Aggregate Data is Not Enough to Show Domestic Industry in a Section 337 Proceeding.

Posted on May 8, 2024 by bwheelock

In Zircon v. ITC, [2022-1649] (May 8, 2024), the Federal Circuit Court affirmed the ITC determination of no violation of section 337. The case involved U.S. Patent Nos. 6,989,662, 8,604,771, and 9,475,185, on electronic stud finders.

To establish a section 337violation, Zircon was required to show that “an industry in the United States, relating to the articles protected by the patent . . . exists or is in the process of being established.” 19 U.S.C. § 1337(a)(2). This is referred to as the “domestic industry” requirement. The ALJ found that the economic prong of the domestic industry requirement was not satisfied with respect to any of the asserted patents. The Commission upheld the ALJ’s determination that there was no violation of section 337, for two independent reasons. First, with respect to the domestic industry requirement, the Commission affirmed the ALJ’s determination that Zircon had not satisfied the economic prong of that requirement. Second, the Commission found each of the claims of the ’662, ’771, and ’185 patents that were before the Commission were either invalid or not infringed.

To meet the domestic injury requirement, a complainant can show that, “with respect to the articles protected by the patent,” there is “(A) significant investment in plant and equipment; (B) significant employment of labor or cap-ital; or (C) substantial investment in its exploitation, including engineering, research and development, or licensing.” 19 U.S.C. § 1337(a)(3)(A)–(C). That provision is referred to as the “economic prong” of the domestic industry requirement.

Zircon has relied on evidence of its cumulative expenditures on all 53 of its domestic industry products to argue that its investments in plant and equipment, labor or capital, and/or research and development have been significant or substantial. Zircon had acknowledged, however, that not all 53 products prac-tice all three of the asserted patents. Rather, Zircon’s evidence showed that of the 53 products, 14 practice all three of the asserted patents; 21 practice both the ’771 and ’185 patent; 16 practice only the ’662 patent; and two practice only the ’771 patent. Zircon did not allocate its expenditures on its 53 stud finder products separately with respect to each of its products or each of the asserted patents. The Commission found that Zircon’s failure to do such an allocation precluded the Commission from evaluating the significance of Zircon’s investments with respect to each asserted patent.

On appeal, Zircon argued that the Commission erred by requiring a patent-by-patent breakdown of its investments and that, in doing so, the Commission departed from its “flexible, market-oriented approach to domestic industry” in Certain Wireless Devices with 3G and/or 4G Capabilities & Com-ponents Thereof, Inv. No. 337-TA-868, USITC Pub. 4475, Initial Determination at 413 (July 29, 2013).

The Federal Circuit found the ITC actions were consistent with Federal Circuit precedent, noting that it has held that where a party seeks to rely upon research and development activities, it must show that those activities the complainant must show that those activities “pertain to products that are covered by the patent that is being asserted.” The Federal Circuit explained that “[i]n cases in which all the domestic industry products practice all the asserted patents, it follows from the language of section 337 and our case law that the complainant could satisfy the economic prong as to all asserted patents based on the entire product group. But in cases in which the complainant’s products or groups of products each practice different patents, the complainant would need to establish separate domestic industries for each of those different groups of products.”

Zircon further argued that in a case such as this one, the Commission’s analysis should proceed on the basis that there is a single industry which exploits the patents. But the Federal Circuit distinguished ZIrcon’s precedent because Zircon sought to aggregate were not all protected by the same patent or patents. The Federal Circuit noted that Zircon might have been able to show the substantial or significant investment requirement was met by its investment in the 14 products that practice all three asserted patents, but Zircon provided no way for the Commission to assess the significance of Zircon’s investment in that product group because Zircon presented its investments in the aggregate for all 53 products, which practiced multiple different combinations of patents.

Because it upheld the Commission’s ruling on the domestic industry issue, the Federal Circuit said it was unnecessary for it to reach Zircon’s challenges to the Commission’s infringement and invalidity rulings.

Exemplary Claiming, Not Exemplary Claims

Posted on May 7, 2024 by bwheelock

When drafting claims it is permissible to use exemplary language (“for example” or “such as”). According to MPEP 2173.05(d) use of such language “does not by itself render the claim indefinite,” although the section then rattles off five examples where exemplary language was found to be indefinite. Even if exemplary language is permissible, is it a good idea?

Modern patents occasionally issue with claims containing exemplary language. Consider claim 14 of U.S. Patent No. 11972683:

14. The tracking arrangement as claimed in claim 13, wherein the “cooperative awareness message <CAM>” has the following vehicle-specific, vehicle-characteristic message parameters: type of different vehicles belonging to the road users, for example bus, automobile, motorcycle, etc., in the group; time stamp of vehicles belonging to the road users in the group should be close in terms of time; position of different vehicles belonging to the road users in the group should be adjacent; direction of vehicles belonging to the road users in the group should be the same; speed of vehicles belonging to the road users in the group should be comparable; length of different vehicles belonging to the road users is used as a group identifying feature; width of different vehicles belonging to the road users is used as a group identifying feature; issuing authority of the cryptographic certificates for the signature of the status messages; certificate hierarchy for validating the certificate for the signature of the status messages; repetition rate of the change of the parameters.

What do the examples do for this claim? Does the absence of “trucks” is the list affect the meaning of “type of different vehicles”?

What about claim 11 of U.S. Patent No. 11965836:

11. The detection assembly as claimed in claim 10, wherein the matrix array of light-emitting diodes is made of a longitudinal succession of strips of LED tape which are secured, for example glued, transversely to the inner surface.

Does “glued” affect the meaning of “secured”? There is a presumption that every word in a claim is to be given meaning, so what does “glued” for claim 11.

Then there are claims structured like claim 13 of U.S. Patent No. 11965415:

13. The method as claimed in claim 1, wherein the injected current comprises an alternating current signal having a frequency of 1 Hz or lower, for example 0.5 Hz or lower, or 0.25 Hz or lower.

Does the claim cover all frequencies below 1Hz? What is the significance of 0.5 Hz? Of 0.25 Hz?

While claims can include exemplary language, it may not result in exemplary claims.

Cinco de Mayo, Dos Mil Veinticuatro

Posted on May 5, 2024 by bwheelock

Cinco de Mayo, also known as Battle of Puebla Day, is a holiday celebrating the date of the Mexican Army’s May 5, 1862, victory over France at the Battle of Puebla during the Franco-Mexican War. Although hostilities continued for five more years, General Ignacio Zaragoza success represented a great symbolic victory for the Mexican government and bolstered the resistance movement.

A minor holiday in Mexico, it is more widely celebrated in the United States, and most U.S. celebrations feature margaritas. Like most things involving tequila, the origin of the margarita is unclear. Some claim that the margarita is a variation of the brandy daisy, remade with tequila instead of brandy. Others claim that the margarita was invented in 1938 by Carlos “Danny” Herrera the Rancho La Gloria restaurant in Baja California. Still other claims that the margarita was in 1938 by a bartender in honor of Mexican showgirl Rita de la Rosa. Still others claims that it was invented in Ensenada, Baja California, in 1941 by bartender Don Carlos Orozco. There are also claims that the margarita was first mixed in Juárez, Chihuahua, at Tommy’s Place Bar on July 4, 1942, by Francisco “Pancho” Morales.

Whatever its origins, margaritas are a popular cocktail, and the drink of choice on Cinco de Mayo, so it is not surprising that a bit of technology has been developed around the margarita.

Tools

U.S. Patent No. D743217 protects the appearance of a margarite tool:

U.S. Patent No. D566452 protects the appearance of a Margarita Maker:

Glassware

U.S. Patent No. 11,033,131 protects the glass for serving a bottle of beer:

U.S. Patent No. similarly protects a device for serving a margarita with a bottle of beer:

U.S. Patent No. D540120 protects the appearance of a Margarita Glass:

U.S. Patent No. D454758 also protects the appearance of a Margarita Glass:

U.S. Patent No. D453093 also protects the appearance of a Margarita Glass:

U.S. Patent No. 5842590 protects a Nestable Margarita Glass Apparatus and Method:

Margarita-Themed Products

U.S. Patent No. D545005 protects the appearance of a Margarita-styled Bird Feeder:

May the 4th be wIth You

Posted on May 4, 2024 by bwheelock

Happy Star Wars Day. What better way for a patent lawyer to celebrate than with a collection of Star Wars patents?

Vehicles

D254080 Toy Spacecraft (X-Wing Fighter)
D254081 Toy Spacecraft (TIE Fighter)
D257160 Aerial Toy (Landspeeder)
D265668 Toy Space Vehicle (Twin-Pod Cloud Car)
D266777 Toy Vehicle (AT-AT)
D267025 Toy Space Vehicle (Snowspeeder)
D268192 Toy Space Vehicle (Rebel Transport)
D268200 Toy Space Vehicle (TIE Bomber) –
D268773 Toy Space Vehicle
D271780 Toy Space Vehicle (Rebel Medical Frigate)
D277116 Toy Vehicle (Imperial Shuttle)
D277120 Toy Vehicle (Tatooine Skiff)
D277200 Toy Spacecraft (A-Wing)
D277201 Toy Spacecraft (B-Wing)
D277398 Toy Vehicle (Speeder Bike)
D277493 Toy Vehicle (Sail Barge)

Characters

D264109 Toy Action Figure (Boba Fett)
D265109 Toy Figure (Ugnaught)
D265330 Toy Figure (FX-7)
D265331 Toy Figure (IG-88)
D265332 Toy Figure (Hoth Stormtrooper)
D265754 Toy Figure (Yoda)
D266685 Toy Figure (Bossk)
D266780 Toy Figure (Dengar)
D268941 Toy Figure (2-1B)
D277206 Toy Figure (Gamorrean Guard)
D277207 Toy Figure (Emperor’s Royal Guard)
D277208 Toy Figure (Admiral Akbar)
D277209 Toy Figure (Bib Fortuna)
D277210 Toy Figure (Klaatu)
D277213 Toy FIgure (Snootles)
D277214 Toy Figure (Wicket)
D277215 Toy Figure (Paploo)
D277303 Toy FIgure (Droopy McCool)
D277883 Toy Figure (Max Rebo)

Weapons

D256485 Toy Sword (Light Sabre))
D259578 Toy Helmet (Helmet)
10065127 Sword Device with Retractable, Internally Illuminated Bllade

April 22, 2024, The 55th Earth Day

Posted on April 22, 2024 by bwheelock

The first Earth Day was April 22, 1970, it was not until 20 years later, that the impact of Earth Day was recorded in the U.S. Patent collection. In U.S. Patent No. 5090559, issued in 1992 on Reusable Garment Bags for Dry Cleaning, acknowledged that ” ‘Earth day,’ citizen activist groups, scientists and a large number of television documentaries and public information and service programs have all increased public awareness of [issues with disposable bags.”

In 1997, U.S. Patent No. 5601204 on a Tank Vault With Sealed Liner, noted:

Since the 1970s, the world, and in particular, the United States, has been concerned with the environment and the contamination of that environment, including the earth’s soil, its atmosphere and its water. The first Earth Day in 1970 resulted in the eventual creation of the Environmental Protection Agency by the United States Congress.

Since the 1970s, the world, and in particular, the United States, has been concerned with the environment and the contamination of that environment, including the earth’s soil, its atmosphere and its water. The first Earth Day in 1970 resulted in the eventual creation of the Environmental Protection Agency by the United States Congress.

U.S. Patent No. 5595114 issued in 1996 on a Simulated Musical Rainmaker, which it described as “a perfect toy to celebrate Earth Day, which is slowly becoming an important holiday in the calendar year.”

U.S Patent No. D407127 issued on a baseball with an Earth Day logo:

U.S. Patent No. 7560822 issued in 2009 on an Educational Electrical Generation Kit that is “sturdily and durably configured, particularly since it may be used in crowded environments with children present (e.g., in schools, science fairs, Earth Day events, open houses at utility companies, museums, etc.).”

U.S. Patent Nos. 8870061 issued in 2014 and 9302818 issued in 2016 disclose a Reusable Envelope, which the patents indicate is particularly adapted for Earth Day mailings.

U.S. Patent No. 10107029, issued in 2018, commented that “forty years after capturing the imagination of many people during the first observance of Earth Day, America’s recycling revolution is getting mixed reviews.” While the patent noted that “140 million Americans recycle—more than vote in national elections,” we can certainly do better, and as the 55th Earth Day approaches, hopefully, we will.

Reasonable Expectation of Success Made Claims Obvious

Posted on April 11, 2024 by bwheelock

In Salix Pharmaceuticals. Ltd v. Norwich Pharmaceuticals Inc., [2022-2153, 2023-1952] (April 11, 2024), the Federal Circuit affirmed the district court determination that Norwich infringed claim 8 of U.S. Patent 8,624,573, claim 6 of U.S. Patent 9,421,195, and claims 11
and 12 of U.S. Patent 10,335,397 and had failed to prove that those claims were invalid.

Rifaximin, the active ingredient in Salix’s commercial product Xifaxan®, has been widely used as an antibiotic for decades, having been first synthesized in the early 1980s
in Italy and approved there as an antibiotic in 1985. The FDA approved Xifaxan nearly 20
years later, in 2004, as 200 mg tablets for the treatment of travelers’ diarrhea. The FDA subsequently approved 550 mg tablets for hepatic encephalopathy in 2010 and for irritable bowel syndrome with diarrhea (“IBS-D”) in 2015.

Norwich sought to market a generic version of rifaximin and, in 2019, filed an ANDA for 550 mg tablets with the same indications as Xifaxan, certifying pursuant to 21 U.S.C. § 355(j)(2)(vii)(IV) that Salix’s rifaximin patents were invalid. Salix timely sued, asserting that Norwich’s
ANDA infringed dozens of valid, Orange Book-listed patents. By the time of trial, the case had been streamlined to three groups of patents:

the ’573, ’195, and ’397 patents, directed to treating hepatic encephalopathy
the ’569 and ’667 patents, directed to treating irritable bowel syndrome with diarrhea with 550 mg rifaximin three times a day (1,650 mg/day) for 14 days; and,
the ’199 and ’206 patents, directed to rifaximin form β

Following a bench trial, the district court held that Norwich infringed the hepatic encephalopathy patents’ claims and had failed to establish their invalidity. Norwich did not appeal those holdings. The court also held that Norwich’s ANDA infringed the irritable bowel syndrome and polymorph patents, but that those patents’ claims would have been obvious
over the prior art. Salix appealed those invalidity holdings.

Norwich then amended its ANDA in an attempt to remove the infringing hepatic encephalopathy indication and moved to modify the judgment under Federal Rule of Civil Procedure 60(b), asserting that the amendment negated any possible infringement. The court denied Norwich’s motion, and Norwich cross-appealed.

Validity of the Irritable Bowel Syndrome Claims

The key limitation on appeal is the dosage amount that appears in the claims: 550 mg, three times per day (“TID”), for a total of 1,650 mg/day. Norwich challenged the IBS-D claims’ validity by asserting as prior art references a clinical trial protocol that had been published and a 2006 journal article by Pimentel. The Protocol described a Phase II study evaluating
twice-daily doses of 550 mg (1,100 mg/day) and 1,100 mg (2,200 mg/day) for 14 and 28 days for the treatment of irritable bowel syndrome. Pimentel taught administering 400 mg, TID (1,200 mg/day), for the treatment of irritable bowel syndrome but further opines that the “optimal dosage of rifaximin may, in fact, be higher than that used in our study.” The district court found that those two references disclose each and every limitation of the challenged irritable bowel syndrome claims, and further found that a skilled artisan would have been motivated to combine those two references to arrive at what is claimed with a reasonable expectation of success.

Salix appealed, asserting that the court erred in finding that a skilled artisan would have had a reasonable expectation of success in using the claimed 1,650 mg/day dosage to treat irritable bowel syndrome. According to Salix, the highest prior art dosage amount
that could have been supported with a reasonable expectation of success was the 1,200 mg/day dose evaluated by Pimentel. The Federal Circuit disagreed, noting that while the Protocol alone might not support the reasonable expectation of success, in combination with Pimentel, which taught that “[r]ecent data suggest that the optimal dosage of rifaximin may, in fact, be higher than that used in our study,” it was not error for the district court to conclude that there was a reasonable expectation of success as to the efficacy of 550 mg TID dosing.

Validity of the rifaximin form β Claims

Norwich challenged the polymorph claims’ validity by asserting, inter alia, Cannata, which discloses that rifaximin exists in crystalline form with “outstanding antibacterial properties.”

The district court held that expert testimony supported a conclusion that, in view of the prior art, (1) a skilled artisan would have had good reason to characterize the crystalline
rifaximin obtained by following the Cannata protocols, (2) that such characterization was routine and could have been performed “in one day,” and (3) that doing so would have led the skilled artisan to have “detected rifaximin β.”

The Federal Circuit noted that the scope and content of the prior art here includes preparations of crystalline rifaximin, which expert testimony supports would have yielded the β form of rifaximin. The difference between the prior art and the claims is thus effectively nothing more than the performance of routine characterization to identify the polymorphic forms that result from the known Cannata processes.

Salix argued that the rifaximin’s β form nonetheless constituted a non-obvious invention because, although skilled artisans actually succeeded in producing and characterizing it, they would not have expected to succeed because, as of the critical date, the polymorphic nature of rifaximin had not yet been reported and the identity of the β form remained undisclosed. Salix further argues that there could have been no expectation of success because the skilled artisan would not have been able to predict what polymorphic forms might result from following the preparation protocols disclosed in the prior art. The Federal Circuit disagreed, noting that Salix has done no more than combine known elements of the prior art to verify readily accessible information concerning a compound already in the hands of those of ordinary skill in the art, and such routine efforts do not justify removing this polymorph from the public domain.

The Federal Circuit noted that it was not holding that there is always a reasonable expectation of success in accessing or characterizing polymorphs. It was simply reviewing the district court’s decision before it as to its factual finding of a reasonable expectation of success, and in so doing, have not been left with a definite and firm conviction that a mistake was made in reaching that finding.

Norwich’s Cross Appeal

On cross-appeal, Norwich raises two related but distinct arguments that arose after the district court held that Norwich infringed the HE patents and failed to establish invalidity. Norwich first argues that the district court misinterpreted 35 U.S.C. § 271(e)(4)(A), which directs a court, following a finding of infringement, to order the FDA to defer final approval of an ANDA until the expiration of the infringed patent. According to Norwich, that statute precludes delaying final approval of an entire ANDA, and instead requires delaying only the approval of the infringing use.

The Federal Circuit said Section 271(e)(4)(A) instructs that, following a finding of infringement, “the court shall order the effective date of any approval of the drug or veterinary biological product involved in the infringement to be a date which is not earlier than the date of the expiration of the patent which has been infringed.” Norwich argued that the language of § 271(e)(4) requires courts to tie the restriction on FDA approval to the
indication for which the ANDA seeks approval when that indication was the source of infringement. The district court order concerned only the specific ANDA in question that included an infringing use, referred to the ANDA by its number, and enjoined the approval
of that ANDA.

Since the FDA does not approve drugs in the abstract, but rather approves drugs for particular uses (indications) of that drug, the statute is appropriately construed as directed to approval of particular infringing uses of the drug, not all uses of the drug including non-infringing uses. The statutory scheme makes clear that the relevant infringement is the submission of the ANDA that included an infringing use. That the ANDA further recited a non-patent-protected indication does not negate the infringement resulting from the ANDA’s submission. The order thus appropriately delayed the effective final approval date of “this
infringing ANDA” submission.

Norwich’s second argument arises from its decision to amend its ANDA to carve out the infringing HE use after final judgment. Following that amendment, Norwich filed a motion to modify the final judgment to allow for prompt approval of the amended ANDA that purportedly no longer sought approval for the infringing HE use. The district court denied that motion, holding that Norwich “fully litigated the merits of its non-infringement and invalidity case, lost, and now seeks a way around the final judgment through Rule 60(b).

The Federal Circuit said that a district court may reconsider its own finding of infringement
in light of an amended ANDA, but the court need not do so, and the Federal Circuit said that the court reasonably held that consideration of the amended ANDA would be inequitable
and inappropriate. The court noted that it is not a simple matter to determine whether an
ANDA applicant has successfully carved out language from a label to turn infringement into non-infringement” and that what Norwich sought in its Rule 60(b) motion would essentially be a second litigation” following final judgment.

Total Eclipse of the Sun on April 8

Posted on April 7, 2024 by bwheelock

Several inventors have addressed the problem of safely watching a total eclipse of the sun. One of the earliest is U.S. Patent No. 548868, which issued October 29, 1895, on an Apparatus for Observing Eclipses:

This patent is long ago expired, so feel free to adapt for your use on April 8, A more modern device is disclosed in U.S. Patent No. 9123285, which provides a Transparent Display Device and Transparency Adjustment Method Thereof, which explains:

U.S. Patent No. 11438494 on a Device for Viewing and Imaging the Sune and Solar Phenomena, the augments a user’s smartphone:

U.S. Patent No. 10103768 provides a Mobile Device Casing that includes a filter 304 for photographing solar eclipses:

U.S. Patent No. 11536947 on a Tunable Window System for a Vehicle, that can adapt to “local conditions (e.g., solar eclipse).

Solar eclipses have inspired some to make games, like U.S. Patent No. 5678823 on a Total Solar Eclipse Game of Skill:

Others have named plants after solar eclipses, as in U.S. Patent No. PP23647:

The technology is there to have a safe viewing experience. Enjoy the April 8 solar eclipse.

Reading Limitations into the Claims and Failure to Follow Proper Obviousness Inquiry Required Non-obviousness Determination to be Vacated

Posted on April 2, 2024 by bwheelock

In Jannsen Pharmaceuticals, Inc., v. Teva Pharmaceuticals USA, Inc., [2022-1258, 2022-1307] (April 1, 2024), the Federal Circuit affirmed the district court’s determination that the claims of U.S. Patent NO. 9,439,906 were not indefinite, and vacated and remanded the determination that the claims were not obvious.

The patent, which generally relates to dosing regimens of paliperidone palmitate, is the last remaining Orange Book patent for Invega Sustenna. Teva First argued that the district court’s analysis of obviousness required Teva to show that it would have been obvious to use the recited dosing regimens for the general population of patients—i.e., a generalized dosing regimen. The court found that the prior art did not demonstrate population-wide safety and efficacy and thus did not teach a generalized dosing regimen. Teva contended that the claims were not directed to a generalized dosing regimen and therefore the district court asked for a showing of obvious-ness that went beyond what was claimed, and the Federal Circuit agreed, saying nothing in the claims requires that the regimen be used for—let alone be ideal for—the patient population generally or a certain percentage of the patient population.

Teva argued that the court also read a “mild” limitation into the renal-impairment claims, whereas the claims do not specify a level of renal impairment. Janssen countered that Teva presented an obviousness theory that was pred-icated on dosing a patient with mild renal impairment. The Federal Circuit agreed that many of the district court’s statements suggest that it understood the claims themselves to require administration to a patient with mild renal impairment, yet there was no such requirement in the claims.

Teva also argue that the court’s analysis was impermissibly rigid and did not comport with KSR or otherwise reflect the Federal Circuit’s obviousness jurisprudence. The Federal CIrcuit agree, noting that Instead of considering the prior art in context or in combination, the district court’s analysis seems to tackle the ex-press statements of each reference one-by-one—identifying each difference or dissimilarity between an individual ref-erence and the claims, but not fully assessing the teachings in toto. This seemingly siloed and inflexible approach left insufficient room for consideration of how background knowledge in the art would have impacted a POSA’s un-derstanding of, or motivation to modify, the primary refer-ences at issue, thereby inflating the significance of minor variations between the prior art and the claims.

Among other things, the Federal Circuit criticized the district court for concluding that in the pharma-ceutical context, if a prior art reference does not contain safety and efficacy data, there is no reason to combine it with other prior art references. The Federal Circuit also criticized the court for looking for Teva to demonstrate an explicit problem to provide motivation, notning among other things that the motivation analysis is not limited by the problem or need recognized by the inventors. The Federal Circuit said that:

A motivation “may be found explicitly or implicitly in market forces; de-sign incentives; the interrelated teachings of multiple patents; any need or problem known in the field of endeavor at the time of invention and addressed by the patent; and the background knowledge, creativity, and common sense of the person of ordinary skill.”

Overall, the district court’s analysis ran afoul of KSR’s basic mandate in a number of ways. It failed to consider the “interrelated teachings of multiple” references, “the back-ground knowledge possessed by a person having ordinary skill in the art,” or “the inferences and creative steps that a person of ordinary skill in the art would employ.” Instead, the court sought an explicit indication in the prior art that an improvement was re-quired—at times also suggesting that it was searching for an indication that the claims captured the singular way the protocol would be modified.

Finally, Teva argued and the Federal Circuit agreed, that the district court did not apply the correct test for teaching away. A teaching that a particular value is optimal is not a criticism of all other values, nor is the fact that a reference does not disclose the claimed value a teaching away. The Federal Circuit instructed that the district court should have analyzed whether the claimed value was “criticize[d], discredit[ed], or otherwise discourage[d].”

Indefiniteness

To satisfy the definiteness requirement, a patent’s claims, viewed in light of the specification and prosecution history, must inform those skilled in the art about the scope of the invention with reasonable certainty. The Federal Circuit has held that claim scope is not reasonably certain where a claimed characteristic can be measured in multiple ways, those different measurements “would typically yield a different result” when applied to the same sample, and the intrinsic record fails to provide reasonable certainty about which measurement was intended by the claims.

The claims contain a particle-size limitation, but do not specify what measurement technique should be used to determine whether the particle-size limitation is met. The specification states that the particle size can be measured by art-known conventional techniques, such as sedimentation field flow fractionation, photon correlation spectroscopy or disk centrifugation. Teva argued that the different particle-size measure-ment techniques, which were all allowed by the claims, would yield meaningfully different results. However, the district court found that the actual discrepancy in particle-size measurement that Teva relied on was “an outlier measurement taken with a defective device,” i.e., was not based on a discrepancy typical of the measurement technique used. Teva has not shown that the court’s outlier finding was clearly erroneous. As a result, the district court correctly determined that, on this record, Teva did not meet its burden to show that the challenged claims were invalid as indefinite.

April Showers

Posted on April 1, 2024 by bwheelock

April is known for spring rains, and fortunately for us, inventors have our backs with umbrellas of all kinds. An all-time favorite is the combination umbrella/lightning rod in U.S. Patent No. 4,447,847, which only issued after the inventor, Drulard, successfully appealed the Examiner rejection that the invention lacked utility:

Inventors have provided protection for infants, U.S. Patent No. 849055 provides an umbrella mount for a stroller:

and the aged, U.S. Patent No. 10285893 provides an umbrella mount for a walker:

Even pets are covred (literally). U.S. Patent No. 6871616 provides a pet umbrella:

Inventors have protected us during all of our daily activities. U.S. Patent No. 8556141 provides a backpack with an umbrella:

U.S. Patent No. 639634 provides a bike with an umbrella:

U.S. Patent No. 5609321 provides a golf cart with an umbrella:

U.S. Patent No. 10952487 provides an umbrella for hands-free drinking:

U.S. Patent No. 7967274 provides an umbrella for getting in and out of a car:

U,S, Patent No. D664761 provides an umbrella for watching sports:

Inventors have provided us umbrellas that protect our phones. U.S. Patent No. D822370 protects a cell phone mount for an umbrella::

So, when April showers may come your way, remember that they bring the patents that issue in May (and the rest of the year).

Patently Easter

Posted on March 29, 2024 by bwheelock

One of the earliest references to Easter in the patent collection is U.S. Patent No. 1,234,939 on a Carrier for Eggs, which issued July 31, 1917. (The earliest reference was just a few months in April 1917, on a perpetual calendar.