Only an Expert Can Testify about What Would Be Obvious to a Non-Expert

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In HVLPO2, LLC, v. Oxygen Frog, LLC, [2019-1649] (February 5, 2020), the Federal Circuit reversed and remanded the district court’s determination that U.S. Patent Nos. 8,876,941 and 9,372,488 directed to methods and devices for controlling an oxygen-generating system, would have been obvious, because the district court abused its discretion by admitting lay witness testimony regarding obviousness.

At trial, Oxygen Frog argued that the claims were obvious in view of a combination of two prior art references. The author of one of the references, Piebes, was not qualified as an expert witness, but did provide deposition testimony as a fact witness. HVO objected to Mr. Piebes’ testimony regarding obviousness as improper expert opinion testimony. The district court overruled the objection, and instead gave the jury a limiting instruction prior to playing Mr. Piebes’ deposition testimony.

The Federal Circuit found that under the circumstances here, the district court’s limiting instruction was insufficient to cure the substantial prejudice caused by Piebes’ testimony, and thus the district court abused its discretion by denying a motion for a new trial.

The Federal Circuit said that the admission of Piebes’ testimony opining that it would be “obvious” to modify a prior art system in a particular way that would match the claimed invention was improper. It noted that Federal Rule of Evidence 702 provides:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:
(a) the expert’s scientific, technical, or other spe-cialized knowledge will help the trier of fact to un-derstand the evidence or to determine a fact in issue; . . .

The Federal Circuit said that this precisely described testimony which would pertain to an obviousness invalidity challenge in a patent trial. The Federal Circuit said that Issues of infringement and validity are analyzed in great part from the perspective of a person of ordinary skill in the art, such that a witness who is not ‘qualified as an expert by knowledge, skill, experience, training, or education’ in the pertinent art cannot assist the trier of fact to understand the evidence or to deter-mine a fact in issue. Thus, the Federal Circuit said. “it is an abuse of discretion to permit a witness to testify as an expert on the issues of non-infringement or invalidity unless that witness is qualified as an expert in the pertinent art.

The Federal Circuit said that the prohibition of unqualified witness testimony extends to the ultimate conclusions of infringement and validity as well as to the underlying technical questions. A witness not qualified in the pertinent art may not testify as an expert on obviousness, or any of the underlying technical questions, such as the nature of the claimed invention, the scope and content of the prior art, the differences between the claimed invention and the prior art, or the motivation of one of ordinary skill in the art to combine these references to achieve the claimed invention.

Because the district court abused its discretion by admitting lay witness testimony regarding obviousness, the Federal Circuit reversed and remanded for a new trial.

Federal Circuit Asks PTAB to Give it a Go and Decide Whether Indefinite Claims Were otherwise Patentable

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In Samsung Electronics America, Inc. v. Prisua Engineering Corp., 2019-1169, 2019-1260 (February 4, 2020) the Federal Circuit affirmed the PTAB determination that claim 11 of U.S. Patent No. 8,650,591 was invalid for obviosuness, but vacated the PTAB’s decision declining to decide whether claims 1-4 and 8 were patentable because these claims were indefinite.

The claims of the ‘591 patent are directed to methods and apparatuses for generating a displayable edited video data stream from an original video data stream. The Board determined that claim 1 (and claims 2-4 and 8) claimed both an apparatus and a method, and thus was indefinite under IPXL Holdings. Because the claims were indefinite, the Board declined to determine whether they otherwise defined patentable subject matter. The Board also found the claims indefinite because of the inclusion of “digital processing unit” which the Board found invoked 112(f), without identifying any corresponding stucture in the claims.

Samsung appealed arguing that the Board should have declared the claims in valid for indefiniteness. The Federal Circuit agreed with the Board that the Board did not have the authority to invalidate claims on that ground.

Samsung’s secondary argument was that the Board should have nonetheless assessed the patentability of claims 1 and 4–8 under sections 102 or 103. On this point, the Federal Circuit agreed.

The Federal Circuit noted that on the first ground of indefiniteness — mixed method and apparatus claiming, the indefiniteness problem was one of understanding when infringement occurred, and not necessarily what the claim actually means. Moreover, the Federal Circuit noted that the Board had previously held that IPXL-type indefiniteness does not prevent the Board from addressing patentability.

Thus the Federal Circuit remanded the case for the Board to attempt to apply 102 and 103 to the claims.

As to the second ground of indefiniteness, that “digital processing unit” invoked 112(f) without providing corresponding structure in the claims, the Federal Circuit disagreed. The Federal Circuit said that the question whether the term “digital processing unit” invokes section 112, paragraph 6, depends on whether persons skilled in the art would understand the claim language to refer to structure, assessed in light of the presumption that flows from the drafter’s choice not to employ the word “means. The Federal Circuit said that the Board pointed to no evidence that a person skilled in the relevant art would regard the term “digital processing unit” as purely functional. In fact, the patent owner argued to the Board, based on testimony from its expert (the inventor), that the digital processing unit recited in the claims is “an image processing device that people in the art are generally familiar with.” Moreover, the fact that claim 1 required the “digital processing unit” to be operably connected to a “data entry device” supports the structural nature of the term “digital processing unit,” as used in the claim.

The Federal Circuit rejected the Board’s conclusion that the term “digital processing unit,” as used in claim 1, invoked means-plus-function claiming,
and that for that reason claims 1 and 4–8 cannot be analyzed for anticipation or obviousness.

Recognizing the History-Makers in Black History Month

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An important part of black history is the many inventive contributions of black Americans. The achievements of just a few of them are highlighted below.

George Washington Carver was an African American scientist and educator, famous for many inventions relating to peanuts. He as born into slavery but become one of the most prominent scientists and inventors of his time, as well as a teacher at the Tuskegee Institute. Carver did not patent most of his inventions, but did receive three patents, including U.S. Patent No. 1,522,176 on a Cosmetic and Process for Making Same, and U.S. Patent No. 1,632,236 on Process of Producing Paints and Stains.

Lonnie G. Johnson is a former Air Force/NASA engineer who among other things, invented the Super Soaker water gun, for which he received U.S. Patent No. 5,074,437.

U.S. Patent No. 5,074,437

Johnson’s other patents include U.S. Patent No. 5,982,144 on Rechargeable Battery Power Supply Overcharge Protection Circuit; U.S. Patent Nos. 6,000,386 and 6,003,503 on Toy Gun with Fluid Pulsator; U.S. Patent No. 6,099,266 on Air Pump; U.S. Patent No. 6,180,281 on Composite Separator and Electrode; U.S. Patent No. 6,220,237 on Compressed Air Toy Gun; U.S. Patent No. 6,223,449 on Apparatus for Extracting Plasticizer; U.S. Patent Nos. 9,266,085 and 9,387,453 on Johnson Ambient-Heat Engine.

Garrett Morgan, the son of a freed slave, started out as a sewing-machine mechanic, but went to patent several inventions, including a hair-straightening product, a breathing device (U.S. Patent No. 1,113,675), an improved sewing machine and an improved traffic signal (U.S. Patent No. 1,475,074).

Lewis H. Latimer was an patent draftsman and inventor in his own right who worked with Thomas Edison, Alexander Graham Bell, and Hiram Maxim. His greatest invention may be the carbon filament for light bulbs , a vital component of the light bulb (U.S. Patent No. 252,386).

U.S. Patent No. 252,386

His other inventions included Water-Closets for Railroad-Cars (U.S. Patent No. 147,363); Electric Lamp (U.S. Patent No. 247,097), Globe Supporter for Electric Lamps (U.S. Patent No. 255,212); Apparatus for Cooling and Disinfecting (U.S. Patent No. 334,078); Locking Rack for Hats, Coats, Umbrellas, &c. (U.S. Patent No. 557,076); and Book Supporter (U.S. Patent No. 781,890).

Marie Van Brittan Brown was an African-American inventor, who, motivated by how long it would take the police to arrive in her neighborhood, invented the first form of a home security system. Her U.S. Patent No. 3,482,037 issued in 1969.

U.S. Patent No. 3,482,037

Otis Frank Boykin was an African American engineer and inventor of as many as 27 electronic devices, but he is best known for inventing electronic control devices for guided missiles, IBM computers, and the pacemaker. His other inventions included a Resistor, U.S. Patent 2,634,352 and 2,891,227; Electrical Resistor And Method Of Making The Same, U.S. Patent No. 4,418,009, and 4,561,996; Self Supporting Electrical Resistor Composed Of Glass, Refractory Materials And Noble Metal Oxide (U.S. Patent No. 4,267,074.

Marian R Croak is a Vice President of Engineering at Google. She was previously Senior Vice President of Research and Development at AT&T Labs, where she is credited as a developer of Voice over IP (VoIP) creating most of methods and features that both improved its reliability and ushered in its nearly universal adoption, and more than 125 of her more than 200 U.S. patents cover VoIP.

Her U.S. patents include: 10,295,358, 9,823,087, 9,621,719, 9,360,327, 9,344,322, 9,282,198, 9,224,108, 9,219,820, 9,210,027, 9,137,361, 9,078,023, 9,054,887, 9,014,053, 9,001,987, 8,983,046, 8,954,352, 8,953,763, 8,942,367, 8,934,474, 8,897,436, 8,885,638, 8,867,525, 8,867,524, 8,855,908, 8,837,695, 8,836,752, 8,804,703, 8,804,539, 8,799,976, 8,798,258, 8,793,150, 8,787,551, 8,775,639, 8,755,496, 8,750,479, 8,737,584, 8,737,575, 8,737,381, 8,731,164, 8,730,952, 8,730,941, 8,718,265, 8,711,680, 8,705,518, 8,705,401, 8,699,681, 8,693,665, 8,687,502, 8,682,711, 8,681,633, 8,676,702, 8,675,857, 8,675,638, 8,670,323, 8,667,545, 8,660,903, 8,654,788, 8,654,670, 8,644,296, 8,638,656, 8,625,770, 8,625,754, 8,625,578, 8,615,004, 8,615,003, 8,614,959, 8,612,512, 8,611,258, 8,600,009, 8,594,128, 8,593,939, 8,588,216, 8,588,083, 8,582,590, 8,576,832, 8,570,906, 8,565,409, 8,553,863, 8,549,156, 8,538,005, 8,532,088, 8,520,816, 8,520,811, 8,515,045, 8,457,108, 8,437,337, 8,437,246, 8,411,668, 8,379,817, 8,369,230, 8,358,770, 8,358,760, 8,355,314, 8,340,261, 8,307,091, 8,306,190, 8,295,461, 8,284,679, 8,279,856, 8,275,828, 8,265,256, 8,259,608, 8,254,540, 8,243,912, 8,238,353, 8,213,584, 8,199,744, 8,199,742, 8,184,792, 8,184,548, 8,155,295, 8,150,009, 8,130,934, 8,130,932, 8,130,923, 8,107,459, 8,098,803, 8,098,281, 8,094,568, 8,072,968, 8,072,881, 8,064,452, 8,064,438, 8,059,645, 8,018,835, 7,995,739, 7,995,709, 7,995,486, 7,995,464, 7,983,404, 7,978,601, 7,974,292, 7,965,700, 7,958,561, 7,948,965, 7,933,213, 7,925,503, 7,924,814, 7,912,039, 7,903,798, 7,899,159, 7,881,294, 7,881,289, 7,852,991, 7,852,832, 7,843,964, 7,843,841, 7,839,992, 7,801,115, 7,801,114, 7,797,459, 7,792,269, 7,783,024, 7,778,402, 7,773,734, 7,760,861, 7,756,254, 7,756,024, 7,746,771, 7,738,641, 7,738,446, 7,734,024, 7,734,022, 7,734,021, 7,733,850, 7,733,847, 7,715,548, 7,715,412, 7,715,368, 7,668,714, 7,664,252, 7,664,241, 7,664,237, 7,664,106, 7,664,101, 7,664,099, 7,664,039, 7,664,038, 7,664,033, 7,639,793, 7,639,790, 7,627,106, 7,626,980, 7,626,941, 7,623,647, 7,613,113, 7,609,830, 7,602,900, 7,602,887, 7,599,359, 7,599,357, 7,593,520, 7,593,343, 7,593,325, 7,583,794, 7,583,660, 7,580,792, 7,555,113, 7,532,579, 7,522,717, 7,468,984, 7,450,502, 7,447,160, 7,447,159, 7,440,445, 7,417,984, 7,415,010, 7,411,942, 7,369,506, 7,231,210, 7,224,773, 5,987,508.

General Knowledge is Available in Obviousness Inquiry Even Though IPRs are Limited to Documentary Prior Art

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In Koninklijke Philips N.V. v. Google, [2019-1177] (January 30, 2020), the Federal Circuit affirmed the PTAB determination that claims 1-11 of U.S. Patent No. 7,529,806 were unpatentable as obvious.

Philips presetnted three arguments on appeal. First, that the Board erred by instituting inter partes review on the ground that the claims would have been obvious over SMIL 1.0 in light of Hua because Google did not advance that specific combination in its petition. Second, that the Board erred in finding that the claims would have been obvious in view of SMIL 1.0 because the Board impermissibly relied on “general knowledge” to supply a missing claim limitation. Third, that the Board’s obviousness findings are nevertheless unsupported by substantial evidence.

On Philips’ first point, the Federal Circuit agreed, holding that the Board erred by instituting inter partes review based on a combination of prior art references not advanced in Google’s petition. 35 U.S.C. § 311(a) does not contemplate a petition that asks the Director to initiate whatever kind of inter partes review he might choose.

On Philips’ second point, the Federal Circuit disagreed with Philips’ argument that because 35 U.S.C. § 311(b) expressly limits inter partes reviews to “prior art consisting of patents or printed publications,” and because general knowledge is neither of those, § 311(b) prohibits use of general knowledge to supply a missing claim limitation in an inter partes review. The Federal Circuit explained that although the prior art that can be considered in inter partes reviews is limited to patents and printed publications, it does not follow that we ignore the skilled artisan’s knowledge when determining whether it would have been obvious to modify the prior art.

The Federal Circuit also disagreed with Philips that the Board’s reliance on “general knowledge” violated Arendi. The Federal Circuit explained that in Arendi it cautioned that although “common sense and common knowledge have their proper place in the obviousness inquiry,” (a) invoking “common sense . . . to supply a limitation that was admittedly missing from the prior art” should generally only be done when “the [missing] limitation in question [is] unusually simple and the technology particularly straightforward;” and (b) references to common sense “cannot be used as a whole-sale substitute for reasoned analysis and evidentiary support.” The Federal Circuit said that in Arendi, the Board relied on nothing more than “conclusory statements and unspecific expert testimony” in finding that it would have been “common sense . . . to supply a limitation that was admittedly missing from the prior art.” Conversely, in the present case, the Federal Circuit found that the Board relied on expert evidence, which was corroborated by Hua, in concluding that pipelining was not only in the prior art, but also within the general knowledge of a skilled artisan.

Finally, the Federal Circuit disagreed with Philips third point, that the finding of obvious was not supported by substantial evidence. The Federal Circuit noted that the Board thoroughly explained why the modified prior art disclosed all the limitations of claim 1, The Federal Circuit said that relying on an expert declaration and reference as evidence of a skilled artisan’s general knowledge, the Board found that a skilled artisan “would have been motivated to modify the prior art. The Board also determined that there would have been a reasonable expectation of success. The Federal Circuit concluded concluded that the Board’s findings are supported by substantial evidence.

Patent Office Ignores Federal Circuit, and Gets Away with It

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In Biodelivery Sciences International, Inc., v. Aquestive Therapeutics, Inc., [2019-1643, 2019-1644, 2019-1645] (January 13, 2020) the Federal Circuit declined to rehear this appeal en banc. The Federal Circuit earlier remanded IPR2015-00165, IPR2015-00168, and IPR2015-00169 for the PTAB to consider all claims as required by the Supreme Court in SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018). The PTAB failed to do so, and the panel on the resulting appeal allowed them to do so.  Judge Newman wrote separately in dissent “because of the significance of the balance of agency and judicial authority, and the rules of procedural law in the administrative state.”

Posted in IPR

Affirmed; Patent Owner’s Claim Construction that Excluded Preferred Embodiments Was Not Correct

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In Eko Brands, LLC, v. Adrian Rivera Maynez Enterprises, Inc., [2018-2215, 2018-2254] (January 13, 2020), the Court of Appeals for the Federal Circuit affirmed the judgment of invalidity of U.S. Patent No. 8,720,320 owned by ARN, on an adaptor device for use with Keurig® single-brew coffee machines and of infringement of U.S. Patent No. 8,707,855 owned by EKO on a reusable filter cartridge device for use with single-serve beverage brewing machines.

On appeal ARM argued that brewing chamber in the claims of the ‘320 patent required a closed chamber, and thus the prior art did not make the claimed invention obvious.  The Federal Circuit distinguished other patents that showed closed brewing chamber, noting that these specifically describe the chamber as sealed. The Federal Circuit also rejected the argument that several embodiments of in the ‘320 patent that showed sealed brewing chambers, meant that brewing chamber had to be sealed, because there were also several embodiments with unsealed brewing chambers.  The Federal Circuit applying the Canon of Claim construction that “a claim construction that ‘excludes the preferred embodiment is rarely, if ever, correct and would require highly persuasive evidentiary support” to find that the district court’s construction was correct.  The Federal Circuit also affirmed the award of attorneys fees to the accused infringer of the ‘320 patent.

On the issue of infringement of the ‘855 patent, ARM argued that the claims of the patent required a single serve beverage brewer (“A beverage brewing device for use with a single serve beverage brewer having a brewing holster . . .”).  The Federal Circuit disagreed, noting that on its face does not require a beverage brewer, even if the preamble is limiting. To the extent that claim mentions a beverage brewer it is only as a “reference point” to define the purpose and structure of the brewing device.  Thus the Federal Circuit affirmed the finding of infringement.  The Federal Circuit also affirmed the finding of no willful infringement, noting that the instruction as a whole was not legally erroneous given the limited nature of Eko’s objection.

Lack of Showing of Criticality Dooms Claims with Ranges Overlapping the Prior Art

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Genentech, Inc., v. Hospira, Inc., [2018-1933] (January 10, 2020), the Federal Circuit affirmed the PTAB holding claims 1–3 and 5–11 of U.S. Patent 7,807,799 directed to methods of purifying certain antibodies and other proteins unpatentable as anticipated or obvious.

Important to the invention was operating at a low temperature to eliminate the need for subsequent purification steps, the claims specified a range of “about 10°C to about 18°C”, which the Federal Circuit found overlapped the prior art range of “18–25°C,” regardless of the construction of “about 18°C.” The Federal Circuited noted that the patentee own proposed construction for “about 18°C” embraces temperatures up to 19°C, which further reinforces the overlap with the prior art’s disclosed temperature range.

The Federal Circuit said a prior art reference that discloses an overlapping but different range than the claimed range can be anticipatory, even where the prior art range only partially or slightly overlaps with the claimed range.  Once a patent challenger has established, through overlapping ranges, its prima facie case of anticipation, the court must evaluate whether the patentee has established that the claimed range is critical to the operability of the claimed invention.  The Federal Circuit found that the the patentee failed to show criticality of the range.

As to obviousness, the Federal Circuit noted that even a slight overlap in range establishes a prima facie case of obviousness, and that the burden of production falls upon the patentee to come forward with pertinent evidence that the overlapping range would not have been obvious in light of the prior art.  One way in which the patentee may rebut the presumption of obviousness is by showing that there is some-thing special or critical about the claimed range.  The Federal Circuit found that presumption of obviousness applies here, and the Board found that Genentech failed to establish criticality for the claimed temperature range, which Genentech did not appeal. The Federal Circuit said that another way in which the presumption can be rebutted is by showing that a process parameter, such as temperature, was not recognized as “result-effective.”  However, Federal Circuit said that the Board reasonably found that a skilled artisan would have been motivated to optimize the temperature given the teachings of the prior art, and that given the ease with which temperature can be varied, finding an optimal temperature range would have been nothing more than routine experimentation.

IPR Decision Wipes Out Patent Owner’s Earlier Victory in District Court

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Personal Audio, LLC, v. CBS Corporation, [2018-2256] (January 10, 2020), the Federal Circuit affirmed the district court judgment of infringement of U.S. Patent No. 8,112,504, on a a system for organizing audio files, by subject matter, into “program segments.”

A jury found that three claims of the ‘850 patent not invalid and were infringed.  Subsequently the PTAB issued a final written decision determining that those claims are unpatentable.  The district court, with the parties’ consent, stayed entry of its judgment in this case until completion of the Federal Circuit review of the PTAB decision.  The Federal Circuit affirmed the PTAB, and the parties agreed that CBS was entitled to entry of final judgment in its favor.  Personal Audio appealed.

The Federal Circuit said that to the extent that Personal Audio challenges the Board’s final written decision, the district court lacked jurisdiction to consider the challenges, and the Federal Circuit had no jurisdiction to review them on appeal from the district court’s judgment. The Federal Circuit said that the exclusive avenue for review of the PTAB decisions was a direct appeal from the final written decision.

The Federal Circuit said that to the extent that Personal Audio challenges the district court’s determination of the consequences of the affirmed final written decision for the proper disposition of this case, Personal Audio conceded that governing precedent required judgment for CBS, and thus the Federal Circuit affirmed.

Posted in IPR

Settlement Agreement Did Not Void Earlier Covenant Not to Sue

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Molon Motor and Coil Corp. v. Nidec Motor Corp., [2019-1071](January 10, 2020), the Federal Circuit affirmed judgment in favor of Nidec Motor Molon’s claim for infringement of U.S. Patent 6,465,915, on the ground that Molon was barred from enforcing the ’915 patent against Nidec pursuant to a covenant not to sue that Molon granted in 2006.  Molon contended that the 2006 Covenant was extinguished by a clause in a Settlement, License and Release Agreement that the parties entered into in 2007, which stated that all prior covenants “concerning the subject matter hereof” are “merged” and “of no further force or effect.” The Federal Circuit agreed with the district court that the two agreements concern different subject matter and therefore do not merge.

Molon sued Nidec’s predecessor for infringement of one patent, and Nidec’s predecessor counterclaimed for a declaratory judgment invalidity/non-infringement of two others including the ‘915 patent.  To eliminate the counterclaim, Molon granted Nidec’s predecessor a covenant not to sue under the two additional patents.  Eventually Molon and Nidec’s predecessor settled the original ligation with a settlement agreement granted a limited license under all three patents.  This settlement agreement had an integration clause that provided:

The district court found that the 2006 Covenant gives Nidec a right to avoid suit for patent infringement on two patents, one of which is the ’915 patent, while the 2007 Settlement is in some ways broader—it is an exclusive license, it includes more than a dozen patents and applications, and it provides Nidec with some enforcement rights—and in other ways narrower—it is limited to a defined market of customers—than the 2006 Covenant.

All prior and contemporaneous conversations, negotiations, possible and al-leged agreements, representations and covenants concerning the subject matter hereof, are merged herein and shall be of no further force or effect.

The Federal Circuit agreed with Nidec and the district court that it is incorrect to broadly define the subject matter of both agreements as the right to practice the ’915 patent. Rather, to determine the subject matter of each agreement, the Federal Circuit said it must examine the actual language of the agreements themselves, and consider how the language of each agreement conveys the substantive rights and obligations exchanged between the parties.  The Federal Circuit observed:

The 2006 Covenant is a unilateral promise by Molon not to sue [Nidec’s predecessor] for infringement of two patents, one of which is the ’915 patent. The 2007 Settlement, in contrast, is a bilateral contract through which Molon transferred to [Nidec’s predecessor] a share in the existing and potential exclusionary rights under more than a dozen listed patents and applications, one of which is the ’915 patent. Moreover, the 2006 Covenant is limited to products existing at the time of its execution, while the 2007 Settlement includes both existing and future products. And the 2006 Covenant is not limited to any specific market, while the 2007 Settlement is limited. The court concluded, the 2006 Covenant remains in effect be-cause it does not concern the same subject matter as the 2007 Settlement.

Markush Groups Open to Additional Elements

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Amgen, Inc. v. Amneal Pharmaceuticals LLC, [2018-2414, 2019-1086] (January 7, 2020), the Federal Circuit vacated and remand the district court’s judgment that Amneal did not infringe U.S. Patent 9,375,405, and affirmed that Piramal did not infringe and that Zydus did infringe the ‘405 patent.

On appeal Amgen challenged the district court’s construction of a Markush group of binders:

from about 1% to about 5% by weight of at least one binder selected from the group consisting of povidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, and mix-tures thereof

and a Markush group of disintegrants:

from about 1% to 10% by weight of at least one disintegrant selected from the group consisting of crospovid[o]ne, sodium starch glycolate, croscarmellose sodium, and mixtures thereof

The district court held both of these Markush groups were closed, such that additional binder and disintegrant substances in addition to the ones specified in the Markush ground avoided infringement.

The Federal Circuit said that Multilayer and Shire did not hold broadly that, whenever “consisting of” Markush group language is present in a particular claim limitation, even when the limitation follows a general claim transition phrase of “comprising,” all components of an accused product that perform the general function of the particular limitation must meet the requirements of that limitation, thus precluding components outside the Markush group.  The Federal Circuit explained that those decisions do not apply in this case, where the question is whether the “binder” or “disintegrant” claim limitations are written to preclude other binders and disintegrants in the claimed composition. The Federal Circuit concluded that they are not.

In Multilayer, the Markush group was closed because the language of the claim was closed, requiring “each layer being selected from the group consisting of . . . “.  In Multilayer the Federal Circuit further held that dependent claim 10, which added a requirement that “at least one said inner layer” contain a resin not listed in the element, was invalid because it was inconsistent with the independent claim.  In particular, the Federal Circuit said, it had no occasion to, and did not, consider the effect of the transition phrase “comprising”.

In construing the (a) and (b) Markush groups in Shire, the Federal Circuit explained that the “consisting of” language defined the groups and created a “very strong presumption” that the Markush groups were closed to additional elements not specified in the claim.  The Federal Circuit pointed out that this was also decided without reference to the comprising transition.  The claim specified that  the outer matrix of the claimed composition “consists of” the compounds in the Markush group. The outer matrix, by the terms of the element, had to “consist of” of those compounds to meet that limitation.

The Federal Circuit found that the decisive issue in the current case is critically different from any issue decided in Multilayer or Shire. The issue is whether all binders or disintegrants in the claimed formulation are subject to the specific binder or disintegrant limitations. The Federal Circuit concluded that they were not.  First, the Federal Circuit noted that there is no language in Amgen’s claim indicating that every binder or disintegrant in the claimed formulation must be within the Markush groups.  The Federal Circuit said that the limitations merely require that those particular binders or disintegrants meet the specified weight-percentage requirements, which is not inconsistent with the overall composition containing other binders or disintegrants.

The Federal Circuit said that the plain language of the claim requires “at least one” of the Markush members and certainly does not indicate that the only binders and disintegrants in the claimed formulation are those listed in the groups. The Federal Circuit did not see a sufficient basis for a different conclusion in the specification or in the prosecution history.  The Federal Circuit also noted the transition “comprising,” which makes clear that the claim does not preclude the presence of components or steps that are in addition to, though not inconsistent with, those recited in the limitations that follow.  The Federal Circuit said that the use of the “comprising” transition phrase reinforces the conclusion that the language of those limitations is best construed not to foreclose such additional binders and disintegrants. The Federal Circuit vacated the district court’s decision as to the Amneal product.  However, the Federal Circuit agree that prosecution history estoppel prevented Amgen from asserting that Piramal’s product infringed under the doctrine of equivalents.