In re Huai-Hung Kao et al; In re Harry Ahdieh (CAFC 2010-1307, 2010-1308, 2010-1309) precedential; Judges Radar, Linn (author), Moore

11/680,432 lived to see another day.

The CAFC knows dope. A reminder why the opium dens are closed - "frequent administration of opioids can result in a variety of side effects, ranging from disturbed sleep to altered mental states."

To overcome the difficulties associated with immediate release formulations, the '432 Application discloses controlled release formulations containing the opioid oxymorphone, and capable of relieving pain for between twelve and twenty-four hours.

The examiner rejected claims 1 and 20 as obvious in view of Patent Cooperation Treaty Publication No. WO 01/08661 to Maloney ("Maloney"), both alone and in combination with United States Patent No. 5,047,248 to Calanchi et al. As is relevant here, the examiner found that, with the exception of the claimed dissolution rate, Maloney disclosed controlled release opioid formulations that taught the recited limitations. The examiner stated that the burden fell on Endo to show why Maloney failed to satisfy the claimed dissolution rate because, in her view, the controlled release system described by Maloney satisfied the other limitations of the claims.

In response, Endo submitted declarations explaining that because Maloney only disclosed a dissolution profile for a controlled release formulation containing oxycodone, an opioid with markedly different bioavailability than oxymorphone, it provided little guidance on the appropriate design of a controlled release oxymorphone formulation. The declarations further explained that controlled release oxymorphone formulations exhibit an unexpected result: Over time the formulations cause multiple peaks in oxymorphone blood concentration, which help prevent patients from building a tolerance to the opioid. Endo also included evidence that Opana® ER, a commercial embodiment of the invention, had experienced significant commercial success. The examiner concluded that the declarations were insufficient to show that Maloney did not suggest the claimed range of dissolution profiles. The examiner also found that the evidence of unexpected results and commercial success offered by Endo was not commensurate with the scope of the claims, because that evidence largely related to Opana® ER and the claims encompassed a large number of other formulations, for which no secondary considerations were shown.

The patent board affirmed the examiner, and found the secondary considerations "not commensurate with the scope of the claims and, therefore, failed to overcome the rejections."

Case law backdrop -

A claimed invention is unpatentable "if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art." 35 U.S.C. § 103(a). Whether an invention is obvious is a question of law based on underlying facts. In re Kotzab, 217 F.3d 1365, 1369 (Fed. Cir. 2000). This court reviews the Board's ultimate determination of obviousness de novo and the Board's fact findings for substantial evidence. In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000). "Substantial evidence is such relevant evidence as a reasonable mind might accept as adequate to support a conclusion." In re Kumar, 418 F.3d 1361, 1366-67 (Fed. Cir. 2005) (quotation omitted).

Endo contended that the Board was smoking its own dope.

Endo contends that the examiner failed to present a prima facie case of obviousness because there is no evidence that substituting oxymorphone for oxycodone in Maloney's Formula 6 would result in a formulation that satisfies the claimed dissolution profile. Endo claims that the Board improperly relied on speculation and hindsight to conclude otherwise.

But first, an interlude of prosecution lapse. Endo failed to "present separate arguments concerning claim 20 to the Board, and that claim 20 therefore stands or falls with claim 1. Endo responds by pointing to various portions of the record where it contends it separately argued the patentability of claim 20."

We agree with the Office that Endo waived the right to have the Board separately consider claim 20. Under 37 C.F.R. § 41.37(c)(1)(vii), "the failure of appellant to separately argue claims which appellant has grouped together shall constitute a waiver of any argument that the Board must consider the patentability of any grouped claim separately." The portions of the record cited by Endo merely mention claim 20 and lack any type of separate, substantive argument concerning the claim as required by 37 C.F.R. § 41.37(c)(1)(vii). See also In re McDaniel, 293 F.3d 1379, 1383 (Fed. Cir. 2002) ("[T]he Board is free to select a single claim from each group of claims subject to a common ground of rejection as representative of all claims in that group and to decide the appeal of that rejection based solely on the selected representative claim" in the absence of a clear statement asserting separate patentability of the claims.).

The panel scolds the patent board for "erroneous reasoning," then remands in the fond hope of less erroneous reasoning.

On the merits, this court agrees with Endo that the Board relied on erroneous reasoning in making the factual determinations that underlie its conclusion that claim 1 is obvious, and that its factual findings are therefore unsupported by substantial evidence. However, because the evidence of record may yet satisfy the required substantial evidence standard, the Board's determination will be vacated and remanded.

The ping-pong of the burden ball -

An examiner bears the initial burden of presenting a prima facie case of obviousness. See In re Glaug, 283 F.3d 1335, 1338 (Fed. Cir. 2002). Once the examiner establishes a prima facie case of obviousness, the burden shifts to the applicant to rebut that case. "The prima facie case is a procedural tool, and requires that the examiner initially produce evidence sufficient to support a ruling of obviousness; thereafter the burden shifts to the applicant to come forward with evidence or argument in rebuttal." In re Kumar, 418 F.3d at 1366. However, once the applicant has come forward with rebuttal evidence, the examiner must consider the totality of the evidence to determine whether the obviousness rejection should stand. "When rebuttal evidence is provided, the prima facie case dissolves, and the decision is made on the entirety of the evidence." Id.

To cut to the chase, the patent board read the invention into the prior art.

Accepting that it would be obvious to substitute oxymorphone in Maloney's Formula 6, the Board's reasoning nonetheless does not pass the substantial evidence threshold as to whether such a substitution would indeed fall within the dissolution profile of pending claim 1. As an initial matter, it should be clear that it makes no difference, a priori, to the question of obviousness whether the hypothetical person of ordinary skill in the art would have understood the claimed dissolution profile in terms of a Paddle-Method or a Basket-Method test range, just as it would make no difference whether the hypothetical person of skill in the art preferred to think in English or Metric units. The claimed subject matter is not presumed to change as a function of how one elects to measure it. The reason this "correlation" appears to matter on the Board's formulation of the present case is that there is a lack of direct factual support in the record for the view that the claimed range of dissolution rates actually overlaps with the dissolution rate disclosed in Maloney, a premise upon which the Board's reasoning is founded. Thus, while it matters not whether the hypothetical skilled artisan would have appreciated the "correlation" at issue here, it matters greatly whether anything the skilled artisan would be prompted by the prior art to do is in fact within the scope of the pending claim.

The Board's own conjecture does not supply the requisite substantial evidence to support the rejections, i.e., "such evidence as a reasonable mind might accept as adequate to support a conclusion." Consol. Edison Co. v. Nat'l Labor Relations Bd., 305 U.S. 197, 229 (1938). For these reasons, the Board's reliance on its own conjecture regarding whether a direct substitution of oxymorphone in Formula 6 would satisfy the claimed range of dissolution rates is improper.

While the Board did not base its factual conclusions regarding the correlation of the two ranges on substantial evidence, the importance, or lack thereof, of the claimed range to the alleged nonobviousness of the invention is a question we leave for the Board to consider on remand. See, e.g., Ormco Corp. v. Align Technology, Inc., 463 F.3d 1299, 1311 (Fed. Cir. 2006) (explaining that overlap between claimed range and prior art gives rise to a presumption of obviousness; where claimed range and prior art value are insubstantially different, prima facie obviousness rejection is proper).

The Board's decision is vacated and remanded so that the Board can consider whether, under the proper analysis, the evidence of record is sufficient to maintain an obviousness rejection. As the Supreme Court has explained:

When there is. . . market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.

KSR Intern. Co. v. Teleflex Inc., 550 U.S. 398, 402-403 (2007). Thus, while the Board should neither rely upon conclusory reasoning nor its own conjecture in assessing the weight of evidence, the Board may, or may not, still find that the evidence supports the examiner's rejection.

The weighting of secondary considerations remains vague.

To start, when secondary considerations are present, though they are not always dispositive, it is error not to consider them. See Stratoflex v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir. 1983) ("[E]vidence rising out of the so-called 'secondary considerations' must always when present be considered en route to a determination of obviousness."); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372 (Fed. Cir. 2007) ("Although secondary considerations must be taken into account, they do not necessarily control the obviousness conclusion.").

Evidence of secondary considerations must be reasonably commensurate with the scope of the claims. See In re Tiffin, 448 F.2d 791, 792 (CCPA 1971); In re Hiniker, 150 F.3d 1362, 1369 (Fed. Cir. 1998). This does not mean that an applicant is required to test every embodiment within the scope of his or her claims. If an applicant demonstrates that an embodiment has an unexpected result and provides an adequate basis to support the conclusion that other embodiments falling within the claim will behave in the same manner, this will generally establish that the evidence is commensurate with scope of the claims. See In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978) (concluding that evidence of secondary considerations was not commensurate with the scope of the claims where that evidence related to a single compound and there was no adequate basis to conclude that other compounds included within the scope of the claims would exhibit the same behavior); In re Cescon, 474 F.2d 1331, 1334 (CCPA 1973) (concluding that, although not every compound within the scope of the claims was tested, the evidence of secondary considerations was sufficient where evidence showed a correlation and there was no factual basis to expect the compounds to behave differently in different environments).

Whether the claimed invention was a "nexus of success" matters greatly.

But there is a more fundamental requirement that must be met before secondary considerations can carry the day. "For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention." Wyers v. Master Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010) (quotation omitted). Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention. Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 (Fed. Cir. 2011) ("If commercial success is due to an element in the prior art, no nexus exists."); Ormco Corp., 463 F.3d at 1312 ("[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent."); In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) ("The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims . . . . [and] in such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." (citations omitted)).

What can be expected in arguing unexpected results is that the BPAI will ignore evidence to patentability if it can.

Because the Board ignored the evidence of record and relied instead upon its own conjecture, its treatment of Endo's argument regarding unexpected results was improper.

The Board also discounted Endo's evidence of commercial success of Opana® ER on the grounds that it was not commensurate with the scope of the claims. But an applicant "need not sell every conceivable embodiment of the claims in order to rely upon evidence of commercial success, so long as what was sold was within the scope of the claims." In re DBC, 545 F.3d 1373, 1384 (Fed. Cir. 2008). See also Applied Materials, Inc. v. Advanced Semiconductor Materials Am. Inc., 98 F.3d 1563, 1570 (Fed. Cir. 1996) ("[A] patentee need not show that all possible embodiments within the claims were successfully commercialized in order to rely on the success in the marketplace of the embodiment that was commercialized."). As this court recently explained, "[i]t seems unlikely that a company would sell a product containing multiple, redundant embodiments of the patented invention . . . . Under the [Office's] logic, there would never be commercial success evidence for a claim that covers more than one embodiment." In re Glatt Air Techniques, Inc., 630 F.3d. 1026, 1030 (Fed. Cir 2011). The Board's refusal to credit the applicant's evidence of commercial success because it was not proven across the entire claimed range of dissolution rates was improper.

Nonetheless, the record is nearly silent on whether the commercial success was caused by the merits of the invention as distinct from the prior art. In short, if it is not established that the claimed and novel range for a controlled release oxymorphone formulation causes commercial success where the prior art range would not, then it will be difficult to show the required nexus. Applicants' expert opined that the unexpected in vivo concentration was likely responsible for the commercial success of the embodying product. Applicants' expert further opined that the amelioration of analgesic tolerance to which Applicants attribute commercial success "is precisely the practical impact [he] would expect from the biphasic and triphasic pK behavior" of the commercial embodiment. But if the same behavior would be observed in any oxymorphone controlled release formulation, then there is no necessary nexus between the commercial success and the claimed formulation. On remand, the Board, in considering the commercial success argument, should make a factual determination as to whether the commercial success of the embodying product resulted from the merits of the claimed invention as opposed to the prior art or other extrinsic factors.

Vacated and remanded as to the '432 application. The other two applications affirmed obvious.