Small v. Nobel Biocare USA, LLC
| Decision Date | 01 August 2013 |
| Docket Number | 05 Civ. 3225 (NRB),06 Civ. 683 (NRB) |
| Parties | DR. PAULA SMALL, Plaintiff, v. NOBEL BIOCARE USA, LLC and IMPLANT DIRECT MFG. LLC d/b/a IMPLANT DIRECT, LLC, Defendants. |
| Court | U.S. District Court — Southern District of New York |
Plaintiff Dr. Paula Small ("Small") brings these patent infringement actions against defendants Nobel Biocare USA, LLC ("Nobel") and Implant Direct Mfg. LLC, d/b/a Implant Direct, LLC ("Implant Direct"), alleging their products infringed U.S. Patent Nos. 5,580,246 (the "'246 Patent") and RE38,945 (the "'945 Patent" or "reissue patent"). Both patents describe a method to rehabilitate a damaged dental implant and an improved dental implant design to prevent the crown mounted upon the implant from rotating.
Presently before the Court are three motions for summary judgment. With respect to the '246 Patent, Nobel moves for summary judgment on the grounds that an invention embodying the asserted claims was on sale and in public use more than one yearbefore the patent application was filed. With respect to the '945 Patent, Nobel moves for summary judgment asserting the invalidity of the asserted claims on three separate bases: they allegedly fail to comply with the written description requirement, violate the rule against reissue recapture, and anticipate the prior art. Implant Direct joins that motion and moves for summary judgment on non-infringement grounds, arguing that its accused products do not embody all of the asserted claims.
For the reasons set forth herein, we grant Nobel's motion for summary judgment seeking the invalidity of the '246 Patent claims, finding that an invention embodying those claims was in public use more than one year before filing. We further grant Nobel's motion for summary judgment seeking the invalidity of the asserted '945 Patent claims on the ground that the patent lacked an adequate written description of those claims. Alternatively, we conclude that the '945 reissue application did not provide sufficient notice of the asserted claims within the requisite two-year statutory period. Finally, because we invalidate the '945 Patent claims asserted in these actions, we grant Implant Direct's motion for summary judgment due to non-infringement of the '945 Patent as well.
Dental implants are metal screws inserted in a patient's jaw bone to serve as anchors for prosthetic teeth. An oral surgeon typically installs an implant by making an incision in the patient's gum to expose the jaw bone, drilling a hole into the jaw bone, and screwing the implant into the hole so that its "proximal," or top, end sits level to the gum surface. The implant eventually integrates into the patient's jaw bone during a process known as "osseointegration," after which the gum is reopened to expose the implant for placement of the prosthetictooth. The prosthesis, usually a ceramic crown, is then mounted on a component part called an "abutment," which in turn is attached to the implant using a small "abutment screw." These components are shown in the diagram below.
Image materials not available for display.
Dental implants are generally divided into two categories based on the mechanism by which they connect to an abutment. External connection implants have a protruding hexagonal head, or "boss," at their top end. The boss serves two functions: First, it attaches to the wrench or driver used to screw the implant into the patient's jaw bone; and second, it is received in a matching hexagonal socket in the abutment, which is intended to secure the abutment to the implant. (See '945 Patent, Murray Decl. Ex. 3, at 4:54-61, Fig. 2.) The prototypical external connection or "bossed" implant, commonly referred to as the "Branemark-type" implant, is shown in the diagram below.
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'945 Patent Fig. 2
(Brancniark-Type Implant)
By contrast, internal connection implants are designed to receive a projecting feature on the abutment, such that the implant contains a socket or "recess," rather than a boss, at its proximal end. (See Murray Decl. Ex. 4, at 78.) In this way, internal connection implants reverse the features of external connection or bossed implants: instead of the implant having a projection and the abutment a recess, the implant has the recess and the abutment has the projection. An example of an internal connection or "recessed" implant, Nobel's Core-Vent implant, is shown in the diagram below.
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In October 1993, while working at the N.Y.U. College of Dentistry's dental clinic, Small treated a patient whose crown had begun rotating on top of a previously-inserted Branemark-type implant. (Nobel '246 56.1 ¶ 5; Pl. '246 56.1 ¶ 5; see Small Dep., Murray Decl. Ex. 5, at 77:15-17, 78:20-24.) Upon removing the patient's crown, Small observed that the hexagonal boss on the top of the implant had become "stripped," or rounded, thereby diminishing the implant's ability to stabilize the crown and causing it to loosen. (Small Dep., Murray Decl. Ex. 5, at 79:12-17; see '246 Patent, Murray Decl. Ex. 1, at Col. 2:12-28, 35-40.)
To avoid having to remove the implant from the patient's jaw, which would have necessitated a rather brutal procedure by which the implant would have to be drilled out of the bone, Small decided to modify the implant in vivo by drilling "slots," or indentations, into the top of the implant. (Nobel '246 56.1 ¶ 6; Pl. '246 56.1 ¶ 6; Small Dep., Murray Decl. Ex. 5, at 97:3-99:8.) The patient consented to the proposed procedure, but did not fill out any particular waiver beyond the clinic's standard consent form. (Nobel '246 56.1 ¶ 9; Small '246 56.1 ¶ 9; Small Dep., Murray Decl. Ex. 5, at 104:6-10.) No confidentialityrestrictions of any kind were placed upon the patient regarding the implant modification. (Small Dep., Murray Decl. Ex. 5, at 104:11-25, 124:2-10.) Moreover, although the patient paid for the procedure according to the clinic's standard fee-for-services payment structure, the patient did not render payment specifically for the slotted modification. (Nobel '246 56.1 ¶ 10; Small '246 56.1 ¶ 10; Small Dep., Murray Decl. Ex. 5, at 126:6-22.)
While a graduate student assisting the procedure took photographs, Small drilled two slots into the top of the implant's hexagonal boss. She did not measure the depth of the slots.2 (Small '246 56.1 ¶ 6; Small Dep., Murray Decl. Ex. 5, at 101:18-24.) She then made dental impressions of the patient's mouth which she gave to a lab technician, Leonard Marotta,3 who used them to create a custom crown with matching projections that would engage theslots. (Small Dep., Murray Decl. Ex. 5, at 101:25-102:19, 102:20-103:16, 105:1-8, 106:2-12, 118:4-8.)
In November 1993, Small reopened the patient's incision and attached the custom-made crown to the implant. (Id. at 123:11-124:17.) She observed that the modified implant design served its intended purpose, that is, to match the projections in the crown and prevent it from rotating. (Id. at 116:6-12, 19-20, 116:23-117:1.)
Subsequent to the filing of her initial patent application, Small performed similar in vivo modifications on two other previously-inserted Branemark-type implants. (Id. at 131:8-22.) However, she conducted no further testing of the implants' design, nor did she create a prototype of a slotted, bossed implant. (Id. at 163:22-164:1, 204:6-12; see also Marotta Dep., Murray Decl. Ex. 6, at 104:13-15.)
On January 30, 1995, Small filed her first patent application directed to slotted dental implants. ('246 Patent, Murray Decl. Ex. 1.) The initial application disclosed both a method to rehabilitate a damaged implant in a patient's mouth and an improved implant with slots to better resist rotation of the abutment. (Id. at col. 2:55-59.) The 1995 application issued as the '246 Patent on December 3, 1996.
As issued, the '246 Patent discloses no written description or drawings directed to an implant with recesses rather than bosses. Rather, as shown in the example below, its specification describes only implants with bosses, and each of its claims requires an external connection. (Id. at Claims 1-22.)
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Small asserts Claims 11, 14, and 15 of the '246 Patent against Nobel.4 Claim 11, an independent claim, recites:
A dental implant for insertion in the jaw bone of a patient, comprising: an elongated body having a longitudinal axis and a proximal surface generally transverse to said longitudinal axis, said proximal surface is a portion of a radially extending flange on said body, said flange having thickness, a bossextending from said proximal surface, said boss having a transverse face and a non-round cross section as viewed transversely along said axis, and an axial hole in said body, at least one slot penetrating at least one of said proximal surface and said transverse face of said implant and terminating within the thickness of said flange.
(Id. at col. 13:9-18.)
Claims 14 and 15, which depend from Claim 11, require additional features beyond those disclosed above. In particular, Claim 14 describes a dental implant "as in claim 11, wherein said non-round cross section is polygonal." (Id. at col. 13:27-28.) Claim 15 describes an implant "as in claim 11, wherein said axial hole is threaded." (Id. at col. 13:29-30.)
On December 2, 1996, just one day before the '246 Patent issued, Small filed a continuation-in-part application5 (the "1996 application"), which relied in part on the '246 Patent as well as new text and drawings describing additional features. (1996 Appl., Murray...
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