Tag Archives: obviousness

In my view, Obviousness is the most fundamental of patent law doctrines, and certainly much of the work of patent attorneys is to convince patent examiners that the claims are not obvious.

Secondary Considerations Get Short Shrift in Airbed Patent Fight

by Dennis Crouch

Team Worldwide Corp v. Intex Recreation Corp. (Fed. Cir 2023)

I was disappointed to see the Federal Circuit’s no-opinion affirmance in this case — affirming the PTAB finding that Team Worldwide’s inflatable airbed invention was unpatentable as obvious.  US9211018. The case peaked my interest because I have been working on a short article focusing on what the courts term “secondary considerations” of obviousness, and the patentee raised substantial evidence of commercial success.   Ultimately the PTAB sided with the patent challenger and and that determination was affirmed on appeal in a R.36 no-opinion judgment.

TWC’s patent claims an “inflatable product,” such as an air mattress, that has a built-in electric pump.  In particular, the electric pump is built into and recessed within the exterior wall of the mattress with just one side of the pump body exposed through the exterior wall. The rest of the pump body is hidden inside the inflatable body and permanently held in place within the exterior wall of the inflatable body. The recessed design keeps the pump partially hidden and out of the way when not in use.

The key prior art references in the case are

  • U.S. Patent No. 6,018,960 (1996) (“Parienti”), which discloses an air mattress having an externally-attached solar powered pump.
  • U.S. Patent No. 2,493,067 (1945) (“Goldsmith”), which discloses ordinary inner-spring mattress having an attached fan used for temperature control (not inflation).  One embodiment includes “housing arranged within … said mattress and carrying a blower and temperature changing means therein.

This product has been a huge seller via brands such as Intex, Bestway, Boyd, Airtek, Air Cloud, Air Comfort, AirBedz, Altimair, Pittman, and TexSport.  The patentee has sued a number of folks for infringement, and they fought back with this Inter partes review proceeding.

The PTAB initially sided with the patentee, concluding that the claims had not been proven obvious. However, on appeal, the Federal Circuit vacated and remanded.

The Board misapplied the obviousness standard, and misapprehended Intex’s argument, when it fixated on whether the prior art literally disclosed Intex’s theory of modifying Parienti only slightly by taking the pump attached to the outside of the mattress and recessing it partially within the mattress. Intex’s argument regarding its proposed modification showed that Parienti was already close to the challenged claims, and only a slight change was needed to satisfy the broadest reasonable interpretation of “wholly or partially” recessing a pump. This showing, together with Intex’s showing that numerous references since the late 1800s illustrated prior artisans’ intuitive desire to recess pumps to save space, satisfied Intex’s burden [under KSR]. The Board erred in concluding to the contrary.

Intex (Fed. Cir. 2021).  Thus, in its 2021 decision the Federal Circuit concluded that Intex had satisfied its burden of proving the invention obvious. The only problem though was that the PTAB/CAFed had not yet considered secondary indicia of non-obviousness offered by the patentee.  Thus, remand was needed for the PTAB to address issues it previously declined to reach. Specifically, the PTAB had not addressed Team Worldwide’s evidence on objective indicia of non-obviousness.

On remand, the PTAB flipped its decision, finding the claims obvious despite substantial sales and other secondary considerations.  In its most recent appeal, Team Worldwide argued that the PTAB erred in its assessment of the objective evidence of nonobviousness. Specifically, Team Worldwide argued that the PTAB did not properly weigh the evidence presented regarding commercial success, failure of others, and industry praise.

Regarding commercial success, the PTAB found that Team Worldwide was entitled to only “some, but not considerable, weight in favor of non-obviousness” for the evidence of sales of infringing products, citing the impact of non-patented features on customer demand.  However, Team Worldwide argued that the PTAB ignored evidence that the majority of sales were of products admitted or shown to infringe, which constitutes overwhelming commercial success under Federal Circuit precedent. See Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 655 F.3d 1364, 1376 (Fed. Cir. 2011).

For failure of others, the PTAB concluded that Team Worldwide’s evidence was entitled to only “some weight.” But Team Worldwide argued that the PTAB improperly minimized competitors’ failed attempts to design around the claims, contrary to Federal Circuit precedent finding failure of others entitled to considerable weight. See WBIP, LLC v. Kohler Co., 829 F.3d 1317 (Fed. Cir. 2016).

Regarding industry praise, the PTAB found Team Worldwide’s evidence was entitled to some, but not considerable weight. However, Team Worldwide contended that the PTAB ignored relevant testimony praising the invention, which should be afforded considerable weight under Federal Circuit law. See Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034 (Fed. Cir. 2016) (en banc).

In sum, Team Worldwide argued that the PTAB did not properly weigh the objective evidence of nonobviousness as required under controlling Federal Circuit precedent and that this evidence outweighed the PTAB’s finding of obviousness.

Unfortunately, on appeal the Federal Circuit did not take the time to work through these issues but rather simply issued its R.36 Affirmance without opinion.

In addition to the general role of objective indicia, the appeal asked an important question about burdens of proof: “Did the Board err by inappropriately applying a standard of proof that required TWW to prove the validity of its claims in light of secondary considerations when the burden of proof statutorily remains with Petitioner to prove invalidity including in light of secondary considerations?”

Sisvel v. Sierra Wireless – Useful Guidance for Prosecutors on Motivation to Combine and Means-Plus-Function Claims

by Dennis Crouch

Today’s post introduces the new decision in Sisvel International S. A. v. Sierra Wireless, Inc., No. 22-1493 (Fed. Cir. Oct. 6, 2023).  Here, I focus on two distinct issues. The first part has to do with motivation-to-combine, with the decision offering some good language for patent prosecutors attempting to overcome weakly worded office actions.  The second part focuses on means-plus-function language and concludes with my rant about the court’s unduly complicated layers of tests.  The case also upholds a single-reference obviousness holding, but I didn’t write about that portion of the decision.

Justifying a Motivation to Combine

In the IPR, the PTAB cancelled some claims of Sisvel’s U.S. Patent No. 6,529,561 based upon a single-reference obviousness determination (Chen; WO 99/26371), but sided with the patentee as to other claims. The Board particularly found no motivation to combine One of the key reasons was because of a lack of motivation to combine Chen with other GSM references.

On appeal, the Federal Circuit affirmed these findings.  US patent law has a long history of debate with regard to combination claims, with the Supreme Court’s most recent pronouncement in KSR reaffirming its old pronouncement that a combination of known elements is likely obvious absent some justification for deciding otherwise.  KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).

[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. . . . The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.

Id.  Referencing Sakraida v. Ag Pro, Inc., 425 U.S. 273 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57 (1969); and Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147 (1950).

Despite this lower bar, IPR petitioners still have the burden of at least explaining why a skilled artisan would have been be motivated to combine various references to form the claimed invention.  This is so, even if that explanation is simply a showing of how its case fits the model set out in KSR.

Here, however, the Board concluded that the IPR petitioner had failed that low burden.  In particular, in this case the petitioner offered “reasons to combine [that] were merely assertions that the references were analogous art, which, without more, is an insufficient articulation for motivation to combine.”  Rather, as KSR suggests, the known elements need to be combined “according to known methods” and yield only “predictable results.”  Although the petitioner might have recited these legal conclusions in its petition, the Board found them too conclusory and lacking in clarity.  Rather, the Board indicated that a proper motivation to combine analysis would explain how the primary reference is modified by the GSM reference.  As I mentioned above, this is a fairly low standard under KSR, but the Board explained that the petition failed to explain: “what reference is the primary versus secondary reference, what elements are missing from the primary reference, what elements should be added from the secondary reference to reach the claimed invention, or why those particular elements would be obvious to add.”

On appeal, the Federal Circuit affirmed the lack of motivation to combine – holding that “we cannot fault the Board for being at a loss in trying to decipher Cross-Appellants kitchen-sink of unclear and confusing motivation-to-combine arguments.”

Sisvel’s ’561 patent, owned by Sisvel, relates to improving channel coding techniques in transmitting data for radio systems. Channel coding adds redundant data bits to a data block before transmission to allow a receiver to better detect and correct errors caused by noise or other interference. The invention particularly employs “link adaptation” and “incremental redundancy” to optimize channel coding. Link adaptation allows the transmitter to adjust the code rate between data block transmissions by changing the number of redundant bits. Incremental redundancy allows the receiver to combine original and retransmitted data blocks to improve decoding.

The Federal Circuit’s affirmance on motivation to combine could be useful for patent prosecutors facing obviousness rejections. While the explanatory burden on an IPR petitioner is higher on the IPR petitioner than on a patent examiner, prosecutors may find Sisvel helpful in arguing an examiner provided inadequate rationale for combining references. Patent applicants could cite Sisvel in contending an office action improperly combines references without particularly explaining: (1) the primary and secondary references; (2) missing elements supplied by the secondary reference; (3) why a skilled artisan would have looked to the secondary reference to fill gaps in the primary reference; (4) why adding the secondary reference’s teaching would yield predictable results; etc. Although Sisvel arose in the context of invalidity allegations by an IPR petitioner, the motivation to combine principles apply equally during prosecution. By requiring examiner explanations meet KSR’s standards, applicants may succeed in overcoming some obviousness rejections.

= = =

The Noah Test as One Layer of Means Plus Function Analysis

The case also includes an interesting discussion about a means-plus-function limitation found in some of the claims, and the question of whether the claim is indefinite.  As you know, a claimed means plus function limitation is interpreted as covering the corresponding structures disclosed within the specification along with their equivalents.  35 U.S.C. 112(f).  But we have a special null case — if no such structures are disclosed then the Federal Circuit has ruled that the associated claim is automatically invalid as indefinite.  This gets a bit trickier for inter partes review proceedings since the petitioner is not permitted to challenge claims based upon indefiniteness. In Intel Corp. v. Qualcomm Inc., 21 F.4th 801 (Fed. Cir. 2021), the Federal Circuit instructed the PTAB to take the following approach to potentially indefinite MPF claims:

  1. Impossibility: Determine that the claim is indefinite and then decide whether the indefiniteness prevents a prior art analysis (the “impossibility” conclusion); or
  2. Possibility: Explain why it is able to construe the claim and resolve the prior art issues despite potential indefiniteness.

In either case, the PTAB needs to make some moves toward determining whether the limitation includes sufficient structural support in the specification.

Here, Claim 5 of the ’561 patent requires a “means for detecting a need for retransmission.”  The specification does not specify a particular algorithm to accomplish this goal, but does disclose protocols like “ARQ” and “hybrid ARQ.”  In situations like this, the Federal Circuit has created an unduly complicated framework  to determine whether expert testimony can be used to fill gaps in the structural explanation of algorithmic MPF claims. Noah Systems, Inc. v. Intuit Inc., 675 F.3d 1302 (Fed. Cir. 2012). At step one, the Noah framework specifically asks whether any algorithm is disclosed.  If no algorithm then no expert. In Noah step two, where an algorithm is disclosed but arguably inadequate, its sufficiency is judged based on a skilled artisan’s perspective and expert testimony is permitted to support the conclusions. Id.

Here, the PTAB found that references to “ARQ” and “Hybrid ARQ” were not algorithms.  On appeal the Federal Circuit found error in that conclusion. In particular, the court held the PTAB erred by not evaluating the protocol names under the step two framework. The court explained that even “brief disclosures” may warrant assessing expert views on their import to a skilled artisan. Because the specification explicitly referenced protocols, it was not wholly devoid of structure. The court vacated and remanded for the PTAB to conduct a step two analysis, including evaluating expert testimony.

This holding provides useful guidance for assessing computer-implemented means-plus-function claims. The Federal Circuit appropriately avoided rigid formalism, recognizing algorithm disclosures need not detail every step and by recognizing that  reference to commercially available tools can satisfy the structural requirement of 112(f).  Still, I would have simplified this approach and simply held that the claim covered the disclosed protocols. After Sisvel, courts evaluating software means-plus-function limitations must carefully walk the line between Noah’s step one and two.

Conclusions: The means-plus-function doctrine was originally designed to allow patent applicants to claim an element by the functions it performs rather than reciting structure, with the goal of providing a simple and flexible claiming technique. However, as evidenced by the complicated Noah framework sitting atop Williamson and Donaldson, Sisvel’s nuanced analysis of whether disclosed protocols qualify as algorithms, means-plus-function claims have become one of the more complex and controversial doctrines in patent law. The current morass of rules, exceptions, and expert testimony required to assess even basic computer-implemented means-plus-function claims suggests the doctrine has veered far from its original purpose. In my view, courts should seek to simplify the rules and refocus on whether the specification provides sufficient information to allow a skilled artisan to understand the boundaries of the functional claim element.

= = =

  • Sisvel International S.A.: Represented by Robert Gajarsa, Timothy Devlin, and Neil Benchell of Devlin Law Firm.
  • Sierra Wireless, Inc.: Represented by Kourtney Merrill of Perkins Coie LLP and Amanda Tessar.
  • Telit Cinterion: Represented by Guy Yonay of Pearl Cohen and Kyle Auteri.
  • Opinion: Authored by Judge Chen and joined by Chief Judge Moore and Judge Clevenger.

Broad Claims Bite Back: Drafting Narrower Scope in the Age of IPR

by Dennis Crouch

The Federal Circuit recently affirmed a PTAB IPR decision invalidating claims of Masimo U.S. Patent RE47,218 (“the ’218 patent”) as obvious under 35 U.S.C. § 103. Masimo Corp. v. Sotera Wireless, Inc., 2022-1415 (Fed. Cir. Sept. 28, 2023) (nonprecedential). The Federal Circuit panel of Judges Prost, Wallach, and Chen determined (1) the Board correctly construed the disputed claim terms and (2) its obviousness ruling was supported by substantial evidence.  Id. (authored by Judge Wallach).

The case is yet another example of a patentee’s broad claim language and attempts to avoid limitations coming back to bite during IPR proceedings.  Unlike a decade ago, patent prosecutors are operating in today’s AIA world where IPR challenges have become commonplace.  The old model of broad-as-possible clearly has deficiencies.  To withstand post-issuance validity challenges, prosecutors should carefully craft claims early on with an eye toward narrower scope and avoiding abstraction even if you are doing enough to satisfy the USPTO on 112 and 101. Prosecutors can take full advantage of the 20 ‘free’ claims to pursue both broad and narrow protection. In the case here, the patent owner may have benefited from prosecuting more specific claims early on, as the disclosure arguably supported narrower alternatives that an IPR petitioner would have struggled to knock out.

The ’218 patent relates to an adaptive alarm system for use with pulse oximetry sensors in patient monitoring.  A common problem is nuisance alarms generated when oxygen saturation briefly goes outside preset limits. This patent aims to improve alarm management by making the thresholds adaptive based on the patient’s current SpO2 levels and trends. Basically, an alarm threshold is calculated based upon a patient’s recent SpO2 levels rather than based upon an objective predetermined standard.  Key adaptive alarm functions are:

  1. The alarm threshold changes over time based on the patient’s recent SpO2 level
  2. But, the threshold offset shrinks as SpO2 drops closer to a minimum – making it more sensitive to drops when the patient’s readings are already low.

Sotera petitioned for inter partes review (IPR) challenging the claims as obvious over a combination of prior art references including U.S. Patent Nos. 7,079,035 (“Bock”) and 6,597,933 (“Kiani”), along with PCT Publication WO 2009/093159 (“Woehrle”). The Board instituted review and ultimately ruled all instituted claims obvious based on these references.

On appeal, Masimo first argued the Board misconstrued the claim limitation “trigger a second alarm based on . . . exceeding the second alarm threshold” in finding obviousness over Bock/Kiani. The Board had treated the requirement as a “condition precedent”, but ruled that the claim does not require that exceeding the threshold directly triggers the alarm.  On appeal, the court found this consistent with the plain claim language under Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), and the specification.

We agree with the Board that the plain meaning of “based on” and “threshold” in claim 1 are both broad, and this broad claim language does not exclude the use of additional alarm thresholds or other conditions to trigger an alarm. Further, claim 5 depends from claim 1 and provides for an additional condition in the form of a time delay, and Masimo does not dispute that the meaning of “based on” allows for additional conditions for triggering an alarm. We also agree with the Board that disclosure of an embodiment in the specification that does not include any additional thresholds or conditions for triggering an alarm does not support reading such a limitation into the claim.

This intrinsic evidence thus supports construing “based on” and “threshold” broadly — a ruling that was key to upholding the Board’s obviousness determination.

Masimo also challenged the Board’s interpretation of “predetermined” in certain claims as referring to a predetermined formulaic calculation rather than a fixed value. Again, the Federal Circuit upheld the Board’s construction as entirely consistent with the adaptive alarm thresholds described in the claims.

Ben Katzenellenbogen from Knobbe argued for the patentee appellant. Rudy Telscher from Husch took the other side. The IPR case here relates to the parallel litigation still pending in Masimo Corp. v. Sotera Wireless, Inc. and Hon Hai Precision Industry Co. Ltd., Civil Action No. 3:19-cv-01100-BAS-NLS (S.D. Cal.). In that case, the patentee Masimo asserted nine patents, all of which were challenged in IPR petitions.  The PTAB granted 8 of those and cancelled all the challenged claims.  Parallel appeals are still pending in several of the others.  The infringement litigation has been stayed pending outcome of the IPRs.

How Prosecution History Can Support a Motivation to Combine

by Dennis Crouch

Elekta Ltd. v. Zap Surgical Systems, Inc., — F.4th — (Fed. Cir. Sept 21, 2023)

The recent Federal Circuit decision in Elekta v. ZAP Surgical provides an interesting case study and also warning on how prosecution history can be used to support a finding of a motivation to combine prior art references, even when those references come from different fields.  Here, the patentee claimed a radiation therapy invention, but included references to imaging devices in its IDS.  That inclusion (along with some other evidence) led to an inference that PHOSITA would generally be motivated to combine art across these two fields.

Background on the Elekta Case

In Elekta, the patent-at-issue claimed a device for treating patients with ionizing radiation using a radiation source mounted on concentric rings. U.S. Patent No. 7,295,648. During an inter partes review (IPR) proceeding, the Patent Trial and Appeal Board (PTAB or Board) found the claims obvious based on a combination of two prior art references:

  • Grady, which disclosed an X-ray imaging device with the X-ray tube mounted on a sliding arm connected to rotating support rings. This was an imaging device.
  • Ruchala, which disclosed a radiation therapy device using a linear accelerator (linac) as the radiation source, where the linac rotates around the patient to deliver the radiation dose. This was a therapy device.

On appeal, Elekta argued that a person having ordinary skill in the art would not have been motivated to combine an imaging device like Grady with a therapy device like Ruchala. The Federal Circuit affirmed the Board, finding substantial evidence supported a motivation to combine, including the prosecution history.

Using the Prosecution History to Find an Implicit Motivation to Combine

A key dispute in Elekta was whether a person having ordinary skill would have been motivated to combine references from different fields – here, imaging and therapy.  Elekta argued that a key difference made the imaging art inapplicable to therapy. In particular, the linear accelerator used for therapy is quite heavy and so support systems designed for imaging are typically will not work.

The Board disagreed with the patentee and found a motivation to combine the imaging reference with the therapy reference. A key factor for the Board was that the patentee had cited imaging references in its information disclosure statement.

The Board supported this conclusion by reviewing “the prosecution of the ’648 patent, [which demonstrated that] patents directed to imaging devices were cited, and were not distinguished based on an argument that imaging devices were not relevant art.”

Slip Op.   Digging into the case history, I found that the patentee had cited an imaging device in its IDS filing and the examiner had cited the reference in an office action rejection.  The patentee distinguished the reference based upon its particular mounting configuration. But, the patentee did not raise any written objection to the reference being an imaging system rather than a treatment system.   Later, in the notice of allowance the examiner cited a different imaging system as state of the art for mounting radiation sources.  Again, the patentee did not raise any express objection to that characterization and its applicability to the claimed therapy system.

On appeal, the Federal Circuit affirmed that it was proper for the Board to infer a motivation to combine based (in part) on this citation history:

We hold that the Board’s finding that a skilled artisan would have been motivated to combine the [imaging] device with Ruchala’s linac [therapy device] is supported by substantial evidence, including the prosecution history of the ’648 patent … Specifically, as explained above, during prosecution, the patentee notably did not argue that prior art references directed to imaging devices were not relevant art.

Id.  The court found this prosecution history suggested an implied admission that both imaging and therapy references were relevant to the claimed invention, and thus established an implied motivation to combine the references.

I want to be clear on the holding here. The imaging references cited during prosecution are different from those relied upon in the IPR.  But, citing those imaging references created an inference that PHOSITA would consider other imaging references and even have a motivation to combine them with the therapy prior art.

One note – neither the Board nor the FedCir distinguished the particular prosecution history acts that were sufficient to create the inference.  When I first read the case, I assumed it was simply IDS citations, but learned of the rejection/NOA citations as I dug into the briefing.  In the briefing, the challenger noted that the imaging patent was the first-cited-reference and therefore was important – but the tribunals did not appear to give credence to that particular statement.  Bottom line, it appears that an IDS statement could be sufficient to trigger the inference, but the actual threshold is is unclear.

Takeaways from Elekta — Disclaimers

This case demonstrates the need for patent prosecutors to be very thoughtful and strategic when citing references, responding to rejections, and notices of allowance in order to avoid creating an unintended prosecution history record that could imply motivation to combine disparate references. The following are some specific steps prosecutors could take include:

  • When citing a reference in an IDS, drafting an explicit statement that the citation should not be construed as an admission that the cited reference comes from an area that is analogous or directly applicable to the invention, and rather that the reference is being cited out of an abundance of caution.
  • If an examiner cites a reference in a rejection from a separate area of technology, not remaining silent and instead actively responding on the record with an explanation of why the particular area of technology is not applicable or combinable due to key differences.
  • Even if rejections are eventually overcome on other grounds, reiterating for the record (and especially in the face of a contrary reason-for-allowance) that no admission is made regarding the applicability of art.
  • Drafting tailored disclaimers and statements to avoid implications of compatibility between disparate references, while balancing the need to prevent unintended admissions.

While it is important to avoid unnecessary concessions, applicants must be deliberate and strategic in crafting the intrinsic record, while also recognizing that these additional statements are contrary to substantial conventional wisdom advising applicants to avoid unnecessary statements in the prosecution history.

A Point of View vs The Point of View: Federal Circuit’s Subtle Claim Construction

by Dennis Crouch

The Federal Circuit recently vacated and remanded a pair of Patent Trial and Appeal Board (PTAB) decisions that had upheld patent claims owned by Corephotonics. Apple Inc. v. Corephotonics, Ltd., No. 2022-1350 (Fed. Cir. Sept. 11, 2023). The appellate court held the PTAB erroneously construed a disputed claim term by failing to appreciate the significance of “a” versus “the” in the claims. It also found the PTAB violated the Administrative Procedure Act (APA) by resting its obviousness determination on arguments and evidence not squarely raised by the parties.

The Dispute Over Dual-Lens “Portrait Mode”

The patent at issue, U.S. Patent No. 10,225,479 (‘479 patent), relates to using dual-aperture camera systems in smartphones to create aesthetically pleasing “portrait photos.” Specifically, the patent discloses combining images from a wide-angle “Wide” lens and a telephoto “Tele” lens to produce a fused image showing a sharp subject in front of a blurred background.  Portrait mode is incredibly popular on Apple and Android phones and so the industry is eager to invalidate the patent held by Tel Aviv based Corephotonics.

Apple filed two petitions for inter partes review (IPR) challenging claims of the ‘479 patent as obvious based primarily on a prior art reference known as Parulski, which discloses a dual-lens digital camera but does not specify how image fusion occurs.  U.S. Patent No. 7,859,588.

Claim Construction – The Significance of “A” vs. “The”

In the first proceeding (IPR2020-00905), the parties disputed the proper construction of the claim term “fused image with a point of view (POV) of the Wide camera.” Apple argued this term required maintaining either the Wide image’s perspective or position point of view in the fused image, while Corephotonics contended it mandated both Wide perspective and position. Patentees often argue for narrow constructions during IPR proceedings in order to avoid the prior art. Here, the patentee’s narrow construction won the day and the PTAB found Apple failed to show the claims were obvious under this narrower construction.

Examining claim construction de novo, the Federal Circuit concluded that the PTAB had erroneously construed the term too narrowly based upon use of the indefinite article “a POV” as well as intrinsic evidence from the patent specification.

The court first looked at the claim language in context, noting the claims recite “a point of view” rather than “the point of view” of the Wide camera, suggesting the fused image need only maintain one type of Wide point of view. While the specification discloses that “point of view” includes both perspective and position, the claims’ use of “a” rather than “the” was critical:

A reasonable reading of [the specification] is that Wide perspective and Wide position are two different types of Wide point of view. The claim term requires only that the fused image maintain ‘a point of view of the Wide camera,’ i.e., only one of the disclosed types of Wide point of view.

Slip Op.  The court also explained that limiting the claims to require both Wide perspective and position would improperly exclude disclosed embodiments where the fused image has a “mixed” point of view, like Wide perspective but Tele position.

Taken together and in context, however, the intrinsic evidence supports that the claim term requiring a fused image maintaining ‘a point of view of the Wide camera’ requires only that the fused image maintain Wide perspective point of view or Wide position point of view, but does not require both.

With this broader construction, the Federal Circuit vacated the PTAB’s first decision and remanded for further analysis of whether the prior art disclosed the disputed limitation under the clarified standard.

While the Federal Circuit suggested the patentee could have defined “point of view” to require both perspective and position by using “the” in the claims, this may have been improper due to lack of antecedent basis. Generally, a new limitation should be introduced using an indefinite article like “a” rather than a definite article like “the.” The existence of this rule of patent claim drafting raises the question of how much interpretive weight should be given to a patentee appropriately following the rule. Here, the use of “a point of view” in the claims adhered to the common rule of using “a” to introduce a new limitation. The Federal Circuit relied heavily on this choice of article in reaching its broader construction. But because patentees are expected to follow this drafting rule, it is debatable whether such weight should be placed on the patentee’s decision to use “a” in accordance with standard practice rather than “the.” This highlights some tension between claim drafting best practices and reliance on subtle differences in claim language during claim construction.  Of course, the patentee could have simply drafted claims that clearly stated the structure being claimed.  Here, the Board noted that the disclosure was “not a model of clarity,” something that should weigh against the patentee.

Sua Sponte Findings Without Adequate Explanation or Opportunity to Respond

In the second proceeding (IPR2020-00906), Apple asserted specific claims reciting detailed camera parameters would be obvious based on combining Parulski with the Ogata reference. U.S. Patent No. 5,546,236. But the PTAB rested its determination that Apple had not proven obviousness almost entirely on typographical errors in the declaration of Apple’s expert, Dr. Sasián, which were barely mentioned by the parties.

Apple appealed both PTAB decisions to the Federal Circuit.

The appellate panel held that resting a determination of nonobviousness primarily on typographical errors in Apple’s expert declaration, without prior notice to the parties, violated the APA. The court explained that while the PTAB can reject unreliable expert testimony, it must provide a reasoned explanation supported by evidence and base its decision on issues the parties had notice and chance to address. Those factors were not present here:

Corephotonics did not rely on [the expert’s] error in any of its arguments on the merits. And it did not contend that this error demonstrated that there would have been no reasonable expectation of success or that it alone was a sufficient basis to find all of Dr. Sasián’s analysis unreliable.

Slip Op. Further, while the PTAB identified additional errors, these inconsistencies were never raised by the parties and appeared to lack evidentiary support.  The PTAB’s “explanations must be supported by substantial evidence, and its decisions must be reached only after the parties have been provided fair notice and an opportunity to be heard.”  Because the PTAB focused on peripheral issues not squarely presented by the parties, it failed to resolve the core obviousness disputes actually raised.

On remand, the PTAB will have the chance to try again — and, more particularly, Apple will get another bite at the Corephotonics patent.

Narrowing the Analogous Arts with a Problem-Solution Statement

by Dennis Crouch

The Federal Circuit recently issued an important decision regarding the analogous art doctrine in Netflix v. DivX, No. 22-1138, — F.4th — (Fed. Cir. Sept. 11, 2023).  The Patent Trial and Appeal Board’s sided with the patentee, holding that a key prior art reference was not analogous art.  On appeal, the Federal Circuit has partially affirmed, but vacated and remanded on a procedural ground.  This case also raises questions about the value of explicitly stating the problem solved within the patent document, and perhaps directly in the patent claims.

The statutory obviousness test requires a comparison of the claimed invention and the prior art from the perspective of a person having ordinary skill in the art (PHOSITA). 35 U.S.C. 103.  Although prior art is generally defined by Section 102(a), courts have concluded that for obviousness purposes, a PHOSITA would only consider “analogous” prior arts. A prior art reference is considered analogous if it fits either of two prongs:

  1. Is the art is from the same field of endeavor, regardless of the problem addressed
  2. Is the reference reasonably pertinent to the particular problem with which the inventor is involved.

An oddity of the analogous art test is that it generally takes a binary approach—either a reference qualifies as analogous art and is considered as valid prior art, or it is deemed non-analogous and categorically excluded. This differs from typical evidence law, where the bar for relevance is low but the fact-finder must still weigh the probative value of the evidence. An alternative approach could apply a more flexible test assessing how closely related a reference is to the field of endeavor or problem addressed, rather than a threshold yes/no question. Under this view, references closely related to the invention would be given greater weight as prior art, while more distantly related references would be considered but afforded less significance in the obviousness analysis. Rather than wholesale exclusion, references could be evaluated along a spectrum. While this incremental approach may have some merits, the Federal Circuit has to date applied the analogous arts test in a binary fashion.

In the case at hand DivX owns US8472792, a patent related to encoding, transmitting, and decoding multimedia files to enable “trick play” functionality like fast forwarding.  Netflix filed an IPR challenging claims of the ‘792 patent as obvious over a primary reference (Zetts) in view of a secondary reference (Kaku).

Kaku discloses using AVI files and index chunks to reproduce motion images in digital cameras, and the IPR focused on whether Kaku qualifies as analogous art to the ‘792 patent. The Board determined Kaku did not qualify as analogous art under either the “field of endeavor” or “reasonably pertinent” tests.  On appeal, Netflix argued the Board erroneously required “magic words” within the petitioner briefing to identify the field of endeavor and that its briefing was sufficient to identify AVI files or encoding/decoding multimedia as potential fields of endeavor. Netflix also challenged the Board’s reasonably pertinent analysis.

On appeal, the court agreed with Netflix that the PTAB abused its discretion by requiring explicit identification of a field of endeavor using specific “field of endeavor” language within the briefs. The court explained that its precedent does not mandate using “magic words” and that Netflix’s briefing, taken as a whole, sufficiently identified potential fields of endeavor. The court remanded for the Board to reconsider the field of endeavor issue under the appropriate standard.

However, the court affirmed the Board’s finding that Kaku was not reasonably pertinent to the ‘792 patent’s problem of facilitating trick play in streaming multimedia. The court found substantial evidence supported the Board’s determination that Kaku addressed a different problem related to image compression and camera memory limitations.

Unlike many patents, the ‘792 patent clearly articulated the goal of enabling trick play functionality directly in the claims. When a patent identifies the purpose or advantage of the invention in its claims, it limits the scope of applicable prior art compared to a patent with vague, generic claims. This is especially true because many patentees intentionally refuse to directly state the problem being addressed within the specification.  By including “enabling trick play functionality” in every claim, the ‘792 patent restricted the field of endeavor and pertinent prior art to references focused on trick play features.

This case raises this question: Should best practices for patent drafting include an explicit statement of the particular problem the invention seeks to solve? As the patent owner here demonstrated, doing so may limit the applicable scope of prior art during litigation. On the other hand, a narrow articulation in the patent itself may make the claims more vulnerable to workarounds. What do you think?

Navigating Claim Construction and Broadening Amendments: Lessons from Sisvel v. Sierra Wireless

by Dennis Crouch

In 2019, Sisvel began asserting its U.S. Patent Nos. 7,433,698 and 8,364,196 against cell phone makers, wireless chip suppliers, and cellular network operators. These patents claim methods and systems for exchanging frequency information between a mobile station and a mobile switching center to facilitate switching a mobile device’s connection point within a cellular network. Several defendants petitioned the Patent Trial and Appeal Board (PTAB) for inter partes review (IPR), arguing that the challenged claims were invalid as anticipated and/or obvious based on prior art references. The PTAB instituted IPR and ultimately issued final written decisions concluding that the claims were unpatentable. See IPR2020-01070, Paper No. 31 (PTAB Nov. 8, 2021); IPR2020-01071, Paper No. 30 (PTAB Nov. 8, 2021).

On appeal to the Federal Circuit, Sisvel challenged the PTAB’s claim construction of the term “connection rejection message” and its denial of Sisvel’s revised motion to amend the ‘698 patent claims. The Federal Circuit, in an opinion authored by Judge Stark and joined by Judges Prost and Reyna, affirmed on both issues. Sisvel International S.A. v. Sierra Wireless, Inc., No. 22-1387 (Fed. Cir. September 1, 2023).

Claim Construction

The claims at issue particularly focus on the use of a “connection rejection message” to confer certain information to a mobile device.  The term is used throughout both the patent specification and the claims.  However, it is not expressly defined. The key dispute was it should be construed broadly to mean simply “a message that rejects a connection” or narrowly limited to “a message from a GSM or UMTS telecommunications network rejecting a connection request from a mobile station.”  As is usual for IPR proceedings, the patentee was asking for the narrow construction in order to avoid the prior art.

The Board and the Federal Circuit both applied the Phillips standard. Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc)  Under Phillips, claims are construed according to their plain and ordinary meaning as understood by a person of ordinary skill in the art, looking at the intrinsic evidence including the claims, specification, and prosecution history. Although the specification provides guidance, limitations found within described embodiments should not be imported into the claims absent a clear intent by the patentee to limit claim scope.  Extrinsic evidence, such as dictionary definitions are less important.

On appeal, the Federal Circuit agreed with the PTAB that the plain and ordinary meaning of “connection rejection message” is “a message that rejects a connection.” It found no persuasive basis in the intrinsic evidence to restrict the term only to GSM or UMTS networks. The patentee’s argument here was that the embodiments found in the specification were all directed to UMTS or GSM networks.  But, the problem is that the specification also states that the invention is could work “in many different cellular telecommunications systems” of which UMTS and GMS are two examples. The specification goes on to state that the system work work in any system that involves sending a rejection message in the manner outlined.  Thus, although the specification only the two networks, the court found that the claims and specification were drafted broadly and did not limit the invention only to GSM/UMTS. The court  ultimately declined to confine the claims only to the disclosed embodiments and instead affirmed the broad construction.

Result — invalidity affirmed.

Motion to Amend

Sisvel also challenged the PTAB’s denial of its revised contingent motion to amend claims of the ‘698 patent. The PTAB found the proposed substitute claims impermissibly broadened the scope of the original claims, specifically by changing “based at least in part on” to merely “using” when referring to information from the connection rejection message.  The AIA explicitly prohibits broadening amendments in IPR proceedings. 35 U.S.C. § 316(d)(3) states that amended claims “may not enlarge the scope of the claims of the patent.” Similarly, 37 C.F.R. § 42.121(a)(2)(ii) provides that a motion to amend may be denied if it seeks to enlarge the scope of the claims.

Sisvel contended that when all limitations were considered together, the substitute claims were narrower overall. On appeal, the Federal Circuit explained that a claim is broadened if it is broader in any respect–even if narrowed in some other respects, if it is broadened in any respect. Here, the change from “based on” to “using” broadened the claims by removing the requirement that the frequency parameter impact the value.

Key Takeaways

In hindsight, this is a situation where the patentee could have drafted the claims in these patents in a way that would have at least avoided the arguments raised here.  Of particular note, it often makes sense to include a dependent claims that narrow aspects of the claim to the same level provided by the embodiments. Here, the court also latched-onto throwaway language in the specification stating that the system could work on any network even though the rest of the specification focused on GSM and UMTS networks.  Still, at the time the statement likely made sense as an attempt to explain why it was proper to allow claim scope that is not limited to those networks.

Double Patenting and Patent Term Adjustment

by Dennis Crouch

The Federal Circuit recently issued an important decision in In re: Cellect, LLC (Fed. Cir. Aug. 28, 2023) regarding how Patent Term Adjustment (PTA) interacts with terminal disclaimers and obviousness-type double patenting (ODP). This case establishes binding precedent that a terminal disclaimer cuts off any extended patent term granted through PTA.

This holding contrasts with the court’s prior rulings regarding Patent Term Extension (PTE), where the extended term is calculated from the disclaimed expiration date, not the original expiration date. Thus, PTE extends beyond a disclaimed term, while PTA does not.

This result was expected by many patent experts, although some in the pharmaceutical industry had pushed for PTA to extend beyond disclaimed terms similarly to PTE. In the end, the statutory language expressly addressing disclaimers in the context of PTA proved decisive. This precedent will apply to all patents already in-force as well as those issued in the future.  Thus, applicants will want to carefully consider PTA and terminal disclaimer strategy for patent families.

If I were the judge, I would (more…)

9th Circuit Revives False Claims Act Action for Fraud on the Patent Office

by Dennis Crouch

The U.S. Court of Appeals for the Ninth Circuit recently issued a pair of decisions in the qui tam case Silbersher v. Valeant Pharmaceuticals concerning the False Claims Act’s (FCA) public disclosure bar.  The case sets significant precedent in linking FCA claims to patent prosecution and fraud upon the patent office.  The case can be contrasted with Silbersher v. Allergan, Inc., 21-15420, — F.4th — (9th Cir. Aug. 25, 2022) [21-15420], that Silbersher lost.

(more…)

“Bald Girls Do Lunch” Unable to Sway the Federal Circuit in Case Involving Deuterated Drug for Alopecia Areata

By Chris Holman

Sun Pharmaceutical v. Incyte, 2023 WL 5370639, Not Reported in Fed. Rptr. (Fed. Cir. Aug. 22, 2023)

Bald Girls Do Lunch (“BDGL”) is a nonprofit organization dedicated to improving the quality of life for females living with alopecia areata (“AA”).  AA has been described as “an autoimmune skin disease resulting in partial to complete hair loss on all hair-bearing areas of the body, including, for example, on the face, resulting in loss of eyebrows and eyelashes.” According to BDGL, “AA is not a simple cosmetic problem—it is a chronic, often devastating condition that has substantial and wideranging implications, affecting patient’s physical, mental, and emotional health.  Indeed, in severe cases, AA can lead to chronic depression.” (more…)

PTAB Captains Take Notice: Carefully Weigh Secondary Considerations

By Dennis Crouch

The nexus requirement serves as a threshold that must be met before secondary indicia will be even considered as relevant to the obviousness inquiry.  In its recent Volva Penta decision, the Federal Circuit found that the PTAB had  (1) created too high of a burden to prove nexus and (2) been unduly dismissive of the patentee’s evidence of commercial success and copying.  The case reinforces the notion that patentees should attempt to include some claims that are largely coexistive with its product line, especially in today’s world of likely copying. The case also serves as a reminder that product copying still caries significant weight in the obviousness analysis. Volvo Penta of the Americas, LLC v. Brunswick Corp., 22-1765, — F.4th — (Fed. Cir. August 24, 2022). (more…)

Size Matters: Element-by-Element Analysis in Obviousness

by Dennis Crouch

In re Universal Electronics, Inc., No. 2022-1716 (Fed. Cir. Aug. 15, 2023) (non-precedential)

This was a consolidated appeal from two Patent Trial and Appeal Board (PTAB) decisions affirming the rejection of claims from Universal Electronics, Inc.’s (UEI) U.S. Patent Application Nos. 12/645,037 and 16/279,095 as obvious under 35 U.S.C. § 103.  On appeal, the Federal Circuit has affirmed. (more…)

Three issues: Law/Fact Distinction in Obviousness; Envisaging the Invention; and Newman in Dissent

by Dennis Crouch

Incept LLC v. Palette Life Sciences, Inc., No. 21-2063 (Fed. Cir. Aug. 16, 2023) (Majority by Judges Schall and Taranto; Dissent-in-part by Judge Newman)

The most interesting line in the case for appellate attorneys (and legal scholars) is probably the court’s law/fact distinction in the context of obviousness analysis.  The majority wrote: “We see no reversible error … whether viewed as a factual one about the level of [commercial] success or a legal one about the weight of any such success in the overall obviousness analysis.”  The law/fact divide is important because of the evidentiary requirements in the first instance and the standard for review on appeal. Here, the court makes clear that the weight given to any objective indicia of non-obviousness is a question of law rather than a question of fact.  The result then is that its analysis can generally be based upon reason rather than evidence, and that issue is one that will be heard de novo on appeal. (more…)

ApoA1-Fc Fusion Proteins: Federal Circuit keeps Patent Hopes Alive, Holding that the USPTO Must Explain its Decisions

In re Theripion, Inc., 2022-1346 (Fed. Cir. Aug. 10, 2023) (nonprecedential) (Opinion by Judge Stark, joined by Judges Hughes and Cunningham).

ApoA1 is a key component of HDL, also known as “good cholesterol.” The founders of Therapin created a synthetic “fusion protean” of ApoA1 linked to the Fc portion of an antibody (the stem).  That fusion extends the half-life of injected HDL and allows it to be a better potential drug treatment. The claims require a specific linker protein of 10-40 amino acids between the ApoA1 and Fc portions. Theripion discovered that this longer linker improved cholesterol efflux activity compared to fusion proteins having shorter 2 amino acid linkers or no linker.  So the essence of the invention as claimed is an ApoA1-Fc fusion protein with an optimized 10-40 amino acid linker that enhances the fusion protein’s ability to remove cholesterol from cells as compared to a much shorter or absent amino acid linker.  To be clear, the prior art (including some work by the inventors here) had created ApoA1-Fc fusions, but with a short linkage. And, various types of connectors of the claimed length were also known. (more…)

Shifting Arguments at the PTAB

by Dennis Crouch

The Federal Circuit’s new decision in Rembrandt Diagnostics, LP v. Alere, Inc., 2021-1796 (Fed. Cir. Aug 11, 2023) complements the court’s recent decision in Axonics, Inc. v. Medtronic, Inc., 2022-1532 (Fed. Cir. Aug. 7, 2023). Ordinarily, an IPR petitioner must stick to the arguments and reasoning that it sets forth in the original petition.  These two cases take a contrary position and permit the petitioner to shift as late as the  final reply brief. The court permits these changes only if responsive to new arguments by the patentee and sufficiently linked to previously raised arguments.

This post focuses on Rembrandt.  A prior post looked at Axonics.

Rembrandt was previously before the Federal Circuit on the full-institution issue that the Supreme Court addressed in SAS Institute.  The PTAB had originally instituted Alere’s IPR petition on some but not all grounds presented.  In its 2019 decision, the Federal Circuit affirmed the PTAB’s claim construction but remanded for the PTAB to consider non-instituted grounds.   On remand, the PTAB instituted on all grounds and eventually concluded that additional claims were also unpatentable as obvious. On appeal this time, the Federal Circuit has affirmed — finding that the PTAB had properly found the claims obvious.

Rembrandt owns U.S. Patent No. 6,548,019 related to assay test strip devices for testing biological fluids.  As the figure shows, the setup is quite simple and allows for multiple strips to be tested at once.

One of the key issues raised on appeal was the presentation of new theories mid-stream by the petitioner Alere.  In particular, Rembrandt pointed to Alere’s reply brief as offering new theories.

Rembrandt argued Alere raised new theories about cost/time savings as a motivation to modify the MacKay reference to hold multiple test strips. However, the Federal Circuit found this was responsive to Rembrandt’s argument that there was no motivation to modify MacKay. Further, the cost/time savings was viewed as properly expanding on Alere’s previous “efficiency” argument.

Alere’s reply argument discussing cost and time savings has a nexus to Rembrandt’s prior argument and is responsive. It refutes Rembrandt’s assertions that there is no motivation to add multiple test strips or an expectation of success. And by discussing time and cost savings as a form of efficiency, it also properly expands on and is a fair extension of its previously raised efficiency argument.

Slip Op.

The Federal Circuit found an alternative reason to affirm — holding that forfeited its argument.  Before the PTAB, Rembrandt had generally objected to new theories presented by Alere.  However, the Federal Circuit concluded that generic objection was insufficient to timely assert its right. The Federal Circuit’s position was bolstered by the fact that Rembrandt had made a very specific objection regarding another new-theory issue that is not on appeal. “We hold that Rembrandt’s generic objection is insufficient to constitute a proper objection—especially because Rembrandt expressly objected to other allegedly new theories without doing so here.”

In addition to these procedural issue, the court also concluded that the Board’s conclusions were supported by substantial evidence. A key here is that Rembrandt did not provide expert testimony to rebut Alere’s expert. The prior art and expert testimony provide substantial evidence to support the PTAB’s findings on the teachings of the prior art and motivation to combine.

Shamoon v. Resideo: Obviousness affirmed

by Dennis Crouch

Shamoon v. Resideo Technologies, Inc., No. 2021-1813 (Fed. Cir. Aug. 8, 2023) (opinion by Judge Newman; joined by Judges Reyna, and Cunningham) (non-precedential)

Charles Shamoon is the inventor and owner of U.S. Patent No. 8,064,935. The patent relates to a remote access system that allows users to monitor and control “environmental devices” like alarm and HVAC systems in their home using a base control unit and a remote unit.  Resideo challenged the patent in a pair of IPR petitions, and the PTAB eventually found the challenged  claims unpatentable as obvious over a combination of two/three prior art references.

On appeal, the Federal Circuit affirmed and rejected Shamoon’s three challenges.

The claims require a microcontroller, and Shamoon argued that the term should be construed as requiring a particular type of microcontroller that included certain memory elements. That narrowed definition might have helped Shamoon avoid the prior art.  But, the Federal Circuit upheld the PTAB’s broad claim construction of “microcontroller” — finding that it was broadly used both in the claims and the specification.

Some of the claims required a confirmation message be sent once an instruction had been executed, and Shamoon argued that the prior art failed to teach a confirmation message related to an environmental device command.  On appeal though, the court found that it was proper to combine the teaching of a confirmation message from a reference not related to environmental devices.  “Because Oinonen and Whitley disclose the environmental devices and  commands, it does not avail Mr. Shamoon to complain that Menard does not.” Slip Opinion.  Shamoon’s argument here

Finally, Shamoon argued that applying AIA proceedings to his pre-AIA patent was impermissible taking by the United States without just compensation, in violation of the Fifth Amendment.  The court quickly rejected this argument based upon its prior precedent in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019) (“retroactive application of IPR proceedings to pre-AIA patents is not an unconstitutional taking under the Fifth Amendment.”).

PTAB Strategy: Balancing the Sandbagging

by Dennis Crouch

The Federal Circuit’s recent Axonics decision reflects an ongoing tension between IPR petitioners and patent owners concerning litigation strategies and procedural fairness. A prevalent patentee strategy aims to force the petitioner to lock in specific arguments, only to provide a game-changing response later on.

In Axonics, the patentee offered a new claim construction proposal in its post-institution response. On appeal, the Federal Circuit determined that it was only just, and mandated by the APA, for the petitioner to present new responsive arguments and evidence in its reply briefing. Additionally, the court suggested that the patentee should then have the opportunity to submit further evidence in a sur-reply. The PTAB had adopted the patentee’s claim construction proposal and refused to consider Axonics reply arguments and evidence — finding them to represent improper new arguments.  The Federal Circuit vacated that decision and sent the case back down for reconsideration.

Sandbagging Risk and the Need for Balance

In his opinion for the court, Judge Dyk quotes from the oral argument transcript after getting an admission from Medtronic’s attorney (Naveen Modi from Paul Hastings) that the PTAB approach risks sandbagging by the patentee:

The Court: “But isn’t there a risk here of sandbagging, that you realize there’s a good claim construction argument, [and] you leave it out of your preliminary response. If you argued it in your preliminary response, then maybe institution would be denied and there would
be no estoppel. But if you hold back on the argument and wait to make it until the response, then you get the estoppel. Isn’t there a risk of that?”

Medtronic’s counsel: “Certainly, your honor, there is a risk of that . . . .”

Oral Arg. at 14:24–51.  Modi went on to explain that the risk could also affect the petitioner. The new rule permits the petitioner to provide an unreasonable initial claim construction, then present new evidence later if challenged. Here, the court explicitly concluded that petitioners are not bound to preemptively address all potential reasonable claim interpretations.

Important Caveats and Ongoing Questions

The case has some important caveats regarding what argument/evidence can be provided in reply.  The court made clear that a petitioner cannot raise entirely new prior art references in a reply to a patent owner’s response: “a petitioner may not in reply rely on new prior art to teach a claim limitation.”  And, the court refused to decide an intermediary question of whether the petitioner can rely upon “new embodiments” from the already presented prior art in order to counter a new claim construction proposal. “We leave for another day the question of whether, when presented with a new claim construction, a petitioner can rely in its reply on new embodiments from the prior art references that were relied on in the petition.”  That particular situation was not at issue because “Axonics, in the reply, relied on the same embodiments as it relied on in the petition.”

In essence, while a petitioner cannot introduce entirely new prior art references in a reply, it remains an open question whether new portions or embodiments from the same preexisting references can be cited to address a new claim construction proposed post-institution.

Striking a Middle Course

In this frame, the decision shows the Federal Circuit steering a middle course – allowing petitioners to respond to changed claim constructions with arguments tied to the same prior art, while prohibiting entirely new prior art in replies. Ongoing cases will likely continue to shape the precise boundaries between fair response and improper new arguments in this contentious field.

Citation: Axonics, Inc. v. Medtronic, Inc., 2022-1532 (Fed. Cir. Aug. 7, 2023) (opinion by Judge Dyk, joined by Judges Lourie and Taranto).

In July 2023, the same panel released a separate decision involving the same parties and also siding with the petitioner Axonics in holding that Board erred in its obviousness analysis by improperly framing the motivation-to-combine inquiry. [LINK]

The result: Although the Board sided with the patentee on the four challenged patents, the Federal Circuit vacated those holdings and given the petitioner another chance to prove its case. and See U.S. Patent Nos. 8,036,756, 8,457,758, 8,626,314, and 8,738,148.  As with most Medtronic patents, the inventions are super interesting. One set relates to implanting a neurostimulation lead and the second set relates to transcutaneous charging of implanted medical devices.

Claim Construction Order Sets Stage for Moderna v. Pfizer Vaccine Patent Showdown

by Dennis Crouch

Moderna filed a patent infringement lawsuit against Pfizer and BioNTech in August 2022, alleging that the defendants COVID-19 vaccine infringes three patents related to Moderna’s mRNA vaccine technology.  United States Patent Nos. 10,898,574, 10,702,600, and 10,933,127. The lawsuit centers around two key components of Moderna’s mRNA platform that it claims Pfizer copied – the use of modified nucleosides like 1-methylpseudouridine and the encoding of a full-length coronavirus spike protein. Moderna asserts that it pioneered these innovations years before the COVID-19 pandemic and patented them between 2011-2016. The complaint alleges Pfizer and BioNTech initially tested different vaccine designs but ultimately chose to copy Moderna’s approach, despite being aware of Moderna’s patents. In the lawsuit, Moderna is seeking monetary damages for patent infringement but not injunctive relief taht would remove the Pfizer vaccine from the market. Although Moderna pledged not to enforce its COVID-19 patents during the pandemic, it signaled in March 2022 that expected companies to respect its intellectual property rights going forward.

In its response, Pfizer denied Moderna’s allegations of patent infringement and explained that it independently developed its COVID-19 vaccine without copying Moderna’s technology. Pfizer argues that Moderna’s patents are invalid because of the way they reach beyond Moderna’s actual contributions to mRNA technology and improperly claim fundamental discoveries made by other scientists.  In this vein, Pfizer raises several affirmative defenses, including invalidity and non-infringement of the asserted patents. Pfizer also asserts defenses based on implied license, waiver, and acquiescence stemming from Moderna’s public pledge not to enforce its COVID-19 patents during the pandemic.  As is usual, the answer also includes counterclaims that mimic the affirmative defenses — seeking declarations that the patent claims are invalid, not infringed, and unenforceable against Pfizer.  Here, these particular pleadings are rather limited and, for the most part, generally assert “35 U.S.C. 101, 102, 103, and/or 112.”

Docs:

The case is slowly moving forward in before Judge Richard Stearns with a trial rougly set for Fall 2024. Most recently, Judge Stearns issued a claim construction order following a Markman hearing.  As is common, the patentee did not ask for any construction, the defendants asked the court to define several terms.  Some of the proposals ask for broad definitions of certain terms (that would help Pfizer prove invalidity); while others sought narrow definitions of other terms (that would help Pfizer avoid infringement).  I tried to note the impact of the various constructions below. As you can see, each party won and lost arguments, but in the whole this looks like a good decision for Moderna.

  • The court adopted a broad definition of “unmodified mRNA” suggested by Pfizer that includes a statement that “Unmodified may, but does not always, refer to the wild type or native form of a biomolecule.”  (This will help Pfizer prove invalidity)
  • For the term “betacoronavirus,” the court rejected Pfizer’s argument that it is limited to betacoronaviruses in existence at the time of filing. The court found the intrinsic evidence indicates the term encompasses betacoronaviruses discovered after the filing date.  (This will help Moderna prove infringement)
  • The court construed “S protein” as simply “spike protein, a structural protein forming a spike.” It declined to include functional limitations proposed by Pfizer.  (This will help Moderna prove infringement)
  • The court construed “open reading frame” to apply to both DNA and mRNA. Pfizer had suggested limiting the term to just DNA contexts. (This helps Moderna prove infringement).
  • The court construed the term “mRNA” to mean “messenger RNA, i.e., a ribonucleic acid (RNA) that encodes a polypeptide and can be translated to produce the encoded polypeptide.” This roughly aligns with Moderna’s proposed construction.   Pfizer had asked that for a definition that included mRNA as a “template for encoding” a polypeptide.  (It is not clear to me the impact of this ruling, however it likely favors Pfizer’s invalidity arguments focusing on whether certain prior art references sufficiently disclose mRNA).

For those of you new to claim construction, the district court is charged with defining terms used in the patent claims when they are a bit too unclear, or when the parties are disputing over their meaning.  The basic approach is that the court should provide the meaning that would a person of ordinary skill in the art would give to the terms at the time of the invention, and after reviewing the claims, the specification, and the prosecution history. See Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). Extrinsic evidence such as dictionary definitions and expert opinion can play a role, but is usually secondary to the intrinsic evidence.  This ruling on claim construction is really setting of the stage, with the real action coming soon via summary judgment motions and eventually the trial.

In my analysis above, I noted some inference about the impact of the various claim construction rulings. Please note that the parties have not yet briefed these issues and so we’ll see what happens.  There may be an immediate summary judgment motion, but I don’t see that as likely until the close of discovery.  It is important to remember that claim construction is not a final determination on infringement or invalidity, but  simply provides interpretations of disputed terms that will be used in those later determinations. In addition, parties often ask a court to reconsider its claim construction.

Although Pfizer obviously does not want to be liable for patent infringement here, Pfizer also holds and is seeking numerous patents on its own related technology.  I expect that Pfizer’s invalidity arguments will be targeted toward specific concerns with the Moderna patents rather than attempting to substantially expand the law.  We might see a different strategy if a non-profit or consumer-focused group had filed. We saw the latter in the Supreme Court’s 2013 Myriad decision.

= = =

Claim 1 of the ‘600 Patent is directed to the mRNA composition designed to encode a betacoronavirus spike protein or subunit, formulated in a lipid nanoparticle.

1. A composition comprising: a messenger ribonucleic acid (mRNA) comprising an open reading frame encoding a betacoronavirus (BetaCoV) S protein or S protein subunit formulated in a lipid nanoparticle.

Note that the court broadly defined betacoronavirus to include later-invented forms.  This leaves the claim open to enablement and written description challenges.

The ‘574 patent claims methods of using modified messenger RNA (mmRNA) with reduced immune activation properties compared to unmodified mRNA and also a slightly different composition claim. Unlike the ‘600 patent, these do not focus on the spike protein but are more generic versions of using the mRNA technology.

1. A method of producing a polypeptide of interest in a cell in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising a modified messenger RNA (mmRNA) such that the mmRNA is introduced into the cell, wherein the mmRNA comprises a translatable region encoding the polypeptide of interest and comprises the modified nucleoside 1-methyl-pseudouridine, and wherein the pharmaceutical composition comprises an effective amount of the mmRNA providing for increased polypeptide production and substantially reduced innate immune response in the cell, as compared to a composition comprising a corresponding unmodified mRNA.

2. A pharmaceutical composition comprising: a plurality of lipid nanoparticles comprising a cationic lipid, a sterol, and a PEG-lipid,

wherein the lipid nanoparticles comprise an mRNA encoding a polypeptide, where in the mRNA comprises one or more uridines, one or more cytidines, one or more adenosines, and one or more guanosines and wherein substantially all uridines are modified uridines.

Finally, the ‘127 patent claims methods of administering a composition comprising mRNA encoding a betacoronavirus spike protein formulated in a lipid nanoparticle.  These claims specify percent ranges for ionizable cationic lipid, neutral lipid, cholesterol, and PEG-modified lipid components in the lipid nanoparticle.

1. A method comprising administering to a subject a messenger ribonucleic acid (mRNA) comprising an open reading frame encoding a betacoronavirus (BetaCoV) S protein or S protein subunit formulated in a lipid nanoparticle in an effective amount to induce in the subject an immune response to the BetaCoV S protein or S protein subunit, wherein the lipid nanoparticle comprises 20-60 mol % ionizable cationic lipid, 5-25 mol % neutral lipid, 25-55 mol % cholesterol, and 0.5-15 mol % PEG-modified lipid.

 

Federal Circuit’s Sleepy Obviousness Decision and Vanda’s En Banc Rehearing Petition

by Dennis Crouch

Documents: FedCir Vanda DecisionVanda EnBanc Brief

The Federal Circuit recently sided with the accused infringers Teva and Apotex, affirming the invalidation claims from four Vanda patents covering methods of using tasimelteon to treat circadian rhythm disorders. However, the patent owner has petitioned the court for en banc rehearing, arguing the panel improperly disregarded evidence of nonobviousness.  Responsive briefing from the generics are due on August 1.

This case provides an interesting look at the application of the obviousness standard to pharmaceutical treatment methods.

Background: Vanda Pharmaceuticals owns patents covering use of the drug tasimelteon to treat Non-24-Hour Sleep-Wake Disorder (Non-24), a condition caused by lack of synchronization between a person’s circadian rhythm and the 24-hour day. Tasimelteon is sold under the brand name Hetlioz and has over $100m in annual sales. Several generic drug makers, including Teva and Apotex, filed Abbreviated New Drug Applications (ANDAs) with the FDA seeking to market generic versions of tasimelteon and with allegations. Vanda sued, alleging infringement of four patents that were listed in the Orange Book. RE46604 (Claim 3); US10149829 (Claim 14); US9730910 (Claim 4); US10376487 (Claim 5). The district court found all asserted claims obvious based on prior art teachings about tasimelteon and related drugs. Vanda appealed.

In a May 2023 decision, the Federal Circuit affirmed the invalidity ruling. The panel found no error in the district court’s determination that the prior art would have provided a reasonable expectation of success for the claimed inventions.

Key Aspects of the Federal Circuit’s Obviousness Analysis

The inventions here involved fairly narrow differences, and the Federal Circuit concluded that a PHOSITA would have seen a reasonable expectation of success:

  • Administering without food: There was a motivation to try and a reasonable expectation of success here since FDA guidance recommended food studies, and there are just two potential options (with or without food).  There result here is close to a per-se obviousness ruling.
  • 20 mg dose to “entrain patients”: The prior art disclosed 20 mg dose and suggested entrainment.  Still obvious even though the prior study results (Rajaratnam) were not statistically significant.  In a different patent application, Vanda had characterized Rajaratnam as showing that an oral dose of 20 mg was effective.  The court also noted that an ongoing clinical trial at the time was testing 20 mg — further contributed to the expectation of success.
  • Avoiding Co-administration with CYP enzyme inhibitors: A similar drug (ramelton) had shown problems with co-administration with these CYP enzyme inhibitors, creating a reasonable expectation that tasimelteon would also show similar results. On this point, the testimony was that PHOSITA would not have “ruled out an interaction.”

The key with all of these is reliance on KSR‘s flexible approach and expanded use of the reasonable expectation of success standard.  Although Vanda argued objective indicia, it was given very little consideration by the appellate panel.

Vanda’s Petition for Rehearing En Banc

Vanda’s en banc brief asks three questions:

  1. With or Without Food: Whether method-of-treatment patents directed to the effect of food on a particular drug are per se obvious because of FDA Guidance acknowledging that food may affect the bioavailability of drugs and should be studied.
  2. Clinical Trial as Evidence of Reasonable Expectation of Success: Whether a disclosure showing existence of an ongoing clinical trial is evidence of a reasonable expectation of success as to the result of the trial.  See OSI Pharms v. Apotex (Fed. Cir. 2019) (clinical trial provides only hope, not expectation of success).
  3. Results from Similar Drug: Whether a drug-drug interaction patent is obvious when a POSA could not “rule out” the interaction because another compound in the same general category has shown such an interaction.

The petition urges the full Federal Circuit court to take the case en banc to maintain uniformity of obviousness precedents. I’m sure that companies in the life sciences sector will be closely watching this case as it continues to unfold.

A National Right of Publicity: the Federal Anti-Impersonation Right (FAIR)

by Dennis Crouch

Intellectual property rights in the U.S. have long been a mix of state common law rights and federal statutory rights.  Patents and copyrights were established in the Constitution and enacted by the First Congress in 1790.  Those rights were fairly quickly established as exclusively federal, meaning that there is effectively no patents or copyrights offered by individual states.  Trademarks and trade secrets followed a different path – developing under state common law before later later gaining federal protections; with trade secrets moving federal most recently via the Defend Trade Secrets Act (DTSA) of 2016.  Unlike patent and copyright, trademarks and trade secrets continue to be concurrent and overlapping, meaning that state rights continue to exist and be enforceable alongside the federal right.  It is common for litigation to assert both.  With trademark law, the federal right has been around since 1870 and today occupies most of the space.  Because the federal trade secrecy right is so new (and no registration is available), it is still unclear whether we’ll see the same result.

The straggler here is the right of publicity, often termed Name Image & Likeness or NIL rights.  Although publicity rights initially emerged as a privacy interest, I find that students are quick to see its kinship to trademark law and unfair competition.  While typical privacy rights focus on personal interests and one’s peace of mind, the right of publicity is more economic and commercial in nature.  The basic idea here is that a person’s reputation is an asset — commercial goodwill.  And, that person’s brand is their name, image, and likeness.

The growth of the internet and influencer culture has raised the awareness and importance of publicity rights as the a key transferable with endorsement deals and celebrity advertising.  In the background, we also have the emergence of deep fake AI tools that allow digital impersonation of celebrities at a level never experienced (as exemplified by my AI created version of Swift above).

In a recent hearing on AI IP issues before the US Senate IP subcommittee, Adobe proposed creating a new federal right of publicity called the Federal Anti-Impersonation Right (FAIR). This would establish a minimum level of protection against the unauthorized commercial use of a person’s name, image, likeness, or other identifying aspects of their persona. Adobe argued this is needed to protect artists and creators from having their style or likeness copied by AI tools and used by others for commercial gain.  A national right of publicity could provide more consistent protections similar to those created for trademarks and trade secrets. It could also facilitate enforcement across state lines and could eventually serve as the basis for international treaties in this increasingly global space where persona rights are often exploited online and across multiple platforms.

Adobe’s proposal is largely in theory, and the terms have not yet been drawn-up. Obviously, key policy questions remain:

  • Should protections apply only to famous personalities or to anyone whose NIL is used for commercial gain?
  • How should we balance free speech, parody, and fair use concerns?
  • To what extent should online platforms be shielded from liability?
  • Should rights vest only for commercial exploitation or is there a privacy interest to protect?

The origins of publicity rights stem from privacy protections rather than commerce. This conceptual difference from trademark law is important, and I would suggest that any federal right should consider personal dignity and reputational interests, not just economic harms from impersonation.

What do you think? Are you ready for a national right of publicity?