In re Abbott Diabetes – Prosecution Lessons

by Ryan Alley on October 2, 2012

in +, CAFC PTAB appeals

Case Nos. 2011-1516 (Lourie, Prost, Wallach)

Broadest reasonable interpretations of claim terms during prosecution might not always be so, well, broad. In re Abbott Diabetes Care builds on cases like Suitco Surface in illustrating situations where claim context and specification treatment can mandate a claim interpretation short of the prior art. What makes Abbott especially interesting and useful is that the USPTO’s claim construction was not altogether beyond what prosecutors are accustomed to seeing their claims stretched to, and Abbott’s arguments closely resembled those are routinely dismissed as “importing limitations from the specification.” So there may be lessons and citable material here against an Examiner’s particularly taut claim interpretation.

Abbott DiabetesUS Patents 6,175,752 and 6,565,509, dealing with blood glucose sensors, were ensnared in some ex parte reexamination requests that stayed their litigation. During the reexamination, the Examiner rejected all claims at issue as met by several patent and non-patent references centering around EPO application 0 098 592 to Shichiri and US Patent 5,390,671 to Lord. In applying this prior art, the examiner relied on broad constructions of the following claims:

1. A sensor control unit comprising:
a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor extending out of the skin having a plurality of contact pads;
a plurality of conductive contacts disposed on the housing and configured for coupling to the plurality of contact pads on the electrochemical sensor; and
an rf transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the electrochemical sensor.

Other claims under reexamination added that “the portion of the sensor above the skin is maintained in a substantially fixed position relative to the position of the sensor control unit when the sensor control unit is placed on the skin and receives the proximal end of the sensor transcutaneously positioned.”

The Examiner rejected all these claims by interpreting the recited “electrochemical sensor” as inclusive of wires or cables that connected the sensor to various other components under BRI. The Board affirmed these rejection and denied a rehearing for the same in both patents under reexam. The Board further interpreted the “substantially fixed” term to include only somewhat restrained relative movement between the sensor and control unit, such as a freely-movable control unit on a patient’s wrist tethered to a sensor elsewhere on the body, in the denial for rehearing.

On appeal, Abbott marshaled three arguments against the USPTO’s construction of “electrochemical sensor”:

1) Claim language of “contact pads” that are “coupled to” or “receive[d]” by “conductive contacts” was narrower than language that would require unlimited electrical connection types. This suggested intermediate external wiring was not involved.

2) The specifications of both the ’752 and ’509 patents disparaged external cables and wires between the sensor and external devices, stating that the “size of the sensor guides and presence of cables and wires hinders the convenient use of [the prior art] for everyday applications.”

3) Every disclosed embodiment in the ‘752 and ‘509 specification and figures lacked free external wiring or any discussion of the same.

The Federal Circuit held that these three pieces of evidence constrained the broadest, reasonable interpretation of “electrochemical sensor” to a sensor that used something other than cables or wires to connect to the sensor unit. The court agreed with the first point – the claim language fairly suggested a direct pad/contact connection without wires. But this suggestion alone was likely insufficient to narrow the claim; the panel found the combination of the suggestion and consistency of the specification to be dispositive. In doing so, the court refuted several common bases advanced by the USPTO for a broader construction. The Office argued disparagement of prior art sensors using only wires or cables nonetheless demonstrated that wires and cables fell within the understanding of a sensor. The Office noted that the specification further lacked any explicit redefinition or In re Bigio-required disclaimer of “electrochemical sensor”; instead, the specification discussed a lack of cables or wires only in connection with the control unit, and even there the treatment was ambiguous. But this was not the correct treatment of the specification:

“Although the PTO emphasizes that it was required to give all claims their broadest reasonable construction, . . . this court has instructed that any such construction be consistent with the specification, and that claim language should be read in light of the specification as it would be interpreted by one of ordinary skill in the art.” In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2011) (internal citation and quotation marks omitted). Indeed, “the specification ‘is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.’” Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). Here, the specification contains only disparaging remarks with respect to the external cables and wires of the prior-art sensors: “[t]he size of the sensor guides and presence of cables and wires hinders the convenient use of these devices for everyday applications.” ’752 patent col.1 ll.57-59; ’509 patent col.1 ll.61-63. In fact, the primary purpose of the invention was to provide “a small, compact device that can operate the sensor and provide signals to an analyzer without substantially restricting the movements and activities of the patient.” ’752 patent col.1 ll.60-63; ’509 patent col.1 ll.64-67.

Even more to the point, every embodiment disclosed in the specification shows an electrochemical sensor without external cables or wires. Indeed, the only mention of a sensor with external cables or wires in Abbott’s patents is a single statement addressing the primary deficiency of the prior art. It is true that the specification does not contain an explicit statement disclaiming electrochemical sensors with external cables or wires. But this is not an instance where the specification would necessarily have to disavow an embodiment that would otherwise be covered by the plain language of the claims—rather, claim terms like “coupl[ed]” and “receiv[ed]” are entirely consistent with and even support the specification’s exclusive depiction of an electrochemical sensor without external cables or wires. We have held that “[e]ven when guidance is not provided in explicit definitional format, the specification may define claim terms by implication such that the meaning may be found in or ascertained by a reading of the patent documents.” Irdeto Access, Inc. v. Echostar Satellite Corp., 383 F.3d 1295, 1300 (Fed. Cir. 2004) (internal quotation marks omitted). Here, Abbott’s patents “repeatedly, consistently, and exclusively” depict an electrochemical sensor without external cables or wires while simultaneously disparaging sensors with external cables or wires. Id. at 1303.

To build on the redefinition by implication phenomenon supported by Irdeto Access, the panel revisited some very prominent BRI caselaw. The exegesis strongly suggested that consistent, unfavorable treatment of a particular interpretation of a claim terms in the specification would take that interpretation outside of BRI:

While Abbott’s patents define the electrochemical sensor’s connectivity by implication, the PTO argues that our case law still requires an explicit disclaimer of external cables or wires. But the PTO’s reliance on cases like Amer[i]can Academy of Science and Retractable Technologies is misplaced. Although the patentee in Amer[i]can Academy of Science argued that it had disparaged and therefore disclaimed the use of “multi-user computers such as mainframes” in the background of the invention section of its patent, that same background section and the “specification as whole” actually supported configurations that included multi-user computers. 367 F.3d at 1367. And in Retractable Technologies, the patentee’s supposed disclaimer of “cutting” in the background of the invention was undermined by an embodiment in the specification that indicated that some forms of cutting fell within the scope of the claimed invention. 653 F.3d at 1306. In the case before us, however, nothing suggests or even hints that the claimed electrochemical sensor can include external cables or wires. Instead, Abbott’s patents consistently show the opposite.

Under this reasoning, the discussion of usually no wires or cables only in connection with the control unit was insufficient to raise American Academy of Science- or Retractable Technologies-like inconsistencies in the non-wired treatment of sensors. Because the specification consistently disclosed example embodiment sensors as limited to non-wire-dependent structures and disparaged prior art relying on wires or cables, this confirmed the claim’s suggestion of so limiting the recited sensor. The rejections based on an interpretation of “electrochemical sensor” as including only free, external wires and cables for communication was reversed and remanded for proceedings consistent with an interpretation of “electrochemical sensor” that used non-wired contacts.

The court also reversed and remanded the “substantially fixed” interpretation with very brief analysis. Specifically, the Board’s (re-)interpretation of the term in the denial was simply inconsistent with the specification. The court stated that a control unit freely movable on the arm away from a body-bound sensor was,

not only significantly greater than the movement allowable under the Board’s original construction of “substantially fixed,” it is also greater than the movement described in the specification. Indeed, the embodiments disclosed in the ’509 patent all show the above-skin portion of the electrochemical sensor maintained in a fixed position. Specifically, the specification teaches a “support structure 82” that “hold[s], support[s], and/or guide[s] the sensor 42 into the correct position.” ’509 patent col.34 ll.54-55.

Lessons: Abbott looks like a great case to cite against an Examiner’s broad claim interpretation when 1) the specification explicitly treats the Examiner’s interpretation unfavorably, and 2) disclosed example embodiments and claim language in no way counter this by favorably treating, requiring, or “suggesting” the Examiner’s interpretation. Under the first prong, Abbott makes it clear that absolute disclaimer, redefinition, or disavowal is not required. Although the facts in Abbott involved mere criticism of the prior art, I would think that clear criticism of anything in the specification, regardless if it is prior art, would work. For the second requirement, you probably need claim language that suggests a more limited construction by using terms that are narrower than the broader interpretation, and that “narrower” needs to be in the “direction” of the limited construction (e.g. “pads . . . received by . . . contacts” is narrower than “electrically connected to” in a way that moves away from free-wire/cable-based connections).

Some best practices counsel for never making any negative comments about the prior art or elements not present in the invention; that is, everything is to be stated as an advantage of example embodiments. This practice is borne out of concerns about inequitable conduct in misleading the Office about the nature of the prior art, running afoul of MPEP 608.01(r), and providing the Examiner an “obviousness roadmap” by finding other prior art that also lacks the negative features. While I think this “all advantages” route in application drafting has merit if unsure about the prior art, it probably won’t invoke the limiting rule of Abbott, which seems to require a clear negative/problem statement. It’s a case-by-case situation, but where an invention does recognize and overcome an existing problem in known features that one would never want claim scope coverage over, I see little downside in including a general statement of problems newly recognized in existing features. Abbott adds to the worth of this approach in that it can help turn back a broad claim construction that recaptures the prior art features causing the problems.

I don’t draw any strong lessons from the court’s reversing the interpretation of “substantially fixed.” The opinion is a little conclusory in saying that the asserted prior art wrist attachment interpretation was inconsistent with the specification. I’m not sure if it was because the Board somewhat capriciously adopted that interpretation only in rehearing or because “substantially fixed” is a degree-type limitation that necessarily is more closely tied to the specification for its understanding. Maybe consider a cite to Abbott when faced with a really broad interpretation of a degree-type term that is described much more narrowly in the specification, and let me know how it goes.

Comment: I see this opinion as drawing the “broadest, reasonable interpretation” standard back from its current border, at least in the above-identified specific circumstances of Abbott. To me, the interpretation set down by the Federal Circuit feels closer to a litigation construction. That’s not a huge problem, sometimes the two standards are equivalent. I just observe that Abbott is very likely now prosecution history estopped from ever trying to assert their claims over devices that use sensors with only wired or cabled connections to an outside device. Had this issue in reexamination and case never occurred, however, would a proper claim construction at litigation have also not included the wire/cable interpretation? The answer must be “yes” given BRI never being narrower than litigation constructions, right? Yet I wonder if cases looking at specification implicit redefinition and disclaimer in claim construction would always require a non-wired construction.

Lastly, the ‘752 patent is claimed to for priority by over 100 different child applications. Talk about a fertile application.

Ryan Alley October 2, 2012 at 6:25 pm

Without getting any clerks in trouble, I noted some typos in this opinion as well: the BPAI lower opinion number is wrong in the intro, American is misspelled Amercan, and Irdeto is mispelled Iredeto. Completely, totally unacceptable. ;)

AAA JJ October 3, 2012 at 10:33 am

The BPAI decision, and the denial of the request for rehearing, are prime examples of the monumental ignorance of the law by the APJ’s. Why the Solicitor decided to defend this POS decision is a mystery. The Solicitor should have told the APJ’s to remove their heads from their rectums and go back and decide the case correctly.

Ryan Alley October 3, 2012 at 11:16 am

Thanks for the comment, AAA. I agree that there was some messed up stuff here, especially the Official Notice rejections (which aren’t covered in my post, and which the Solicitor *did* give up on) and the Board’s wavering re-definitions of “substantially fixed.” But on the “electrochemical sensor” issue, I thought the USPTO’s interpretations and arguments were not unreasonable and, moreover, very much in mainstream/typical Office practice. Not saying that’s correct; I just don’t think it was as clear a loser as you presumably do.

AAA JJ October 3, 2012 at 11:43 am

Ryan, the PTO doesn’t have anybody, including in the CRU or on the PTAB or in the Solicitor’s office, who understands BRI, or claim interpretation in general. The primary focus over there is, and despite Mr. Kappos’s best efforts appears to remain, “What do we have to put down on this piece of paper to reject these claims, no matter how unreasonable, or even silly, it is?” The reason for that is simple: there are ZERO consequences for them when they are, like in this case, slapped upside the head by their reviewing court. The examiner who wrote these pitiful rejections is not going to face any consequences over this, and in fact is most likely told every year during review time that he’s doing an “outstanding” quality job, despite the fact that this case more than amply demonstrates that he is woefully ignorant of the law. The APJ’s aren’t going to suffer any consequences. The Fed. Cir. basically told them that they don’t even understand one of the most basic requirements of their job, i.e. claim interpretation under the BRI standard. Think any of them are gonna get demoted? Think any of them are gonna get sent to remedial administrative law classes? I doubt it.

history buff October 4, 2012 at 4:08 pm

The Abbott Diabletes opinion is indeed closer to a litigation (presumed valid) construction than a proper BRI review. Notice that the panel says claim terms may be defined “by implication,” citing Iredeto [sic; Irdeto] Access v. Echostar, which has nothing to do with BRI.

Kip October 6, 2012 at 2:08 pm

1. As a prosecutor who thinks that the BRI rule should be abolished, I love this opinion. Sub silentio, it overrules case law like Bigio that required an express disclaimer for narrower claim scope. And it confirms that such disclaimers can be implicit.
2. But, to be honest, I think that the Board actually got this one right. The CAFC here is using a claim construction standard that is more specification-based than in Thorner v. Sony Computer – and Thorner isn’t even a BRI case (it’s a Phillips/litigation case)!
3. How is this decision consistent with Thorner and overwhelming case law saying that the invention will not be limited to the embodiments in the claim, even a single embodiment?
4. How is this decision consistent with case law saying that claims will not be rewritten to make them valid?
5. How is this decision consistent with case law saying that the U.S. uses a technical peripheral claiming standard, and a not a central “gist of the invention” standard?
6. How are attorneys supposed to know what the hell the scope of the claims is, given all of this inconsistent case law?
7. What’s happening is that more and more postgrant proceedings are getting to the CAFC. These are important patents that the CAFC doesn’t want to invalidate, and the patentee has many big reasons for not amending the claims. So the CAFC is implicitly, and gradually, scaling back the BRI standard for these cases. And that case law will apply to conventional prosecution too.
8. As far as I know, the Supreme Court and Congress have NEVER blessed the BRI standard. The CAFC created it out of thin air in the late 80s. I would like to see the Supreme Court review the BRI rule in view of Markman, considering the notice function of patents etc.

Ryan Alley October 7, 2012 at 11:43 am

Thanks for the thoughtful comment Kip!

I think you’re right that this case is a departure from BRI as typically employed at the Office. I would almost hedge my take-aways here until more cases come out like this or favorably cite Abbott.

history buff October 8, 2012 at 2:18 pm

The CAFC created BRI out of thin air in the late 80′s?

“Here the issue is that of patentability over the prior art cited; the claims before us were not copied from a patent but are original to the applications involved, and we are unable to discern any sound reason why they should not be given the broadest interpretation of which they are reasonably susceptible. In the case of In re Carr, 54 App. D. C. 283, 297 F. 542, 543, the court said: ‘After a patent has issued, and it no longer is possible for the patentee to control the phraseology of his claims, the courts will so interpret them, if possible, as to protect him; but there is no reason as we many times have observed, why an applicant in the Patent Office should not draw his claims to cover his actual invention only. For this reason we have uniformly ruled that claims will be given the broadest interpretation of which they reasonably are susceptible. This rule is a reasonable one, and tends not only to protect the real invention, but to prevent needless litigation after the patent has issued.’”

In re Horton, 54 F.2d 961, 964-65 (CCPA 1932).

Ryan Alley October 8, 2012 at 3:42 pm

Interesting find hb! I hope Kip responds with his thinking on the date.

Kip October 11, 2012 at 1:26 am

HistoryBuff and RyanAlley:

Here is my thinking on this issue: I was wrong!

I thought that the CAFC created the BRI standard in the late 80s, because that is what the CAFC always cites. Cases like In re Morris (97), which cites In re Zletz (89), In re Yamamoto (84), and Burlington v. Quigg (88). Morris is a major BRI case, but does not even mention Horton. In fact, *none* of those cases cite Horton (if my keyword search is right). In fact, the CAFC has never cited Horton, and the last time the CCPA did was in 1962 (In re Sue), after which point it fell off the map (if my Google Scholar searching is accurate).

So I was flat wrong, and that’s why. If I had been writing in a more formal medium (rather than a blog post), I would have done more legal homework and (hopefully) discovered my error before running my mouth.

One last point: even if Horton did create the BRI rule in 1932 at the CCPA, it still remains true that:

1. Neither Congress nor the Supreme Court has blessed it, as far as I can tell
2. Horton is based on the idea that the applicant can amend the claims. But Horton was decided way, way, way before the Festo and RCE/PTA changes that made amendments less attractive to applicants
3. Conversely, Horton is based on the idea that patentees can’t amend their claims, which is less true in the age of reissue, reexam, postgrant, etc.
4. Horton also bases its BRI on the doctrine that patented claims should be interpreted to preserve their validity – a doctrine that the CAFC has eviscerated.

So, my larger criticism of the BRI remains accurate, I think. But thanks for correcting me. I should have said “The CCPA created the BRI rule out of thin air in the 1930s” instead of “the CAFC created the BRI rule out of thin air in the late 80s.”

Kip October 11, 2012 at 11:52 am

Actually, Horton quotes earlier case law. But Google Scholar and the citations don’t go back that far. So I have no idea when the CCPA (or whatever) created the BRI rule. The essentials were created a long, long time ago.

Ryan Alley October 11, 2012 at 4:19 pm

Thanks Kip! If your critiques of BRI are intact despite the doctrine’s creation date, perhaps you should write a more formal paper or essay on the (timeless) problems with BRI…

AAA JJ October 11, 2012 at 5:07 pm

Dawn-Marie Bey wrote a very good article on the problems with BRI. I’m sure you could find it. Not that I wouldn’t want to read Kip’s upcoming paper on the subject. Assuming he’s going to write one.

Kip October 12, 2012 at 10:24 am

I’ve already written a 4 page draft. I think I emailed it to you, Ryan. Gene will be publishing it soon.

6 October 15, 2012 at 7:25 pm

DMB’s paper(lol) on the unreasonableness of the BRI standard.

AAA JJ October 8, 2012 at 4:36 pm

I would like to see the Fed. Cir. revisit this issue, particularly in light of their decision in Philips. Given that text searching is the predominant methodology used by examiners, they need guidance beyond the simple idea that just because a result from their search “matches” some of the terms in the claims the reference(s) is(are) relevant. Terms of art also evolve. What a term meant 5, 10, 20 years ago and what it means at the time of filing may not be the same.

I also dislike the term/euphemism “BRI” because, as somebody (can’t remember who) recently commented, it leaves out the “consistent with…” qualifier, which the examiners simply ignore. I get a lot of responses from examiners to the tune of, “Applicant hasn’t provided an explicit definition, so the examiner is free to make any interpretation that results in rejection of the claims.” Applicants don’t have to provide explicit definitions, lest every application become nothing more than a glossary. The Fed. Cir. needs to give the PTO some guidance and PTO management needs to enforce it.

Ryan Alley October 9, 2012 at 4:14 pm

You and me both AAA.

AAA JJ October 24, 2012 at 12:44 pm

It looks like we may get our wish with the Flo Healthcare case recently decided. Let’s hope the Fed. Cir. doesn’t decide the claim construction issue en banc and announce some silly deference to PTO BUI.

Ryan Alley October 24, 2012 at 6:52 pm

Very interesting stuff. I should do a post on Flo at some point. (I’ve been really behind with work lately and slow to post).

I also see Kip’s paper was published on IPWatchDog on very similar issues. Maybe all this attention will give rise to a more thoughtful review by the CAFC.

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