The document discusses the Patent Prosecution Highway (PPH) program which allows applicants to request expedited examination of corresponding applications filed in multiple patent offices. It provides an overview of how PPH works, its purpose of promoting work sharing and efficiency. The history and implementation of global and IP5 PPH pilot programs are described. Eligibility requirements and required documents for PPH requests to the USPTO are outlined. The processing of requests as granted, dismissed or denied is also summarized.
The aim of this lecture is to provide
an overview of the management of various toxic exposures.
emergency medical services that should be immediately contact to provide advanced life support for patient with unstable vital signs resulting from a poisoning exposure.
Tools used in Pharmacovigilance (Clinical Research & Pharmacovigilance).pptxDureshahwar khan
Let’s take a look at some software used in Pharmacovigilance for the management and reporting of Adverse events.
Some software’s used in pharmacovigilance are:
-Oracle Argus Safety
-ArisG
-Oracle Adverse Event Reporting System (AERS)
-ClinTrace
-PvNET
-repClinical
-Vigilanz Dynamic Monitoring System
-WebVDME Pharmacovigilance Signal detection and Signal management software
-PV works
The aim of this lecture is to provide
an overview of the management of various toxic exposures.
emergency medical services that should be immediately contact to provide advanced life support for patient with unstable vital signs resulting from a poisoning exposure.
Tools used in Pharmacovigilance (Clinical Research & Pharmacovigilance).pptxDureshahwar khan
Let’s take a look at some software used in Pharmacovigilance for the management and reporting of Adverse events.
Some software’s used in pharmacovigilance are:
-Oracle Argus Safety
-ArisG
-Oracle Adverse Event Reporting System (AERS)
-ClinTrace
-PvNET
-repClinical
-Vigilanz Dynamic Monitoring System
-WebVDME Pharmacovigilance Signal detection and Signal management software
-PV works
A BRIEF OVERVIEW ABOUT CDSCO.
YOU CAN DOWNLOAD FILES FROM HERE-
MY SLIDESHARE ACCOUNT-
https://www.slideshare.net/varshawadnere
IF YOU HAVE ANY DOUBTS YOU CAN ASK ME THROUGH EMAIL-
pharmacypharmd8@gmail.com
THANK YOU.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
This presentation provides a knowledge about Safety Pharmacology, It's aim & objectives, issues, consideration in selection and design of study and test study, duration of study, various studies involved in safety pharmacology, its guidelines, preclinical safety pharmacology. An assignment for the subject, Clinical Research and Pharmacovigilance, 1st year M.Pharm, 2nd semester.
Setting up of new pharmacovigilance centresPriti Gupta
this is just an overview of the setting up of pharamcovigilance with fake name of company and product. budget is also an imagination. there is not exact representation of the actual situation.
A BRIEF OVERVIEW ABOUT CDSCO.
YOU CAN DOWNLOAD FILES FROM HERE-
MY SLIDESHARE ACCOUNT-
https://www.slideshare.net/varshawadnere
IF YOU HAVE ANY DOUBTS YOU CAN ASK ME THROUGH EMAIL-
pharmacypharmd8@gmail.com
THANK YOU.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
This presentation provides a knowledge about Safety Pharmacology, It's aim & objectives, issues, consideration in selection and design of study and test study, duration of study, various studies involved in safety pharmacology, its guidelines, preclinical safety pharmacology. An assignment for the subject, Clinical Research and Pharmacovigilance, 1st year M.Pharm, 2nd semester.
Setting up of new pharmacovigilance centresPriti Gupta
this is just an overview of the setting up of pharamcovigilance with fake name of company and product. budget is also an imagination. there is not exact representation of the actual situation.
What Does it mean?
To understand go through the whole document...
Nothing but this is basically intended to give message about the term "Patent Applications"? What they are? Benefits? Drawback? etc
The examination of a patent application's patentability in Vietnam is time-consuming. A typical examination would necessitate access to databases of prior art for novelty and inventiveness comparisons against what has already been disclosed or practiced. Despite recent advancements in conducting substantive examination for patent applications, the Intellectual Property Office of Vietnam (VNIPO) tends to grant patents based on the grant of the corresponding patent from countries with more developed IP systems or examination results of the corresponding patent application from more established Patent Offices such as those of the United States, Japan, South Korea, and the European Patent Office.
Knobbe Martens co-hosted a 2-hour seminar in San Diego on Protecting Your Intellectual Property with a distinguished panel of global patent practitioners.
Similar to Navigating the Patent Prosecution Highway (20)
Pitfalls to be Aware of When Working with Inventions Funded Through Governmen...Workman Nydegger
Sometimes a client’s technology is funded by a government grant, e.g., through a federal agency. Complex provisions governing ownership, disclosure, election, patent filing, and other requirements for such technology are governed by the Bayh-Dole act of 1980 (35 U.S.C. §200-212). Some of the “strings” imposed and governed by Bayh-Dole that are particularly relevant to patent practitioners include:
• disclosure of developed inventions;
• election of ownership to the technology by the contractor;
• compulsory government license that attaches to developed technology;
• possibility of U.S. Government exercise of “March-In Rights”;
• requirements for U.S. manufacture;
• issues relative to protecting trade secrets of the contractor.
In addition to the need to comply with the many provisions of Bayh-Dole, where government funded inventions are developed, export provisions under ITAR/EAR may also be applicable. Such ITAR and EAR export control regulations cover not only articles, software, and services that may be listed on either the US Munitions List (for ITAR) or the Commerce Control List (for EAR), but also cover technical data, such as that used by patent practitioners in conducting a patentability search or preparing a patent application for the contractor.
2018 mar-09 - jens jenkins - finjan your claims to patent eligibility (update...Workman Nydegger
On January 10, 2018 the Federal Circuit (hereinafter the ‘Court’) released its decision in Finjan v. Blue Coat Systems, Inc. (Finjan v. Blue Coat Systems, Inc. (case no. 2016-2520; January 2018)).
In Finjan, the Court took the opportunity to further clarify the line between inventions that are patent eligible and those that are merely directed to abstract ideas and, therefore, patent ineligible. The Court reiterated the precedent of Enfish, that “software-based innovations can make ‘non-abstract improvements to computer technology’ and be deemed patent-eligible subject matter.” (Enfish, 822 F.3d at 1335-36).
Interestingly, the virus screening claims in Finjan were found to be “directed to a non-abstract improvement in computer functionality, rather than [an] abstract idea…”, even though the same Court had previously found virus screening claims to be patent ineligible for being directed to a well-known abstract idea. (See Intellectual Ventures I LLC v. Symantec Corp., 838 F. 3d 1307, Court of Appeals, Federal Circuit 2016).
In concluding the Finjan claims were directed to non-abstract and patent eligible ‘improvements to computer functionality,’ the Court appeared to rely on logic associated with typical 103 obviousness-type arguments. In particular, the Court noted that the operation of the Finjan virus screening was found to be “distinguished from traditional, ‘code-matching’ virus scans” and employed “a new kind of file that enables a computer security system to do things it could not do before.”
Finjan is now included as one of only a few cases identified in the February 2018: Eligibility Quick Reference Sheet provided by the USPTO. Accordingly, Finjan appears to be a great case to reference when dealing with 101 subject matter eligibility rejections. When responding to these types of 101 rejections, it may be helpful to reference Finjan and articulate how the claims represent an ‘improvement’ over traditional computer products and how the claimed invention enables, for example, ‘a computer to do things it could not do before.’
Enhanced Damages for Patent Infringement - Workman NydeggerWorkman Nydegger
Enhanced damages in patent infringement suits in recent years have been limited due to the application of the Seagate test. This test was developed as a standard used by courts to determine when to award enhanced damages. The Supreme Court’s recent decision in Halo v. Pulse found the Seagate test to be unduly rigid and inconsistent with the actual statute regarding enhanced damages. The Court restored the process of awarding enhanced damages to its intended scope.
We review the history of enhanced damages in patent infringement suits, including the introduction of the Seagate test. Halo v. Pulse is reviewed and the Supreme Court’s reasoning behind eliminating the Seagate test is described. We also discuss the impact the removal of the Seagate test has on patent infringement suits and potential patent infringers.
http://www.wnlaw.com/blog/enhanced-damages-patent-infringement-halo-v-pulse/
How to Obtain Permanent Residency in the NetherlandsBridgeWest.eu
You can rely on our assistance if you are ready to apply for permanent residency. Find out more at: https://immigration-netherlands.com/obtain-a-permanent-residence-permit-in-the-netherlands/.
In 2020, the Ministry of Home Affairs established a committee led by Prof. (Dr.) Ranbir Singh, former Vice Chancellor of National Law University (NLU), Delhi. This committee was tasked with reviewing the three codes of criminal law. The primary objective of the committee was to propose comprehensive reforms to the country’s criminal laws in a manner that is both principled and effective.
The committee’s focus was on ensuring the safety and security of individuals, communities, and the nation as a whole. Throughout its deliberations, the committee aimed to uphold constitutional values such as justice, dignity, and the intrinsic value of each individual. Their goal was to recommend amendments to the criminal laws that align with these values and priorities.
Subsequently, in February, the committee successfully submitted its recommendations regarding amendments to the criminal law. These recommendations are intended to serve as a foundation for enhancing the current legal framework, promoting safety and security, and upholding the constitutional principles of justice, dignity, and the inherent worth of every individual.
Responsibilities of the office bearers while registering multi-state cooperat...Finlaw Consultancy Pvt Ltd
Introduction-
The process of register multi-state cooperative society in India is governed by the Multi-State Co-operative Societies Act, 2002. This process requires the office bearers to undertake several crucial responsibilities to ensure compliance with legal and regulatory frameworks. The key office bearers typically include the President, Secretary, and Treasurer, along with other elected members of the managing committee. Their responsibilities encompass administrative, legal, and financial duties essential for the successful registration and operation of the society.
2. PPH: A Brief Overview
• How PPH works:
– Claims determined allowable in a participating Office of Earlier Examination
(OEE); the corresponding U.S. application (in Office of Later Examination
(OLE)) is advanced out of turn – Still examined according to U.S. patent law.
• Purpose of PPH:
– Work sharing: OLE can utilize work product (search and examination results) of
OEE; more thorough examination; improve patent quality.
– Office efficiency: avoiding duplication of work among jurisdictions.
– Time and cost savings: expedites the examination process in the OLE;
determine patentability faster in multiple jurisdictions.
3. PPH: A Brief History
• July 2006 – US launches PPH pilot program(s) and develops
“partnerships” - agreements with each partnering Office, individually.
– an application whose claims have been determined to be patentable in an Office of First Filing
(OFF) may be eligible for accelerated examination in an Office of Second Filing (OSF).
• January 2010 – US implements PCT-PPH; ISR “allowable” claims
(novelty / inventive step / industrial application).
• May 2010 – PPH 2.0; PPH request no longer requires petition to make
special under 1.102(d) – for reasons other than age/illness/energy/etc. –
and $130 fee under 1.17(h).
– Instead, advance out of turn under 1.102(a) – expedite business of Office; w/o fee.
• July 2011 – US implements revised requirements.
– Replace OFF / OSF with OEE / OLE for applications sharing a priority/filing date.
• January 2014 – US launches Global PPH / IP5 PPH pilot programs;
“Uniformity” of rules among partner states.
– USPTO treats all PPH requests and PPH approved applications the same.
– All partner Offices adhere to same minimum requirements.
4. Global / IP5 PPH: Implementation
• Global PPH and IP5 PPH pilot programs are running
concurrently AND are substantially identical.
– differing only with regard to their respective participating offices and trial period.
– Global PPH pilot runs for 1 year (ending January 5, 2014).
– IP5 PPH pilot runs for 3 years (ending January 5, 2017).
– Either may be extended or terminated with approval of ALL Offices.
– Any Office may opt-out at any time for any reason.
• USPTO opted for participation in BOTH programs.
– file request based on work product of any office participating in either program.
– same request form and no need to specify which program is being utilized.
– Global PPH and IP5 PPH pilot programs supersede any prior PPH program between
USPTO and each Global PPH and IP5 PPH participating Office.
– Any existing PPH programs between the USPTO and offices that are not
participating in either Global PPH or IP5 PPH pilot program remain in effect.
5. NON-Global / IP5 PPH: Individual
partners (special forms)
Austria
Columbia
Czech Republic
Germany
Mexico
Nicaragua
Philippines
Singapore
Taiwan
6. Global / IP5 PPH: Eligibility
Requirements in USPTO
• (1) OEE must be a Global / IP5 PPH participating Office.
– “corresponding” (earlier-examined) national or regional application filed
with another Global / IP5 PPH participating office; or
– “corresponding” (earlier-examined) PCT international application where a
Global / IP5 PPH participating offices was the ISA or IPEA.
7. Global / IP5 PPH: Eligibility
Requirements in USPTO
• (2) U.S. application for later examination must have
the same earliest date (priority or filing) as the earlier-
examined, corresponding application.
– US utility + foreign-filed and/or PCT application – filed on same day.
– US utility foreign-filed and/or PCT application – priority claim.
– US provisional US non-provisional + foreign-filed application –
priority claim.
– foreign-filed and/or PCT application US utility / national stage entry
– priority claim.
8. Global / IP5 PPH: Eligibility
Requirements in USPTO
• (3) The corresponding application has at least one claim
indicated to be allowable / patentable by the OEE in its
capacity as a national or regional Office, ISA, or IPEA.
– A claim determined as novel, inventive, and having industrial application by
the ISA or IPEA has the meaning of allowable / patentable for the purposes
of this program.
9. Global / IP5 PPH: Eligibility
Requirements in USPTO
• (4) ALL claims in the U.S. application must sufficiently
correspond (or be amended to sufficiently
correspond) to the allowable / patentable claims in the
corresponding OEE application.
– “sufficiently correspond” = accounting for differences due to claim
format requirements, the claim is of the same or similar scope as a
claim indicated as allowable / patentable in the OEE application.
– “sufficiently correspond” = narrower dependent claim depending from a
claim of same or similar scope as a claim indicated as allowable /
patentable in the OEE application.
– BUT, cross-category claims ≠ “sufficiently correspond” - e.g., OEE
application contains only process claims; any product claims in the
U.S. application are not considered to sufficiently correspond, even if
the product claims are dependent on process claims which sufficiently
correspond to allowable /patentable claims in the OEE application.
10. Global / IP5 PPH: Eligibility
Requirements in USPTO
• (5) Substantive examination of the U.S. application
(i.e., in the OLE) has NOT begun.
– Notice to File Missing Parts ≠ substantive examination.
– Restriction Requirement ≠ substantive examination.
• NOTE: at this point, you may not need PPH; application will not likely be
examined any faster than its normal examination process even if your PPH
request is granted – Examiners will generally examine an application within
60 days from the date a reply to the restriction requirement is filed (i.e., by
the time your PPH request is decided, your application would probably be
examined in its regular turn anyway).
11. Global / IP5 PPH: Required
Documents
• (1) A request for participation in the Global / IP5 PPH
pilot program and a request that the U.S. application
be advanced out of turn for examination by order of
the Director to expedite the business of the Office
under 37 CFR 1.102(a). NO FEE is required.
• (2) A claims correspondence table in English,
indicating how and certifying that all the claims in the
U.S. application correspond to allowable / patentable
claims in the OEE application.
– NOTE: each submitted via EFS-Web and indexed with the document
description "Petition to make special under the Patent Pros Hwy."
12. Global / IP5 PPH: Required
Documents
• (3) A copy of the allowable claims and OEE work
product relevant to allowability, including:
(A) the office action issued just prior to the "Decision to Grant a
Patent" (e.g., the latest "Notification of Reasons for Refusal") in the OEE
national / regional application, along with an English translation thereof, if
applicable; or
(B) the latest work product in the international phase of the OEE PCT
application (e.g., the Written Opinion of the ISA or, where a demand under
PCT Chapter II has been filed, the Written Opinion of the IPEA or the
International Preliminary Examination Report), along with an English
translation thereof, if applicable.
– NOTE: if the office action or PCT work product is already present in
the U.S. application or is available via the Dossier Access system or
the PATENTSCOPE system of the World Intellectual Property
Organization (WIPO), the applicant must identify the document and
request USPTO obtain a copy, but need not supply a copy thereof.
13. Global / IP5 PPH: Required
Documents
• (4) An information disclosure statement (IDS) listing
the documents cited in the office action or PCT work
product submitted under item (3) above, along with
copies of all documents except U.S. patents and U.S.
patent application publications.
– NOTE: submitted via EFS-Web and indexed with the document
description “Information Disclosure Statement (IDS).”
– NOTE: any IDS or document copies submitted in the U.S. application
prior to the Global / IP5 PPH request need not be resubmitted.
– NOTE: document copies not in English require a concise explanation
of relevance. English language version of search report indicating
degree of relevance is sufficient.
14. Global / IP5 PPH: U.S. request
Granted; Dismissed; Denied
• Requests that meet all eligibility requirements AND
properly include all required documentation are
GRANTED, and the application is advanced out of turn.
• Requests that do not meet all eligibility requirements are
immediately DENIED, and application awaits action in its
regular turn.
• Requests that meet all eligibility requirements BUT do not
properly include all required documentation are
DISMISSED, and applicant is given ONE chance to fix it.
• DISMISSED requests that are not properly corrected are
then DENIED.
15. Global / IP5 PPH: Misc.
• Following a DENIED request, a continuation or
divisional application may be filed and a new request
submitted.
• Special status granted in an application carries over to
an RCE of the application.
• A preliminary amendment may be filed along with the
request, but must be indexed with the document
description “preliminary amendment.”
• Amendments filed after a PPH request is granted must
sufficiently correspond to one or more allowable /
patentable claims in the OEE application and the
applicant must submit a statement certifying the
same.
16. Global / IP5 PPH: Misc.
• The Global / IP5 PPH pilot program does not absolve
applicants of all their duties of candor and good faith
under 1.56 and 11.18.
– NOTE: by properly submitting an IDS and OEE work product,
applicant would be considered to have complied with the duty to bring
to the attention of the USPTO any material prior art cited in
corresponding foreign applications
• Participating Offices will use the online systems to
access and assess supporting documents as much as
possible.
• Machine translations are acceptable unless they are of
insufficient quality; then manual translation required.
• PTA is still available to PPH applications.
• While no extension of time is available during request
for PPH treatment, extensions of time are still
available during prosecution of PPH applications.
17. Global / IP5 PPH: For More
Information, please visit:
http://www.uspto.gov/patents/init_events/pph/
http://www.jpo.go.jp/ppph-portal/aboutpph.htm