Written Description and Creating Ranges from Examples

April 7, 2022

At the close of last year, the Federal Circuit affirmed a decision by the PTAB in IPR2019-00329 that a claimed range created from examples was not patentable because it lacked written description in the application as filed. In its decision the PTAB “second guessed” an examiner’s ex Parte decision that the claimed range had written description in the application as filed.  Written description was at issue because the patent challenged, U.S. Patent 9,687,454 (‘454), filed January 6, 2016, needed benefit of its parent application serial number 12/537,571 published on February 10, 2011, as 2011/0033541 (‘541), to avoid ‘541 from being prior art otherwise, most of the ‘454 claims were anticipated by ‘541. The ‘454 claim 1 is directed to a mucoadhesive film comprising about 40 wt.% to about 60 wt.% of a water-soluble polymeric matrix and claim 7 to a range of from about 48.2 wt.% to about 58.6 wt.%. Neither range was found in the ‘454 patent as filed; the claims were added during prosecution. The ‘454 describes the film as “may contain any desired level of self-supporting film forming polymer”; in “one embodiment, the film forming composition” may be at least 25 weight per cent of the composition; alternatively, at least 50 weight per cent of the composition. No upper limit was described.<... Read more

Patent Invalidation Under Section102(b)'s On-Sale Bar Based on a Letter Including Commercial Terms Sent Before the Critical Date

March 28, 2022

Mr. Junker, the named inventor of U.S. Design Patent No. D450,839, sued Medical Components, Inc. and Martech Medical Products, Inc. (“MedComp”) for infringement of the D’839 patent. The parties filed cross-motions for summary judgment, debating whether a letter sent before the critical date was a commercial offer for sale of the claimed design, rendering the claim invalid under the on-sale bar, 35 U.S.C. § 102(b). The district court granted Mr. Junker’s motion for summary judgment of no invalidity under the on-sale bar. MedComp appeals the district court’s summary judgment of no invalidity under the on-sale bar, the judgment of infringement, and the damages award.<... Read more

Plural Unreduced Selections with Unpredictable Effect Not Necessarily Routine Optimization

March 8, 2022

The PTAB in Ex parte Sturgis (Appeal 2021-002857; USSN 15/696,282) reversed an examiner’s obviousness rejection of claims for failing to sufficiently establish obviousness via routine optimization The reversal was mainly based upon plural selections being claimed without any particular directions on choosing in the prior art and an unpredicted effect based on the cited art.<... Read more

Markush Language Distinguishes over Multi-Component Solvent

January 31, 2022

The Patent Trial and Appeal Board (PTAB) overturned the examiner’s obviousness finding in Ex parte PETER KAPITAN and ALEXANDER SAJTOS (Appeal 2021-001272; USSN 14/409,522) substantially on the basis of a recitation of “… the solvent … is an alkane selected from a group consisting of pentane and hexane” distinguishing over the prior art description of the optional use of petroleum ether, with evidence that petroleum ether is not simply pentane or hexane.<... Read more

Is There Any Hope For Antibody Patents in the United States?

January 25, 2022

Conclusion

Okay, let’s get this out of the way up front. The answer is maybe… but only with a lot more work and with substantially reduced claim scope.<... Read more

Supplementing Element 1 with Element 2 Lacking the Claimed Function is not Obvious

December 27, 2021

In Ex parte FRANÇOIS ROY, JONATHAN CLOUTIER, and VINCENT TANGUAY (Appeal 2021-000050; USSN 13/966,396), the Patent Trial and Appeals Board (PTAB) recently reversed an examiner’s finding of obviousness in a rather involved rejection based upon four references, which hinged upon the presence of “thermofusable glue droplets providing a mechanical retention force to retain the wood strips in an interconnected spaced-apart relationship.”<... Read more

ModernaTx, Inc. v. Arbutus Biopharma Corp.: Sublicense Not Enough to Show Standing

December 13, 2021

On Dec. 1, 2021, the Federal Circuit held that Moderna lacked standing in an appeal from a Patent Trial and Appeal Board (“PTAB”) decision against rival Arbutus where the PTAB determined U.S. Patent No. 9,364,435 (“the ’435 patent”) was not unpatentable as obvious.[1] The ’435 patent concerns vaccine delivery technology, particularly a lipid nanoparticle delivery system used to protect nucleic acids delivered to cells as utilized in vaccines including Moderna’s COVID-19 vaccine.<... Read more

Biogen v. Mylan Written Description - What Does The Federal Circuit's Decision Really Mean?

December 8, 2021

Following up on my post last week (Dec 1.), I have read commentary about how the Federal Circuit’s decision in Biogen v. Mylan was incorrect. Is it really the case that the decision was wrong and that the Federal Circuit needs to address it en banc (or that the Supreme Court needs to address it)? <... Read more

Biogen v. Mylan: Make Sure Your Patent Applications Cover Your Current R&D

December 1, 2021

Yesterday, in Biogen v. Mylan, the Federal Circuit ruled that claims in Biogen’s U.S. patent 8,399,514 (the ’514 patent) were invalid under 35 U.S.C. §112 for failing to satisfy the written description requirement. The Federal Circuit upheld the district court’s previous invalidity determination.<... Read more

Another Example of Invalid Claims For Lack of Written Description and Enablement

October 18, 2021

In its recent decision, the PTAB (“the Board”) determined that all challenged claims of U.S. Patent No. 10,301,638 B2 were unpatentable under 35 U.S.C. § 328(a) for lack of written description and lack of enablement.<... Read more