is correct in that pending claim 1 does not preclude any finishing steps, such a finishing step to remove any flash lines and/or gate points for the plastic is unnecessary in the method of pending claim 1, which requires that the front wall and side wall of the piston body are formed free of any flash lines and/or gate points for the plastic at the injection molding step.
(Emphasis added.)
The Board agreed with the Applicant and reversed the Chiba anticipation rejection:
We are in agreement with Appellant that the Examiner’s findings are insufficient to establish that Chiba inherently performs a step to remove the flash lines and gate point created in the disclosed molding process. As explained by Appellant, there are a number of reasons why the flash lines and gate point formed in the gasket during the Fig. 2(a)-(c) molding process might not be illustrated in the syringe shown in Fig. 1, though actually present in the final molded product. (Rep. Br.10 5-7.)
My two cents: Right result, and an example of good advocacy. The Applicant didn't just say that the Examiner was wrong, but explained why. And every time the Examiner provided more information about what he was thinking, the Applicant explained in even more detail why this was wrong. Perhaps the Board would have looked at the facts and decided for the Applicant anyway – but the Applicants arguments made it easy for the Board to reach that result.
The Examiner's mistake in thinking that the reference anticipated because the claim didn't exclude a finishing step is a common one. Yes, it's true that the transition term "comprising" allows additional steps. But not one that is excluded by other claim limitations, which is the case here: "said piston body ... being formed such that the front side and side wall thereof are free of any flash lines and/or gate points for the plastic." As the Federal Circuit so aptly put it, " '[c]omprising' is not a weasel word with which to abrogate claim limitations." (Dippin' Dots, Inc. v. Mosey, 476 F.3d 1337, 1343 (Fed.Cir.2007).)