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Archive for the ‘IP Development by LPBI Group Team & Other Organizations’ Category


Information Innovation and the Power of LPBI Group

Author: Rick Mandahl, MBA

LPBI Group, Business Development Team

 

“Science evolves”[1]. This simple quote from a position paper by William S. Harten[2], eminent database architect, genealogist and entrepreneur describes why he designed a new laboratory process management technology capable of adapting as processes changed. From the notion that the software system must support the science rather than the science being bound to the limitations of predefined rigid systems opened new vistas for exploration, and progress across many process intensive domains and certainly in the realm precision medicine moving into widespread clinical deployment. Science evolves.

Decades earlier Robert R. Johnson, PhD[3] leader of the GE engineering team responsible for computerizing the check processing system for the Bank of America, and in the process delivered technology that changed banking globally.  The initial exploratory endeavor began around 1950 at Stanford Research Institute [aka, SRI International, Menlo Park, CA] to address the exponential expansion of check processing bound by manual methods, thus the need to change a system that was conceived in Venice in 1431, roughly the same era as the invention of the Gutenberg Press. In Project ERMA among other things, developed the human and machine readable alphanumerics still found on every check issued in the world today. The same information could be shared by humans and machines and this realtime translation, realtime information [4] that helped manage the exponential increase in demand for financial services in the post World War Two era.

Technology supporting science, supporting commerce in our era changes centuries established methods.  Do scientific publications today advance science or simply report it? Can we do better?  How far are we beyond Gutenberg today? In 1995, Nicholas Negroponte of MIT’s Media Lab lamented that the FAX machine was barely a step beyond Gutenberg.[5] In the ensuing generation has scientific publishing advanced with the science it reports? LPBI Group thinks not.

What of new innovation in the expanding realm of life sciences? Where are the friction points that may impede progress in rapidly advancing areas of medical sciences – science whose validation rests on rigorous observation and adherence to scientific method, findings vetted by peer review and shared in scholarly journals of learned societies. Are there ways to improve, approaches to help ameliorate the current concern over “research productivity”?

Personal Reflection of an Innovation Case Study

In the early eighties upon returning from a year’s assignment in  France, I looked up a former skiing and climbing partner now Head Coach of the US Ski Team. I had heard that he was working on a new design of racing bicycle handle bars – which from afar seemed quite curious. A visit to his home near Sun Valley  resulted in an astonishing perspective. In a field where just about every innovation had been made for this simple machine, the bicycle, Boone Lennon theorized that aerodynamic improvement – the way a rider sat on the bicycle could deliver improved performance – this insight gained by observing and coaching some of the best ski racers in the world on improving their aerodynamic form in the greatest of alpine ski sports – the Downhill. Those body position principles, so important to a sport where the difference between victory or defeat is measured in hundredths of a second – those principles ought to apply to bicycle racing where on straight away courses with “two equally matched and equipped competitors, the racer with the new bars and improved aerodynamic position will win.”[6] The theory was proven when in 1989 Greg Lemond the first American to win the Tour de France used the new “aero bars” . This second of three Tour de France victories (also 1986 and 1990), was attributed by Mr. Lemond to the final time trial where he outpaced his opponent by eight seconds, the tightest margin in Tour de France history. LeMond’s superior aerodynamics brought him victory[7] – he triumphed where two comparably qualified and equipped competitors had different tools that resulted in different levels of efficiency, thus performance. 

Winning Strategy in the Information Age

In the competitive world of scientific and medical research, where can efficiencies be gained, productivity be improved?

  • Containing Information Explosion,
  • Combatting Information Obsolescence.

The game changing innovations of LPBI Group offer simple yet profound innovations to help scientists and clinicians advance at the pace they can reasonably pursue because LPBI Group’s products help keep pace with life sciences new research insights and scientific discoveries. LPBI Group  ongoing questions provide answers using curation of current scientific research results. 

  • No longer are scientific papers obsolete by the time they are published, rather
  • They are living and dynamic repositories of searchable curated knowledge to build upon, while leveraging past established benchmarks.
  • Equally qualified and equipped, what investigator, which team might advance faster?
  • Access to the best and current information would certainly be of help.
  • Access absent enormous subscription cost might help as well.
  • Accelerate information access, eliminate exorbitant access cost.

The Founders, The Finders, The Funders. 

To build a team, to create a venture, to have commercial impact, the initial founder(s) must be joined by team members who help build, refine, adapt and change as the initial concept grows to advancing stages of maturity.

The time comes when the greatest intellectual and commercial impact is likely delivered by partners whose established business channels and financial strength enable the full realization of innovation or enabling technology far beyond the operational capacities of the initial team, but exactly according their ultimate vision.

Thus, as LPBI Group grows, we seek to identify and recruit strategic partners to grow, to expand and to merge with a new structure to follow. The global community of scientists indeed all the humankind are the beneficiaries of our endeavors in knowledge creation and dissemination.


[1] UNIFlow® by UNIConnect White Paper, William S. Harten

[2] Mr. Harten in addition to being founder of UNIConnect, LC, acquired by Sunquest Information Systems is inventor of GEDCOM, the global standard for the exchange of genealogical information.

[3] Robert Royce Johnson, PhD Cal Tech, Leader of Project ERMA, VP of Engineering Emeritus- Burroughs; Professor and Chairman Emeritus Dept of Computer Science, University of Utah College of Engineering. Founder and Managing Partner n-Dimensional Visualization, LLC.

[4] Waves of Change, James L McKenney, Harvard Business School, Harvard Business Press, 1995

[5] Being Digital, Nicholas Negroponte, MIT Medial Lab, Random House 1995

[6] Personal conversations with Daniel “Boone” Lennon, Head Coach Emeritus, US Ski Team and inventor of the Aero Bar for cyclists.

[7] Simon Symthe, “How Greg LeMond’s aero bars revolutionized time trialling”, Cycling, July 9, 2015.

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Cancer Immunotherapy Pilot Program – A Notice by the Patent and Trademark Office on 06/29/2016

ACTION

Notice.

SUMMARY

The United States Patent and Trademark Office (USPTO or Office) is implementing a pilot program to provide for earlier review of patent applications pertaining to cancer immunotherapy (“Cancer Immunotherapy Pilot Program” or “Pilot Program”) in support of the White House national $1 billion initiative to achieve ten years’ worth of cancer research in the next five years (“National Cancer Moonshot”). The USPTO will advance applications containing a claim(s) to a method of treating a cancer using immunotherapy out of turn for examination if the applicant files a grantable petition to make special under the Pilot Program. The objective of the Pilot Program is to complete the examination of the application within twelve months of special status being granted. Under the Cancer Immunotherapy Pilot Program, an application will be advanced out of turn for examination without meeting all of the current requirements of the accelerated examination program (e.g., the requirement for an examination support document) or the Prioritized Examination (Track I) program. This notice outlines the conditions, eligibility requirements, and guidelines of the Pilot Program.

TABLE OF CONTENTS

DATES:

Effective Date: June 29, 2016.

Duration: The Cancer Immunotherapy Pilot Program will run for twelve months from its effective date. Therefore, petitions to make special under the Cancer Immunotherapy Pilot Program must be filed before June 29, 2017. The USPTO may extend the Pilot Program (with or without modifications) or terminate it depending on the workload and resources needed to administer the Pilot Program, feedback from the public, and the effectiveness of the Pilot Program. If the Pilot Program is extended or terminated, the USPTO will provide notification to the public.

FOR FURTHER INFORMATION CONTACT:

Pinchus M. Laufer, Senior Legal Advisor (telephone (571) 272-7726; electronic mail at pinchus.laufer@uspto.gov) or Susy Tsang-Foster, Senior Legal Advisor (telephone (571) 272-7711; electronic mail at susy.tsang-foster@uspto.gov), of the Office of Patent Legal Administration, Office of the Deputy Commissioner for Patent Examination Policy.

For questions relating to a specific petition, please contact Gary B. Nickol, Supervisory Patent Examiner (telephone (571) 272-0835; electronic mail at gary.nickol@uspto.gov) or Brandon J. Fetterolf, Supervisory Patent Examiner (telephone (571) 272-2919; electronic mail at brandon.fetterolf@uspto.gov), of Technology Center 1600.

SUPPLEMENTARY INFORMATION:

On February 1, 2016, the White House Office of the Press Secretary announced a new, national $1 billion initiative to achieve ten years’ worth of cancer research in the next five years, with the intent to aid in the global fight against cancer. See the White House Web site at https://www.whitehouse.gov/the-press-office/2016/02/01/fact-sheet-investing-national-cancer-moonshot. To support this initiative, the USPTO is implementing the Cancer Immunotherapy Pilot Program to advance patent applications pertaining to cancer immunotherapy out of turn for examination to provide for earlier review. The objective of the Pilot Program is to complete the examination of an application containing a claim(s) to a method of treating a cancer using immunotherapy within twelve months of special status being granted. See Part XII below (Twelve-Month Goal) for more information.

New patent applications are normally taken up for examination in the order of their U.S. filing date. See section 708 of the Manual of Patent Examining Procedure (9th ed., 7th Rev., November 2015) (MPEP). The USPTO has procedures under which an application will be advanced out of turn (accorded special status) for examination if the applicant files a petition to make special under 37 CFR 1.102(c) and (d) with the appropriate showing or a request for prioritized examination under 37 CFR 1.102(e). See 37 CFR 1.102 and MPEP section 708.02. The USPTO revised its accelerated examination procedures effective August 25, 2006, requiring that all petitions to make special comply with the requirements of the revised accelerated examination (AE) program, except those based on an inventor’s health or age or the Patent Prosecution Highway (PPH) Pilot Program. See Changes to Practice for Petitions in Patent Applications To Make Special and for Accelerated Examination, 71 FR 36323 (June 26, 2006), 1308 Off. Gaz. Pat. Office 106 (July 18, 2006) (notice); see also MPEP section 708.02(a).

The USPTO is implementing the Cancer Immunotherapy Pilot Program to permit an application containing at least one claim to a method of treating a cancer using immunotherapy to be advanced out of turn (accorded special status) for examination without meeting all of the current requirements of the accelerated examination program set forth in item VIII of MPEP section 708.02(a) (e.g., examination support document) if the applicant files a grantable petition to make special under the Pilot Program. Applications that have been accorded special status based on any USPTO established procedures (such as PPH, Prioritized Examination, Accelerated Examination, Age, Health, or any other pilot program that takes up an application out of order for examination) are not eligible to be made special under the Cancer Immunotherapy Pilot Program. Applications are accorded special status under the Cancer Immunotherapy Pilot Program after grant of special status until a final disposition (defined in Part XII (Twelve-Month Goal)) is reached in the application. Under special status, an application that has not been acted on or an application with a proper RCE request will be placed on the examiner’s special new docket until a first Office action on the merits. For an application in the Pilot Program where applicant is responding to a first Office action, the application will be placed on the examiner’s regular amended docket. Under the Pilot Program, the USPTO is providing examiners with incentives to handle these applicant responses promptly.

The USPTO will accept petitions to make special under the Cancer Immunotherapy Pilot Program provided that the petitions, and applications in which they are filed, meet all of the requirements set forth in this notice. The USPTO will periodically evaluate the Pilot Program to determine whether and to what extent its coverage should be expanded. In addition, the USPTO may extend the Pilot Program (with or without modifications) or terminate it depending on the workload and resources needed to administer the Pilot Program, feedback from the public, and the effectiveness of the Pilot Program. If the Pilot Program is extended or terminated, the USPTO will provide notification to the public.

Applicants may participate in the Cancer Immunotherapy Pilot Program by filing a petition to make special under 37 CFR 1.102(d) meeting all of the requirements set forth in this notice in either a new application or in a pending application. However, continuing applications will not automatically be accorded special status based on papers filed with a petition in a parent application. Each application must, on its own, meet all requirements for special status. No fee is required. The fee for a petition to make special under 37 CFR 1.102(d) based upon the procedure specified in this notice is hereby waived.

Part I. Requirements for Petitions To Make Special Under the Cancer Immunotherapy Pilot Program: A petition to make special under the Cancer Immunotherapy Pilot Program may be granted in an application provided the eligibility requirements set forth in Part II and the following conditions are satisfied:

(1) Types of Applications. The application must be a non-reissue, non-provisional utility application filed under 35 U.S.C. 111(a), or an international application that has entered the national stage under 35 U.S.C. 371.

(2) Claim Limit and No Multiple Dependent Claims. The application must not contain more than three independent claims and more than twenty total claims. The application must not contain any multiple dependent claims. For an application that contains more than three independent claims or twenty total claims, or any multiple dependent claims, applicant must file a preliminary amendment in compliance with 37 CFR 1.121 to cancel the excess claims and/or the multiple dependent claims at the time the petition to make special is filed. The petition must include a statement that applicant agrees that the application will not have more than three independent claims, more than twenty total claims, and any multiple dependent claims while the application is in special status under the Pilot Program.

(3) The Application Must Include at Least One Method Claim of Treating a Cancer Using Immunotherapy. The application must include at least one claim to a method of treating a cancer using immunotherapy that meets the eligibility requirements in Part II of this notice. The petition must include a statement that the applicant agrees to include at least one claim to a method of treating a cancer using immunotherapy that meets the Pilot Program eligibility requirements while the application is in special status. For applications that have been previously examined, applicants will not be permitted to switch inventions in order to participate in the Pilot Program. See MPEP section 821.03.

(4) Statement Regarding Method of Treating a Cancer Using Immunotherapy. The petition to make special must state that special status under the Pilot Program is sought because the application contains a claim to a method of treating a cancer using immunotherapy that meets the eligibility requirements discussed in Part II of this notice.

(5) Statement Regarding Restriction Requirement. The petition must include a statement that, if the USPTO determines that the claims are directed to multiple inventions, applicant will agree to make an election without traverse in a telephonic interview, and elect an invention directed to a method of treating a cancer using immunotherapy that meets the eligibility requirement discussed in Part II of this notice.

(6) Statement that Special Status Was Not Previously Granted Under Any Program. The petition must state that the application has not been previously granted special status. A petition to make special under this Pilot Program may not be filed in an application in which special status was previously granted under this Pilot Program or in any other program (e.g., age, health, PPH, AE, prioritized examination).

(7) Time for Filing Petition. In general, the petition to make special under the Pilot Program must be filed (i) at least one day prior to the date that notice of a first Office action (which may be an Office action containing only a restriction requirement) appears in the Patent Application Information Retrieval (PAIR) system (applicant may check the status of an application using PAIR); or (ii) with a proper request for continued examination (RCE) that is in compliance with 37 CFR 1.114.

For patent applicants whose claimed cancer immunotherapy both (i) meets the eligibility requirements for this Pilot Program and (ii) is the subject of an active Investigational New Drug (IND) application filed by patent applicant or their agent (e.g., a licensee of the patent applicant or the patent applicant’s assignee) at the U.S. Food and Drug Administration (FDA) that has entered phase II or phase III clinical trials, the petition may be filed any time prior to an appeal or a final rejection if patent applicant certifies both (i) and (ii) in the petition. For an application that has an outstanding Office action, patent applicant must file a complete response together with the petition.

Therefore, the petition is only required to contain the above applicant certification if the patent application has received a first Office action or a request for continued examination (RCE) was not filed with the petition. By default, for applications that have been previously examined, if applicant makes the above certification in the petition, the above certification would necessarily apply to at least one of the examined claims since applicants are not permitted to switch inventions in order to participate in the Pilot Program. See MPEP section 821.03.

(8) Office Form Available for Filing Petition. Applicant should use form PTO/SB/443 for filing the petition. The form will contain a check-box for the applicant to certify that the claimed cancer immunotherapy both (i) meets the eligibility requirements for this Pilot Program and (ii) is the subject of an active IND application filed by patent applicant or their agent at the FDA that has entered phase II or phase III clinical trials. The form will be available as a Portable Document Format (PDF) fillable form in EFS-Web and on the USPTO Web site at http://www.uspto.gov/web/forms/index.html. The Office of Management and Budget (OMB) has determined that, under 5 CFR 1320.3(h), Form PTO/SB/443 does not collect “information” within the meaning of the Paperwork Reduction Act of 1995. Information regarding EFS-Web is available on the USPTO Web site at http://www.uspto.gov/learning-and-resources/support-centers/patent-electronic-business-center. Failure to use the form or its equivalent could result in the Office not recognizing the request or delays in processing the request.

(9) Electronic Filing of Petition Required. The petition to make special must be filed electronically before June 29, 2017, using the USPTO electronic filing system, EFS-Web, and selecting the document description of “Petition for Cancer Immunotherapy Pilot” on the EFS-Web screen. Any inquiries concerning electronic filing of the petition should be directed to the Electronic Business Center (EBC) at (866) 217-9197.

(10) Publication Requirement for Applications. For unpublished applications, the petition to make special must be accompanied by a request for early publication in compliance with 37 CFR 1.219. If applicant previously filed a nonpublication request in the application, applicant must file a rescission of a nonpublication request no later than the time the petition to make special is filed. Applicant may use form PTO/SB/36 to rescind the nonpublication request.

Part II. Eligibility Requirements—Applications Pertaining to Cancer Immunotherapy. To be eligible for the Cancer Immunotherapy Pilot Program, patent applications should be in the field of Oncology. The applications must contain at least one claim encompassing a method of ameliorating, treating, or preventing a malignancy in a human subject wherein the steps of the method assist or boost the immune system in eradicating cancerous cells. For example, this can include the administration of cells, antibodies, proteins, or nucleic acids that invoke an active (or achieve a passive) immune response to destroy cancerous cells. The Pilot Program also will consider claims drawn to the co-administration of biological adjuvants (e.g., interleukins, cytokines, Bacillus Comette-Guerin, monophosphoryl lipid A, etc.) in combination with conventional therapies for treating cancer such as chemotherapy, radiation, or surgery. Claims to administering any vaccine that works by activating the immune system to prevent or destroy cancer cell growth are included. The Pilot Program also will consider in vivo, ex vivo, and adoptive immunotherapies, including those using autologous and/or heterologous cells or immortalized cell lines.

As in other programs, eligibility for this pilot is not restricted by (i) the nationality of the patent applicant or its agents, (ii) the location where the underlying research was undertaken or the technology was developed, or (iii) the location where the invention may be produced or manufactured.

Part III. Decision on Petition To Make Special Under the Cancer Immunotherapy Pilot Program. If applicant files a petition to make special under the Cancer Immunotherapy Pilot Program, the USPTO will decide the petition once the application has been docketed for examination. Any inquiries concerning a specific petition to make special should be directed to the appropriate Technology Center handling the petition. If the petition is granted, the application will be accorded special status under the Cancer Immunotherapy Pilot Program until a final disposition (see Part XII (Twelve-Month Goal)). Under special status, an application that has not been acted on or an application with a proper RCE request will be placed on the examiner’s special new docket until a first Office action on the merits. For an application in the Pilot Program where applicant is responding to a first Office action, the application will be placed on the examiner’s regular amended docket. Under the Pilot Program, the USPTO is providing examiners with incentives to handle these applicant responses promptly.

Applicant will be notified of the decision on the petition by the deciding official. If the application does not comply with the sequence requirements as set forth in 37 CFR 1.821 through 1.825, such that the application is not in condition for examination, or has an outstanding Office action, or if the application and/or petition does not meet all the formal requirements set forth in this notice, the USPTO will notify the applicant of the deficiency by issuing a notice. The notice will give the applicant only one opportunity to correct the deficiency. If the applicant still wishes to participate in the Cancer Immunotherapy Pilot Program, the applicant must file a proper petition and make appropriate corrections within one month or thirty days, whichever is longer. The time period for reply is not extendable under 37 CFR 1.136(a). If the applicant fails to correct the deficiency indicated in the notice within the time period set forth therein, the application will not be eligible for the Cancer Immunotherapy Pilot Program, and the application will be taken up for examination in accordance with standard examination procedures. If the application does not contain a method claim that complies with the eligibility requirements discussed in Part II of this notice, the petition will be dismissed, and the applicant will not be given an opportunity to correct the deficiency.

Part IV. Requirement for Restriction. If the claims in the application are directed to multiple inventions, the examiner may make a requirement for restriction in accordance with current restriction practice. The examiner will contact the applicant by telephone and request an oral election of a single invention for prosecution. Applicant must make an election without traverse in a telephonic interview of an invention that is to a method of treating a cancer using immunotherapy that meets the eligibility requirements for this Pilot Program. If the applicant does not respond by telephone to an examiner’s request for an election within two working days or refuses to make an election of an invention that is to a method of treating a cancer using immunotherapy, the examiner will treat the first group of claims directed to a method of treating a cancer using immunotherapy that meets the eligibility requirements of this notice as constructively elected without traverse for examination.

Part V. First Action Interview Pilot Program Not Available. Applications accepted into the Cancer Immunotherapy Pilot Program will not be eligible to participate in the First Action Interview Pilot Program. However, standard interview practice and procedures applicable to regular ex parte prosecution will still be available See MPEP section 713.02.

Part VI. Period for Reply by Applicant. The time periods set for reply in Office actions for an application granted special status under the Pilot Program will be the same as those set forth in section 710.02(b) of the MPEP. However, if an applicant files a petition for any extension of time under 37 CFR 1.136(a), the special status of the application will be terminated, and the application will be taken up for examination in accordance with standard examination procedures.

Part VII. Reply By Applicant. A reply to an Office action must be limited to responding to rejections, objections, and requirements made by the examiner. Any amendment to a non-final Office action will be treated as not fully responsive if it attempts to: (A) Add claims which would result in more than three independent claims, or more than twenty total claims, pending in the application; (B) add any multiple dependent claim; or (C) cancel all method claims to treating a cancer using immunotherapy. If a reply to a non-final Office action is not fully responsive because it does not comply with the Pilot Program claim requirements, but is a bona fide attempt to advance the application to final action, the examiner may, at his or her discretion, provide one month or thirty days, whichever is longer, for applicant to supply a fully responsive reply. Extensions of this time period under 37 CFR 1.136(a) to the notice of nonresponsive amendment will not be permitted in order for the application to remain in special status. Any further nonresponsive amendment will be treated as non-bona fide and the time period set in the prior notice will continue to run.

Part VIII. After-Final and Appeal Procedures: The mailing of a final Office action or the filing of a Notice of Appeal, whichever is earlier, is a final disposition for purposes of the twelve-month goal for the Cancer Immunotherapy Pilot Program. During the appeal process, the application will be treated in accordance with the normal appeal procedure (see MPEP Chapter 1200). Any amendment, affidavit, or other evidence after a final Office action and prior to appeal must comply with 37 CFR 1.116. The filing of an RCE is a final disposition for purposes of the twelve-month goal for the Cancer Immunotherapy Pilot Program. The application will not retain its special status after the filing of a proper RCE.

Part IX. Post-Allowance Processing. The mailing of a notice of allowance is a final disposition for the purposes of the twelve-month goal for the Pilot Program. The failure to pay the required issue fee within one (1) month of the mailing date of the Form PTOL-85 or the submission of a non-USPTO required submission under 37 CFR 1.312 will result in the allowance being processed according to the regular allowance process. A submission that includes both USPTO required changes and non-USPTO required changes under the provisions of 37 CFR 1.312 will be considered as a non-USPTO required submission for purposes of the allowance processing.

Part X. Proceedings Outside the Normal Examination Process: If an application becomes involved in proceedings outside the normal examination process (e.g., a secrecy order, national security review, interference, derivation proceeding or petitions under 37 CFR 1.181through 1.183), the USPTO will place the application in special status under the Cancer Immunology Pilot Program before and after such proceedings. During those proceedings, however, the application will not be under special status. For example, during an interference proceeding, the application will be treated in accordance with the normal interference procedures and will not be in special status under the Cancer Immunology Pilot Program. Once any one of these proceedings is completed, the application will continue in special status under the Pilot Program until it reaches a final disposition, but that may occur later than twelve months from the grant of special status under the Pilot Program.

Part XI. Withdrawal From Pilot Program. There is no provision for “withdrawal” from special status under the Pilot Program. However, filing a petition for any extension of time under 37 CFR 1.136(a) will result in the application being taken out of the Pilot Program. An applicant may abandon the application that has been granted special status under the Pilot Program in favor of a continuing application, and the continuing application will not be given special status under the Pilot Program unless the continuing application is filed with a petition to make special under the Pilot Program.

Part XII. Twelve-Month Goal. The objective of the Cancer Immunology Pilot Program is to complete the examination of an application within twelve months of special status being granted under the Pilot Program (i.e., within twelve months from the mailing date of the decision granting the petition to make special). The twelve-month goal is successfully achieved when one of the following final dispositions occurs within twelve months from the grant of special status under the Pilot Program: (1) The mailing of a notice of allowance; (2) the mailing of a final Office action; (3) the filing of an RCE; (4) the abandonment of the application; (5) or the filing of a Notice of Appeal. The final disposition of an application, however, may occur later than the twelve-month time frame in certain situations (e.g., applicant files an amendment that does not comply with the Pilot Program claim requirements or applicant petitions for extension of time under 37 CFR 1.136(a)). See Part X for more information on other events that may cause examination to extend beyond this twelve-month timeframe. In any event, however, this twelve-month time frame is simply a goal. Any failure to meet the twelve-month goal or other issues relating to this twelve-month goal are neither petitionable nor appealable matters.

Dated: June 24, 2016.

Michelle K. Lee,

Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.

[FR Doc. 2016-15533 Filed 6-28-16; 8:45 am]

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TSUNAMI in HealthCare under the New Name Verily.com

Curator: Aviva Lev-Ari, PhD, RN

 

UPDATED on 6/8/2016

The Tricorder project was announced only 3 months after Google entered the life sciences field, according to the report, and came from the same incubator which rolled out the company’s self-driving car and recently cancelled Google Glass.

Verily CEO Andrew Conrad said the scientific basis for the device was proven upon unveiling in 2014, but experts have presented conflicting views on the reality of such a device, STAT Newsreports.

“What (Verily is) really good at is physical measurements — things like temperature, pulse rate, activity level. They are not particularly good at … the chemical and the biological stuff,” Walt toldSTAT news.

Four former Verily employees said the Tricorder “has been seen internally more as a way to generate buzz than as a viable project,” according to the report.

SOURCE

http://www.massdevice.com/googles-star-trek-tricorder-bid-flops/?spMailingID=9031578&spUserID=MTI2MTQxNTczMjM5S0&spJobID=940786327&spReportId=OTQwNzg2MzI3S0

 

UPDATED on 4/16/2016

SOURCE

http://recode.net/2016/04/13/verily-alphabet-profitable/

Verily, Alphabet’s medical business, is profitable, Sergey Brin tells Googlers

20160413-verily-google-life-sciences

Verily | YouTube

SCIENCE

Publicly, Alphabet has said very little about its assortment of companies not named Google.

But internally, Alphabet is a little more forthcoming.

As we reported earlier, Nest CEO Tony Fadell appeared before Google’s all-hands meeting two weeks ago to address recent criticism of his company. During that meeting, Google co-founder and Alphabet exec Sergey Brin also defended another company under the holding conglomerate: Verily, the medical tech unit previously called Google Life Sciences.

Lumped together, Alphabet’s moonshots aren’t making money yet — but Verily is, Brin said.

Verily was the target of a scathing article — in Stat, a medical publication from the Boston Globe — scrutinizing its CEO, Andy Conrad. Several former employees told Stat that Verily suffered a talent exodus due to “derisive and impulsive” leadership by Conrad.

Here’s what Brin said in response at Google’s TGIF meeting:

I have seen a smattering of articles. And, you know, it’s actually sad to see sometimes where it appeared that … former employees or soon-to-be former employees talked to the press. But, anyhow, I can tell you what’s going on with these companies, fortunately. So in Verily’s case, despite a handful of examples, their attrition rate is below Google’s and Alphabet’s as a whole. And also, there are articles that have generally said we are blowing a lot of money and so forth. It’s true that, you know, as whole our Other Bets are not yet profitable, but some of them are, including Verily on a cash basis and increasingly so. So we’re pretty excited about these efforts.

Verily makes money through

  • partnerships with pharmaceutical companies — such as Novartis, which is licensing and planning to sell Verily’s smart contact lens — and
  • medical institutions.

It is one of three units contributing to the Other Bets total revenue ($448 million) in 2015, along with

  • Google Fiber and
  • Nest.

As we reported earlier, Nest likely brought in around $340 million of that and Fiber pulled close to $100 million, meaning that Verily’s sales were somewhere around $10 million. During the year, all the moonshot units combined reported operating losses of $3.6 billion.

Note Brin’s stipulation that Verily’s profit comes on a “cash basis.” That probably means that it’s not making profit on the normal basis, meaning when you take into account total sales minus total costs. But “cash positive” suggests they’re booking sales faster than they’re spending money, which is a positive sign. Companies normally report financials accounting for all costs. And that’s how Alphabet will next week, when it shares first-quarter results for Google and the Other Bets — although we almost certainly won’t see figures on Verily’s profitability.

We reached out to Alphabet and Verily reps for more clarity, but didn’t get any.

SOURCE

http://recode.net/2016/04/13/verily-alphabet-profitable/

 

Original Curation dated 12/14/2015

  1. Part 1: Verily in Action
  2. Part II: Innovations at a Different Scale: GDE Enterprises – A Case in Point of Healthcare in Focus – Work-in-Progress

12/31/2015 – All time

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Part 1: Verily in Action

They write @ https://verily.com/

When Google[x] embarked on a project in 2012 to put computing inside a contact lens — an immensely challenging technical problem with an important application to health — we could not have imagined where it would lead us. As a life sciences team within Google[x], we were able to combine the best of our technology heritage with expertise from across many fields. Now, as an independent company, Verily is focused on using technology to better understand health, as well as prevent, detect, and manage disease.

Andy Conrad, Ph.D.

Chief Executive OfficerFormerly the chief scientific officer of LabCorp, Andy is a cell biologist with a doctorate from UCLA. He has always been passionate about early detection and prevention of disease: Andy co-founded the National Genetics Institute, which developed the first cost-effective test to screen for HIV in blood supply.

Brian Otis, Ph.D.

Chief Technical OfficerBrian’s team focuses on end-to-end innovation ranging from integrated circuits to biocompatible materials to sensors. He joined Google[x] as founder of the smart contact lens project and now leads our efforts across all hardware and device projects, including wearables, implanted devices, and technology like Liftware.

Jessica Mega, M.D., MPH

Chief Medical OfficerJessica leads the clinical strategy and research team at Verily. She is a board-certified cardiologist who trained and practiced at Massachusetts General Hospital and Brigham and Women’s Hospital. As a faculty member at Harvard Medical School and a senior investigator with the TIMI Study Group, Jessica directed large, international trials evaluating novel cardiovascular therapies.

Linus Upson

Head of EngineeringA long-time Google software engineer, Linus has been a team lead in developing products that now help billions of people worldwide find the information they need on the Internet, including Chrome and Chrome OS. He now oversees our engineering teams.

Tom Stanis

Head of SoftwareTom spent nine years working on core Google products before joining Google[x] in 2014 to work on the Baseline Study. He now leads all our Software projects, including the development of machine learning algorithms for applications ranging from robotic-assisted surgery to diabetes management.

Vikram (Vik) Bajaj, Ph.D.

Chief Scientific OfficerVik’s broad research interests in industry and as a former academic principal investigator have included structural and systems biology, molecular imaging, nanoscience, and bioinformatics. Vik now leads the Science team in research directions related to our mission.

What are the Dimensions of the Tsumani in Healthcare?

  • prevention,
  • detection,
  • management of disease

 

Hardware

  • contact lens with an embedded glucose sensor for measuring the glucose in human tears.

Software

  • multiple sclerosis, for example, combines wearable sensors with traditional clinical tests
  • signals that could lead to new knowledge about the disease and why it progresses differently among individuals.

Clinical

  • Constituencies industry, hospitals, government, academic centers, medical societies, and patient advocacy groups
  • The Baseline Study is one of these dedicated efforts, a multi-year initiative that aims to identify the traits of a healthy human by closely observing the transition to disease.

Science

  • Understand processes that lead to conditions like cancer, heart disease, and diabetes
  • computational systems biology platforms and life sciences tools
  • bio-molecular nanotechnology for precision diagnostics and therapeutic delivery
  • advanced imaging methods for applications ranging from early diagnosis to surgical robotics.

 

FOLLOW the LEADER of Parish in the Tsunami

 

Google[x] searches for ways to boost cancer immunotherapy | Science/AAAS | News

http://news.sciencemag.org/math/2015/01/googlex-searches-ways-boost-cancer-immunotherapy

 

Google Life Sciences and American Heart Association commit $50M to study heart disease | VentureBeat

http://venturebeat.com/2015/11/08/google-life-sciences-and-american-heart-association-commit-50m-to-study-heart-disease/

 

Google Life Sciences Division Is Now Called… Verily?

http://gizmodo.com/google-life-sciences-division-is-now-called-verily-1746729894

 

WIRED: Google’s Verily Is Spinning Off ‘Verb,’ a Secretive Robot-Surgery Startup

Alphabet’s Verily, née Google Life Sciences, has announced its first spinoff, a brand new robot-assisted surgery company.

http://www.wired.com/2015/12/googles-verily-is-spinning-off-verb-a-secretive-robot-surgery-startup/

 

Google Life Sciences Rebrands as Verily under Alphabet – Fortune

Vik Bajaj, CSO

http://fortune.com/2015/12/08/google-alphabet-verily/

Verily, I Swear, Google Life Sciences debuts a New Name

By CHARLES PILLER  DECEMBER 7, 2015

http://www.statnews.com/2015/12/07/verily-google-life-sciences-name/

 

Why biomedical superstars are signing on with Google Tech firm’s ambitious goals and abundant resources attract life scientists.

Erika Check Hayden 21 October 2015

http://www.nature.com/news/why-biomedical-superstars-are-signing-on-with-google-1.18600

 

GOOGLE LIFE SCIENCES MAKES DIABETES ITS FIRST BIG TARGET

http://www.wired.com/2015/08/google-life-sciences-makes-diabetes-first-big-target/

 

GOOGLE WON THE INTERNET. NOW IT WANTS TO CURE DISEASES

http://www.wired.com/2015/08/google-won-internet-now-wants-cure-diseases/

 

Google Reveals Health-Tracking Wristband

Caroline Chen and Brian Womack

June 23, 2015 — 9:30 AM EDT

http://www.bloomberg.com/news/articles/2015-06-23/google-developing-health-tracking-wristband-for-health-research

 

Google Moves to the Operating Room in Robotics Deal With J&J

ALISTAIR BARR and JOSEPH WALKER

http://blogs.wsj.com/digits/2015/03/27/google-moves-to-the-operating-room-in-robotics-deal-with-jj/

 

Google, Biogen Seek Reasons for Advance of Multiple Sclerosis

Caroline Chen

January 27, 2015 — 9:00 AM EST

http://www.bloomberg.com/news/articles/2015-01-27/google-biogen-seek-reasons-for-advance-of-multiple-sclerosis

 

Google’s Newest Search: Cancer Cells

Google X Team Hopes to Develop Nanoparticles to Provide Early Detection of Cancer, Other Diseases

ALISTAIR BARR and RON WINSLOW

Updated Oct. 29, 2014 11:17 a.m. ET

http://www.wsj.com/articles/google-designing-nanoparticles-to-patrol-human-body-for-disease-1414515602

 

A Spoon That Shakes To Counteract Hand Tremors

Updated May 14, 201411:43 AM ET

INA JAFFE

http://www.npr.org/sections/health-shots/2014/05/13/310399325/a-spoon-that-shakes-to-counteract-hand-tremors

 

Google’s New Moonshot Project: the Human Body

Baseline Study to Try to Create Picture From the Project’s Findings

ALISTAIR BARR

Updated July 27, 2014 7:24 p.m. ET

http://www.wsj.com/articles/google-to-collect-data-to-define-healthy-human-1406246214

 

Novartis Joins With Google to Develop Contact Lens That Monitors Blood Sugar

MARK SCOTT JULY 15, 2014

http://www.nytimes.com/2014/07/16/business/international/novartis-joins-with-google-to-develop-contact-lens-to-monitor-blood-sugar.html

 

Google[x] searches for ways to boost cancer immunotherapy

Jon Cohen

15 January 2015 6:25 am

http://news.sciencemag.org/math/2015/01/googlex-searches-ways-boost-cancer-immunotherapy

 

SOURCE

https://verily.com/

Part II: Innovations at a Different Scale: GDE Enterprises

A Case in Point of Healthcare in Focus –

Work-in-Progress

 

 

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