Alza Corporation v. Mylan Laboratories, Inc., et al.
A Suggestion To Combine Need Not Be Found in the Prior Art Under “Our Non-Rigid ‘Motivation-Suggesting-Teaching’ Test.”
On appeal from the district court, Alza contested the judgment of noninfringement by Mylan and invalidity of claims in Alza’s U.S. Patent No. 6,124,355 (the 355 patent). The CAFC affirmed the judgment in favor of Mylan and found the disputed claims to be obvious in light of three prior art references.
The technology at issue relates to a once-a-day controlled release formulation of the anti-incontinence drug oxybutynin, marketed by Alza as Ditropan XL®. Important to the analysis in this opinion, oxybutynin has lipophilic characteristics. Mylan had filed two Abbreviated New Drug Applications (“ANDAs”) for a generic version of the drug, and the litigation arose out of these filings.
The primary issue confronting the CAFC regarding validity of Alza’s claims was whether one of ordinary skill in the art would have been motivated to combine the cited references, which in combination described all the elements of the disputed claims? In particular, Alza argued that there was no motivation to design an oral dosage form capable of releasing oxybutynin over more than an approximately 8-12 hour time course, because such drug would be released in the colon, and one of ordinary skill in the art would not have believed that oxybutynin could be absorbed at that point in the GI tract.
In reaching a conclusion of invalidity based on obviousness, the CAFC relied upon the “motivation-suggesting-teaching” (TSM) test. The TSM test was applied “against the background of the Graham factors” in an attempt “to reach a nonhindsight driven conclusion.” Interestingly (and maybe with KSR v. Teleflex at the forefront of the court’s collective mind), the CAFC stressed the flexibility of the TSM test in stating that such factors can be found implicitly in the prior art.
We do not have a rigid test that requires an actual teaching to combine before concluding that one of ordinary skill in the art would know to combine references. . . . This [flexible] approach has permitted us to continue to address an issue of law not readily amenable to bright-line rules, as we recall and are guided by the wisdom of the Supreme Court in striving for a “practical test of patentability.”
The CAFC also highlighted the history of the test, as related to CCPA holdings that have been ”developed consistent with the Supreme Court’s obviousness jurisprudence as expressed in Graham.”
In light of the above standards, the court relied upon witness testimony and journal references which demonstrated the general predictive utility of lipophilicity in estimating the extent of colonic absorption. Thus, while colonic absorption of oxybutynin was not guaranteed, the evidence was clear and convincing in that a person of ordinary skill in the art would have been motivated to combine the prior art references to make the claimed invention. Thus, the holding of invalidity based on obviousness was affirmed.
JW Note: See also the recent opinion of Ormco Corporation, et al. v. Align Technology, Inc. , also discussing obviousness standards
They Invented What? (No. 15)
U.S. Pat. No. 6,826,983: Light bulb changer.
We claim:
1. A light bulb changer apparatus, comprising: means for immediately detecting a burned out condition in a light bulb; means for automatically removing the burned out bulb upon; and means for automatically replacing the burned burned out bulb with a replacement bulb, wherein the detecting means, removal means, and replacing means occurs automatically in succession without human intervention.
2. The light bulb changer apparatus of claim 1, further comprising: a light fixture.
3. The light bulb changer apparatus of claim 1, wherein the detecting means includes: an optical light sensor.
4. The light bulb changer apparatus of claim 1, wherein the detecting means includes: a power switch.
Wiki Community Patent Review
A “wiki” site is a type of website that allows visitors to easily add, remove, or otherwise edit and change some available content. A famous example of a wiki site is Wikipedia, which I have discussed or used as a resource in previous postings.
Apparently, the wiki concept has now been applied to the wide world of patents. At WikiPatents, the public is allowed to comment on issued patents and (in the future) pending patent applications in a wiki format. This beta site states that WikiPatents was established to provide public patent clarity, and that it presently represents only “the tip of the iceburg” of future development aimed to improve the US patent system. It is hoped by the site’s administrators that Wikipatents will become an indispensable resource for patent Examiners, law firms, future litigants, licensees, potential investors, inventors, and patent owners.
Anyone can join the WikiPatents Community for free and voice concerns, praise, comments, and opinions on any issued patent. Specifically, Wikipatent members have the ability to do the following:
▪ Add prior art, and vote and comment on its relevancy and implications;
▪ Add relevant links and other useful resources;
▪ Promote specific patents by linking them to social news, bookmarking, and networking sites;
▪ Comment and vote on the legal strength and technical merits of patents;
▪ Value patents by calculating market size, market share, and reasonable royalties;
▪ Discuss licensing options;
▪ Add relevant information about the inventor(s) and/or owner(s) of patents;
▪ Comment on the legal strength and technical merits of patents; and
▪ Download free patent PDFs.
So, ok . . . a potential new tool for inventors, practitioners and Examiners to use. More tools is always better, and I hate to jump to any conclusions one way or another. However, I am apprehensive that the quality of a wiki patent review may be questionable, particularly in light of the quality problems known and admitted with Wikipedia. A consensus conclusion is not necessarily the correct conclusion.
Only time will tell, and I’ll try to visit this site over the next several months to see what it offers (and will provide updated posts accordingly).
Ormco Corporation, et al. v. Align Technology, Inc.
Secondary Considerations Only Relevant to Obviousness If There’s a Nexus Between the Claimed Invention and the Secondary Considerations.
Ormco appealed from the judgment of the U.S. District Court (C.D. Cal.) finding claims of Align’s U.S. Patent Nos. 6,554,611 (the 611 patent) and 6,398,548 (the 548 patent) valid and infringed. On appeal, the CAFC reversed and found that all claims at issue are obvious and invalid under 35 U.S.C. Section 103(a).
The technology at issue relates to orthodontic devices for moving teeth from an initial configuration to a final configuration, e.g. retainers. Claim 1 of the 611 patent recites all of the limitations at issue, and is simply stated as follows:
1. A system for repositioning teeth from an initial tooth arrangement to a final tooth arrangement, said system comprising
a plurality of dental incremental position adjustment appliances . . . ; and
instructions which set forth that the patient is to wear the individual appliances in a predetermined order . . . , [and]
a package . . . wherein the appliances are provided in a single package to the patient.
Ormco argued that the orthodontic practices and instructions sheets of one Dr. Truax rendered the Align patent claims obvious. Align argued that the Truax art did not disclose the “single package” or “instructions” limitations of the claims, that the Truax art teaches away from providing all appliance at once, and that the claims were nonobvious in light of certain objective secondary considerations.
The CAFC held that these limitations were not novel or patentable features. Packaging items in a manner most convenient to the purchaser is a well-known practice. Also, statutes and regulations generally require instructions for such medical devices. Thus, the “single package” or “instructions” limitations of the claims did not render the claims nonobvious. The CAFC also found the “teaches away” argument unpersuasive based on its analysis of the express disclosure of the Truax instructions.
In reaching these conclusions, it is worth noting that the CAFC reiterated the “TSM” test for obviousness (presently on the Supreme Court chopping block in KSR v. Teleflex). Additionally, the court articulated the analysis for implicit TSM showings. ”A suggestion, teaching or motivation to combine the relevant prior art teachings does not have to be found explicitly in the prior art, but may be implicit.” “The test for an implicit showing is what the combined teachings, knowledge of one of skill in the art, and the nature of the problem to be solved as a whole would have suggested to one of skill in the art.”
In considering the Graham secondary considerations for rebutting a prima facie case of obviousness, the CAFC also stated that evidence of commercial success or other secondary considerations is only significant if there is a nexus between the claimed invention and the commercial success. Here, even though the Align product was commercially successful, the success was related to other factors such as aesthetics and improved comfort, and not the features claimed novel by Align.
Let’s Talk Rule 56 Compliance.
The filing and prosecution of a patent application in the USPTO requires more than mere compliance with U.S. patent laws. Everyone involved in drafting and prosecuting U.S. patent applications (including every inventor, attorney, and assignee) owes a duty of disclosure to the USPTO, also known as the duty of candor, under the Code of Federal Regulations Rule § 1.56.
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