Written Description

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Federal Circuit Affirms Rejection of Broad, Computer-Based ClaimsAs we’ve covered in other summaries, the Federal Circuit continues to define the line between computer-implemented claims that are patent ineligible under 35 U.S.C. § 101 for being directed to an abstract idea with no inventive concept applied to it and eligible claims directed to more than simply an abstract idea. The Federal Circuit’s recent decision in In re: Downing illustrates that broad, vague claims directed to an aspirational idea to be implemented on a computer will continue to be rejected. The decision further illustrates that such claims are also vulnerable to rejections under § 112. Applicants seeking computer-based claims should be mindful that claims addressing a technological problem in a specific, well-defined way remains the best path to avoid these pitfalls.

In Downing, the Federal Circuit affirmed the Patent Trial and Appeal Board’s decision that rejected all pending claims of the application as directed to ineligible subject matter, lacking adequate written description, and indefinite.

The Claims at Issue

The application at issue, No. 12/454,528 related to an allegedly new and improved planning model using electronic spreadsheets. Claim 1 was the only pending independent claim:

  1. A resource planning forecast product operable in a computer and recorded on a non-transitory computer-readable medium for retrieval interlinking non-business or business information relevant to the end user without mandatory reliance on a network or another computer file or Internet access to operate wherein the product is produced by processes of:

(a) designing a diffusion-based proprietary forecasting technique on an Excel computer platform for operation within a resource planning framework to: (1) simplify forecasting initialization with defaults option and exclusion of advanced statistical requirements in forecasting, (2) consider social and technological change, (3) make forecasts of operations and development and strategic plans of 1-5-15 years simultaneously, and (4) provide automatic updates reducing manual operations and storage requirements such that this process taken in combination improves the end user’s ease of operation and assessments;

(b) structuring presentations on the same computer platform by linking display of the forecasted data with features of: (1) additional resource planning applications beyond the typical such as an information resource utility and intangibles, (2) adjacent display of the operations and development and strategic plans’ 1-5-15 year forecasts, and (3) comprehensive print views available simultaneously of forecasted activity reports, resource plans, and yearly performance next 15 years such that this process taken in combination expands the utility of resource planning in the field of forecasting; and

(c) constructing one-time settings for the structure, on the same computer platform, for the capability of accommodating the full extent of resource planning cited and more efficient operation by: (1) fixed display of self-explanatory instructions and definitions, (2) only 4 required settings of initializing diffusion indices, starting calendar date, nonfinancial or financial mode, and the names for activity reports, resource plans, and optional information reports, and (3) optional settings related to goals-objective-missions, allocations, and risk-impact data such that this process taken in combination improves the end users’ ease of use and availability of forecasted resource planning applications;

such that this product’s capabilities and features accommodate the full extent of resource types and resource planning (encompassing the five categories of planning noted) for operation by nontechnical or technical users in one unbundled computer file through end user interaction with displays.

The PTO’s Decision

The examiner rejected all pending claims on three grounds: 1) they were directed to patent-ineligible subject matter, 2) they lacked adequate written description support, and 3) they were indefinite. Specifically, the examiner concluded the claims were directed to the abstract idea of creating an electronic spreadsheet for personal management and did not contain significantly more than that idea as any additional limitations were generic computer elements. The examiner further concluded that the term “intangibles” in the asserted claims lacked adequate written description. The term was not included in the original specification, and the examiner rejected amendments to the specification to describe the term as introducing new matter. Finally, the examiner concluded the claims were indefinite for two reasons: 1) it was unclear what class of invention the claims were directed to and 2) the term “end user” lacked antecedent basis. On appeal, the Board affirmed the examiner’s rejections on all three grounds. Downing then appealed to the Federal Circuit.

The Federal Circuit’s Decision

Beginning with the eligibility rejection, the Federal Circuit applied its standard two-step test from Alice Corp.: 1) whether the claims are directed to a patent-ineligible concept and, if so, 2) whether an element or combination of elements in the claim provides an “inventive concept” that amounts to more than a patent on the ineligible concept itself. At the first step, the Federal Circuit agreed that the claims were directed to the ineligible concepts of personal management, resource planning, or forecasting. The court likened the claims to others related to collecting, analyzing, and displaying information that it previously rejected as directed to abstract ideas and was not persuaded Downing’s reliance on cases such as McRO, Inc. v. Bandai Namco Games Am., Inc., 873 F.3d 1299 (Fed. Cir. 2016), and DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014), in which the court approved the eligibility of claims directed to improvements in computer technology. At step two, the court found no inventive concept as the claims recited only generic computer elements such as a “computer platform” using Excel or a “display.”

Turning to the written description rejection, the Federal Circuit agreed that “intangibles” lacked sufficient written description. The court noted that written description must be judged as of the filing date. As a result, written description must be found in the originally filed specification, and any amendments to add new matter to the specification during prosecution are prohibited. Echoing the examiner’s statement, the court found that “intangibles” was not disclosed or mentioned in the original specification. The court also agreed with the examiner’s objection to Downing’s attempt to amend the specification to define “intangibles” during prosecution. Lastly, the court approved the Board’s finding that a person of ordinary skill in the art would not have understood “intangibles” to refer to several specific items Downing pointed to in the specification.

Finally, the Federal Circuit agreed that the claims were indefinite. The court explained that while the claims purported to be product-by-process claims—“wherein the product is produced by processes of”—the remaining limitations did not define the process for making the product. Instead, those claim limitations—“designing a diffusion-based proprietary forecasting technique on an Excel computer platform for operation within a resource planning framework,” “structuring presentations on the same computer platform,” and “constructing one-time settings for the structure, on the same computer platform”—described functions or features of the product. Because the claims did note recite the steps for making the claimed product, they were indefinite.

The court disagreed with the Board’s conclusion that the claims were also indefinite because “end user” lacked antecedent basis. The court noted that the claims referenced one “end user,” which could only refer to the end user of the product. Thus, lack of an antecedent basis for that term did not render it indefinite.

The claims at issue were exactly the type an applicant for a computer-implemented invention should seek to avoid—vague, difficult-to-follow claims directed to an aspirational idea to be implemented on a computer. The takeaway continues to be that an applicant seeking to avoid Alice eligibility problems should focus on defining a technological problem and claiming a specific implementation that solves that problem and improves computer functionality.

In a decision issued by the Federal Circuit on October 24, 2018, the court affirmed a finding by the Patent Trial and Appeal Board (PTAB) that a multiple sclerosis (MS) treatment claimed in A Morass of Possible Combinations Does Not Satisfy the Written Description Requirement under 35 U.S.C. § 112an application owned by FWP IP APS (FWP) was not supported by adequate written description under 35 U.S.C. § 112. While the non-precedential nature of the decision might have indicated to some that the dispute was not all that important, the claims in dispute relate to Biogen’s blockbuster drug Tecfidera, which accounted for over a billion in sales for Biogen last year. As a result of the Federal Circuit’s ruling, Biogen’s patent for Tecfidera remains intact and FWP will not be able to realize its goal of collecting future royalty payments on sales of Tecfidera from Biogen. In addition, the opinion itself serves as a reminder for patent practitioners that laundry lists and kitchen sinks are better suited for households than patent applications.

Background

The case arises from an interference between the named parties, FWP and Biogen. Biogen owns U.S. Patent No. 8,399,514 (the ʼ514 patent), which describes and claims a specific method of treating MS with a daily dosage of 480 mg of fumaric acid esters (fumarates). Prior to the filing of Biogen’s application that issued as the ʼ514 patent, FWP filed a patent application (U.S. Application No. 11/576,871 (the ʼ871 application)) disclosing controlled-release compositions of fumarates. Upon issuance of Biogen’s ʼ514 patent, FWP canceled the then-pending claims in the ʼ871 application and added new claims that closely tracked to Biogen’s ʼ514 patent claims.  The PTAB declared an interference between FWP’s application and Biogen’s ʼ514 patent.

The PTAB distilled the interference count down to three main limitations: (1) an MS treatment, (2) by oral administration of a therapeutically effective amount of dimethyl fumarate and/or monomethyl fumarate, at (3) a specific dosage of 480 mg per day. Biogen moved the PTAB for a judgment that FWP’s claims were not adequately supported by the ʼ871 application’s specification. The PTAB ruled in Biogen’s favor and held that, even though each of the claim limitations were generally mentioned in FWP’s specification, the specification did not disclose the claimed invention in a manner that adequately described the claimed MS treatment to a skilled artisan and thus, the ʼ871 application did not meet the written description requirement.  FWP appealed.

The Federal Circuit’s Decision

Not surprisingly, the Federal Circuit affirmed the PTAB’s decision. While the court agreed with the PTAB that the ʼ871 application identified dimethyl fumarate and/or monomethyl fumarate as useful for treating a large number of described conditions (including MS) and that a dosage of 480 mg per day was generally disclosed, the court held that the ʼ871 application did not adequately teach a specific treatment of MS at a dosage of 480 mg per day.

In addressing the treatment of MS, the court noted that the ʼ871 application merely states that the fumarates in general are “contemplated to be suitable to use in the treatment of one or more of the following conditions.” While the “following conditions” were further described to include over 20 diseases and conditions including, for example, psoriasis, psoriatic arthritis, inflammatory bowel disease, and autoimmune diseases (including MS as one of the 11 listed), the only conditions discussed in any detail in the ʼ871 application were psoriasis and conditions associated with psoriasis. The court determined that, based on the laundry list of diseases and conditions discussed and the wide variability of the pathophysiologies of each of those listed diseases and conditions, the inventors of the ʼ871 application had yet to definitively conclude at the time of invention that fumarates and, more specifically, dimethyl fumarate and/or monomethyl fumarate, were effective for treating all of the 20 diseases and conditions identified.

The court came to a similar conclusion with respect to the dosage requirement. FWP argued that a table in the ʼ871 application expressly discloses a dosage of 480 mg per day during the seventh week of a contemplated nine-week scale-up period and a skilled artisan would have recognized that all of the listed dosages in the table are therapeutically effective dosages for all of the conditions and diseases listed. However, the court disagreed and determined that FWP failed to provide any persuasive evidence why a skilled artisan would have understood that a dosage for only one of the weeks in the nine-week scale-up period would be therapeutically effective for treating MS. Rather, the court determined that the table was simply providing guidance on gradual dosing to help patients’ gastrointestinal systems acclimate to the side effects of fumarates.

Interestingly, in a last attempt to save the claims, FWP further argued that the original claims, which FWP canceled and replaced with new claims to provoke the interference, provided sufficient support for the claims in the interference. Like the PTAB, the court found that the large number of disease conditions, dosages, active ingredients, and pharmaceutical formulations covered in the original claims detracted from FWP’s argument that it possessed and invented the claimed, specific MS treatment. Moreover, the court took issue with the improper multiple dependent format in which the original claims were written, stating “[f]inding a treatment for MS with 480 mg of DMF and/or MMF per day in the morass of possible combinations of the impermissibly drafted original claims would … take ‘the patience of a yogi to decipher their meaning, as they stand.’”

In view of the lack of specificity in the ʼ871 application with regard to a treatment for MS with a precise dosage of 480 mg per day using specific fumarates, the Federal Circuit affirmed the PTAB’s finding that the claimed MS treatment was not supported by the application’s specification as required by 35 U.S.C. § 112.

Key Takeaway

The court’s holding serves as an important reminder that the written description requirement requires more than the mere mention of a claim limitation in the specification. While FWP’s patent application described the use of fumarates in a broad fashion across a variety of medical conditions, there was not sufficient detail in the disclosure such that a person of ordinary skill in the art would be able to appreciate any and all specific treatments that might be possible permutations (including the specific MS treatment claimed in Biogen’s patent). Had FWP’s application described MS in more detail and included one or more working examples of treating MS patients with dosages at or around 480 mg per day of fumarates, the outcome may have been different for FWP.