• Congresswoman Lofgren Sends Letter to USPTO Director Iancu Opposing Proposed Changes to Claim Construction Rule at PTAB

    Congresswoman Lofgren is now opposing a rule change she previously endorsed as an original co-sponsor of a bill that would have changed the claim construction rule in exactly the same way proposed by Director Iancu… But how is adopting a rule that would have already been the law had Lofgren had her way possibly frustrate or disregard Congress? Of course, we aren’t supposed to ask that question. Once the “patent troll” boogeyman card is played everything else is supposed to fade away.

    The…

    Continue Reading ...
  • Is Elon Musk a Modern Day Rasputin?

    Musk also continues to be exposed by news headlines. Twice Musk has delayed his own deadline to reach the 5,000-per-week production goal he has set for Tesla’s Model 3. He’s broken promises not only to his shareholders but also his workforce, 9 percent of which he recently laid off in an attempt to make Tesla into a profitable company. At the time of this writing, Tesla shares were in the $310 price range despite predictions from major investment bank Goldman Sachs that Tesla may need to raise…

    Continue Reading ...
  • Webinar on Patent Drafting for Machine Learning

    Strafford will be offering a webinar entitled “Patent Drafting for Machine Learning: Structural Claim Limitations, Avoiding 101 or 112 Rejections” on August 16, 2018 from 1:00 to 2:30 pm (EDT). Gregory Rabin of Schwegman Lundberg & Woessner and Michael D. Stein of Baker & Hostetler will guide patent practitioners in overcoming the challenges when seeking patent protection for machine learning inventions, and also discuss what can be done to anticipate and minimize the risks of § 101 or § 112 rejections. The webinar will review the following issues: • What are the hurdles for patent counsel to demonstrate inventorship? •…

    Continue Reading ...
  • Linear gadolinum imaging agents and clear and convincing evidence

    In this post, we look at how different medical bodies, specifically those in Europe (the European Medicines Agency (EMA) ) and in the United States (the FDA) look at evidence that might be considered “clear and convincing.” Specifically, in the context of linear gadolinium imaging agents, they have reached different conclusions. But first, a quick trip to the law of “clear and convincing” evidence.

    In Halo v. Zimmer, 136 S. Ct. 1923; 195 L. Ed. 2d 278; 2016 U.S. LEXIS 3776; 84 U.S.L.W. 4386; 118 U.S.P.Q.2D (BNA) 1761 , the U.S. Supreme Court delved into the evidentiary standard of clear and convincing evidence:


    The Seagate test is also inconsistent with §284 because it requires clear and convincing evidence to prove recklessness. On this point Octane Fitnessis again instructive. There too the Federal Circuit had adopted a clear and convincing standard of [***20] proof, for awards of attorney’s fees under §285 of the Patent Act. Because that provision supplied no basis for imposing such a heightened standard of proof, we rejected it. See Octane Fitness, 572 U.S., at ___, 134 S. Ct. 1749, 188 L. Ed. 2d 816. We do so here as well. Like §285, §284 “imposes no specific evidentiary burden, much less such a high one.” Ibid. And the fact that Congress expressly erected a higher standard of proof elsewhere in the Patent Act, see 35 U.S.C. §273(b), but not in §284, is telling. Furthermore, nothing in historical practice supports a heightened standard. As we explained in Octane Fitness, “patent-infringement litigation has always been governed by a preponderance of the evidence standard.” 572 U.S., at ___, 134 S. Ct. 1749, 188 L. Ed. 2d 816. Enhanced damages are no exception.

    The Supreme Court did not get into definitions. Earlier, in 1983, the CAFC in SSIH, 718 F.2d 365 , gave some explanatory text:

    A particular quantum or burden of proof at the trial level (standard of proof) is generally a judge-made requirement shaped in accordance with considerations of due process and/or the importance of certain facts. Herman & MacLean v. Huddleston, 459 U.S. 375, 103 S. Ct. 683, 691, 74 L. Ed. 2d 548 (1983). As explicated in Addington v. Texas, 441 U.S. 418, 423-25, 60 L. Ed. 2d 323, 99 S. Ct. 1804 (1979), three levels of proof are generally recognized: preponderance (or weight) of the evidence, clear and convincing proof, and beyond a reasonable doubt.

    (…)

    We probably can assume no more than that the difference between a preponderance of the evidence and proof beyond a reasonable doubt probably is better understood than either of them in relation to the intermediate standard of clear and convincing evidence. Nonetheless, even if the particular standard-of-proof catchwords do not always make a great difference in a particular case, adopting a “standard of proof is more than an empty semantic exercise. ” Tippett v. Mar-yland, 436 F.2d 1153, 1166 (CA4 1971) (Sobeloff, J., concurring in part and dissenting in part), cert. dismissed sub nom. Murel v. Baltimore City Criminal Court, 407 U.S. 355, 32 L. Ed. 2d 791, 92 S. Ct. 2091 (1972). [Footnote omit-ted.]

    Within Pfizer v. Apotex, 480 F.3d 1348; 2007 U.S. App. LEXIS 6623; 82 U.S.P.Q.2D (BNA) 1321 , one has the text:


    Although an exact definition is elusive, “clear and convincing evidence” has been described as evidence that “place[s] in the ultimate factfinder an abiding conviction that the truth of its factual contentions are highly probable.” Colorado v. New Mexico, 467 U.S. 310, 316, 104 S. Ct. 2433, 81 L. Ed. 2d 247 (1984) (internal quotations omitted).

    In New Jersey, the Supreme Court of New Jersey has supplied a useful definition of clear and convincing evidence as that which

    produce[s] in the mind of the trier of fact a firm belief or conviction as to the truth of the allegations sought to be established, evidence so clear, direct and weighty and convincing as to enable [the factfinder] to come to a clear conviction, without hesitancy, of the truth of the precise facts in issue.

    In re Jobes, 108 N.J. 394, 529 A.2d 434, 441 (N.J. 1987)

    With these definitions in mind, one has some questions about the safety of linear gadolinium contrast agents.

    From ITNonline:


    August 29, 2017 — The European Medicines Agency (EMA) issued a final opinion that recommended restricting the use of some linear gadolinium-based contrast agents (GBCAs) and suspending the marketing authorizations of others, while supporting the continued use of macrocyclic GBCAs.

    Importantly, the EMA confirmed that “there is currently no evidence that gadolinium deposition in the brain has caused any harm to patients; however EMA has recommended restrictions for some intravenous linear agents in order to prevent any risk that could potentially be associated with gadolinium brain deposition.”

    From Eur Radiol. 2018 Apr;28(4):1579-1584. doi: 10.1007/s00330-017-5065-8. Epub 2017 Oct 23:


    Abstract
    The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) earlier this year recommended to suspend some marketing authorisations for Gadolinium Containing Contrast Agents (GCCAs) based on linear chelators due to the potential risk of gadolinium retention in the human body. These recommendations have recently been re-evaluated by EMA’s Committee for Medicinal Products for Human Use (CHMP), and confirmed the final opinion of the European Medicines Agency. This editorial provides an overview of the available GCCAs and summarises the recent evidence of gadolinium retention. Moreover, a critical appraisal of the strengths and limitations of the scientific evidence currently available on gadolinium retention is given.

    KEY POINTS:
    • EMA recommended suspension of some EU marketing authorisations of four linear GCCAs. • Brain MRI findings indicating gadolinium retention have been confirmed by mass spectrometry. • Current scientific evidence for gadolinium retention has several methodological limitations. • No clear clinical evidence exists indicating that gadolinium retention causes neurotoxicity. • Long-term safety of GCCAs, however, remains unclear.

    See also Gadolinium should go: Risk experts want MRI contrast agent pulled off market,
    https://www.afr.com/business/health/gadolinium-should-go-risk-experts-want-mri-contrast-agent-pulled-off-market-20170319-gv1r0i


    The first committee, the PRAC, found convincing evidence of accumulation of gadolinium in brain tissue many months after the last contrast MRI was performed. (…) It noted deposits had been found in other organs and tissues and non-clinical studies had shown it to be harmful in tissues.

    See also Neeley et al., Br J Radiol. July 2016; 89(1063): 20160027. Acute side effects of three commonly used gadolinium contrast agents in the paediatric population

    ***As to the impact of gadolinium being retained in the brain on LATER brain MRIs, note

    Recent papers have demonstrated that gadolinium accumulation with concomitant T1 shortening
    can be seen in the brains of patients who have received multiple doses of gadolinium contrast.
    The effect is most noticeable in the globus pallidi, thalami, pons, and dentate nuclei.
    The magnitude of the effect is proportional to the cumulative lifetime dose administered
    and occurs without renal or hepatic dysfunction.

    link: http://mriquestions.com/gd-accumulation.html

    See also: http://mriquestions.com/paramagnetic-relaxation.html

    Continue Reading ...
  • 後部

                            目次はこちら

    後部

    (BACK)
    $$ The spring 26 also causes the first seal 4 and second seal 21 to be pierced by a piercing detail 19 on the back of the hollow hypodermic …

    Continue Reading ...
  • Simple, yet non-obvious

    If the first wearable pair of eyeglasses — i.e. the handheld type that one holds on the bridge of the nose — were invented in the 13th century in Italy, when do you think “legs” were invented?  Legs are the portion that fit over the wearer’s ears. Answer below the break: As hard as it […]

    Continue Reading ...
  • The Plight of the Patentee

    Having produced a non-obvious, non-abstract invention and playing by the patent office’s rules is no guarantee of a patent granting. Some examiners have refused to issue patent applications regardless of the merits because doing so would run the risk of them losing their jobs if they received further negative reviews from the Patent Quality initiative. All patents run the risk of expensive oppositions from well-funded competitors. 

    The post The Plight of the Patentee appeared first on…

    Continue Reading ...