• All Courts
  • Federal Courts
  • Bankruptcies
  • PTAB
  • ITC
Track Search
Export
Download All
Displaying 159-173 of 180 results

2009 Exhibit: Ex 2009 61 Fed Reg 52,602 10796

Document IPR2020-00152, No. 2009 Exhibit - Ex 2009 61 Fed Reg 52,602 10796 (P.T.A.B. Jul. 22, 2020)
The quality system regulation includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use.
Under section 520(f) of the act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for the methods used in, and the facilities and controls used for the manufacture, packing, storage, and installation of medical devices.
The Supreme Court recently addressed the preemptive effect, under section 521 of the act (21 U.S.C. 360k), of the original CGMP regulation and other FDA requirements for medical devices on State tort actions.
The extent of the documentation necessary to meet the regulation requirements may vary with the complexity of the design and manufacturing operations, the size of the firm, the importance of a process, and the risk associated with the failure of the device, among other factors.
Because of a number of competitive and other issues, including sharply divided views by members of the GMP Advisory Committee at the September 1995 meeting, FDA has elected to address application of the CGMP requirements to persons who perform servicing and refurbishing functions outside the control of the original manufacturer in a separate rulemaking later this year, with another opportunity for public comment.
cite Cite Document

2017 Exhibit: Ex 2017 510k Premarket Notification No K920752, Ethicon

Document IPR2020-00152, No. 2017 Exhibit - Ex 2017 510k Premarket Notification No K920752, Ethicon (P.T.A.B. Jul. 22, 2020)
/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&productcode=GDW Page Last Updated: 07/13/2020 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
| Kreyòl | Ting Vit | | Tagalog | | Language Assistance Available: Español | | | English Ayisyen | Français | Polski | Português | Italiano | Deutsch | Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Nondiscrimination Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph.
cite Cite Document

2010 Exhibit: Ex 2010 Excerpted File History for US7954683 Knodel

Document IPR2020-00152, No. 2010 Exhibit - Ex 2010 Excerpted File History for US7954683 Knodel (P.T.A.B. Jul. 22, 2020)
al. Cardica, Inc. Feeder Belt with Integrated Surgical Staples 11/956,988 Filing Date: Lindsay M. Low Group Art Unit: December 14, 2007 3721 January 28, 2011 Commissioner for Patents P.O.
al. Cardica, Inc. Feeder Belt with Integrated Surgical Staples 11/956,988 Filing Date: Lindsay M. Low Group Art Unit: December 14, 2007 3721
In contrast, U.S. Pat. No. 6,391,038 describes staples connected to only a single lateral edge of a backbone 66, as acknowledged by the annotated Figure 10A from Vargas on page 6 of the Office Action.
Anyreply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term adjustment.
Application/Control Number: 11/956,988 Art Unit: 3721 Page 8 Regarding claim 5, the modified row of staples is frangibly connected along a line located betweenthe lateral edges of the feeder belt (see Fig. 3 of Green).
cite Cite Document

2016 Exhibit: Ex 2016 510k Premarket Notification No K983536, Ethicon Endo Surgery

Document IPR2020-00152, No. 2016 Exhibit - Ex 2016 510k Premarket Notification No K983536, Ethicon Endo Surgery (P.T.A.B. Jul. 22, 2020)
/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&knumber=K983536 Page Last Updated: 07/13/2020 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
| Kreyòl | Ting Vit | | Tagalog | | Language Assistance Available: Español | Ayisyen | Français | Polski | Português | Italiano | Deutsch | | | English Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Nondiscrimination Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph.
cite Cite Document

1009 Exhibit: US Pat No 5,507,426 to Young et al

Document IPR2020-00152, No. 1009 Exhibit - US Pat No 5,507,426 to Young et al (P.T.A.B. Nov. 19, 2019)
Inventors: Wayne P. Young, Brewster, N.Y.; Daniel E. Alesi, Sherman; Kenneth E. Toso, Wilton, both of Conn. Assignee: United States Surgical Corporation, Norwalk, Conn. .
In some instru- includes an actuator which is configured to progressively ments a knife is provided to cut the tissue which has been movethe anvil member from the open position to the closed joined by the fasteners.
The distal ends of each ofthe firing bars includes a wedged cam surface 78 which engages staple pushers 35 as actuation mechanism 50 translates through fastener applying assem- bly 16.
The leading edge of support beam 52 defines a cutting blade 80 whichis configured to form an incision in the tissue located between the parallel rows of staples applied by assembly 16.
Although the subject apparatus has been described with respect to preferred embodiments, it will be readily apparent to those having ordinary skill in the art to which it appertains that changes and modifications may be made thereto without departing from the spirit or scope as defined by the appended claims.
cite Cite Document

1005 Exhibit: US Pat No 4,429,695 to Green et al

Document IPR2020-00152, No. 1005 Exhibit - US Pat No 4,429,695 to Green et al (P.T.A.B. Nov. 19, 2019)
pusher bar cams and knife blade as these elements move 3,275,211 9/1966 Hirsch et al... along the jaws to resist forces created during staple 3,315,863" 4/1967 O'Dea: —- ejection and shaping which tend to vertically separate 3,317,105 5/1967 :.
design which allows the instrument to be manufactured in the main from relatively light weight disposable ma- terials while still providing proper alignmentand stabi- lization of the jaws duringstapling.
The knife 42, whichtrails the pusher bar camsslightly and rides in central longitudinalslits in the cartridge and anvil, cuts the grippedtissue along a line between the twopairs of staple rows.
Intermediateits length, upper frame member 12 haslaterally projecting lugs 13 which fit in complementary openings 15 formed in a bifurcated locking handle 26.
The improvement of claim 1 wherein each ofsaid jawshas a longitudinal passageway defined therein and wherein said support means includes upper and lower shoes carried by said pusher bar and knife assembly in the region of said pusher bar cams, said shoes fitting in said passageways andtravelling therealong during lon- gitudinal movement of said assembly to provide said local support for said jaws.
cite Cite Document

1021 Exhibit: US Pat App Pub No 20060175375 Shelton 375

Document IPR2020-00152, No. 1021 Exhibit - US Pat App Pub No 20060175375 Shelton 375 (P.T.A.B. Oct. 28, 2020)
With [0017] FIG. 1 is a right side elevation view of a surgical stapling and severing instrument(traction biased pawl) in an open (start) condition, with a shaft partially cut away to expose a closure tube andfiring rod.
[0054] FIG. 47 is a partially disassembled left side view in elevation of the alternative surgical stapling and severing instrument of FIG.46 with the linked rack omitted depicting the manualfiring release lever disengaging the anti-backup mechanism.
stapling and severing instrument, [0066] A surgical whether with a conventional solid or linked rack as advan- tageously depicted for a shorter handle, incorporates a multiplefiring stroke capability allowing greaterfiring travel without an excessive amount of force required to squeeze a firing trigger.
An implementportion 22, formed by the end effector 12 and shaft 18, is advantageously sized for insertion through a trocar or small laparoscopic opening to perform an endo- scopic surgical procedure while being controlled by a sur- geon grasping the handle 20.
[0102] Having a toothed upper surface 222 ontheleft side 304 that is distinct from the ramped central track 282 advantageously allows a nonbinding, strong engagement between the pawl 270 and the linked rack 200, even if the firing trigger 34 has been stroked with varying ranges of motion.
cite Cite Document

1002 Exhibit: File history of the 650 Patent

Document IPR2020-00152, No. 1002 Exhibit - File history of the 650 Patent (P.T.A.B. Nov. 19, 2019)
(B) RESIDENCE:(CITY and STATE OR COUNTRY) REX Medical, L.P. Radnor, PA Please check the appropriate assignee categoryor categories (will not be printed on the patent) : CV individual XJ Corporation or other private group entity (J Government Aa.
Paymentinformation: The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows: Deposit Account 501283 Electronic AcknowledgementReceipt eteennmie Title of Invention:
Arecord from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of settlement negotiations.
Part of a Department of Commerceinitiative, this website includes self-help "toolkits" giving innovators guidance on howto protectintellectual property in specific countries such as China, Korea and Mexico.
Part of a Department of Commerceinitiative, this website includes self-help "toolkits" giving innovators guidance on howto protectintellectual property in specific countries such as China, Korea and Mexico.
cite Cite Document

1004 Exhibit: US Pat No 5,645,209 to Green et al

Document IPR2020-00152, No. 1004 Exhibit - US Pat No 5,645,209 to Green et al (P.T.A.B. Nov. 19, 2019)
Another object of the present invention is to provide a self contained gas powered surgical apparatus having a mecha- nism which will prevent clamping of tissue unless the cattridge has been properly inserted in the instrument.
Thepresent invention advantageously permits surgeons to perform internal surgical procedures including stapling and/ or cutting simply by manually clamping the tissue to be manipulated and pneumatically actuating the fastener apply- ing means.
Pulicy 248 is maintained within shroud portion 232 by opposed fastener ring pairs 250 and 252 and functions in cooperation with a mechanism for moving anvil member 56 between an open position and.
itis also envisioned that, where a wider section of translation is desired, pivot block 422 and any associated structural ele- ments of the apparatus may be modified to achieve at least 60° of articulation in either direction relative to the longi- tudinal axis of the instrument.
At the distal extreme of the longitudinal stroke, the overhanging ledges 292 of cam bars 286 and 288 drop over the edge of the forward cartridge housing 270 thus abutting vertical surface thereof.
cite Cite Document

1014 Exhibit: US Pat No 5,389,098 to Tsuruta et al

Document IPR2020-00152, No. 1014 Exhibit - US Pat No 5,389,098 to Tsuruta et al (P.T.A.B. Nov. 19, 2019)

cite Cite Document

2001 Exhibit: Ex 2001 IPR2020 00152 Dolgin Declaration refiled as exhibit

Document IPR2020-00152, No. 2001 Exhibit - Ex 2001 IPR2020 00152 Dolgin Declaration refiled as exhibit (P.T.A.B. Feb. 24, 2020)

cite Cite Document

1011 Exhibit: US Pat No 5,865,361 to Milliman et al

Document IPR2020-00152, No. 1011 Exhibit - US Pat No 5,865,361 to Milliman et al (P.T.A.B. Nov. 19, 2019)

cite Cite Document

1007 Exhibit: US Pat No 4,605,001 to Rothfuss et al

Document IPR2020-00152, No. 1007 Exhibit - US Pat No 4,605,001 to Rothfuss et al (P.T.A.B. Nov. 19, 2019)

cite Cite Document

1006 Exhibit: US Pat No 5,465,895 to Knodel et al

Document IPR2020-00152, No. 1006 Exhibit - US Pat No 5,465,895 to Knodel et al (P.T.A.B. Nov. 19, 2019)

cite Cite Document

1008 Exhibit: US Pat No 5,954,259 to Viola et al

Document IPR2020-00152, No. 1008 Exhibit - US Pat No 5,954,259 to Viola et al (P.T.A.B. Nov. 19, 2019)

cite Cite Document
<< 1 2 3 4 5 ... 11 12 13 >>