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IPR2015-00693, No. 1026 Exhibit - US App Ser No 13736,166, Office Action dated May 16, 2013 (P.T.A.B. Feb. 4, 2015)
Office Action Summary AlA (First Inventor to File) Status No -- The MAILING DATE of this communication appears on the cover sheet with the correspondence address - Period for Reply Examiner
Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any earned patent term adjustment.
* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a participating intellectual property office for the corresponding application.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Fisher et ai./Chin-Loy to include a foil cover on the cap, as taught by Hoang et al., for the purpose of providing a moisture barrier (Para 12).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Peluso et ai./Chin-Loy to include an impervious pliable material cover on the cap, as taught by Hoang et al., for the purpose of providing a moisture barrier (Para 12).
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IPR2015-00693, No. 1026 Exhibit - US App Ser No 13736,166, Office Action dated May 16, 2013 (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1002 Exhibit - Declaration of Karl Leinsing (P.T.A.B. Feb. 4, 2015)
In the relevant timeframe, one of ordinary skill in the art of the patent in my opinion would have had a Bachelor's degree in mechanical engineering or equivalent education and training and at least one to two years of experience in the medical device industry.
As can be seen in the expanded portion of Figure 5 of Aalto, shown below left, the member (elastomeric insert) [55] engages with the "interior edge of an opening of the lumen" (outlet) [60] when the cap and connector are attached.
Aalto's specification explains that when the cap and connector are attached, the member enters the lumen: "As the sealing closure is brought into mating contact with the Luer fitting 20, the elastomeric insert 36 is compressed further.
One of ordinary skill in the art would have understood that when the cap was in use and attached to the luer connector, the biasing structure (spring) [60] would exert a pushing force, or "thrust", on the member (movable frit) [30], as in claim 12 of the patent.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Fisher et al./Chin- Loy to include a foil cover on the cap, as taught by Hoang et al., for the purpose of providing a moisture barrier (Para 12)."
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IPR2015-00693, No. 1002 Exhibit - Declaration of Karl Leinsing (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1001 Exhibit - US Pat No 8,641,681 (P.T.A.B. Feb. 4, 2015)
Buchman, et al., A New Central Venous Catheter Cap: Decreased Microbial Growth and Risk for Catheter-Related Bloodstream Infec tion, The Journal ofVascular Access, 2009, 10: pp.
Guidelines from the Centers for Disease Control and Pre- vention describe various ways to limit bloodstream infections in hospital, outpatient, and home care settings.
When assembly 100 is in a pre-use or initially packaged state, the internal parts and surfaces thereof can be sterile, and these are able to reduce, prevent, or eliminate contamination of connectors with which caps 102, 104 can be coupled.
For example, alcohol or another stable liquid antiseptic may be added from a container 166 to be received within, wet, soak, or saturate pad 160 to a predetermined concentration level.
Accordingly, although the antisep- tic 1033 is schematically depicted in FIG. 10 as a series of droplets, the antiseptic 1033 is not necessarily liquid and may fill the pad 1032 to a greater or lesser extent than what is shown.
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IPR2015-00693, No. 1001 Exhibit - US Pat No 8,641,681 (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1027 Exhibit - Affidavit of Process Server Serving Ivera Medical Corporation with Summons, Complaint, and Motion for Preliminary Injunction, dated February 10, 2014 (P.T....
with (list documents) Summon~ In a Civil Action; Complaint; Motion for Preliminary Injunction 6V"b ~lf\f.vN IJII5 P\ 1'1\l~ll'l\ \\) 9W\ by leaving with Bobby E. Rogers Agent for Service At
iZl Substituted at Residence: By leaving copies at the dwelling house or usual place of abode of the person being served with a member of the household over the age of 18 and explaining the general nature of the papers.
Non-Service: After due search, careful inquiry and diligent attempts at the address(es) listed above, I have been unable to effect process upon the person/entity being served because of the following reason(s): 0 Service Cancelled by Litigant 0 Unable to Serve in Timely Fashion 0 Moved, Left no Forwarding 0 Unknown at Address 0 Address Does Not Exist 0 Other _ _ _ _________ _ _ ___ _ _ ___ __ _ Service Attempts: Service was attempted on: {1)
Age __ Sex _ _ Race __ Height _ __ Weight _ __ Hair _ _ Beard __ Giasses __ - (4 ) _ _
:{by Sca\t 0'(~.1~~ //1 SUBSCRIBED AND SWORN to before me this Proved to me on the basis of satisfactory evidence to be the person(s) who appeared before me.
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IPR2015-00693, No. 1027 Exhibit - Affidavit of Process Server Serving Ivera Medical Corporation with Summons, Complaint, and Motion for Preliminary Injunction, dated February 10, 2014 (P.T.A.B. Feb. 4
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IPR2015-00693, No. 1022 Exhibit - US Provisional App Ser No 61073,051 dated June 17, 2008 (P.T.A.B. Feb. 4, 2015)
DEPARTMENT OF COMMERCE Under the Paperwork Reduction Act of 1995. no persons are required to respond to a collection of information unless it contains a valid OMB control number.
Background art The medical procedure known as peritoneal dialysis has rapidly grown in clinical acceptance as the technique of choice for treating many patients who have lost their kidney function.
In order to preserve sterile conditions in the fluid transportation system, a respective capping device 5 is attached (Fig. 1C) to each of the connectors 2, 4 so as terminate the same and to cover the exposed surface portions (Fig. 1D).
Figs 5E-5F illustrate yet another alternative embodiment, in which one or more grooves 20 (four shown) are defined in the cylindrical wall portion 16 so as to form fluid channels that lead the disinfectant onto the connector when the seal 15 is urged towards the cavity 14.
However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope and spirit of the invention, which is defined and limited only by the appended patent claims.
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IPR2015-00693, No. 1022 Exhibit - US Provisional App Ser No 61073,051 dated June 17, 2008 (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1011 Exhibit - International Standard ISO 5942, 2nd ed 1998 (P.T.A.B. Feb. 4, 2015)
Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher.
However, parties to agreements based on this part of ISO 594 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below.
ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements.
Maximum distance from tip of male lock fitting to the bottom of first complete thread form of the internal thread Maximum chord length at base of lug in a plane at right angles to axis of fitting only, to be measured on a chord of a circle the diameter of which is J min.
5.3.2.2 Connect the female reference fitting, via a leakproof joint of minimal volume, to a syringe which has passed the test in accordance with ISO 7886-1 for leakage past the piston during aspiration.
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IPR2015-00693, No. 1011 Exhibit - International Standard ISO 5942, 2nd ed 1998 (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1003 Exhibit - US Pat No 8,617,482 (P.T.A.B. Feb. 4, 2015)
In one embodiment, the sealing element comprises at least one rigid protrusion for causing a local deformation of a wall portion of the chamber during at least a part of said displace ment, so as to define a fluid path for the disinfectant.
As the capping device 5 is advanced onto the second connector 4, the front end of the projection 10 engages the seal15 and actively presses disinfectant out of the sealed cavity 14 and onto the external surface of the projec tion 10 (as indicated by arrows in FIG. 4).
FIGS. SE-SF illustrate yet another alternative embodiment, in which one or more grooves 20 (four shown) are defined in the cylindrical wall portion 16 so as to form fluid channels that lead the disinfectant onto the connector when the seal15 is urged towards the cavity 14.
However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the 40 scope and spirit of the invention, which is defined and limited only by the appended patent claims.
The capping device of claim 1, wherein the sealing element comprises at least one rigid protrusion configured to cause a local deformation of a wall portion of the chamber during at least a part of said displacement, so as to define a fluid path for the disinfectant.
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IPR2015-00693, No. 1003 Exhibit - US Pat No 8,617,482 (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1016 Exhibit - US App Ser No 13736,166, Notice of Allowance (P.T.A.B. Feb. 4, 2015)
Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
AlA (First Inventor to Art Unit File) Status 3767 No -- The MAILING DATE of this communication appears on the cover sheet with the correspondence address- All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application.
As a result of the allowed claim(s), you may be eligible to benefit from the Patent Prosecution Highway program at a participating intellectual property office for the corresponding application.
The information disclosure statement filed 1/10/2013 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because NPL items DR and DY are missing dates.
The following is an examiner's statement of reasons for allowance: The subject matter of the independent claims could either not be found or was not suggested in the prior art of record.
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IPR2015-00693, No. 1016 Exhibit - US App Ser No 13736,166, Notice of Allowance (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1030 Exhibit - Decision, Institution of Inter Partes Review in IPR2014 01124 (P.T.A.B. Feb. 4, 2015)
According to Ivera, a person of ordinary skill in the art would not have understood the “medical connectors” described in the Howlett ’541 application to necessarily mean “luer connectors,” which are not explicitly disclosed.
connection with connectors commonly used in a variety of medial apparatus (e.g. tubing sets and needless [sic] injection sites/connectors attached to vascular access devices).
Therefore, argues Catheter, it can not only be said that the Examiner considered the issue of priority, but also that Ivera does not credibly allege that there is a disclosure of a cover for at least two caps in the Rogers ’438 application.
Mr. Leinsing, who has extensive experience in the field of medical IV-line related products, declares that “the combination represents the incorporation of a known method for packaging a decontamination device [Lake] with a known Luer connector cap [Hoang/Rogers ’889 publication].”6 Ex. 1002 ¶¶ 2–3, 192, 220.
Ivera quotes Mayoral as reciting: The present invention relates to a system for covering a portion of a fitting or connector on a medical device or other apparatus through which fluid is transferred.
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IPR2015-00693, No. 1030 Exhibit - Decision, Institution of Inter Partes Review in IPR2014 01124 (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1007 Exhibit - US Published App No 20110165020 (P.T.A.B. Feb. 4, 2015)
In order to preserve sterile conditions in the ?uid transportation system, a respective capping device 5 is attached (FIG. 1C) to each of the connectors 2, 4 so as terminate the same and to cover the exposed surface portions (FIG. 1D).
[0064] FIGS. 5E-5F illustrate yet another alternative embodiment, in Which one or more grooves 20 (four shoWn) are de?ned in the cylindrical Wall portion 16 so as to form ?uid channels that lead the disinfectant onto the connector When the seal 15 is urged toWards the cavity 14.
[0083] All embodiments may further include a feedback means (not shoWn), Which is adapted to give an audible, tactile or visual indication When the capping device is prop erly mounted on the connector.
HoWever, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally pos sible Within the scope and spirit of the invention, Which is de?ned and limited only by the appended patent claims.
The capping device of claim 1, Wherein the sealing element comprises at least one rigid protrusion for con?gured to cause a local deformation of a Wall portion of the chamber during at least a part of said displacement, so as to de?ne a ?uid path for the disinfectant.
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IPR2015-00693, No. 1007 Exhibit - US Published App No 20110165020 (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1008 Exhibit - US Pat No 5,184,742 (P.T.A.B. Feb. 4, 2015)
In accordance with the present invention, a dea dender cap is provided for use with a male Luer lock ?tting and which may be used to close the downstream opening after ?ushing liquid through the pressure trans ducer.
Certainly, in the hospital environment, and particularly, due to the major use of invivo blood pres sure sensing in the operating room, or cath lab, accu racy and ?delity of signal is of extreme importance.
As an example, the external threads thecolumn of liquid leading to the patient, is in commu 48 and internal diameter of the cylindrical hub 44 are, of nication with the passageway of disposable pressure course, dimensioned within speci?c tolerances in order transducer and the syringe is isolated from such com to attach to the standard male Luer ?tting that is set by munication.
40 extend outwardly approximately 180° apart to enable In carrying out such tightening, the liquid passing out the user to easily grasp the deadender cap 12 for rotat of passageway 58 through ?at opening 60 is halted ing it in either direction.
50 that extends outwardly from separation wall 42 toward open end 46 and tapers inwardly a predeter Thus there is no dead air space that can cause the forma tion of a bubble.
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IPR2015-00693, No. 1008 Exhibit - US Pat No 5,184,742 (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1025 Exhibit - US App Ser No 12610,141, dated October 30, 2009 (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1025 Exhibit - US App Ser No 12610,141, dated October 30, 2009 (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1006 Exhibit - US Published App No 20060030827 (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1006 Exhibit - US Published App No 20060030827 (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1009 Exhibit - US Pat No 8,740,864 (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1009 Exhibit - US Pat No 8,740,864 (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1021 Exhibit - PCTEP2009057321 dated June 15, 2009 (P.T.A.B. Feb. 4, 2015)
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IPR2015-00693, No. 1021 Exhibit - PCTEP2009057321 dated June 15, 2009 (P.T.A.B. Feb. 4, 2015)
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