ranges Archives - ElementIP Law

Ex parte Nakanishi, is a recent decision of the Patent Trial and Appeal Board (PTAB) addressing obviousness of a claim directed to a steel composition.

The claim at issue recited, in part:

A non-oriented electrical steel sheet having a chemical composition consisting of, in mass%…

Si: 1.0% or more and 4.0% or less;

Mn: 0.10% or more and 3.0% or less…

Al: less than 0.0005%;

Cu: 0.02% or more and less than 0.04%; and

Ca: 0.003% or more and 0.0100% or less…

In asserting obviousness, the examiner cited a single prior art reference disclosing a steel sheet including components and amounts that could overlap with those recited in the claim. Applicant’s arguments focused first on differences between the claimed composition and the prior art composition and then on evidence of unexpected results.

Applicant’s arguments as to composition focused particularly on the amounts of Al, Cu, and Ca in the claims and the prior art reference. Notably, applicant’s ranges of amounts of Al, Cu, and Ca were much narrower than those in the prior art reference.

Component	Claim	Prior Art Reference
Al	Al < 0.0005%	Al ≤ 3%
Cu	0.02% ≤ Cu < 0.04%	Cu ≤ 5%
Ca	0.003% ≤ Ca ≤ 0.0100%	(total content of Mo, W, Sn, Sb, Mg, Ca, Ce, and Co trace elements) ≤ 0.5%

Applicant first argued that the prior art reference did not disclose a single example composition having the claimed amounts of Al, Cu, and Ca. The PTAB quickly dismissed this argument, noting that the prior art reference was “not limited to its examples.”

Next applicant argued that the prior art reference did not recognize that the amounts of Al, Cu, and Ca were result effective and undue experimentation would have been required to arrive at the claimed narrow ranges. The PTAB replied that the prior art reference would have suggested to a skilled artisan that “all Al, Cu, and total trace element amounts within the disclosed ranges are effective for achieving” the goal of the prior art reference, “a non-oriented magnetic steel sheet whose core loss in a high frequency range can be fully reduced… including amounts within the… [claimed] ranges.”

Applicant then turned to its experimental results. Applicant argued that its experimental results showed that adding Ca in the claimed amounts to a steel sheet containing ultra-low amounts of Al unexpectedly reduces iron loss.

The PTAB noted that applicant’s experimental results were limited to compositions having a Si content of 1.3% and 1.6 % and an Mn content of 0.5%, while the claim encompassed Si contents as high as 4.0% and Mn contents as high as 3.0%. The PTAB then noted a statement in applicant’s specification that Si and Mn have the effect of reducing iron loss (the same effect applicant attributed to addition of Ca in describing its experimental results). In view of this statement, the PTAB concluded that applicant would have to provide evidence that its experimental results were representative of compositions including the minimum claimed amount of Ca and the maximum claimed amounts of Si and Mn, to effectively rebut the examiner’s assertion of obviousness.

Takeaway: Once an examiner has established that a prior art range overlaps with a claimed range, it will be difficult to persuade the examiner (or PTAB) that selection of a subrange would not have been obvious in the absence of evidence of unexpected results – in this case, the PTAB seemed annoyed that applicant even tried. It may be preferable to leave out arguments that will never succeed (e.g., the claimed composition is not exemplified in the prior art reference) and emphasize the results that might succeed (unexpected results).

A composition claim with many components, each with its own range of amounts, can make it difficult to prove that evidence of unexpected results is “commensurate in scope” with the claim. In this case, applicant showed a desirable effect over the entire range of amounts of the component it believed was important (Ca amount), provided a limited number of data points for the other components. It is often not practical to prepare a large number of compositions encompassed by a claim, but this can be addressed with a technical explanation for why additional experiments would not be expected to yield significantly different results (even more helpful if such explanation is provided in a declaration by a skilled artisan).

Judges: Owens, McGee, Inglese

Ex parte Myers is a recent decision of the Patent Trial and Appeal Board (PTAB) addressing enablement and written description of a claim amended to recite a range during prosecution.

The claim at issue recited:

A composition comprising oolitic aragonite particles, wherein the oolitic aragonite particles have an average particle size of between 100 nm to 1 mm, and a median (D50) particle size distribution (PSD) of between 2.0 to 3.5 μm, and a Hunter brightness level greater than 90.

The Hunter brightness feature was added during prosecution to distinguish over prior art. Applicant asserted that the following disclosure in the specification enabled and supported the newly added feature:

[T]he size of (milled) aragonite will also have a substantial effect on brightness of the material. For example, when milled to a fine particle size of 2 to 8 micron, the Hunter brightness level is approximately 94, which is very bright white. Thus, by selecting a suitable particle size, brightness of the milled aragonite can be adjusted.

The foregoing was the only disclosure of any Hunter brightness level – only a single value and no disclosure of any range.

The examiner acknowledged the disclosure of a single value of 94 for Hunter brightness level but asserted that such disclosure did not reasonably provide enablement for, or demonstrate possession of, the entire range of “greater than 90.”

As to enablement, the PTAB disagreed with the examiner, finding that the examiner had failed to establish that undue experimentation would be required for a skilled artisan to make and use the claimed composition. The PTAB appeared to find plausible applicant’s contention that disclosure of a single Hunter brightness level paired with disclosure that milling or otherwise adjusting particle size affects Hunter brightness would be enabling.

However, as to written description, the PTAB affirmed the examiner’s rejection. Applicant asserted that the particles described in the specification inherently have Hunter brightness values between 90 and 100. The PTAB noted that, while the specification indicated that particle size related to Hunter brightness, there was nothing in the record to indicate that the particles sizes in the specification necessarily resulted in Hunter brightness values greater than 90. The PTAB further noted that the specification indicated that parameters other than particle size influence Hunter brightness, concluding that the specification did not reasonably convey that applicant was in possession of the recited range of Hunter brightness levels.

Takeaway: US practice is much more flexible than other jurisdictions with respect to the degree of specification disclosure required to support claim amendments made during prosecution. This is especially true when amending ranges to include new endpoints from subranges and/or individual examples in the specification (but keep an eye on the Federal Circuit link, link). However, even under US practice, it will be difficult to create a claimed range from a single data point. If a parameter is important enough to identify in a patent application, it is worth the small additional effort to identify ranges of values that encompass the described invention.

Judges: Hanlon, Gupta, Inglese

AstraZeneca AB v. Mylan Pharm., 2021-1729 (Fed. Cir. Dec. 8, 2021), is a recent decision of the Federal Circuit interpreting the scope of a numerical limitation in a claim.

The claims on appeal in AstraZeneca were directed to pharmaceutical formulations for administration via pressurized metered dose inhalers. The formulations required a formulation stabilizer, PVP K25, and recited “the PVP K25 is present at a concentration of 0.001% w/w.”

The district court interpreted 0.001% w/w as encompassing 0.001% w/w “within one significant figure” – i.e., any value that could be rounded up or down to 0.001% w/w, or 0.0005% to 0.0014% w/w. The Federal Circuit disagreed and interpreted 0.001% w/w as “that precise number, with only minor variations” – i.e., 0.00095% to 0.00104% w/w. A further alternative was offered in Judge Taranto’s dissent.

The Federal Circuit indicated that, in the abstract, the ordinary meaning of 0.001% w/w was consistent with the district court’s interpretation of 0.0005% to 0.0014% w/w (“This is a standard scientific convention, and numbers falling within that range would typically be rounded up or down to 0.001%.”). However, the Federal Circuit found that

…taken as a whole, the intrinsic record supports a narrower construction of 0.001% to reflect that term’s application to the PVP concentration in particular, and the testing evidence in the written description and prosecution history showing that very minor differences in the concentration of PVP—down to the ten thousandth of a percentage (fourth decimal place)—impact stability.

Of particular importance to the Federal Circuit were experimental results in the specification showing significant changes in stability between a composition including 0.001% w/w PVP and a composition including the more precisely defined 0.0005% w/w PVP. The patentee made arguments about the results during prosecution and cancelled claims reciting, e.g., “0.0001% to 0.001% w/w” PVP and “0.0001%, 0.0005%, or 0.001% w/w” PVP. The Federal Circuit further noted that the patentee could have used the term “about” to modify of 0.001% w/w but chose not to.

Based on the Federal Circuit’s construction, the case was remanded for further consideration of infringement.

In his dissent, Judge Taranto found the majority’s approach too exacting. He argued that the disclosure of more precise values in the specification (e.g., 0.0005% w/w PVP) was not a disclaimer of the ordinary meaning of 0.001% w/w PVP. In Judge Taranto’s view, applicant’s arguments during prosecution with respect to stability at most required an exclusion of 0.0005% w/w PVP from the literal scope of 0.001% w/w.

Takeaway: This decision – particularly when the majority and dissent opinions are compared – does not offer much clarity as to how precisely a numerical value in a claim will be interpreted. There appears to be consensus that the starting point is “within one significant figure.” However, based on the majority’s decision, even the mention of more precise values in the specification or prosecution history can impute an additional significant figure to a claimed value. Practitioners should at least be wary of the risks of using different degrees of precision for different data points/values in the specification and claims and consider explicitly defining the degree of error intended for claimed values in the specification.

Judges: Taranto, Hughes, Stoll (Taranto dissenting)

When faced with a limitation involving an open-ended numerical range, an examiner will not only analyze for definiteness under 35 U.S.C. § 112(b) but also scrutinize whether the limitation satisfies the written description requirement and the enablement requirement under § 112(a). In Ex parte Qiu (Appeal 2020-001512), the Patent Trial and Appeal Board (“Board”) considered and reversed the Examiner’s rejection of Appellant’s claims for failing to comply with the written description requirement.

Claim 1 was illustrative and read (in part):

A composition comprising a compound wherein the compound consists of end groups R₁ and R₂ and at least m repeating segments of the following structures:

wherein Y is an anionic group selected from the group consisting of: sulfate, carboxylate, phosphate, phosphonate, and sulfonate, …; wherein the compound comprises substantially no other anionic pendant functional groups, except those selected from the group consisting of: sulfate, carboxylate, phosphate, phosphonate, and sulfonate, wherein the compound has a number average molecular weight of no more than 10,000 grams/mole and an average number of anionic groups of greater than 2.

Noting that the specification disclosed examples wherein the average number of anionic groups ranged from 2.09 to 15, the Examiner rejected claim 1 as failing to meet the written description requirement because the range “greater than 2” did not have an upper limit. In response to Appellant’s rebuttal arguments citing the Federal Circuit’s decision in Anderson Corp. v. Fiber Composites, LLC, the Examiner alleged Anderson only applied to the question of enablement.

The Board clarified that Anderson applied to both questions of enablement and written description. As stated in Anderson, “[o]pen-ended claims are not inherently improper” and “[t]hey may be supported if there is an inherent, albeit not precisely known, upper limit and the specification enables one of [ordinary] skill in the art to approach that limit.” The Board agreed with Appellant that since the claim required an upper limit for the molecular weight of the compound (“no more than 10,000 grams/mole”), the specification as a whole enabled a skilled artisan to determine the inherent upper limit on the number of anionic groups for any particular compound circumscribed by the claimed requirements. That is, the Board found the specification conveyed with reasonable clarity to those skilled in the art that, as of the filing date sought, Appellant was in possession of the invention.

Accordingly, the Board found the specification supported the claimed subject matter.

Takeaway: As compared with a numerical range in which both the lower and upper limits are specified, an open-ended range offers a broader scope. However, an open-ended numerical range often puts an examiner, like the Examiner in Qiu, on alert. The Anderson decision assures that an open-ended range is supported and enabled if the unspecified limit is inherent and the specification is sufficient to enable one skilled in the art to approach that limit. As a backup position, an applicant should consider including at least one dependent claim reciting a concrete endpoint to “close” the open range.

Judges: C. Q. Timm, K. M. Hastings, and J. B. Robertson

2020年4月8日に米国CAFCは、クレームされた物質に関する数値範囲と引例に記載された類似物質に関する数値範囲とが重なる場合、prima facie case of obviousness と判断し得る、と判示しました（Valeant Pharmaceuticals Intl. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)) 。

On August 7, 2020, the Patent Trial and Appeal Board issued a decision in Ex parte Koseoglu (Appeal 2019-002720) and reversed an obviousness rejection of a catalyst composition. Implicit in the Board’s decision was the determination that one of the catalyst components, having only an upper limit on its amount, was present in the catalyst composition.

Cut to the Chase – When Claimed Ranges and Prior Art Ranges Overlap, Focus on Unexpected Results

Cut to the Chase – When Claimed Ranges and Prior Art Ranges Overlap, Focus on Unexpected Results

The Perils of Trying to Convert a Single Data Point into a Claimed Range

How Many Zeros and Where Are They? Significant Figures Can Be Significant in Claim Construction

PTAB Finds Support for An Open-ended Numerical Range

本願物質の数値範囲と引例に記載の類似物質の数値範囲が重なる場合、prima facie case of obviousになるか

Component with Only Upper Limit on Amount Considered Present in Claimed Catalyst Composition; Element IP Lecture Available on Best Practices for Claiming Ranges

USPTO Withdraws Proposed Terminal Disclaimer Rule

USPTO Further Delays Non-DOCX Fee Until January 17, 2024