Takeaway: Claims to a cleaning solution excluding an oxidizing agent were rejected as obvious in view of a kit of prepackaged components for later mixing with the excluded oxidizer. On appeal, the Applicant argued that any "solution" prepared from the kit disclosed in the reference necessarily includes an oxidizing reagent because there was "no suggestion to alter the essential order of addition of its reagents, which requires mixing the oxidizing agent and the surfactant as an initial step." After performing claim construction, the Board relied on a different kit, also disclosed in the reference, to find the solution obvious. The Board noted that the Applicant and Durmowicz both contemplate mixing a oxidizing agent solution with another solution that omits the agent, producing a final solution. Thus, Durmowicz's solution [made from the components in the second kit] "reasonably renders the solution of claim 59 obvious when formulated in the first tube that will later be mixed with a second tube containing the nucleic acid deactivating agent." (Ex parte Nelson, PTAB 2015.)
Ex parte Nelson
Appeal 2013002307; Appl. No. 11/073,085; Tech. Center 1600
Decided: October 26, 2015
The technology on appeal involved nucleic-acid probes, used to test a biological sample for the presence of particular microorganisms. The claims on appeal were directed to cleaning agents used to avoid contamination during the testing.
A representative claim on appeal recited:
59. A homogeneous solution for use in preventing nucleic acids from acting as templates in an amplification reaction when the solution is combined with a nucleic acid deactivating agent,Early in prosecution, the Examiner rejected the claims as anticipated by Durmowicz, relying on a discussion of agents that are pre-packaged as separate components, then mixed before use. The Applicant disputed the Examiner's reading of Durmowicz and specifically argued that Durmowicz's kit of prepackaged agents did not include a solubilizer as claimed:
the solution consisting essentially of
a corrosion-inhibiting agent, a wetting agent, and a solubilizing agent,
each of the agents remaining substantially in solution at 22°C,
[functional limitations related to agents],
wherein the solution does not include a nucleic acid deactivating agent.
In sum, [Durmowicz] requires the inclusion and presence of a nucleic acid oxiding agent in all contemplated embodiments (including kits), whether they are intermediate or final embodiments. In other words, at no point (even transiently) does Durmowicz contemplate a solution containing combined starting materials (e.g., surfactant + builders + solvents), but excluding a nucleic acid oxiding agent.
Examiner recognizes that the cited art Durmowicz et al. teaches the components of the solution recited in instant claims along with many other choices. Furthermore the cited art does not recite a single composition containing all the recited components in one place, hence an obviousness rejection over the cited art is also being made.As a rationale for omitting the deactivator, the Examiner relied on the (allegedly) common biochemical practice of preparing one solution with a oxidizer and a separate solution without, and then mixing the two shortly before use, because oxidizing agents become less active in storage. Finally, the Examiner asserted "a reasonable expectation that the resulting composition where oxidizing agent was freshly added prior to use would be very effective in deactivating nucleic acid from surfaces."
... Durmowicz et al. does not teach a specific composition consisting essentially of the all recited components. It would have been prima facie obvious to one of ordinary skill in the art to make a solution containing [the three agents as claimed] wherein the solution does not include a nucleic acid deactivating agent.
The Applicant responded by arguing that even Durmowicz's kit of prepackaged agents did not suggest the claimed solution, because Durmowicz required the presence of a nucleic acid deactivating agent in each of its solutions.
When the Examiner maintained the obviousness rejection, the Applicant appealed. The Applicant argued the Examiner had not provided sufficient evidence:
The Examiner appears to suggest that although Durmowicz fails to teach the claimed solutions, the Durmowicz teaching to prepare solutions shortly before use explicitly guides one of skill in the art to the claimed solutions. [However, this] conclusion is solely the opinion of the Examiner, with no support in the cited art. For example, no art beyond the Durmowicz reference is relied upon by the Examiner (1) for the above proposition, and (2) for the proof of what one of skill in the art was purported to know or how they would practice at the relevant time.In addition to this attack on the Examiner's prima facie case, the Applicant also argued on the merits. Specifically, the Applicant reiterated that Durmowicz did not disclose a solution without a deactivating agent:
Thus, contrary to the limitations of the present claims, Durmowicz requires the presence of a nucleic acid deactivating agent in each of its solutions. Stated differently, no homogeneous solutions (i.e., multi-component homogeneous solutions, as required in the pending claims) are taught or suggested by Durmowicz that lack a nucleic acid deactivating agent.The Applicant went on to explain the difference between the claimed homogeneous solution and Durmowicz's kit of separate components:
Importantly, these pre-packaged reagents are not identified as, nor are they, "solutions" comprising multiple agents such as the homogenous solutions of the present claims. Rather, para. 52 of Durmowicz discloses separately packaging each reagent of the future "solution" that is to be made. In other words, although Durmowicz discusses separately packaging the "surfactant" agent and the "oxidizing" agent, these individually packaged agents are not the ultimate "solution," as that term is used in the present claims. Moreover, the Durmowicz disclosure provides no suggestion to alter the essential order of addition of its reagents, which requires mixing the oxidizing agent and the surfactant as an initial step. Accordingly, any "solution" prepared according to the Durmowicz kit disclosure includes an oxidizing reagent.The Applicant next questioned the benefit proffered by the Examiner as a reason to separate the oxidizer from the other components:
Durmowicz, therefore, contemplates prepackaging in order to facilitate dissolution of its ingredients, and not to avoid a purported rapid decrease in activity of solutions containing oxidizing agent. As such, the basis for this proposition of the Examiner is lacking in the cited art.Finally, the Applicant made an unexpected results argument:
In fact, those of skill in the art would have expected particulate formation if a corrosion inhibiting agent, wetting agent, and solubilizing agent were combined in the absence of an oxidizing agent. For example, as indicated in the present specification at para. 16, it was the present inventors who discovered that the components of the claimed solution could be combined in the absence of the nucleic acid deactivating reagent without forming a precipitate or an otherwise non-homogenous solution.
The Examiner's Answer repeated the earlier explanation about how and why a POSITA would take Durmowicz' separate components and mix them together before use to obtain the claimed solution:
Hence in biochemical arts to ensure optimal activity each time the solution containing oxidizing agent is used, one practice is to prepare two separate solutions, a solution (1) containing all the remaining components which is stable for longer period of time and the oxidizing agent is kept separate either as powder or another solution (2) which is freshly reconstituted if powder form is used then the solution (2) is mixed with solution (1) shortly before use.The Applicant filed a Reply Brief, but it was denied entry because it included amendments to the claims.
The Board affirmed the obviousness rejection. As discussed above, the Brief had argued that each of Durmowicz's agents was separately packaged for later combination into a future solution, and these individually packaged agents were not the ultimate claimed solution. The Board viewed the teachings of Durmowicz differently.
The Board pointed out that Durmowicz taught two kits. One kit included "appropriate amounts of surfactant and oxidizing agent in separate containers for mixing prior to application." Another kit included "surfactant and organic builder salts such as phosphates or bicarbonates in one tube and the oxidizing (i.e. nucleic acid deactivating agent) in another tube." Moreover, the Board found (as a matter of claim construction) that Durmowicz's builder salts corresponded to the claimed "corrosion-inhibiting agents." The Appeal Brief discussed the first kit but not the second.
The Board concluded the properly construed claim was obvious in view of the second kit and a separate teaching about solvents:
[The second kit] solution with surfactant, organic builder salts such as phosphates and bicarbonates (Finding of Fact 7) and optionally organic solvents such as isopropanol (Finding of Fact 11) reasonably renders the solution of claim 59 obvious when formulated in the first tube that will later be mixed with a second tube containing the nucleic acid deactivating agent (FF 6).The Board dismissed the Appeal Brief discussion of unexpected results (homogeneous solution rather than particulates) because the Applicant did not offer evidence. "Appellants do not identify any teaching in Durmowicz suggesting that the combination of components necessarily results in particulate formation, and indeed, Durmowicz teaches "a non-particulate solution" (see Durmowicz , para. 53).
My two cents: The outcome might have been different if the Applicant had been more proactive and addressed all of Durmowicz's teachings about the kit. It's true the Examiner relied exclusively on general teachings about a kit in para. 52. However paras. 53 and 54 contained more details about first and second kits, respectively, and the Board found that the second kit corresponded to a combination of a corrosion-inhibiting agent, a wetting agent, and a solubilizing agent. The Board found it obvious to combine this later with a deactivator.
I see the Board's affirmance as a new ground of rejection. MPEP 12707 says it's a new ground to "rel[y] on a different portion of a reference which goes beyond the scope of the portion that was previously relied upon" but not a new ground when "citing a different portion of a reference to elaborate upon that which has been cited previously." Relying on a different kit of reagents is "going beyond previously relied upon" than "elaborating on previously relied upon." So if the Applicant filed a Request for Rehearing asking the PTAB to designate a New Ground of Rejection, the law is on the Applicant's side. (That said, I don't think the Board actually grants many of these Requests, and the Federal Circuit has corrected the Board a number of times in the past few years on the subject of New Grounds.)
The way I see it, designation of a New Ground would still be a pyrrhic victory. A New Ground of Rejection in an appeal decision allows the Applicant to file post-appeal amendments and/or evidence without paying for an RCE. Which means the Applicant still waited on appeal for all those years only to lose because the PTAB decided to go farther than the Examiner did.
It's true that the law requires the Applicant only to show error in the Examiner's rejection, and not to show patentability over the cited references. Even so, a more proactive Applicant might have accounted for the two paragraphs following the one relied on by the Examiner. Perhaps that would have led to claim amendments rather than appeal.
Claim construction was also an issue in this case, though neither party appreciated it until too late. The Examiner first addressed claim construction in the Answer, and the Applicant in the Reply Brief – though the Reply wasn't entered because it also contained claim amendments. I'll discuss these claim construction issues in a future post.
Finally, it's worth mentioning that when the Examiner added the § 103 rejection for the first time, he also maintained the anticipation rejection – while at the same time acknowledging that the reference didn't describe a single composition with all the components "in one place." The Examiner explained anticipation as follows:
[B]efore the contents of the container with oxidizing agent is mixed with the surfactant solution, the solution clearly lacks an oxidizing agent. This is the rationale because of which Examiner concludes Durmowicz et al. does teach a solution that lacks an oxidizing agent.The Applicant traversed the § 102 rejection on the basis of the Examiner's admission, and the Examiner then withdrew it, before the Applicant appealed.