Petition for inter partes review U.S. Pat. No. 8,641,681 Paper No. ________ UNITED STATES PATENT AND TRADEMARK OFFICE _______________ BEFORE THE PATENT TRIAL AND APPEAL BOARD _____________ IVERA MEDICAL CORPORATION Petitioner v. CATHETER CONNECTIONS, INC. alleged Patent Owner Patent No. 8,641,681 PETITION FOR INTER PARTES REVIEW UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 ET. SEQ.
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Petition for inter partes review U.S. Pat. No. 8,641,681
Paper No. ________
UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
_____________
IVERA MEDICAL CORPORATION
Petitioner
v.
CATHETER CONNECTIONS, INC.
alleged Patent Owner
Patent No. 8,641,681
PETITION FOR INTER PARTES REVIEW
UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 ET. SEQ.
Petition for inter partes review U.S. Pat. No. 8,641,681
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TABLE OF CONTENTS
NOTICE OF LEAD AND BACKUP COUNSEL ..................................................... 1
NOTICE OF EACH REAL-PARTY-IN-INTEREST ............................................... 1
NOTICE OF RELATED MATTERS ........................................................................ 1
NOTICE OF SERVICE INFORMATION ................................................................ 1
GROUNDS FOR STANDING .................................................................................. 1
STATEMENT OF PRECISE RELIEF REQUESTED .............................................. 2
THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW ........................ 2
I. Introduction .......................................................................................................... 3 A. Technology Background ................................................................................. 3 B. The '681 Patent ................................................................................................ 9 C. Tryggvason Prior Art ..................................................................................... 16 D. Prior Art "Members" Shaped to Enter Into and Engage Against an Interior Edge of an Opening of the Lumen ....................................................................... 18
II. Claim construction ............................................................................................ 27 A. Overview of the challenged claims ............................................................... 27 B. Applicable legal standard for claim construction .......................................... 27 C. Claims 1 and 18 –"means for engaging helical threads" ............................... 27 D. Claims 2 and 3 – "bulge" ............................................................................... 28 E. Claims 4 and 17 – "dome shaped" ................................................................. 28 F. Claims 5 and 12 – "biasing structure" ........................................................... 29 G. Claim 12 – "thrust" ........................................................................................ 30
III. Detailed explaination of reasons for unpatentability ....................................... 30
Ground 1. Claims 1, 2, 4, 9, 10, 11, 13, 14, 15, 17, 18, 21 and 22 are unpatentable under 35 U.S.C. § 103(a) over Tryggvason in view of Aalto. ................................. 30
Ground 2. Claims 3 and 16 are unpatentable under 35 U.S.C. § 103(a) over Tryggvason in view of Aalto, in further view of Sweeney. ..................................... 48
Ground 3. Claims 5 and 12 are unpatentable under 35 U.S.C. § 103(a) over Tryggvason in view of Aalto, in further view of Buchman. .................................... 52
Ground 4. Claims 6, 7, 8, 19 and 20 are unpatentable under 35 U.S.C. § 103(a) over Tryggvason in view of Aalto, in further view of Hoang. ................................ 56
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IV. Conclusion ....................................................................................................... 60
CERTIFICATE OF SERVICE ................................................................................ 61
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TABLE OF EXHIBITS
Exhibit No. Description
1001 U.S. Pat. No. 8,641,681 ("the '681 patent").
1002 Declaration of Karl Leinsing.
1003 U.S. Pat. No. 8,617,482 ("Tryggvason").
1004 U.S. Published App. No. 2005/0147524 ("Bousquet").
1005 U.S. Published App. No. 2008/0132880 ("Buchman").
1006 U.S. Published App. No. 2006/0030827 ("Raulerson").
1007 U.S. Published App. No. 2011/0165020 ("Tryggvason Publication").
1008 U.S. Pat. No. 5,184,742 ("DeCaprio").
1009 U.S. Pat. No. 8,740,864 ("Hoang").
1010 International Standard ISO 594/1, CONICAL FITTINGS
WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES
AND CERTAIN OTHER MEDICAL EQUIPMENT – PART 1: GENERAL REQUIREMENTS (1st ed. 1986).
1011 International Standard ISO 594/2, CONICAL FITTINGS
WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES
AND CERTAIN OTHER MEDICAL EQUIPMENT – PART 2: LOCK FITTINGS (2nd ed. 1998).
1012 U.S. Pat. No. 3,987,930 ("Fuson").
1013 U.S. App. Ser. No. 13/736,166, Preliminary Amendment dated February 28, 2013.
1014 U.S. App. Ser. No. 13/736,166, Office Action dated August 8, 2013.
1015 U.S. App. Ser. No. 13/736,166, Amendment dated September 17, 2013.
1016 U.S. App. Ser. No. 13/736,166, Notice of Allowance.
1017 U.S. Pat. No. 5,954,957 ("Chin-Loy").
1018 U.S. Pat. No. 4,597,758 ("Aalto").
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1019 U.S. Pat. No. 4,624,664 ("Peluso").
1020 U.S. Pat. No. 5,533,980 ("Sweeney").
1021 PCT/EP2009/057321 dated June 15, 2009.
1022 U.S. Provisional App. Ser. No. 61/073,051 dated June 17, 2008.
1023 Tryggvason claim charts.
1024 Buchman claim charts.
1025 U.S. App. Ser. No. 12/610,141, dated October 30, 2009.
1026 U.S. App. Ser. No. 13/736,166, Office Action dated May 16, 2013.
1027 Affidavit of Process Server Serving Ivera Medical Corporation with Summons, Complaint, and Motion for Preliminary Injunction, dated February 10, 2014.
1028 U.S. Provisional App. Ser. No. 60/774,708 dated February 17, 2006.
1029 U.S. App. Ser. No. 13/736,166, Amendment dated June 25, 2013.
1030 Decision, Institution of Inter Partes Review, 37 C.F.R. § 42.108 in IPR2014-01124.
Petition for inter partes review U.S. Pat. No. 8,641,681
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NOTICE OF LEAD AND BACKUP COUNSEL
Lead Counsel for Petitioner Ivera Medical Corporation: Matthew A. Smith
It would have been obvious to one of skill in the art to use the shape of the
member of Aalto in Tryggvason's disinfecting cap. (Ex. 1002, ¶ 134).
Disinfecting caps for luer connectors that included a member that entered into the
lumen to diminish the flow of antiseptic into the lumen were not new at the time of
the invention of the '681 patent (see Bousquet and Raulerson). (Id., ¶ 135). Nor
was it new to include a member that engaged against an interior edge of an opening
in a lumen to reduce or stop fluid flow in luer connector caps (see DeCaprio and
Aalto). (Id., 136). One of skill in the art would have been familiar with these
known prior art luer connector caps, and would have understood the change to the
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member of Tryggvason to be a minor modification. (Id.).
One of skill in the art would have been motivated to use the shape of the
member from Aalto on the cap of Tryggvason to create a more consistently reliable
seal between the cap and connector. (Ex. 1002, ¶ 137). One of skill in the art
would have also been motivated to use the shape of the member from Aalto on the
cap of Tryggvason to allow the antiseptic agent to reach the tip of the lumen (the
most likely area needing disinfecting) during the disinfecting process. (Ex. 1002, ¶
138). The '681 patent acknowledges this as a motivating factor: "Such an
arrangement likewise can allow antiseptic to contact much or all of an external
surface of the luer 2020, including a distal surface of the tip 2021." (Ex. 1001,
32:45-48)(Ex. 1002, ¶ 139).
The combination of Tryggvason with Aalto represents the use of a known
disinfecting cap for a male luer connector with a movable member (Tryggvason),
with the known male luer connector cap having a member shaped to enter into and
engage against an interior edge of an opening into the lumen (Aalto), each without
change of their known functions, and without unpredictable results. (Ex. 1002, ¶
140). See KSR Int'l Co. v. Teleflex, Inc., 127 S. Ct. 1727, 1739-42 (2007). There
do not appear to be any secondary indicia of non-obviousness present. (Ex. 1002, ¶
141). See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18 (1966).
Tryggvason in view of Aalto teaches claims 1, 2, 4, 9, 10, 11, 13, 14, 15, 17, 18,
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21 and 22 of the '681 patent, as shown in the following claim charts.
Claims 1 and 18 share the same elements, addressed in the following chart,
except that claim element 1j is only in claim 1.
1a/18a. A male-disinfecting cap for applying an antiseptic agent to a medical male luer-lock connector, of the type including a post having a lumen through which fluid flows and an internally helically threaded skirt surrounding the post, the cap comprising:
Tryggvason discloses a male disinfecting cap: "[a] capping device is configured to terminate a connector while disconnected from another connector in a fluid transportation system …" (Ex. 1003, Abstract)(Ex. 1002, ¶¶ 142-143).
The cap in Tryggvason is a "disinfecting cap" for "applying an antiseptic agent to a medical male luer-lock connector". The cap has an antiseptic disposed inside, whereby the cap disinfects the connector. (Ex. 1002, ¶ 144). The antiseptic agent is called a "disinfectant", and is seen at [14] in Figure 4 below. (Id.). The specification describes the cap containing a "disinfectant", and then identifies the disinfectant as substances that are antiseptic agents.
"The capping device comprises a body defining a chamber with an opening, a liquid-containing disinfectant in the chamber, …" (Ex. 1003, 3:23-25)(emph. add.)(Ex. 1002, ¶ 145).
"In one embodiment, the disinfectant comprises at least one of: povidone iodine, iodine-containing antimicrobials, and betadine." (Ex. 1003, 4:15-18)(emph. add). (Ex. 1002, ¶ 145).
Povidone iodine, iodine-containing antimicrobials, and betadine are all antiseptic agents. (Ex. 1002, ¶ 146).
The cap in Tryggvason is for use on "medical" connectors. The specification explains
"the disclosed embodiments as well as underlying inventive concepts are generally applicable in applications that require sterile conditions, in particular applications that insert a medical fluid into the body of a patient. Examples of other applications
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where sterile connectors are desirably made include the processing of blood and its fractions, the mixing of sterile solutions, connecting catheters with urinary drainage bags, and hemodialysis or blood oxygenation procedures especially with patients who have diminished immunological capability." (Ex. 1003, 5:53-63)(emph. add.)(Ex. 1002, ¶ 147).
These are medical applications. (Ex. 1002, ¶ 147).
Tryggvason discloses a "male" cap, for use with a male connector with a skirt, a post with a lumen, and an internal helical threading. (Ex. 1002, ¶ 148). This is shown in Figure 4 of the patent, annotated here. Figure 4 shows the cap [5], right, connecting with a male connector [4] with a skirt, a post ("projection") [10] and lumen [9], right. (Ex. 1003, 6:57-58, "The first and second connectors 2, 4 define a respective lumen 8, 9")(Ex. 1002, ¶ 148).
The "lumen" of the male connector is a "lumen through which fluid flows". Tryggvason's specification explains that when the male connector is attached to a female connector prior to use with the cap:
"The first and second connectors 2, 4 define a respective lumen 8, 9. When the first connector 2 is brought into engagement with the second connector 4, an internal projection of the second connector 4 enters the lumen 8 of the first connector 2 to establish a fluid path through the connectors." (Ex. 1003, 6:57-62)(emph. add.)(Ex. 1002, ¶ 148).
The connector in Tryggvason is a "luer-lock" connector. The specification explains:
"The engagement means 6, 7 could be any of a variety of
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mutually engaging constructions such as, for example, threaded fitments, luer connections, friction fits, and snap fittings. … The external surface of the projection may or may not form a luer fitting with the distal end of lumen 8." (Ex. 1003, 6:54-63)(emph. add.)(Ex. 1002, ¶ 149).
The male connector [4] is a "luer-lock" connector, as it has engaging means [6] that "lock" with the lugs [13] on the skirt of the connector. (Ex. 1002, ¶ 150).
Tryggvason also discloses a cap [5] for use with a connector [4] having helical threads, including internal threads on the skirt of the connector. This is shown in Figures 6A-6C of the patent, annotated above, which show a female connector and corresponding cap. (Ex. 1003)(Ex. 1002, ¶ 151). The female connector shown in annotated Figure 6A has a skirt with internal helical threads, identified in the above figure. (Ex. 1002, ¶ 151). The patent specification further states that the helical threads disclosed in Figure 6 could be used on either the female connector and corresponding cap, or on a male connector and corresponding cap. (Ex. 1003, 7:50-52, "It should also be understood that, in all embodiments discussed herein, either one of the connectors 2, 4 could be used as patient connector")(Ex. 1002, ¶ 152). On a male cap, the internally helically threaded skirt would surround the post with a lumen of the male connector. (Ex. 1002, ¶ 153).
1b/18b. a receiving portion defining a chamber into which the post of the male
Tryggvason discloses a receiving portion defining a chamber into which the post of the male luer-lock connector can be received. (Ex. 1002, ¶ 154).
Tryggvason's chamber is discussed in claim limitation 1c/18c. below, and seen highlighted in Figure 4 below. (Ex. 1002, ¶ 155). The chamber extends into the cap, with the receiving portion at
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luer-lock connector can be received,
one end, and the sealing cavity at the other end, and the seal (member) in between. (Id.).
The receiving portion is the opening in the cap that receives the male luer connector, to the right of the sealing member, as shown in Figure 4 here, where the post [10] of the male luer-lock connector is being received into the cap [5]. The male connector is a "luer-lock" connector as described in [1a.] above. (Ex. 1002, ¶¶ 156). The receiving portion is shown highlighted in yellow in the cap portion of Figure 4 here. (Ex. 1002, ¶ 157). The receiving portion defines a chamber, which is shown above, and further in claim limitation [1c/18c.] below. (Ex. 1002, ¶¶ 155, 158).
1c/18c. the chamber having only a single opening,
The chamber of Tryggvason is seen highlighted in yellow in Figure 4 in claim limitation [1b/18b.] above, where it is seen there that the chamber has only a single opening. (Ex. 1002, ¶ 158).
The specification of Tryggvason further explains that, "The capping device comprises a body defining a chamber with an opening …" (Ex. 1003, Abstract, 3:23-24)(emph. add.)(Ex. 1002, ¶ 159).
1d/18d. the receiving portion defining an external surface having means for engaging
The receiving portion of Tryggvason defines an external surface having means for engaging helical threads of the internally helically threaded skirt. As explained above, the proper construction of "means for engaging helical threads" is "threads, lugs or other suitable attachment features that can engage with helical threads, and equivalents thereof". (Ex. 1002, ¶¶ 160, 161).
Tryggvason calls its means for engaging the skirt of the
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helical threads of the internally helically threaded skirt,
connector "engagement means", and its engagement means are seen in Figure 4 below at [6]. (Ex. 1002, ¶ 162). Tryggvason explains that these engagement means could be any of a number of different constructions:
"The engagement means 6, 7 could be any of a variety of mutually engaging constructions such as, for example, threaded fitments, luer connections, friction fits, and snap fittings."(Ex. 1003, 6:54-57)(Ex. 1002, ¶ 163).
The means shown in Figure 4, annotated here, are lugs that would engage helical threads of the internally helically threaded skirt of a corresponding connector. (Ex. 1002, ¶ 164).
1e/18e. wherein the receiving portion is configured to fit within the skirt of the male luer-lock connector when the post is received into the receiving portion;
Tryggvason discloses the receiving portion "configured to fit within the skirt of the male luer-lock connector when the post is
received into the receiving portion". In Figure 4 annotated here, the receiving portion of the cap [5] is seen, highlighted, between the post and skirt of the connector [4]. (Ex. 1002, ¶¶ 165, 166).
1f/18f. an antiseptic agent disposed in the chamber;
Tryggvason discloses an antiseptic agent disposed in the chamber. The antiseptic agent is called a "disinfectant", and is seen at [14] in Figure 4 above, "disposed in the chamber" of the cap. (Ex. 1002, ¶ 167). The specification describes the cap containing a "disinfectant", and then identifies the disinfectant as
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substances that are antiseptic agents. (Ex. 1002, ¶¶ 167, 168).
"The capping device comprises a body defining a chamber with an opening, a liquid-containing disinfectant in the chamber, …" (Ex. 1003, 3:23-25)(emph. add.)(Ex. 1002, ¶ 168).
"In one embodiment, the disinfectant comprises at least one of: povidone iodine, iodine-containing antimicrobials, and betadine." (Ex. 1003, 4:15-18) (Ex. 1002, ¶ 168).
Povidone iodine, iodine-containing antimicrobials, and betadine are all antiseptic agents. (Ex. 1002, ¶ 169)(emph. add.).
1g/18g. a member movably disposed within the chamber,
Tryggvason discloses a chamber as discussed in limitations [1b/18b] and [1c/18c] above.
Tryggvason also discloses a "member movably disposed within the chamber". Tryggvason calls its sealing member a "sealing element". (Ex. 1003, Abstract)(Ex. 1002, ¶ 171). The specification explains that the sealing element is disposed within the chamber, and specifically "arranged in the opening of the chamber":
"The capping device comprises a body defining a chamber with an opening, … [and] a sealing element arranged in the opening". (Ex. 1003, 3:23-25)(emph. add.)(Ex. 1002, ¶ 172).
Tryggvason next discloses that the sealing element is a "movable member". (Ex. 1002, ¶ 173). The specification explains that the sealing element is "displaced", and thus movable, when the connector is inserted into the cap:
"The capping device comprises … a structure for engaging and guiding the first connector towards the body such that a portion of the first connector displaces the sealing element into the chamber". (Ex. 1003, 3:23-29)(emph. add.)(Ex. 1002, ¶ 173).
Tryggvason's sealing member [15] is in the chamber of the
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cap, as shown in Figure 4 and as explained in claim limitations [1b/18b] and [1c/18c] above. (Ex. 1002, ¶ 174).
Aalto also discloses a movable sealing member. Aalto's member is an "elastomeric insert" that is contained in the chamber of the male luer connector cap, as seen at [36] in Figure 2 of the patent here. (Ex. 1002, ¶ 175). The specification explains, "As seen in FIG. 2, the elastomeric insert 36 is compressively retained in the cavity by the cylindrical surface 49". (Ex. 1018, 3:54-56)(Ex. 1002, ¶ 176). The member (elastomeric insert) moves into the lumen of the male connector when the cap and connecter are attached to one another. (Ex. 1018)(Ex. 1002, ¶ 177). The specification explains that the member moves in relation to the insertion of the post of the male luer connector into the chamber of the cap:
"As the sealing closure is brought into mating contact with the Luer fitting 20, the elastomeric insert 36 is compressed further." (Ex. 1018, 4:11-13)(emph. add.)(Ex. 1002, ¶ 178).
1h/18h. the member shaped to enter the lumen so as to engage against an interior edge of an opening of the lumen when the post is received into the receiving portion
Aalto discloses a member shaped to enter the lumen so as to engage against an interior edge of an opening of the lumen when the post is received into the receiving portion. (Ex. 1002, ¶ 179).
Aalto's member is an "elastomeric insert", as described in claim limitation [1g/18g] above, which enters into the lumen of the male connector when the cap and connecter are attached to one another. Ex. 1002, ¶ 180). Aalto calls the lumen an "outlet", and the cap's member and lumen are identified here in Figure 5, where the cap and connector are shown attached to one another:
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(Ex. 1018)(Ex. 1002, ¶ 181). Aalto's specification explains that when the cap and connector are attached, the member "enters" into the lumen:
"As the sealing closure is brought into mating contact with the Luer fitting 20, the elastomeric insert 36 is compressed further. The locking ring 22 on the Luer fitting 20 and the ridges 42 on the sealing closure 32 create a pressure lock. Stated differently, the Luer fitting 20 is forcefully held in mating contact with the tapered inner surface 44. The elastomeric insert 36 creates a liquid-tight seal with the outlet 60 of the Luer fitting 20. The second-end side 55 of the insert 36 will be partially displaced into the outlet 60." (Ex. 1018, 4:11-20)(emph. add.)(Ex. 1002, ¶ 182).
As can be seen in the expanded portion of Figure 5 of Aalto, shown right, the member (elastomeric insert) [55] engages with the "interior edge of the lumen" (outlet) [60] when the cap and connector are attached. (Ex. 1002, ¶ 183). The specification also explains the engagement of the member to the connector as the cap and connector are attached to one another, calling the engagement "mating contact":
"As the sealing closure is brought into mating contact with the Luer fitting 20, the elastomeric insert 36 is compressed further." (Ex. 1018, 4:11-13)(Ex. 1002, ¶ 184).
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1i/18i. to diminish flow of the antiseptic agent into the lumen while permitting flow of the antiseptic agent past the member to the post of the male luer-lock connector; and
The member disclosed in Tryggvason diminishes the flow of the antiseptic agent into the lumen. (Ex. 1002, ¶ 188) Because Tryggvason's member [15] is positioned over the opening of the lumen of the male luer connector, the antiseptic agent flows around the sides of the sealing element (member) [15], to the post [10] of the male luer connector, shown highlighted in Figure 4 here. (Ex. 1003)(Ex. 1002, ¶ 186).
Aalto also discloses a member that diminishes the flow of fluid. Aalto's specification explains that when the cap and connector are attached a "liquid-tight" seal is formed:
"As the sealing closure is brought into mating contact with the Luer fitting 20, the elastomeric insert 36 is compressed further. The locking ring 22 on the Luer fitting 20 and the ridges 42 on the sealing closure 32 create a pressure lock. Stated differently, the Luer fitting 20 is forcefully held in mating contact with the tapered inner surface 44. The elastomeric insert 36 creates a liquid-tight seal with the outlet 60 of the Luer fitting 20. The second-end side 55 of the insert will be partially displaced into the outlet 60." (Ex. 1018, 4:11-20)(emph. add.)(Ex. 1002, ¶ 188).
1j. a gripping portion.
Tryggvason discloses a gripping portion, most clearly seen in Figure 6A above. (Ex. 1002, ¶ 189). The specification explains:
"Returning to FIG. 6, the capping device 5 further comprises a grip portion 23A in the form of a flange that can be gripped by a user in order to screw the capping device 5 in and out of the connector 4." (Ex. 1003, 10:40-43)(emph. add.)(Ex. 1002, ¶ 189).
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2. A cap according to claim 1, wherein the member has a centrally disposed bulge shaped to enter the lumen.
The member of Aalto has a centrally disposed "bulge", as that term is properly construed, shaped to enter the lumen. As established above, the proper construction of the term "bulge" is "a protuberance". (Ex. 1002, ¶ 190)
Aalto's member is described in claim limitations [1g/18g.] and [1h/18h.] above. (Ex. 1002, ¶ 191)
As best seen in the expanded portion of Figure 5 of Aalto, shown right, the member (elastomeric insert) 55 has "a protuberance" that enters into the lumen (outlet) [60] when the cap and connector are attached, (Ex. 1002, ¶ 192).
4. A cap according to claim 2, wherein the bulge is dome shaped.
Aalto's member, described in claim limitation [1h]/[18h] and claim 3 above, is "dome shaped", as that term is properly construed ("rounded or spherical convex shape").
As explained above, the proper construction of the term "dome shaped" is "rounded". As best seen in the expanded portion of Figure 5 of Aalto, shown in claim 3 above, the bulge in the member is "rounded" and thus "dome shaped". (Ex. 1002, ¶ 194).
Claims 9 and 10 relate to a taper in the wall of the cap's chamber. As
discussed above, a 6% taper is the fundamental feature of all luer connectors and,
consequently, luer connector caps. This was well known in the art well in the
relevant timeframe for obviousness. (Ex. 1002, ¶ 195). Indeed, the 6% taper was
standardized by the ISO in 1991. (Ex. 1010)(Ex. 1011)(Ex. 1002, ¶ 195).
9. A cap according to claim 1,
Tryggvason discloses that at least a portion of the wall of the chamber has a taper that narrows toward the interior of the chamber. Because Tryggvason can be used with "luer fittings",
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wherein at least a portion of a wall of the chamber has a taper that narrows toward an interior of the chamber.
the wall of the chamber would necessarily have a 6% taper, corresponding to the taper in the luer fitting, which would narrow as the luer fitting progresses into the chamber of the luer cap. (Ex. 1003, 6:54-63)(Ex. 1002, ¶¶ 196, 197).
Aalto also discloses a cap for a male luer connector with a chamber having a taper that narrows toward its interior. (Ex. 1002, ¶ 198). Aalto explains that its cap is for use with:
"Luer fittings for Luer locks employ male and female tapered mating surfaces for a releasably secure connection between, for example, two portions of a conduit. For example, in the medical field, many intravenous fluid solution sets have at one end a tapered male Luer fitting for connection with a female Luer fitting disposed in the hub of a catheter disposed in a patient." (Ex. 1018, 1:14-20)(emph. add.)(Ex. 1002, ¶ 199).
The tapered wall of the chamber of the cap in Aalto is seen in Figure 2 of Aalto, shown here, the taper narrowing toward the interior of the chamber. (Ex. 1002, ¶ 200). It is also described in the patent's specification:
"Luer fitting 20 is forcefully held in mating contact with the tapered inner surface 44."
(Ex. 1018, 4:16-17)(emph. add.)(Ex. 1002, ¶ 200).
10. A cap according to claim 9, wherein the taper is near the opening of the
Because the tapered luer fitting is inserted into the opening of the chamber of Tryggvason, the taper of the wall of the chamber in Tryggvason is also "near the opening of the chamber" (to correspond to the 6% taper in the luer fitting that is inserted therein). (Ex. 1003, 6:54-63)(Ex. 1002, ¶ 201).
The same is true for Aalto. As seen in Figure 2 of Aalto in claim 9 above, the taper [44] is "near the opening of the
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chamber. chamber" [40], to accommodate the tapered luer connector, and extends through the end of the chamber. (Ex. 1002, ¶ 202).
11. A cap according to claim 1, wherein the means for engaging helical threads includes threading disposed on the receiving portion to engage with threads of the male luer-lock connector
The means for engaging helical threads of the internally threaded skirt of the connector, discussed in claim limitation [1d.] above, disclosed in Tryggvason include corresponding helical threads disposed on the receiving portion of the cap. (Ex. 1003)(Ex. 1002, ¶ 203).
This is shown in Figures 6A-6C of the patent, with 6A shown here, which show a female connector and corresponding cap. (Ex. 1003)(Ex. 1002, ¶ 204). The female connector shown in annotated Figure 6A has a skirt, identified here, with internal helical threads. (Ex. 1002, ¶ 205). The skirt is at the opening of the connector, or "receiving portion" of a corresponding male luer connector cap. (Id., ¶ 206). The engagement is between the threading on the cap and corresponding threading on the connector. (Id., ¶ 207). The patent specification further states that the helical threads disclosed in Figure 6 could be used on either the female connector and corresponding cap, or on a male connector and corresponding cap. (Ex. 1003, 7:50-52, "It should also be understood that, in all embodiments discussed herein, either one of the connectors 2, 4 could be used as patient connector")(Ex. 1002, ¶ 208).
Claims 13 and 21 depend, respectively, from independent claims 1 and 18, and
add the same claim element.
13/21. A cap according to
The chamber of the cap disclosed in Tryggvason has a fixed volume. The chamber is discussed above in claim limitation
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claim [1/18], wherein the chamber has a fixed volume.
1b/18b. As seen in Figure 4, shown there, the chamber of the cap is a fixed size that does not change as the cap is in use, and thus has a fixed volume. (Ex. 1002, ¶ 210).
Claims 14 and 22 depend, respectively, from independent claims 1 and 18, and
add the same claim element.
14/22. A cap according to claim [1/18], wherein the movably disposed member is configured to retain the antiseptic inside the chamber prior to inserting the post into the chamber.
Tryggvason discloses that prior to use the antiseptic is maintained in the cap's chamber by the sealing member. (Ex. 1002, ¶ 212).
Tryggvason discloses this claim element in reference to the cap for the female connector, stating:
"A sealed cavity 14 is formed at the inner end portion of the bore, by a seal or sealing element 15 being fitted into the bore 12."(Ex. 1003, 7:6-8)(emph. add.)(Ex. 1002, ¶ 213).
Tryggvason explains that the cap for the male luer connector "has the same construction as the capping device" for the female connector. (Ex. 1003, 7:32-34). The cap for the male connector also has a sealed cavity. (Ex. 1002, ¶ 214).
The antiseptic is retained within the sealed cavity. As explained in the specification:
"A sealed cavity 14 is formed at the inner end portion of the bore, by a seal or sealing element 15 being fitted into the bore 12. The cavity 14 is thus defined by the seal 15, a cylindrical wall portion 16 and a bottom end surface 17. The cavity 14 is wholly or partly filled with a liquid-containing disinfectant."(Ex. 1003, 7:6-11)(emph. add.)(Ex. 1002, ¶ 215).
The "disinfectant" in Tryggvason is an antiseptic agent, as explained in claim 1, limitation [1a/18a.] above. (Ex. 1003, 4:15-18) (Ex. 1002, ¶ 216).
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15. A cap according to claim 1, wherein the member has a convex surface shaped to enter the lumen.
The member of Aalto has a convex surface shaped to enter the lumen. Aalto's member is described in claim limitation 1h/18h. above. (Ex. 1002, ¶ 217).
As best seen in the expanded portion of Figure 5 of Aalto, shown right, the member (elastomeric insert) 55 has a convex surface that engages with the "interior edge of the lumen" (outlet) [60] when the cap and connector are attached. (Ex. 1002, ¶ 218). As is also seen in this figure, the member is shaped to enter into the lumen. (Id., ¶ 219). This is explained in the specification:
"The second-end side 55 of the insert will be partially displaced into the outlet 60." (Ex. 1018, 4:19-20)(emph. add.)(Ex. 1002, ¶ 220).
17. A cap according to claim 15, wherein the convex surface is dome shaped.
Aalto's member, described in claim limitation [1h]/[18h] and claim 15 above, is "dome shaped", as that term is properly construed. (Ex. 1002, ¶ 220). As explained above, the proper construction of the term "dome shaped" is "rounded or spherical convex shape". As best seen in the expanded portion of Figure 5 of Aalto, shown in claim 3 above, the convex surface in the member is "rounded" and thus "dome shaped". (Ex. 1002, ¶¶ 221, 222).
Ground 2. Claims 3 and 16 are unpatentable under 35 U.S.C. § 103(a) over Tryggvason in view of Aalto, in further view of Sweeney.
Claims 3 and 16 are invalid under 35 U.S.C. § 103 over Tryggvason in view of
Aalto, as set forth in Ground 1, incorporated herein, in further view of U.S. Patent
No. 5,533,980 ("Sweeney"). (Ex. 1020)(Ex. 1002, ¶ 223). Sweeney is prior art
under § 102(b) as it issued in 1996. (Ex. 1020). The level of ordinary skill in the
art is discussed in the Leinsing declaration. (Ex. 1002, ¶¶ 20-21, 225).
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Like claims 2, 4, 15 and 17, discussed above, claims 3 and 16 also relate to the
shape of the member of the claimed cap, and specify a "conical" shape.
Claim 3 states: "A cap according to claim 2, wherein the bulge is
conically shaped."
Claim 16 states: "A cap according to claim 15, wherein the convex
surface is conically shaped."
In reference to Figure 37 of the '681 patent, the
specification describes a member that is "shaped
substantially as a conical disk". (Ex. 1001, 30:64-
65)(emph. add)(Ex. 1002, ¶ 228).
DeCaprio, discussed above, discloses a male luer connector having a conically
shaped member that engages with an interior edge of an opening of the lumen. See
Section I.D.3. (Ex. 1002, ¶ 229). This claim limitation is also disclosed in
Sweeney, wherein the member is both a "bulge" ("protuberance") as in claim 3,
and a "convex surface" as in claim 16 of the '681 patent. (Ex. 1002, ¶ 230).
Sweeney discloses a "Protective Cap Assembly for a Medical Device
Passageway". (Ex. 1020). The protective cap includes "a central sealing
projection 72 for sealingly engaging portions of tip 28 of syringe 14 in proximity
to passage 30" that "may be formed in a generally frusto-conical configuration
which can conveniently seal the tip 28 of the syringe barrel by blocking passage
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30." (Ex. 1020, 6:25-30)(Ex. 1002, ¶¶ 231-232).
The sealing projection of Sweeney is shown right below at [72] in Figure 12a,
and also in Figure 13 of the patent, where the cap is attached to the syringe. (Ex.
1020)(Ex. 1002, ¶ 233). Also shown left below is an expanded portion of Figure
37 of the '681 patent, rotated to be in the same position as the figures in Sweeney.
(Ex. 1002, ¶ 234). The "conically" shaped member is highlighted in each of these
figures. (Id.).
It would have been obvious to one of skill in the art to use the shape of the
sealing projection in Sweeney in combination with the member of Aalto, in the cap
of Tryggvason. (Ex. 1002, ¶ 235). Sweeney, like Tryggvason and Aalto, discloses
a cap for a medical fluid passageway. (Ex. 1020)(Ex. 1002, ¶ 237). As noted by
the Examiner during prosecution of the '681 patent, this type of change to the shape
of the member disclosed in Aalto, to the conical shape shown in Sweeney, "is
generally recognized as being within the level of ordinary skill in the art." (Ex.
1014, p. 7, also explaining that such change "is deemed to have been known by
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those skilled in the art since the instant specification and evidence of record fail to
attribute any significance (novel or unexpected results) to a particular
arrangement")(citations omitted). See also Corning Optical Communications RF,