Source: https://www.medtechsip.com/blog-2
Timestamp: 2019-09-23 21:11:19
Document Index: 238653369

Matched Legal Cases: ['§101', '§101', '§101', '§101', 'Application No. 14', '§\u2002101', '§\u2002112']

Blog — Medical Technologies Intellectual Property Blog
March Madness is over, but the perennial discussion over optimal ranking methodologies is not. Depending upon application, there are numerous factors of subjectivity and objectivity which must be weighed to varying degrees in obtaining “the best of the best.” Further, there are cases where determining ideality is far more critical than ensuring fair basketball match-ups.
Consider the example of US 2014/0244292, which disclosed a method of ranking and recommending treatments for an individual’s medical condition, a determination clearly in the public interest. This application was ultimately abandoned, but not before receiving a pair of §101 rejections for reciting the abstract idea of “comparing new and stored information and using rules to identify options.”
That characterization certainly sounds like any generic ranking methodology. Yet, several applications have managed to clear this hurdle. Consider US 8,898,174, which discloses a method for ranking lawyers and their practices. Or US 9,177,349, which patents a method for rating patents (“and other intangible assets”). At first glance, these certainly seem just as abstract as a medical treatment recommendation method. Yet, both of these patents were issued in due course (the latter overcoming a §101 rejection in a single round of prosecution, the former not receiving a §101 rejection at all).
Indeed, under the continually developing case law and guidance concerning subject matter eligibility, such inconsistency at the USPTO has been debated even at the highest levels. In an effort to address this, the recent 2019 Revised Patent Subject Matter Eligibility Guidance has standardized some of the more loosely interpretable and challenging aspects of §101 rejections.
Of particular interest to this discussion is the new, two-pronged approach for determining whether or not a claim is directed to a judicial exception, including consideration of whether or not a recited judicial exception is integrated into a practical application (and therefore possibly constituting eligible subject matter). This reveals a path for future prosecution strategies for comparison- and rules-based ranking methodologies. Examples provided in the Revised Guidance include integrating judicial exceptions into the improvement of a technology or technical field, implementing the judicial exception with a particular machine or manufacture, and effecting a transformation/reduction of an article to a different state/thing. Most hopeful for cases such as the ‘292 application is the potentially patentable utilization of a judicial exception to effect a particular treatment for a disease or medical condition.
The potential for ranking methodologies (and similar subject matter) under the Revised Guidance is hardly unlimited. The Revised Guidance clearly states that judicial exceptions are not integrated into a practical application merely because the claim recites the words “apply it,” or an equivalent. However, by constructing claims in such a way as to integrate the generation of ranked lists into “real world” practicality, there may yet be opportunities in this space.
Andrew Launder April 15, 2019 Comment
The structure and strategy of a collaborative approach enables technical team members and legal team members to maximize their individual skills and the resulting patent application is more of a melting pot of these ideas due to the collaborative approach. Collaboration occurs not only during the searching, evaluation and drafting phases, but is also carried through during prosecution affording not only more robust patent applications with a smorgasbord of concepts with varying scope, but better ideas for developing a range of options to respond to Office action rejections by the USPTO. Inclusion of these types of diverse strategies in each patent application increases a client’s stronghold around technology, and builds a stronger and higher quality patent portfolio.
Arsalan Zolfaghari March 27, 2019 Comment
Anyone who stays current on topics related to nutrition and human health is well aware of the rampant use of fish oil supplements to reduce risk/susceptibility to everything from cardiovascular disease to cancer, mood disorders and more. The hype is due to fish oil containing omega-3 fatty acids, including at least docasahexaenoic acid (DHA) and eicosapentaenoic acid (EPA).
However, the medical community has debated the efficacy of fish oil supplements for years. The debate appeared to culminate in July of this year, when a study published in the Cochrane Database of Systemic Reviews that included analysis on more than 112,000 participants over the course of 10 years, reported that omega-3 supplements had essentially no effect on cardiovascular health.
The conclusion that omega-3 supplements are worthless however, was recently turned on its head with the report that Vascepa, a purified version of EPA produced by the biopharmaceutical company Amarin Corporation, remarkably lowered the risk of heart attacks and strokes in patients with very high levels of a type of fat in the blood called triglycerides. Specifically, patients on Vascepa who were also on a statin drug for lowering cholesterol showed a 25 percent reduction in the relative risk of a heart attack, stroke, or death due to a cardiovascular event, etc. Remarkably, the 25 percent reduction in risk is on top of a 25 percent reduction in risk that historically has been associated with taking statins. Thus, there appears to be enormous potential for this particular drug when taken in combination with conventional statin treatment.
The critical reason for the success appears to lie in the fact that Vascepa lowers triglycerides, without increasing so-called bad cholesterol (low-density lipoprotein-cholesterol, or LDL-cholesterol). Other supplements previously examined in studies assessing cardiovascular health included DHA along with EPA, and it is thought that because DHA is known to elevate bad cholesterol, that is the reason the previous trials failed. Alternatively, as mentioned, Vascepa is pure EPA.
Upon learning of these incredibly promising results, we were interested in looking into Amarin’s intellectual property holdings regarding this subject matter. Certainly with the overwhelming amount of information out there pertaining to the relationship between statins, cholesterol, triglycerides and omega-3 supplements including EPA and DHA, the prosecution history would provide valuable lessons from which to glean how to overcome Examiner rejections in this space.
Thus, we looked into patents filed in this space by Amarin. Specifically, United States Patent Application No. 14/411815 assigned to Amarin was directed to:
A method of reducing a risk of cardiovascular death, coronary revascularization, and unstable angina in a subject on statin therapy, the method comprising:
Administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of ethyl icosapentate per day, wherein the subject has a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL and optionally has established cardiovascular disease.
The primary rejection during prosecution included a 35 U.S.C. 102 rejection based on prior art teachings of US 2012/0121698, which included all the elements of the method claim of US 14/411815, but which failed to specifically teach the limitations related to “reducing a risk of cardiovascular death, coronary revascularization, and unstable angina in subjects having a baseline triglyceride level of about 135 mg/dL to about 500 mg/dL”, even though methods for treating a cardiovascular-related disease were disclosed. This fact was argued by the Applicant, and was enough to persuade the Office to allow the claims without any further rejections. We were surprised that no further rejections were applied in this case, given the frequency with which the KSR decision (KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)) has been recently readily applied to claims simply by an Examiner finding all the elements in a particular claim in one or more pieces of prior art, and then asserting the claim as being obvious to one skilled in the art.
At any rate, the take-home message is that method of treatment claims directed to specific aspects of disease can in some cases be sufficient to overcome close prior art. The success of Amarin’s trial is good news for investors, as well as patients with high triglyceride levels, which Amarin estimates to be over 50 million adults in the United States alone. More good news is the current list price of Vascepa, which is around $2400 per year, as compared to much higher pricing for other drugs that reduce cardiovascular events in high-risk populations.
Paul Focke October 3, 2018 Comment
Patenting your invention is about protecting your ideas and adding value to your company. Part of that value lies in the reproducibility of your invention. If you or anyone else are unable to reproduce your results, there is decreased value in your discovery and corresponding issues with scientific advancement, credibility, patentability and marketability. The use of outdated tools and methods can contribute to difficulties with reproducibility and ultimately the value of your discovery and subsequent valuations of your company.
Part of receiving the limited monopoly of a patent is a contribution to the body of scientific knowledge. In some ways, a patent can be viewed as a teaching document. In order for an invention to be enabled, as required for patentability, the specification must include enough information to allow someone of skill in the art to make and use the claimed invention. In other words, your invention needs to be reproducible to be valid.
In a survey published in the journal Nature in January 2017, more than 70% of researchers revealed that they have tried and failed to reproduce another scientist’s results based on the information published in scientific literature (Munafò, Marcus R., Brian A. Nosek, Dorothy V. M. Bishop, Katherine S. Button, Christopher D. Chambers, Nathalie Percie Du Sert, Uri Simonsohn, Eric-Jan Wagenmakers, Jennifer J. Ware, and John P. A. Ioannidis. "A manifesto for reproducible science." Nature Human Behaviour1, no. 1 (2017): 0021. doi:10.1038/s41562-016-0021). This reproducibility failure can call into question the validity of a patent that is based on research published in a paper. If someone in the field cannot reproduce a claimed invention, then arguably the claimed invention is not enabled by the patent and therefore the claims are invalid.
As research becomes increasingly computerized, it is important to stay cognizant of software developments and updates as using outdated software may lead to conclusions that are not scientifically valid, and thus such conclusions may not be reproducible when updated software is utilized. While it may be human nature to continue to rely on procedures and software you learned when you first started out, doing so may impact the patentability and any valuations attached to your discovery.
As an example, in the realm of computational biology, the website for TopHat, a spliced read mapper for RNA-Seq originally published in 2009, now states: “[p]lease note that TopHat has entered a low maintenance, low support stage as it is now largely superseded by HISAT2 which provides the same core functionality . . . in a more accurate and much more efficient way.” (Emphasis TopHat’s, https://ccb.jhu.edu/software/tophat/index.shtml).” TopHat has not been updated since February, 2016.
In a letter to the editor published in Nature Methods in 2016 (Wadi, Lina, Mona Meyer, Joel Weiser, Lincoln D. Stein, and Jüri Reimand. "Impact of outdated gene annotations on pathway enrichment analysis." Nature Methods13, no. 9 (2016): 705-06. doi:10.1038/nmeth.3963), the authors wrote that “the use of outdated resources has strongly affected practical genomic analysis and recent literature: 67% of ∼3,900 publications we surveyed in 2015 referenced outdated software that captured only 26% of biological processes and pathways identified using current resources.” What this means is that competitors using more advanced tools and methods have access to differentiating data and models that can be used, either in whole or part with existing knowledge, to more completely describe inventions. This may allow them to either to design around your claims or claim complete novelty.
Enablement is a requirement of patentability. When “the claimed subject matter is inoperable, the patent may indeed be invalid for failure to meet the utility requirement of § 101 and the enablement requirement of § 112,” Process Control Corp. v. HydReclaim Corp. 190 F. 3d 1350 (Fed. Cir. 1999) citing Brooktree Corp., 977 F.2d at 1571, 24 USPQ2d at 1412 (citing Raytheon Co., 724 F.2d at 956, 220 USPQ at 596). Using the most modern tools and methods not only helps increase the breadth of your discovery, it also helps with reproducibility and validation of your claims. Your insights and research are cutting edge, make sure your tools are, too.