Revisiting KSR: “A person of ordinary skill is also a person of ordinary creativity, not an automaton.”
| June 29, 2021
Becton, Dickinson and Company v. Baxter Corporation Englewood
Decided on May 28, 2021
Prost*, Clevenger, and Dyk. Court opinion by Dyk. (*Sharon Prost vacated the position of Chief Judge on May 21, 2021, and Kimberly A. Moore assumed the position of Chief Judge on May 22, 2021.)
Summary
On appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in an inter partes review, the Federal Circuit unanimously revered the Board’s conclusion of non-obviousness of an asserted patent, directed to a “method for performing telepharmacy,” and a “system for preparing and managing patient-specific dose orders that have been entered into a first system.” The Federal Circuit stated that, in analysis of obviousness, a person of ordinary skill would also consider a source other than cited prior art references, and established that cancellation of all the claims of a patent does not affect the status of the patent as pre-AIA Section 102(e)(2) reference.
Details
I. Background
Becton, Dickinson and Company (“Becton”) petitioned for inter partes review of claims 1– 13 and 22 of U.S. Patent No. 8,554,579 (“the ’579 patent”), owned by Baxter Corporation Englewood (“Baxter”).
Becton asserted invalidity of the challenged claims primarily based on three prior art references: U.S. Patent No. 8,374,887 (“Alexander”), U.S. Patent No. 6,581,798 (“Liff”), and U.S. Patent Publication No. 2005/0080651 (“Morrison”).
Claims 1 and 8 are illustrative of the ’579 patent, as agreed by the parties. Claim 1 is directed to a “method for performing telepharmacy,” and claim 8 is directed to a “system for preparing and managing patient-specific dose orders that have been entered into a first system.”
There are two contested limitations on appeal: the “verification” limitation in claim 8, and the “highlighting” limitation in claims 1 and 8. Claim 8 recites three elements, an order processing server, a dose preparation station, and a display. The relevant portion of the dose preparation station in claim 8, containing both limitations, reads:
8. A system for preparing and managing patient-specific dose orders that have been entered into a first system, comprising:
a dose preparation station for preparing a plurality of doses based on received dose orders, the dose preparation station being in bi-directional communication with the order processing server and having an interface for providing an operator with a protocol associated with each received drug order and specifying a set of drug preparation steps to fill the drug order, the dose preparation station including an interactive screen that includes prompts that can be highlighted by an operator to receive additional information relative to one particular step and includes areas for entering an input;
. . . and wherein each of the steps must be verified as being properly completed before the operator can continue with the other steps of drug preparation process, the captured image displaying a result of a discrete isolated event performed in accordance with one drug preparation step, wherein verifying the steps includes reviewing all of the discrete images in the data record . . . .
The Patent Trial and Appeal Board (“Board”) determined that asserted claims were not invalid as obvious. While the Board found that Becton had established that one of ordinary skill in the art would have been motivated to combine Alexander and Liff, as well as Alexander, Liff, and Morrison, and that Baxter’s evidence of secondary considerations was weak, the Board nevertheless determined that Alexander did not teach or render obvious the verification limitation and that combinations of Alexander, Liff, and Morrison did not teach or render obvious the highlighting limitation.
Becton appealed.
II. The Federal Circuit
The Federal Circuit (“the Court”) unanimously revered the Board’s conclusion of non-obviousness because the determination regarding the verification and highlighting limitations is not supported by substantial evidence.
(i) The Verification Limitation
Alexander discloses in a relevant part: “[I]n some embodiments, a remote pharmacist may supervise pharmacy work as it is being performed. For example, in one embodiment, a remote pharmacist may verify each step as it is performed and may provide an indication to a non-pharmacist per- forming the pharmacy that the step was performed correctly. In such an example, the remote pharmacist may provide verification feedback via the same collaboration software, or via another method, such as by telephone.” Alexander, col. 9 ll. 47–54 (emphasis added).
Relying on the above-cited portion of Alexander, the Board found persuasive Baxter’s argument that Alexander “only discusses that ‘a remote pharmacist may verify each step’; not that the remote pharmacist must verify each and every step before the operator is allowed to proceed” (emphasis added).
The Court concluded that the Board’s determination that Alexander does not teach the verification limitation is not supported by substantial evidence because, among other things, the Court found it quite clear that “[i]n the context of Alexander, “may” does not mean “occasionally,” but rather that one “may” choose to systematically check each step.”
(ii) The Highlighting Limitation
Becton did not argue that Liff “directly discloses highlighting to receive additional language about a drug preparation step.” Instead, Becton argued that “Liff discloses basic computer functionality—i.e., using prompts that can be highlighted by the operator to receive additional information—that would render the highlighting limitation obvious when applied in combination with other references,” primarily Alexander.
In support of petition for inter partes review, Dr. Young testified in his declaration that Liff “teaches that the user can highlight various inputs and information displayed on the screen, as illustrated in Figure 14F.”
The Board found that Liff taught “highlight[ing] patient characteristics when dispensing a prepackaged medication.” Baxter did not contend that this aspect of the Board’s decision was erroneous.
Nevertheless, while finding that “this present[ed] a close case,” the Board determined, that “Dr. Young fail[ed] to explain why Liff’s teaching to highlight patient characteristics when dispensing a prepackaged medication would lead one of ordinary skill to highlight prompts in a drug formulation context to receive additional information relative to one particular step in that process, or even what additional information might be relevant.” In addition, the Board found that Becton’s arguments with respect to Morrison did not address the deficiency in its position based on Alexander and Liff.
In contrast, citing KSR (“[a] person of ordinary skill is also a person of ordinary creativity, not an automaton”), the Court concluded that the Board erred in looking to Liff as the only source a person of ordinary skill would consider for what “additional information might be relevant.” The Court reached an opposite conclusion by citing following Dr. Young’s testimony:
“[a] person of ordinary skill in the art would have understood that additional information could be displayed on the tabs taught by Liff” and that “such information could have included the text of the order itself, information relating to who or how the order should be prepared, or where the or- der should be dispensed.”
“[a] medication dose order for compounding a pharmaceutical would have been accompanied by directions for how the dose should be prepared, including step-by-step directions for preparing the dose.”
(iii) An Alternative Ground
As an alternative ground to affirm the Board’s determination of non-obviousness, Baxter argues that the Board erred in determining that Alexander is prior art under 35 U.S.C. § 102(e)(2) (pre-AIA).
It is undisputed that the filing date of the application for Alexander is February 11, 2005, which is before the earliest filing date of the application for the ’579 patent, October 13, 2008; that the Alexander claims were granted; and that the application for Alexander was filed by another.
However, based on the fact that all claims in Alexander (granted on February 12, 2013) were cancelled on February 15, 2018, following inter partes review, Baxter argued that “because the Alexander ‘grant’ had been revoked, it can no longer qualify as a patent ‘granted’ as required for prior art status under Section 102(e)(2).”
The Court rejected Baxter’s argument because “[t]he text of the statute requires only that the patent be “granted,” meaning the “grant[]” has occurred. 35 U.S.C. § 102(e)(2) (pre-AIA)” and “[t]he statute [thus] does not require that the patent be currently valid.”
(iv) Secondary Considerations
The Court rejected Baxter’s argument because “Baxter does not meaningfully argue that the weak showing of secondary considerations here could overcome the showing of obviousness based on the prior art.”
Takeaway
· In analysis of obviousness, a person of ordinary skill would also consider a source other than cited prior art references (petitioner’s testimony in this case).
· Cancellation of all the claims of a patent does not affect the status of the patent as pre-AIA Section 102(e)(2) reference.
