Source: https://patentdocs.typepad.com/patent_docs/page/2/
Timestamp: 2019-04-19 15:19:15+00:00

Document:
There is no registration fee for the seminar. However, those interested in registering for event can do so here.
• What are the critical patentability issues when preparing solid form patents?
• How are pharmaceutical companies using solid form patents?
• What is different about claiming solid form patents concerning "organic chemistry" claims in other composition-of-matter patents?
• What impact does the FDA guidance on cocrystals have on patenting composition of matter?
The registration fee for the program is $145 (BPLA members), $285 (non-members), or free (FCBA members). Those interested in registering for the program, can do so here. Additional information regarding the program can be found here.
• What hurdles must patent counsel overcome to demonstrate inventorship with AI systems?
• How can patent counsel meet the requirements under Sections 101 and 112 in AI systems patent applications?
• What steps should patent counsel take to minimize the likelihood of Section 101 or Section 112 rejections?
Athena Diagnostics filed a Petition for Rehearing of the CAFC decision in Athena Diagnostics v. Mayo on April 8, 2019. Amicus Briefs are due April 22, 2019. Patent Docs has reported on this decision, which continues to apply U.S. Supreme Court-created common law to the analysis of 35 U.S.C. § 101.
Knowles IP Strategies LLC (Sherry M. Knowles) and AddyHart (Meredith Addy) intend to file an Amicus Brief in support of neither party but requesting that the CAFC carry out its constitutional duty to apply strict statutory construction of the literal words of 35 U.S.C. § 101 to decide the case (see "Unconstitutional Application of 35 U.S.C. § 101 by the U.S. Supreme Court," 18 J. Marshall Rev. Intell. Prop. L. 144 (2018), which was discussed and can be accessed here).
As with other recent CAFC and U.S. Supreme Court cases on patent eligibility, the Athena decision omits an appropriate analysis of the wording of the statute it is applying ("Whoever invents or discovers"), and its opinion is inconsistent with the wording of the statute. Instead, it applies judicial exceptions to the statute, which have been created by the U.S. Supreme Court as elaborated in its new common law on the subject. However, as recently well stated by the U.S. Supreme Court in Henry Schein, Inc. v. Archer & White, Inc. (No. 17-1272; January 8, 2019): "This Court may not engraft its own exceptions onto the statutory text".
If your institution or company or you are interested in joining this brief, please send a request to amicus@kipsllc.com by April 17, 2019. The U.S. Constitution is not self-enforcing. The people and institutions of the United States must demand it.
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.
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.
[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.
FiercePharma today reported sales rankings for the top 15 pharmaceutical companies in 2018, in comparison to 2017 sales. As reported today, "the top 15 names are the same against prior year rankings, but the order has shifted." 2018 sales were up for all reported companies except Gilead, AstraZeneca, and Teva, and the change in rankings generally had more to do with competitors' improvements (and increased sales) than reductions in sales 2018 to 2017. Increases were notable for Bristol Myers-Squibb and Takeda, while Sanofi and Gilead showed reduced sales. And the report notes that Boehringer Ingelheim’s exclusion from the data was the result of (relatively) late sales reporting (due April 17th).
As reported, "[f]or these rankings and company profiles, FiercePharma consulted company earnings reports, securities filings, earnings transcripts and analyst reports, plus our own archives," while segregating Bayer's plant science unit as being too far removed from human or animal health."
In addition, the report notes that the industry set a record with 59 novel drugs being approved in 2018. But also included in the report are challenges expected in the industry, including the departure of Scott Gottlieb as head of FDA and calls by politicians on both sides of the aisle, and the Trump administration, for lower drug prices.
Last week, in Cleveland Clinic Foundation v. True Health Diagnostics LLC, the Federal Circuit affirmed a decision by the U.S. District Court for the Eastern District of Virginia holding claim 1 of U.S. Patent No. 9,575,065 and claims 1 and 2 of U.S. Patent No. 9,581,597 invalid under 35 U.S.C. § 101 as directed to an ineligible natural law. Finding the asserted claims to be patent ineligible, the District Court had dismissed a complaint for patent infringement filed by Cleveland Clinic Foundation and Cleveland HeartLab, Inc. ("Cleveland Clinic") against True Health Diagnostics LLC under Rule 12(b)(6) (see "Cleveland Clinic Foundation v. True Health Diagnostics, LLC (E.D. Va. 2017)"). In affirming the District Court, the Federal Circuit determined that its precedent, and not the U.S. Patent and Trademark Office's guidance, must control.
b) detecting elevated MPO mass in said plasma sample, as compared to a control MPO mass level from the general population or apparently healthy subjects, by contacting said plasma sample with anti-MPO antibodies and detecting binding between MPO in said plasma sample and said anti-MPO antibodies.
d) comparing said MPO concentration in said plasma sample from said human subject to a control MPO concentration from apparently healthy human subjects, and identifying said MPO concentration in said plasma sample from said human subject as being elevated compared to said control MPO concentration.
2. The method of claim 1, further comprising, prior to step a), centrifuging an anti-coagulated blood sample from said human subject to generate said plasma sample.
wherein the levels of myeloperoxidase in the bodily [samples] from the test subject relative to the levels of [m]yeloperoxidase in the comparable bodily samples from control subjects is indicative of the extent of the test subject's risk of having atherosclerotic cardiovascular disease.
The opinion also notes that In Cleveland Clinic I, the Court held the methods of the '552 patent invalid under § 101 as being "directed to the ineligible natural law that blood MPO levels correlate with atherosclerotic CVD," and also held that "because the patent did not purport to have invented any of the biological techniques used to detect MPO or the statistical methods used to compare a patient's MPO levels to the control group, the claims recited no further inventive concept sufficient to transform the nature of the claims into a patent-eligible application of the natural law." According to the opinion, the asserted claims of the '065 and '597 patents recite methods of identifying and detecting MPO, in contrast to the method of assessing atherosclerotic CVD risk from blood MPO levels in the '552 patent.
On appeal, Cleveland Clinic argued that the claims are not directed to a natural law, but to the technique of using an immunoassay to measure the blood MPO levels of patients with atherosclerotic CVD, that the correlation between blood MPO levels and atherosclerotic CVD is not a natural law because it can only be detected using certain techniques (since prior art techniques were too invasive or failed to predict CVD risk), and that using an immunoassay to detect the correlation between blood MPO levels and atherosclerotic CVD supplies an inventive concept sufficient to transform the claims into patent-eligible subject matter. True Health countered by arguing that the correlation between atherosclerotic CVD and blood MPO levels is a natural law because it exists in nature apart from human intervention and that using known techniques in a standard way to observe a natural law neither renders the claims directed to something other than the natural law nor supplies an additional inventive concept.
[A]re not directed to new techniques for performing an immunoassay to detect a patient's blood MPO levels. They only recite applying known methods to detect MPO levels in plasma, comparing them to standard MPO levels, and reaching a conclusion: that the patient's blood MPO levels are elevated in comparison to a control group. This conclusion is simply another articulation of the natural law that blood MPO levels correlate with atherosclerotic CVD. Thus, as we held in Cleveland Clinic I, the claims are directed to the patent-ineligible natural law that blood MPO levels correlate with risk of atherosclerotic CVD.
The Federal Circuit also disagreed with Cleveland Clinic's argument that the correlation of blood MPO levels with atherosclerotic CVD is not a natural law because blood MPO levels can only be observed using certain techniques, stating that "[i]nadequate measures of detection do not render a natural law any less natural." The Court also found Cleveland Clinic's argument that the inventive concept was supplied by using an immunoassay to detect the correlation between blood MPO levels and atherosclerotic CVD to be unpersuasive, stating that the argument that "using a known technique in a standard way to observe a natural law can confer an inventive concept—has been consistently rejected by this court in circumstances nearly identical to this case" (citing Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743, 747 (Fed. Cir. 2019), and Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015)).
b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.
c. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.
According to Example 29, claim 1 is considered to be patent eligible and claim 2 is considered to be patent ineligible. The Example explains that claim 1 is eligible because steps (a) and (b) of the claim "do not recite or describe any recognized exception." As a result, the analysis of this claim ends with Step 2A of analytic framework set forth in the Interim Guidance (i.e., determining whether the claim is directed to a judicial exception), and the Example notes that there is no need to proceed with Step 2B of the analytic framework (i.e., determining whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception).
In overcoming the § 101 rejection, Cleveland Clinic argued that the rejected claims more closely resembled claim 1 of Example 29 as opposed to exemplary claim 2 because the rejected claims were directed to a method of detecting myeloperoxidase rather than a method of diagnosing atherosclerotic cardiovascular disease. The Examiner withdrew the rejection and the '065 patent proceeded to issuance. As for the '597 patent, which was similarly rejected under § 101 as being directed to patent ineligible subject matter, Cleveland Clinic overcame the rejection by citing Example 29 and arguing that the claims amount to significantly more than the judicial exception.
On appeal, True Health countered that the USPTO guidance is neither persuasive nor relevant to the eligibility of the asserted claims, and that the District Court correctly found that claim 1 of Example 29 of the USPTO guidance is directed to a method of detecting a protein in a plasma sample without linking the results to a disease or other natural phenomenon.
While we greatly respect the PTO's expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance. And, especially regarding the issue of patent eligibility and the efforts of the courts to determine the distinction between claims directed to natural laws and those directed to patent-eligible applications of those laws, we are mindful of the need for consistent application of our case law.
We have considered Example 29 and the arguments relating to it, but to the extent that Example 29–Claim 1 is analogous to the claims at issue, Ariosa must control. Accordingly, we decline to follow the PTO's Example 29–Claim 1 and conclude that the district court did not err in its consideration of the PTO's subject matter eligibility guidance.
Thus, the Court determined that the District Court correctly concluded that the asserted claims are directed to a natural law and recite no other inventive concept, and therefore affirmed the District Court's decision finding the claims to be patent ineligible and dismissing Cleveland Clinic's complaint.
While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here. CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.
There is no registration fee for the program. However, because space is limited, those interested in attending the program must register by contacting Susan Hall at hall@mbhb.com. When registering, please note at which location you plan to attend: San Diego (Hyatt Regency La Jolla at Aventine) or Burlingame (Hyatt Regency San Francisco Airport).
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.
Additional information regarding this webinar, including instructions for viewing the webinar, can be found here.
• 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?
• When can post-filing data be used?
• What is needed to demonstrate the nonobviousness of antibody claims in the different jurisdictions?
The registration fee for the webinar is $135 (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.

References: v. 
 § 101
 § 101
 § 101
 v. 
 v. 
 v. 
 § 101
 v. 
 § 101
 v. 
 v. 
 § 101
 § 101