IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF OHIO
`
`
`APPLIED MEDICAL TECHNOLOGY, INC.,
`
`
`
`
`Plaintiff,
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`v.
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`Case No. 1:16-CV-02190-PAG
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`CORPAK MEDSYSTEMS, INC.
`
`
`Defendant.
`
`JUDGE PATRICIA A. GAUGHAN
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`INITIAL INFRINGEMENT CONTENTIONS
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`
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`Pursuant to Local Patent Rule 3.1, Plaintiff APPLIED MEDICAL TECHNOLOGY, INC.
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`
`
`
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`(“AMT”) hereby provides the following information to Defendant CORPAK MEDSYSTEMS,
`
`INC. (“Corpak”).
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`L.P.R. 3.1 (a): Infringed Claims
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`Corpak infringes claim 18 of U.S. Patent No. 6,631,715 (the ’715 patent), which is
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`entitled “Magnetic Nasal Tube Bridle System and Related Method,” under 35 U.S.C. § 271 (b).
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`AMT reserves the right to allege that Corpak infringes claim 18 of the ‘715 patent under 35
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`U.S.C. § 271 (a) and/or 35 U.S.C. § 271 (c) as information is provided by Corpak.
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`L.P.R. 3.1 (b): Accused Instrumentalities
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`The above-identified claim of the ‘715 patent is infringed by Corpak’s device for
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`nasogastric/nasointestinal tube retention named the CORGRIP NG/NI Tube Retention System
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`(the “Corgrip System”) when used in accordance with Corpak’s instructions. Product numbers
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`include 25-008, 25-010, and 25-012, for use with NG/NI feeding tubes of sizes 8 French, 10
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`French, and 12 French, respectively.
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`1
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`CORPAK Ex 1009, Page 1
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`L.P.R. 3.1 (c): Claim Chart
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`AMT provides herewith as Exhibit A a detailed Claim Chart identifying specifically
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`where each limitation of the asserted claim is found within each Accused Instrumentality. At
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`present, AMT does not contend that any limitation in the asserted claim is governed by 35 U.S.C.
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`§ 112(6) (pre-AIA).
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`L.P.R. 3.1 (d): Direct Infringers
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`AMT alleges that claim 18 of the ‘715 patent is indirectly infringed under 35 U.S.C. §
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`271(b), and that the direct infringers are each medical care provider that uses Corpak’s Corgrip
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`System following the instructions provided by Corpak with the Corgrip System. See paragraphs
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`14-16 of the Complaint.
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`L.P.R. 3.1 (e): Literal Infringement
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`As set out in the Claim Chart attached as Exhibit A, it is believed that each limitation of
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`the asserted claim is literally present during use of Corpak’s Corgrip System by medical care
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`providers following the instructions provided by Corpak with the Corgrip System. AMT
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`reserves the right to amend these Contentions to describe how such limitations are alternatively
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`met under the doctrine of equivalents, including for example if Corpak contends that one or more
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`limitations of the asserted claim are not present during use of Corpak’s Corgrip System by
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`medical care providers.
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`L.P.R. 3.1(f): Priority Dates
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`The ‘715 patent has a filing date of August 24, 2001, and claims priority of U.S.
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`Provisional Application No. 60/230,525, filed September 1, 2000. AMT contends that the
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`asserted claim has a priority date of August 24, 2001.
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`2
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`CORPAK Ex 1009, Page 2
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`L.P.R. 3.1 (g): Willful Infringement
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`AMT alleges that Corpak willfully infringed the asserted claim for at least the following
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`reasons. Beginning in or about March 2014 Corpak began offering for sale and selling in the United
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`States the Corgrip System. Corpak had actual knowledge of the ‘715 patent when it offered for sale
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`and sold its Corgrip System and provided specific instructions for the use of that system. Corpak
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`learned of the ‘715 patent at least as early as 2011 when it reviewed AMT’s “Bridle” nasal tube
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`retention system in connection with an attempt to acquire the rights to this innovative product from
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`AMT. AMT’s “Bridle” nasal tube retention system practiced the ‘715 patent and was marked with
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`the ‘715 patent number.
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`Further, at about the time when Corpak announced the introduction of its Corgrip System,
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`Corpak filed an Information Disclosure Statement in a patent application at the United States Patent
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`and Trademark Office which disclosed the ‘715 patent, thereby showing that Corpak had knowledge
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`of the ‘715 patent at that time.
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`In addition, Corpak had and has specific intent to encourage and induce medical care
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`providers using the Corgrip System to infringe the asserted claim. This intent is shown in the detailed
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`instructions Corpak has provided and continues to provide for the use of its Corgrip System. These
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`instructions specifically direct medical care providers using the Corgrip System to carry out each and
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`every step of the method claimed in claim 18 of the ‘715 patent as shown in the Claim Chart.
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`Furthermore, medical care providers using the Corgrip System have infringed and continue to
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`infringe the asserted claim by using Corpak’s Corgrip System as instructed by Corpak.
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`The reasonable implication of these facts is that Corpak knows that use of its Corgrip System,
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`in accordance with its instructions for use thereof, infringes the asserted claim, and yet has
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`consciously chosen to have made and sold the Corgrip System in derogation of the ‘715 patent.
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`3
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`CORPAK Ex 1009, Page 3
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`L.P.R. 3.2: Document Production
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`Pursuant to Local Patent Rule 3.2, AMT is producing herewith documents that are
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`required to be disclosed under that Rule. Nothing in these required disclosures shall be
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`considered an admission that such disclosures are prior art or evidence of prior art under 35
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`U.S.C. § 102 (pre-AIA) or § 103 (pre-AIA).
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`
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`Dated: November 8, 2016
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`Respectfully submitted,
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`
`
`/s/ Michael P. Padden
`Michael P. Padden
`Steven J. Solomon
`Gregory M. York
`Pearne & Gordon LLP
`1801 East 9th Street, Suite 1200
`Cleveland, OH 44114
`(216) 579-1700
`mpadden@pearne.com
`Attorneys for Plaintiff Applied
`Medical Technology, Inc.
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`4
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`CORPAK Ex 1009, Page 4
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`CERTIFICATE OF SERVICE
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`I, Kristy M. Wiles, a non-attorney, hereby certify that I served this INITIAL
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`
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`INFRINGEMENT CONTENTIONS by serving a copy of each to the parties listed below by
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`regular U.S. mail and email this 8th day of November, 2016:
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`Attn: Mark R. Jacobs
`Matasar Jacobs LLC
`1111 Superior Ave., Suite 1355
`Cleveland, Ohio 44114
`Phone: (216) 453-8180
`Fax: (216) 282-8600
`Email: mjacobs@matasarjacobs.com
`
`Attn: Richard M. McDermott
`Alston & Bird LLP
`Bank of America Plaza
`101 S. Tryon Street, Suite 4000
`Charlotte, NC 28280
`Phone: (704) 444-1045
`Fax: (704) 444-1745
`Email: rick.mcdermott@alston.com
`
`Attn: Tasneem Dharamsi Delphry
`Alston & Bird LLP
`Bank of America Plaza
`101 S. Tryon Street, Suite 4000
`Charlotte, NC 28280
`Phone: (704) 444-1199
`Fax: (704) 444-1111
`Email: tasneem.delphry@alston.com
`
`Attn: Jitendra Malik
`Alston & Bird LLP
`4721 Emperor Boulevard, Suite 400
`Durham, NC 27703-8580
`Phone: (919) 862-2210
`Fax: (919) 862-2260
`E-mail: jitty.malik@alston.com
`
`
`
`
`
`
`_/s/ Kristy M. Wiles____
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`5
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`CORPAK Ex 1009, Page 5
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`Exhibit A
`Exhibit A
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`CORPAK EX 1009, Page 6
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`CORPAK Ex 1009, Page 6
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`Claim Chart for U.S. Patent No. 6,631,715
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`Claim
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`Corpak’s CORGRIP device
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`
`
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`Corpak’s CORGRIP device is designed and
`intended for use by a medical care provider in
`a method of placing and securing a nasal tube,
`such as a nasogastric tube or nasointestinal
`tube, through a nose into a patient.
`
`Corpak’s instruction manual, on page 2, in the
`section titled “Directions for Insertion,”
`instructs in step 2 to “[p]osition the patient in
`accordance with facility protocol for feeding
`tube placement.” Corpak’s instruction manual
`also illustrates, for example in subsequent step
`5, the presence of the nasal tube so inserted
`into a nare of a nose of a patient. Although
`Corpak’s instruction manual, on page 2, also
`instructs that “[t]he CORGRIP may be placed
`before or after the NG/NI tube,” and although
`the claim recites the step of inserting the tube
`into a nare before reciting the remaining steps,
`the claim does not require that this step be
`carried out in order with respect to the
`remaining steps, but rather just that the step be
`carried out. Thus, Corpak’s instruction manual
`instructs a medical care provider to insert the
`nasal tube into a first or second nare of the
`nose of the patient.
`
`Corpak’s instruction manual, on page 3,
`instructs in step 6 to “[i]nsert the WHITE
`catheter into the OPPOSITE nostril 5-7 cm or
`to the same distance as the YELLOW catheter
`so magnet tips are at the same point behind the
`vomer bone.” Corpak’s instruction manual
`also illustrates in step 6 the insertion of the
`white catheter into a first nare of the nose, in
`this case corresponding to the nare on the left
`side of the illustration, and thus the patient’s
`right nare. For reference, Corpak’s CORGRIP
`device includes a white catheter. The white
`
`
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`What is claimed is:
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`18. A method of placing and securing at least
`one tube through a nose into a patient
`comprising:
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`
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`inserting the at least one tube into a first or
`second nare of the nose;
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`
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`inserting an end portion of a flexible member
`having a magnet attached thereto into a first
`nare of the nose;
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`CORPAK Ex 1009, Page 7
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`catheter includes a flexible member,
`corresponding to umbilical tape. The flexible
`member has an end portion, corresponding to
`an end of the umbilical tape. The end portion
`of the flexible member has a magnet attached
`thereto, corresponding to a magnet attached to
`the umbilical tape by what appears to be heat-
`shrink sleeve. Although Corpak’s instruction
`manual instructs insertion of the white catheter
`after insertion of the yellow catheter, and
`although the claim recites the step of inserting
`an end portion of a flexible member into a first
`nare of the nose, before reciting the step of
`inserting a magnetic probe into a second nare
`of the nose, the claim does not require that
`these steps be carried out in this order, but
`rather just that they be carried out. Thus,
`Corpak’s instruction manual instructs a
`medical care provider to insert an end portion
`of a flexible member having a magnet attached
`thereto into a first nare of the nose.
`
`Corpak’s instruction manual, on page 2,
`instructs in step 5 to “[i]nsert the YELLOW
`retrieval catheter approximately 5-7 cm into
`nare opposite the nasal tube.” Corpak’s
`instruction manual also illustrates in step 5 the
`insertion of the yellow catheter into a second
`nare of the nose, in this case corresponding to
`the nare on right side of the illustration, and
`thus the patient’s left nare. Corpak’s
`instruction manual, on page 3, also instructs in
`step 7 that “[s]ome gentle manipulation of the
`catheters will encourage magnet engagement
`along with deployment of TRUE TORQUE
`TECHNOLOGY in the WHITE catheter,” and
`that “[w]hen the magnets connect behind the
`vomer bone, you will hear the click and/or feel
`the connection.” Corpak’s instruction manual,
`on page 22, in the section “Summary of
`Magnet Locking Progression Behind Vomer
`Bone,” illustrates such connection. For
`reference, Corpak’s CORGRIP device includes
`a yellow catheter. The yellow catheter
`includes a magnet for attracting the magnet
`attached to the end portion of the white
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`inserting a magnetic probe into a second nare
`of the nose for attracting said magnet and said
`end portion of said flexible member;
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`CORPAK Ex 1009, Page 8
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`catheter, as illustrated. Thus, the yellow
`catheter corresponds to a magnetic probe for
`attracting the magnet and the end portion of the
`flexible member. Thus, Corpak’s instruction
`manual instructs a medical care provider to
`insert a magnetic probe into a second nare of
`the nose for attracting said magnet and said end
`portion of said flexible member.
`
`Corpak’s instruction manual, on page 3,
`instructs in steps 8-10 that “[w]hen magnet
`engagement has occurred, press the WHITE
`button on the catheter to release the umbilical
`tape,” “[s]lowly/deliberately withdraw the
`WHITE catheter approximately 10 cm out of
`the nare,” and “[t]hen slowly/deliberately
`withdraw the YELLOW catheter 2-3 cm
`outside of nare allowing the advancement of
`the umbilical tape behind the vomer bone and
`out the opposite nostril.” For reference,
`Corpak’s CORGRIP device is designed to hold
`the umbilical tape in place within the white
`catheter while the white button is not pressed,
`and to release the umbilical tape so it can move
`relative to the white catheter when the white
`button is pressed. Once the magnet and the
`end portion of the umbilical tape have been
`attracted by the magnetic probe, and while the
`white button is being pressed, withdrawal of
`the white catheter from the first nare results in
`the magnet and the end portion of the umbilical
`tape remaining connected to the magnetic
`probe while the white catheter is being
`withdrawn from the first nare of the patient.
`Subsequent withdrawal of the yellow catheter
`from the second nare results in retrieval of the
`magnet and the end portion of the umbilical
`tape, also from the second nare. A portion of
`the umbilical tape is thereby pulled into the
`first nare, around the vomer bone, and out the
`second nare. Thus, Corpak’s instruction
`manual instructs a medical care provider to
`remove said probe from the second nare of the
`nose thereby retrieving said end portion of said
`flexible member through the second nare of the
`nose.
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`removing said probe from the second nare of
`the nose thereby retrieving said end portion of
`said flexible member through the second nare
`of the nose; and
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`CORPAK Ex 1009, Page 9
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`
`Corpak’s instruction manual, on page 4, in the
`section titled “Securing the CORGRIP to the
`NG/NI tube with the SSL (Slot-Slide-Lock)
`Clamp,” instructs in steps 1 and 2 to “SLOT
`the NG/NI tube into the groove of the SSL
`Clamp,” “[t]hen place one or both sides [of]
`the umbilical tape onto the flat area of the
`clamp, in front of the feeding tube,” and
`“SLIDE the clamp up to approximately 1 cm
`from nare.” Corpak’s instruction manual
`illustrates, at the same steps, that the nasal tube
`is positioned into a groove formed in the
`clamp. For reference, Corpak’s CORGRIP
`device includes a clamp. The clamp is a
`receiver, i.e. for the nasal tube. The receiver
`has a channel formed therein, corresponding to
`the groove formed in the clamp. Securing the
`clamp to the nasal tube by pressing the nasal
`tube into the groove results in snapping of the
`nasal tube into the groove. This is snapping,
`based on the nasal tube having an outer
`diameter, and the groove having an opening
`corresponding to a narrow gap, such that the
`outer diameter of the nasal tube is slightly
`greater than the narrow gap of the opening of
`the groove. Thus, pressing is required to force
`the nasal tube to pass through the narrow gap,
`and once the nasal tube is in the groove,
`pulling would be required to free the nasal tube
`from the groove. This is so even if the groove
`has an inner diameter that is greater than the
`outer diameter of the nasal tube. This is
`apparent based on the instructions, noted
`above, to “slot” the tube into the groove of the
`clamp, then to “slide” the clamp up to
`approximately 1 cm from nare. This also is
`apparent based on actually handling and using
`the CORGRIP device in practice.
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`snapping the at least one tube into a channel
`formed in a receiver.
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`CORPAK Ex 1009, Page 10