Source: https://www.patentdocs.org/2019/04/page/3/
Timestamp: 2020-07-05 23:47:52
Document Index: 420210977

Matched Legal Cases: ['§ 112', '§ 161', '§ 1', '§ 112', '§ 2403', '§ 1', '§ 101', '§ 101', '§ 101']

Colas Solutions, Inc. v. Blacklidge Emulsions, Inc. (Fed. Cir. 2019)
Last month, in Colas Solutions, Inc. v. Blacklidge Emulsions, Inc., the Federal Circuit affirmed determinations by the U.S. Patent and Trademark Office Patent Trial and Appeal Board in two inter partes reviews that certain claims of U.S. Patent Nos. 7,503,724 and 7,918,624 are not unpatentable in view of the prior art of record. In particular, the Board found that Colas Solutions, Inc. had failed to establish obviousness based on inherency, and that Colas' alternative obviousness theory was not timely presented.
The '724 and '624 patents, which are directed to a method of applying a specific asphalt emulsion coating, known as a "tack coat," to a road surface, are assigned to Blacklidge Emulsions, Inc. The claimed invention involves a method of bonding layers of asphalt using a tack coat that has a surface that resists adhering to vehicle tires but still functions as an adhesive for subsequent layers of pavement. The claims require that the tack coat has a specific range of "softening points," which is the temperature at which an asphalt composition becomes soft and flowable.
Colas filed petitions for inter partes review of the '724 and '624 patents, arguing that the claims were obvious in view of Bardesi et al., "A Novel Generation of Tack Coat Emulsions to Avoid Adhesion to Tyres," Third World Congress on Emulsions ("Bardesi"), which Colas contended met the "softening point" element of each claim. While Bardesi does not expressly disclose softening points for any of its asphalts, it discloses "pen values" (i.e., penetration value), which measures the distance in dmm (tenths of a millimeter) that a standard needle, under a standard loading, will penetrate a sample in a given time under known temperature conditions. Colas argued that based on the pen values disclosed in Bardesi, the reference inherently discloses the softening point limitation, supporting its argument with testimony from its expert, who opined that asphalt having a hardness of 20-pen or below, which Bardesi specifically teaches, will necessarily have a softening point greater than that recited in the claims. In reaching this conclusion, Colas' expert relied on the Pfeifer equation to calculate potential softening points for the asphalts disclosed in Bardesi.
Blacklidge responded by arguing that the calculations of Colas' expert were flawed, noting that Blacklidge's own expert applied the Pfieffer equation and arrived at different potential softening points for the asphalts disclosed in Bardesi. In its reply, Colas conceded that its expert had made a mathematical mistake and that Blacklidge's expert's calculations were accurate. Colas, however, argued that its expert's calculations still established that "most 10/20 pen asphalts, and certainly the better quality 10/20 pen asphalts" disclosed in Bardesi would have softening points that were encompassed by the claims of Blacklidge's patents, and also contended that "a prima facie case of obviousness still exists when the ranges of a claimed composition overlap the ranges disclosed in prior art."
The Board issued final written decisions concluding that Colas had not shown by a preponderance of the evidence that any of the challenged claims in either patent would have been obvious in view of the prior art. With respect to Colas' inherency theory, the Board noted that in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis, the limitation at issue must necessarily be present, or be the natural result of the combination of elements explicitly disclosed by the prior art. In the instant case, the Board noted that Colas had conceded that not all 10-pen and 20-pen asphalts have a softening points required to meet the claims. With respect to Colas' alternative theory based on overlapping ranges, the Board found that the new theory had been waived because it had not been included in Colas' petitions (the Board also determined that the new theory was unsupported by the evidence). The Board therefore determined that Colas had failed to establish that the challenged claims of the '724 and '624 patents were obvious in view of the cited references.
On appeal, Colas focused solely on the Board's rejection of its alternative theory of overlapping ranges, arguing that the Board erred by declining to consider that theory. The Federal Circuit, however, agreed with the Board that Colas' alternative theory had been waived. In finding that Colas' theory was waived, the Federal Circuit noted that a review of Colas' petitions confirmed that inherency was Colas' only theory for the disputed claim element concerning softening points. The Court stated that "[t]he untimeliness of Colas's alternative theory is self-evident," noting that "Colas fails to point to a single line of its original Petition articulating this theory." The Court explained that:
In sum, inherency was an all or nothing theory. Colas's Petition and its evidence were tailored to prove inherency. That theory failed. Colas's belated attempt to stretch that evidence to fit its alternative "overlapping ranges" theory only underscores that this theory was an afterthought raised for the first time in its Reply. Thus, the Board correctly concluded the theory was waived.
In response to Colas' contention that Blacklidge opened the door to Colas' alternative theory in its Response, the Federal Circuit declared that this was "[n]ot so," pointing out that "[e]ven a cursory review of the record shows that Blacklidge's Response simply pointed out the flaws in the underlying evidence supporting Colas's inherency theory." As for Colas' argument that the Board and Blacklidge were aware of Colas' broader theory that the claimed ranges of softening points would have been obvious to one of skill in the art, the Court indicated that "[t]his argument misconstrues the record," explaining that:
[H]ad Colas adequately articulated such a theory, it would not need to rely on Blacklidge's statements. Colas should be able to point to its location in the Petition. It cannot do so.
The Federal Circuit concluded by noting that "Colas jettisoned its inherency theory and introduced a brand-new theory of 'overlapping ranges' to explain why one of ordinary skill would find the disputed element taught by Bardesi," finding that "[u]nder such circumstances, the Board does not abuse its discretion in declining to consider such untimely theories." The Court therefore affirmed the Board's final written decisions finding the challenged claims to be not obvious in view of the prior art.
Panel: Chief Judge Prost and Circuit Judges O'Malley and Hughes
Posted at 11:17 PM in Federal Circuit, Patentable Subject Matter | Permalink | Comments (2)
April 9, 2019 - Patent Quality Chat on "New pilot program for motions to amend in AIA trial proceedings" (U.S. Patent and Trademark Office) - 12:00 to 1:00 pm (ET)
April 9, 2019 - "Protecting Software as a Medical Device: Patents, Design Patents and Trade Secrets" (Strafford) - 1:00 to 2:30 pm (EDT)
McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Trade Secrets Litigation 2019: Developments from the Trial Courts to the Supreme Court" on April 16, 2019 from 10:00 am to 11:15 am (CT). In this presentation, MBHB attorney and Patent Docs contributor Joshua Rich will address the following topics:
• The consideration requirement to support restrictive covenant cases in various courts, both Federal and State
• Ex parte seizure developments under the DTSA
• Pleading pitfalls in DTSA cases
• The Supreme Court's consideration of the trade secrets exception to FOIA in Food Marketing Institute v. Argus Leader Media
Posted at 09:59 PM in Conferences & CLE's | Permalink | Comments (0)
Posted at 09:57 PM in Conferences & CLE's | Permalink | Comments (0)
The U.S. Patent and Trademark Office will be offering the next webinar in its Patent Quality Chat webinar series from 12:00 to 1:00 pm (ET) on April 9, 2019. In the latest webinar, on the "New pilot program for motions to amend in AIA trial proceedings," Deputy Chief Judge Jackie Bonilla and Lead Judge Jessica Kaiser from the USPTO's Patent Trial and Appeal Board (PTAB) will discuss how the new pilot program will provide opportunities not only to receive feedback from the PTAB about a first motion to amend, but also to file a second motion to amend based on that feedback.
Posted at 09:55 PM in Conferences & CLE's | Permalink | Comments (0)
Strafford will be offering a webinar entitled "Antibody Patenting: U.S. and Asian Perspectives" on April 18, 2019 from 1:00 to 2:30 pm (EDT). Jeffrey M. Jacobstein and Murphy, Amanda of Finnegan Henderson Farabow Garrett & Dunner, Osamu Yamamoto of Yuasa and Hara, and Daniel Miao Cheng of Cheng & Peng will guide patent counsel on the patentability requirements at the USPTO, JPO and CNIPA/CPO when claiming antibodies, recent case law that could impact those claims, and how to protect antibody inventions in light of the latest developments. The webinar will review the following issues:
• How broadly can the applicant claim?
• How much support is needed on a filing?
• What are the differences between U.S. requirements, JPO requirements and CNIPA/CPO requirements?
• What is a sufficient description of a genus?
• Can functional language be included?
• What is needed to demonstrate the nonobviousness of antibody claims in the different jurisdictions?
IPO Webinar on Disqualification
The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Disqualification: Lessons from Recent Cases" on April 10, 2019 from 2:00 to 3:00 pm (ET). William Freivogel, Martin Kaminsky of Greenberg Traurig LLP, and Deanna Kwong of Hewlett Packard Enterprise will look at professional responsibility decisions, as well as the approaches taken by courts when considering disqualification of counsel and discuss whether court disqualification will generally occur solely because of an ethical violation -- or whether the totality of the circumstances will be analyzed. The panel will analyze recent cases with conflicts issues, including those relating to:
• Marketing conversations with prospective clients
• Lateral hires
• The hot potato doctrine
Strafford will be offering a webinar entitled "Protecting Software as a Medical Device: Patents, Design Patents and Trade Secrets" on April 9, 2019 from 1:00 to 2:30 pm (EDT). Cory C. Bell, Elizabeth D. Ferrill, and Susan Y. Tull of Finnegan Henderson Farabow Garrett & Dunner will guide counsel for companies in the medical device industry on protecting software as a medical device (SaMD) and discuss the FDA rules regulating SaMD and how to leverage IP law to protect SaMD. The webinar will review the following issues:
USPTO Implements New System for Ordering Certified Copies of Documents
In a notice posted on the U.S. Patent and Trademark Office website last month, the Office announced that it was implementing the Certified Copy Center (CCC) Storefront, a new web system for ordering certified copies of patent and trademark documents. The new system will replace the current Order Entry Management System (OEMS), which can be accessed through the Private Patent Information and Retrieval (PAIR) system. The new system will be accessed via a user's MyUSPTO page. According to the Office's notice, a beta version of the CCC Storefront was issued last month, and the full production release of the CCC Storefront is scheduled for later this month.
USPTO Announces Expansion of Phase 1 of Access to Relevant Prior Art Initiative
In a Patent Alert e-mail distributed earlier this year, the U.S. Patent and Trademark Office announced an update to Phase 1 of the Office's Access to Relevant Prior Art Initiative, which began on November 1, 2018. The Access to Relevant Prior Art (RPA) Initiative is an effort by the Office to increase patent examination quality and efficiency through the development of an automated tool for USPTO examiners, which will import relevant prior art and other pertinent information from sources such as related U.S. applications, counterpart foreign applications, and International (PCT) applications into pending U.S. patent applications as early as possible in prosecution. The Office envisions the RPA initiative as a way "to potentially reduce the burden on applicants with complying with the duty of disclosure."
In Phase 1 of the RPA initiative, information in the form of citations on PTO/SB/08 and PTO-892 forms from the immediate parent application will be imported into the continuing application for consideration by the Examiner. The Office noted last year that Phase 1 would be limited to select art units -- in particular, Art Unit 2131 in Technology Center 2100, with a wider release to Art Units 1616, 1731, 2431, 2675, 2879, 2922, 3635, and 3753 this year. The Office has now expanded the RPA Initiative to include those additional art units. Applicants will receive a Notice of Imported Citations from the Office informing the applicant that an application has been included in the Initiative and listing the citations from the immediate parent application that have been imported into the application.
ATCC Changes Deposit Requirements for Seeds
In a notice posted on the U.S. Patent and Trademark Office website on March 1, the Office informed stakeholders of a change being implemented by the American Type Culture Collection (ATCC) with regard to the deposit of plant seeds. The Office notes that in order to ensure compliance with 35 U.S.C. § 112 for utility plant inventions (as opposed to patent applications submitted under the Plant Patent Act, 35 U.S.C. §§ 161-164), the deposit of inventive seeds may supplement the disclosure in the specification to provide an adequate written description of the invention and to enable those skilled in the art to make and use the claimed invention. The Office also notes that a deposit must comply with the biological deposit rules (37 C.F.R. §§ 1.801-1.809) to be relied upon to meet the requirements of 35 U.S.C. § 112. For plant seeds, biological deposit rules require that deposits be made with one of seven Budapest Treaty International Depositary Authorities (IDAs), of which the ATCC is one of the largest.
For seed deposits, the ATCC previously required depositors to deposit 2,500 seeds (consisting of 25 packages of 100 seeds each). Because an analysis of past deposits indicated that at most, only four seed packages had been requested for any one deposit, the ATCC has reduced the number of seeds that must be deposited to 625 (i.e., 25 packages of 25 seeds), with the change taking effect on January 1, 2019.
As a result of the ATCC change, the Office has indicated that MPEP § 2403.02 will be revised to indicate that as long as the number of seeds deposited complies with the requirements of the IDA where the deposit is made, the USPTO will consider such submission as satisfying the rules under 37 C.F.R. §§ 1.801-1.809.
Last week, in Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reversed a decision by the U.S. District Court for the District of Delaware holding the claims of U.S. Patent No. 8,808,737 to be ineligible under 35 U.S.C. § 101. In reversing the District Court, the Federal Circuit determined that the asserted claims of the '737 patent are legally indistinguishable from the claims at issue in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd.
The '737 patent, which is owned by Endo Pharmaceuticals Inc., relates to a method of using oxymorphone to treat pain in patients with impaired kidney function. As the opinion notes, a patient's pain relief level can be impacted by the way the patient's body processes oxymorphone. In patients with impaired kidney function (or renal impairment), waste products and drugs that are typically filtered by the kidneys can build up. The inventor of the '737 patent studied the effect of renal impairment on the metabolism of oxymorphone and discovered that patients with moderately or severely impaired kidney function required less oxymorphone to achieve the same level of pain management achieved in patients without impaired kidney function. Claim 1 of the '737 patent is representative (with emphasis in the opinion):
(a) less than about 30 m[L]/min,
Endo and Mallinckrodt LLC filed suit against Actavis LLC, Actavis South Atlantic LLC, Actavis Pharma, Inc., Actavis Elizabeth LLC, Actavis Holdco U.S., Inc. ("Actavis") and Teva Pharmaceuticals USA, Inc. and Barr Laboratories, Inc. ("Teva") for infringement of claims 1-6 of the '737 patent. Actavis moved to dismiss Endo's patent infringement claims, arguing that the asserted claims were patent ineligible under § 101. The Magistrate Judge issued a Report and Recommendation, recommending that the District Court grant Actavis' motion.
In that Report, the Magistrate applied the two-step analysis set forth in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012), and reiterated in Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014). With respect to step 1 of the Alice/Mayo test, the Magistrate determined that the claims are directed to the natural law that the bioavailability of oxymorphone is increased in people with severe renal impairment. With respect to step 2, the Magistrate determined that claim 1 consists of three steps: (1) a "providing" step; (2) a "measuring/determining" step; (3) and an "administering" step. The Magistrate concluded that the "providing" step is similar to the administering step in Mayo because it "merely identifies the specific drug for administration"; the "measuring/determining" step, as in Mayo, "just directs one to use a well-known method to measure creatinine levels to obtain the necessary information to apply a law of nature"; and the "administering step" is indistinguishable from Mayo because it "simply limits the relevant audience to patients and prescribing physicians, who treat chronic or acute pain with oxymorphone," by "merely instruct[ing] physicians to dispense oxymorphone for the treatment of pain in a well-know[n] manner, while utilizing the natural law to manage the dosage." The Magistrate concluded that the patent was not directed to a patent-eligible application of a natural law. Following the Magistrate's recommendation, the District Court granted Defendants' motion to dismiss. Endo appealed the District Court's decision holding the claims of the '737 patent to be patent ineligible.
The Federal Circuit began by noting that while the Supreme Court has established a two-step framework to determine subject matter eligibility under § 101, "[i]f the claims are not directed to a patent-ineligible concept at step one, [the Court] need not address step two of the inquiry," citing Enfish, LLC v. Microsoft Corp. The Court determined that this was the case here, explaining that the Court's analysis accordingly "focuse[d] solely on step one." Citing Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., the opinion notes that "at step one, 'it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is 'directed to.''" And in the instant case, the Court concluded that the asserted claims are not directed to patent-ineligible subject matter, but rather "are directed to a patent-eligible method of using oxymorphone or a pharmaceutically acceptable salt thereof to treat pain in a renally impaired patient."
As in the Federal Circuit's recent decision in Natural Alternatives International, Inc. v. Creative Compounds, LLC, the Endo Court noted that the Federal Circuit held similar claims to be patent-eligible in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., explaining that:
The claims at issue here are legally indistinguishable from the representative claim in Vanda. Both claims recite a method for treating a patient. The Vanda patent claims recite the steps of carrying out a dosage regimen based on the results of genetic testing. . . . Here, the claims similarly recite the steps of carrying out a dosage regimen, though the steps are based on the results of kidney function testing. Additionally, the claims in both cases require specific treatment steps. . . . [And therefore, l]ike the claims in Vanda, the claims here "are directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome." See Vanda, 887 F.3d at 1136.
The panel also noted that "like the claims in Vanda, the claims here differ from those in Mayo in material respects," pointing out that "[a]lthough the representative claim in Mayo recited administering a thiopurine drug to a patient, the claim as a whole was not directed to the application of a drug to treat a particular disease." (In a footnote, the Court also acknowledged that when the District Court held the asserted claims of the '737 patent to be ineligible, it did not have the benefit of considering the Federal Circuit's decisions in Vanda or Natural Alternatives).
The panel next turned to Actavis' arguments that the Endo claims were similar to those at issue in Mayo and could be distinguished from the claims found to be patent eligible in Vanda. With respect to Actavis' argument that unlike the claims in Vanda, the method steps in the Endo claims offer no "practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself," the Court disagreed, stating that "the '737 patent claims are very similar to those in Vanda and any differences in specificity are not of a sufficient degree to convince us to conclude that the claims here should be ineligible as compared to the claims in Vanda." As for Actavis' argument that unlike the Vanda claims, the Endo claims do not require that a biological sample be obtained or assayed in any particular way to determine a patient's creatinine-clearance rate, the Court declared that "this is a distinction without a difference," since "[t]he court in Vanda reasoned that the claim was directed to 'specific patients,' without explicitly emphasizing the precise methods used to identify those specific patients." The Court also disagreed with Actavis' argument that unlike the Vanda claims, the Endo claims "do not specify an amount or frequency of oxymorphone to be administered after patients are categorized by creatinine-clearance rate," noting that "the combination of the administering step and wherein clause claim language, taken together, . . . make the claims-at-issue as specific as those in Vanda such that the patent claims do not 'tie up the doctor’s subsequent treatment decision,'" citing Vanda, 887 F.3d at 1135 (quoting Mayo, 566 U.S. at 86). The Court therefore concluded that:
[T]he '737 patent claims are like those in Vanda. They are eligible because they are "directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome." . . . Our precedent leaves no room for a different outcome.
The opinion found further support for its decision in Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., stating that:
We explained that "[t]he end result of the . . . claims is not simply an observation or detection of the ability of hepatocytes to survive multiple freeze-thaw cycles. Rather, the claims [were] directed to a new and useful method of preserving hepatocyte cells." We further emphasized that "the natural ability of the subject matter to undergo the process does not make the claim 'directed to' that natural ability." Otherwise, claims directed to actually "treating cancer with chemotherapy" or "treating headaches with aspirin" would be patent ineligible. Just like the claims in CellzDirect, the result of the claims here is not simply an observation or detection [citations omitted].
The Court concludes the opinion by noting that neither Ariosa Diagnostics, Inc. v. Sequenom, Inc. nor Athena Diagnostics, Inc. v. Mayo Collaborative Servs., compel a different outcome, pointing out that "the claims here are directed to a treatment method, not a detection method," and adding that "[t]he '737 patent does not 'start[] and end[] with a naturally occurring phenomenon.'" Thus, the Court determined that the '737 patent claims are not directed to patent-ineligible subject matter, and therefore reversed the District Court's decision finding the claims to be patent-ineligible.
Panel: Circuit Judges Wallach, Clevenger, and Stoll
Posted at 11:59 PM in Federal Circuit, Patentable Subject Matter | Permalink | Comments (0)