EXHIBIT 1012
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`DECLARATION OF JAMES J. SUTOR, PTS EMPLOYEE, FILED
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`WITH APPLICANT’S RESPONSE TO THE FINAL OFFICE ACTION
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`ISSUED DECEMBER 8, 2005
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`Infopia Ex. 1012 pg. 1
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`N THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`i-tB 2 l 2006
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`REGENED
`cameo magma
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`' Group Art Unit:
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`1655
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`Examiner:
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`Gitomer, Ralth.
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`Docket No.: 023134.0110PTUS
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`Confirmation No.:
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`7458
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`U.S. Patent Application No.:
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`10/329,044
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`Filing Date: December 23, 20032
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`For: Test Strip and Method For Determining
`HDL Concentration From Whole Blood )
`Or Plasma
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`) ) ) )
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`Applicants: Sunil G. Anaokar et ai.
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`DECLARATION OF JAMES-J. SUTOR
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`l, James J. Sutor, hereby declare:
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`1 .
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`i am the Senior Scientist at Polymer Technology Systems at 7736 Zionsville
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`Road, Indianapolis. lN 46268, where I am involved in conducting various research and
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`development activities, which include analytical test strip development. All statements
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`made herein of my own knowledge are true, and all statements made on information and
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`belief are believed to be true.
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`2.
`I have werked for over 34 years as a chemist, and for more than eight years
`in the specific area of blood analysis.
`I have six issued patents in the area of microbiology
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`and related chemistry. A copy of my curriculum vitae is attached hereto as Exhibit A,
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`a.
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`Polymer Technology Systems is the assignee of the above-identified
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`application (hereinafter, “the Application").
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`4.
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`l submit this Declaration to present to the-Examiner, in an authenticated
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`manner, facts concerning the Office Action dated Decernber 8, 2005 (hereinafter "the
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`Office Action") and the patentabiiity of the claims.
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`5.
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`i have read the Application including the current claims, the Office Action, and
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`the references-cited by the Examiner. i.e.. U.S. Patent No. 5,185,716, August 4, 1992, to
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`Yatin B. Thakore (hereinafter "Thal<ore"), US Patent No. 5,460,974 issued October 24, '
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`1995 to Mary B. Kczak et ai. (hereinafter “Kozak et at”); United States Patent No.
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`6,040,195 issued March 21., 2000 to Patrick Carroll et al. (hereinafter. "Carroll et at"),
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`Serial No. 101328.044
`Declaration of James Sumr ~
`Page1
`21fi952v1
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`Infopia Ex. 1012 pg. 2
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`Fab-Zl-OS Ul:27l1m
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`From-PATTUN BUGGS LLP
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`United States Patent No. 5,426,030 issued January 20, 1995 to Walter Rittersdorf et all
`(hereinafter, “Ritteredorf et at). and United States Patent No, 6,844,149 issued January 18.
`2005 to Richard Mark Goldman (hereinafter. ”Goldman").
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`6.
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`The Office Action states that itwould have been obvious to one skilled in the
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`art to have the blood flow either upwards or downwards because it ls capillary action that
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`makes the blood flow and turning the test strip in any direction would make no difference to
`capillary action and thus the test strip would work in the same fashion irrespective or
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`orientation, The Office Action further states that test strips are not positionally sensitive in
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`general and no unexpected result is seen In positioning a known test strip upside down.
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`While the Examiner is correct in that capillary action is involved in the operation of both the
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`test strip of the prior art and the test Strip of the invention. the portions of these statements
`that state or implythatthe orientation of the teststrip makes no difference and that one of“
`ordinary skill in the art would know to have the blood flow vertically either upwards or
`downwards is incorrect.
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`Final, l note that Thakore would notwork upside down, since there would be
`7'
`no practical way to apply the blood to area 11.
`8.
`Until the teachings of the present application. it was thought that blood had to
`floweitherlaterallyor upward in a test strip inwhich itwas required to separate different
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`It was thought
`types of cholesterol, because such test strips depended on precipitation.
`that if blood flowed leterallyor upward, the precipitates would be left well clear of the
`analytical test area of the strip. That is, the capillary action would work on the plasma. but
`not on the undesired precipitates. However. lithe strip was turned so that the blood flowed
`downward. gravity would cause the precipitates to move downward to either impede the
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`flow of the plasma through the capillaries or get into the analytic area to interfere with the
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`test.
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`it turns out that lateral and upward flow have
`While the above is logical.
`9.
`serious disadvantages, and surprisingly. vertical flow works much better in test strips in
`which one or more cholesterolvbearing lipoproteins are segregated.
`L
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`As pointed out in the Background of the Application, such teettlow strips with ~
`'10.
`purely lateral how, have problems associated with timing and are difficult to make work
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`Serial No. 101329.044
`Declaration of James Sutur-
`Page 2
`‘228952vi
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`Infopia Ex. 1012 pg. 3
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`property. See. page 2. line 24 through page 4, line 7.
`it is suggested that the
`11.
`On page 4, lines 3 ~ 4 of the Office Action,
`advantages of downward vertical flow are not disclosed. To a certain extent this is true,
`since it was admitted in the application that the exact mechanism why the inventive test
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`strips work so well was not certain (see page 7, lines 10-11),
`12.
`However. the Application does, in fact. disclose advantages of the downward
`vertical flow device. As disclosed on page 7, lines 16 — 21. the inventive test strip is
`unexpectedly accurate. Further. the test strip according to the invention permits a smaller
`blood sample and a more compact test strip. See. page 7. line 22 through page 3. line 2.
`in addition, the inventive test strip does not require time-dependent chromatographic flow
`schemes, which are complex and hard to make work well. See. page 8. lines 8-11.
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`Perhaps, more importantly, since the Application was written. time has
`13.
`shown, and it has become more and more clear, that the downward vertical flow has huge
`advantages in both simplicity of design and operation and accuracy in the claimed
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`cholesterol test strips.
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`14. Atthe time of writing of the Application, it was difficult even for the inventors
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`to break away from the state-of-knowledge of the art that lateral flow of some kind was
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`necessary in these test strips. See. page 7. lines 25 — 26.
`15.
`However, as we have become more familiar and experienced with downward
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`vertical flow, we have made the test strips ever more compact, and have designed them to
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`use less and less blood.
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`it turns out that, that vertical downward flow permits much less
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`‘ blood to be used. This is because the blood does not spread out as much as it does when
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`the blood flows lateral or upward, and flows more direclty and more quickly down to the test
`layer. ' The lesser quantity of blood is not only welcomed by the user. but it allows less
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`chemicals to be used, which makes the strip easier to make and more economical.
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`16.
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`However. the most important advantage is the accuracy pointed to in the
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`Application. The lesser amount of blood and the flow downward assisted by both gravity
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`and capillarity, allows the flow to the reaction area to be more direct and faster, and the
`reaction to be more controllable. As we have learned to tmst the vertically downWard flow
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`Serial No. 1 ("329,044
`Declaration of James Sutor
`Page 3
`2895?.“
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`lnfopia Ex. 1012 pg. 4
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`device, accuracy has shot upward. Test strips using the downward vertical flow are two to
`three times more accurate than prior art test strips using upward or lateral flow.
`17.
`t respectfully suggest to the Examiner that while the position taken in the
`office action that vertical downward flow makes no difference, is logical this position
`actually proves the patentability of the present invention. That is. since the logical and
`expected result. as expressedm the Office Aotion,‘IS that vertically downward flow makes
`no difference. and since vertical downward flow does have significant advantages in the
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`claimed test strips, these advantages are unexpected. and therefore palenteble.
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`l hereby declare that all statements made herein of my own knowledge are
`18.
`true and-that all statements made on information and belief are believed to be true; and
`forther that these statements were made with the knowledge that willful false statements
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`and the like are punishable by fine or impn‘sonment. or both, under 18 U.S.C. §1001, and
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`that such willfulfalse statements mayjeopardize the validity of the application or any patent
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`issued thereon.
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`Q~Qo~aocg
`Date
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`Jam 5 J. Sutor
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`Serial No. 101329.044
`Declaration of James Sutor
`Page 4
`22895211
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`Infopia Ex. 1012 pg. 5
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`Feb-Zl-UB 01:28pm
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`From-PATTCIN BOGGS LLP
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`49338949239
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`T-l49
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`P.l4/17
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`F450
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`James J. Sutor
`287 Meander Way
`Greenwood, Indiana 46142-8537
`317-888-4678 home
`317-865-3568 fax
`317—445—5926 mobile
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`‘
`
`Polymer Technology Systems, Indianapolis, IN
`Senior Scientist
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`'
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`2002 - 2006
`i
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`1998 — 2002
`Seradyn, Inc; an Apogent Company, Indianapolis, IN
`1990 - 1998
`Seradyn, 1110., Division ofMitsubishi, Indianapolis, IN
`SeniOr Research Scientist - reporting to the President -— responsible for the research and development of
`all monodispersed micrOSpheree made by Seindyn
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`‘
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`1974 — 1990
`'
`Reilly Industries
`Product Manager Chemical Specialties — Responsible fer production yields and throughput of the
`processes within the Chemical Specialties Group
`Unit Manager — reporting to the Manager of the Chemical Specialties Groups Developed control
`strategies for and superViSed the operation of a fully automated batch sequence controlled plant.
`Research Chemist
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`1973 — 1974
`American Monitor Corporation, Indianapolis. IN
`Production Chemist -— Responsible for the large scale isolation of enzymes for use in clinical diagnostic
`tesr kits.
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`Patents
`US 4,386,209
`US 5,003,069
`EP 0 098 684
`US 5,648,124
`W0 9,637,313
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`MeGill; Charles K.; Sutor; James J., Chiohibabiri Reaction
`McGill; Charles K.; Sutor; James J., Chichibabin Reaction
`McGill; Charles K; Sutor. James J., Chichibabin Reaction
`Sutor; James J., Process for Preparing Magnetically Responsive Micropatticles
`Sutor; James J., Magnetically Responsive Micropanieles and Process for their
`Production
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`Publications
`Griffin; C.; Sutor; 1.; Shun; B., Microparticle Reagent Optimization, Semdyn, Inc, indianapolis, Ind
`Owen; R., Snell; Bo Lowe; M., Sutor; J., Shull; B., Friedman; 11., The Detection of Microspheres
`Centaining Gadolinium Via Magnetic Resonance Imaging, Journal of Investigative Medicine, 511. 2, 59a
`(1999)
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`.
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`Education
`BS. Chemistry 1972
`Graduate Study 1973
`
`Continuing Education
`ACS
`AICHe
`‘ Cmr for me Advmt
`Lehigh University
`Fisher Controls
`Hobbs
`McgraW—I-fill
`PSI
`SkillPath
`Yoksgawa
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`Rose-Holman Institute of Technology
`Eastern Illinois University
`
`Computer Applications in Chemistry
`Fundamentals of Electrochemical Engineering
`Statistical Process Control
`Advances in Emulsion Polymerization and Latex Technology
`Provox Distributed Controls System
`Time-Poiver Management-
`Catalyst and Catalyst Technology
`Effective Process Plant Supervision
`Managing Multiple Projects, Priorities, and Deadlines
`Yewpack Distributed Control System
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`EXHIBIT A
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`Infopia Ex. 1012 pg. 6
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