The Dolcera Blog

Professors Mark Lemley, Chris Cotropia, and Bhaven Sampat recently released a draft of their new article titled “Do Applicant Patent Citations Matter? Implications for the Presumption of Validity.” [Download Here.]

For the article, the trio analyzed the file histories of 1,500+ utility patents issued in 2007 and compared references used in office action rejections with the list of references cited on the patent cover-pages.  The objective was to figure-out the role of applicant-cited prior-art in the examination process.

Findings: Patent examiners rarely rely on applicant-submitted prior-art when making rejections.  Only 13% of the prior art used in office action rejections was applicant-submitted (despite the fact that 74% of cited references are applicant-submitted). Generally, the study found that examiners “effectively ignored” applicant-submitted prior art regardless of how few or how many references were cited; regardless of the timing of the IDS filing; and regardless of whether the submission included an EPO search reports identifying the references as “X-references.”

Implications: The authors suggest several implications of their findings: (1) That it likely does not make sense to find inequitable conduct when an applicant withholds prior art (since the art would not have been used in a rejection anyway); (2) That the presumption of validity associated with patents may be too strong; and (3) That studies based on patent citations likely lack merit.
There are several rational reasons for examiners to cite their own prior art. Because of the backlog, PCTs, and provisional applications, US examination often begins several years after the application was originally filed.  During that interim, many references become available that were not known at filing.  Thus, it is not surprising that applicants rarely cite 102(e) prior art, but examiners cite loads of it.  There is some reason to think that this “newer” prior art is probably better because of technological developments.  It may also be true that the applicant and examiner references are cited for different purposes — namely, applicants cite references that are generally relevant to the invention while examiners are looking for references that teach each particular element in the filed claims.  A third issue is that applicants tend to modify their claims during prosecution. That modification may make their originally cited art less relevant.

Conclusion: Most of the applicant cited references are ignored by the examiners. So, dont really trust on the citations.

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Test of enablement - “Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.”  Source
I have always considered the CAFC judgments as one of the best repository to learn intellectual property. I happened to come across a very interesting case.
Janssen Enablement Alzheimers (pdf) - This case (relating to US Patent No. 4,663,318) goes to prove the necessity of writing very detailed specifications backed with strong experimental data for claims to be upheld in the court of law. In this case, Janssen claimed use of a certain drug ‘galanthamine’ for treating Alzheimers. At the time of submitting the patent for review, the inventor who later on licensed the granted patent to Jansen, did not have sufficient experimental data proving direct probable linkage to use of galanthamine for Alzheimers treatment. USPTO examiner also cited this point, yet issued the patent (this part is weird). Eventually, the claims of this patent were held invalid due to an ‘enablement’ clause - in simple terms, enablement here means the specification did not directly support the claims of the inventor.
The discussions were also adverting to the utility requirement which prevents mere ideas from being patented. As noted in Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997), “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.
Being an inventor myself, this case intrigues me that if we find a novel use for a patented compound, we can get a patent for it. From a business perspective, I feel that it would be prudent that pharmaceutical firms keep track of formulation patents/method of use patents filed by competitors over its own molecule portfolio. This is on the assumption that the competitors are trying to find novel uses of a compound patented by the inventing pharmaceutical firm. If successful, the competition would need to pay royalties to the patent holder of the novel compound (assuming the patent holder is willing to license it on fair terms).
For the patent searching fraternity, the hypothesis of determining patent quality based on disclosed experimental data is quite sound. However, it becomes difficult to retrieve if the experimental data paragraphs are added during the later stages of patent prosecution. The US PAIR information workaround to access the office actions will be of little help especially if the number of patents to be examined is large.

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*IFI Patent Intelligence Analysis of 2008’s Top U.S.-Patent Recipients Suggests America May be Losing Dominance
*Companies Outside the U.S. Tip Scales to 51 Percent Share of New Patents
*Total Patent Grants Up Slightly Over Last Year with IBM Setting an All-Time High;Broadcom, Cisco, Fujifilm, Hon Hai, LG Phillips LCD, Microsoft, and Samsung Also Post Greatest Gains in the Top 35, All Up By More Than 20 Percent
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