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`PATENT
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`In re application of:
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`JAMES E. JERVIS
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`Examiner: Justine Yu
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`Serial No.: 08/483,291
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`Filed: June 7, 1995
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`For: MEDICAL DEVICES
`INCORPORA TING SIM ALLOY
`ELEMENTS
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`Group Art Unit: 3301
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`RESPONSE
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`BOXAF
`Assistant Commissioner for Patents
`Washington, D. C. 20231
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`Sir:
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`V"' The following remarks are submitted in response to the final Office Action, Paper Number
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`11, mailed September 18, 1997. Additional documents accompanying this response include the
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`following: (1) Declaration of Dr. Lee Middleman under 37 C.F.R. §1.132; (2) a copy of U.S. Patent
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`No. 5,597,378, to Jervis, entitled "Medical Devices Incorporating SIM Alloy Elements"; (3) a
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`Petition for a Three;.Month Extension of Time under 37 C.F.R §1.136(a); (4) a Conditional Notice
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`of Appeal; and (5) an Associate Power of Attorney giving the undersigned authority to prosecute the
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`subject application.
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`Edwards Exhibit 1017, p. 1
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`PATENT
`Attorney Docket Number 9438-1
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`STATUS OF THE CLAIMS
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`REMARKS
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`Claims 21,23, and 25-46 are presently pending in the subject application. Reconsideration
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`and reexamination of these claims is respectfully requested.
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`CLAIM REJECTIONS
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`Claims 21,23, 25, and 26-46 were rejected under 35 U.S.C. §l03(a), as being unpatentable
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`over US. Patent No. 4,512,338 to Balko et al. ("Balko") in view of Seader Encyclopedia of Chemical
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`Technology publication ("Seader"), and U.S. Patent No. 4,485,805 to Foster, Jr. ("Foster"). Claims
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`21 and 23 were rejected under the judicially created doctrine of obviousness-type double patenting,
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`as being unpatentable over claims 1 and 2 of US. PatentNo. 5,231,989 to Middleman et al. ("the
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`'989 patent").
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`In addition, Claims 21 and 23 were rejected under 35 US.C. §102(e), as being
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`.anticipated by, or in the alternative, under 35 US.c. §103(a), as being obvious over US. Patent No.
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`5,231,989 to Middleman et al.
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`Applicant respectfully traverses these rejections for the following reasons and for reasons
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`supported by the accompanying expert declarationofDr. Lee Middleman under 37 C.F.R. §1.132
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`(''Middleman Decl."). Evidence in the form ofafIidavits or declarations submitted under 37 C.F.R.
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`§1.132 must be considered by the Examiner, if timely submitted. See M.P.E.P. §716.01. The
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`Middleman Declaration submitted herewith is timely, as it is being submitted with a first response
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`after final rejection for the purpose of overcoming a new ground of rejection made in the final
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`rejection. See M.P.E.P. §716.01.
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`Edwards Exhibit 1017, p. 2
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`PATENT
`Attorney Docket Number 9438-1
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`In view of the reasons discussed below and the accompanying declaration, Applicant
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`respectfully requests that the rejections of claims 21, 23, and 25-46 be withdrawn and that these
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`claims be allowed.
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`.
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`THE PRESENT INVENTION
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`The present invention is directed to a species of a very basic improvement in medical devices.
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`Prior to the present invention, shape memory alloys have been known to be used in medical devices.
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`The difficulty with shape memory alloys is that to get a change in shape, one of three techniques
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`needed to be used: (a) keep the device cold until it is to be used; (b) externally heat the'device for use;
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`or @rely on heating from body warmth so that the device would change its shape.
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`All of these alternatives have significant disadvantages, including lack of reproduceability,
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`difficulty of use in the operating room, additional steps in use and the length of time required to have
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`the device warm up to change shape. It is well known to one skilled in the art that the longer a
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`patient is on the operating table, the greater the chance of complications that may result from an
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`operation.
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`Applicant's present invention is a fundamental invention that uses stress-induced martensite
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`material in place of conventional shape memory alloy material. For this very basic invention,
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`Applicant has already been awarded by the U.S. Patent Office the following U.S. patents: (1) U.S.
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`Patent No. 5,597,378, entitled "Medical Devices Incorporating SIM Alloy Elements"; (2) U.S. Patent
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`No.5, 190,546, entitled "Medical Devices Incorporating SIM Alloy Elements"; (3) U. S. Patent No.
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`5,067,957, entitled "Method of Inserting Medical Devices Incorporating SIM Alloy Elements"; and,
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`3
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`Edwards Exhibit 1017, p. 3
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`PATENT
`Attorney Docket Number 9438-1
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`(4) U.S. Patent No. 4,665,906, entitled "Medical Devices Incorporating SIM Alloy Elements." At
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`least some of these patents have claims broader than claims presented in the present application.
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`In particular, the present invention is directed to a species of Applicant's basic invention,
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`namely, a medical device for insertion into a mammalian body, preferably in the form of a stent. The
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`device comprises a hollow placement device, a memory alloy element formed at least partly from
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`pseudoelastic shape-memory alloy, and a guide wire. The alloy displays reversible stress-induced
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`martensite (SIM) at about body temperature such· that it has a stress-induced martensitic state and
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`an austenitic state. The memory alloy element has a deformed shape when the alloy is in its stress-
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`induced martensitic state, and a different unstressed shape when the alloy is in its austenitic state. The
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`memory alloy element is positioned within the hollow placement device, and the placement device
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`is guidable by the guide wire. The hollow placement device stresses the memory alloy element at a
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`temperature greater than the ~ (temperature at which the alloy starts to revert back to austenite) of
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`the alloy so that the memory alloy element is in its deformed shape. The memory alloy element can
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`be extruded from the hollow placement device by the guide wire at a temperature greater than the ~
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`of the alloy to transform at least a portion of the·alloy from its stress-induced martensitic state, so that
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`the memory alloy element transforms from its deformed shape to its unstressed shape. The alloy is
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`selected so that the transformation can occur without any change in temperature of the placement
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`device or the memory alloy element.
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`The medical device incorporating SIM alloy elements of the present invention provides
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`significant advantages over known medical devices, including those disclosed in the cited references.
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`The present invention discloses a memory alloy formed at least partly from a pseudoelastic shape
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`memory alloy that displays reversible stress-induced martensite at about body temperature, and . the
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`4
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`Edwards Exhibit 1017, p. 4
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`PATENT
`Attorney Docket Number 9438-1
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`present invention requires no temperature change to effect a change in state of the shape memory
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`alloy. Thus, none of the disadvantages associated with heating the shape memory alloy with body
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`heat alone or with external heating sources exist with the present invention. In addition, the simplicity
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`of the present invention, where the d~vice attains its desired configuration without the requirement
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`of any external heating or cooling, provides predictability and ease of operation.
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`REJECTION OVER BALKO. SEADER. and FOSTER
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`Applicant initially submits that the cited Balko reference was previously before the Patent
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`Office and claims broader than those presented herewith were allowed by the Patent Office, i.e., in
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`U. S. Patent No. 5,597,378, to Jervis, entitled "Medical Devices Incorporating SIM Alloy Elements,"
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`the parent case ofthe subject application. A copy of U.S. Patent No. 5,597,378 is enclosed herewith.
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`The claims presented herein are due to a species election requirement in the parent application, and
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`Applicant submits that if the generic invention is nonobvious, then the species must similarly be
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`nonobvious. Moreover, the Examiner relies on the secondary references of Seader for teaching that
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`nitinol has pseudoelastic properties and Foster for teaching a stylet (guide wire). Along with Balko,
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`teachings that nitinol has pseudo~lastic properties and teachings of a guide wire were also already
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`considered by the U.S. Patent Office in allowing r.l~sJ'roader-than_those_Ptesented herein.
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`The Office Action sets forth at page 2 that Balko shows a nitinol (SMA) wire fonned graft
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`structure 22 which is placed inside the sheath head 50 (hollow placement device) and that Balko lacks
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`the description of the nitinol which is a pseudoelastic SMA, but that the teaching on page 733 of
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`Seader discloses that the nitinol has the superelastic (pseudoelastic) behavior, and therefore, it is
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`obvious that the nitinol has the pseudoelastic properties. In addition, the Office Action sets forth at
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`5
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`Edwards Exhibit 1017, p. 5
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`PATENT
`Attorney Docket Number 9438-1
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`page 3 -that Balko differs from Applicant's invention in that Balko lacks a guide wire, but that it is
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`well known in the art that a guide wire is used for guiding a catheter into the body, and that Foster
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`shows a stylet 16 (guide wire), and that it would have been obvious to one of ordinary skill in the art
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`at the time the invention was made to provide Balko's device with a guide wire in order to guide the
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`catheter into a desired location.
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`.-----------
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`Applicant submits that a person skilled in the art would not have been motivated at the time
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`of the invention to combine_Balko,-Seader,_and--Foster_in_the-.way suggested by the -Examiner_
`------- --------------
`Moreover, it would not be obvious to substitute the nitinol of Seader or the guide wire of Foster to
`--.......---~-.. ~ ~----~.- -..-.. _- ........ -----... .
`. ~-------... --------- --~~
`arrive at Applicant's claimed invention because there is no suggestion, teaching, or motivation in
`...... -~ .-, ... -->'--~.--'.~ -.... ~­
`- ----~-----~- -'-"-. - ._ .. , -.
`-__ -c----
`... ----_ .. _---- .. -.. -.
`Balko, Seader, or Foster to combin~th~_~_~_~~.: at AEplicants' claimed invention .
`. --- ---..... -... -.--~
`Balko does not disclose a memory alloy formed at least partly from a pseudoelastic shape
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`- - - ' .
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`-)
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`,
`, "\ -
`\
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`memory alloy that displays reversible stress-induced martensite at about body temperature
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`(Middleman Decl., ~11). Lee Middleman, an expert in the field of stress-induced martensite (SIM)
`.-----------------------.-----~.-----.---'"----
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`all.9yelements, provides, "1 find no suggestion or teaching in Balko, Seader, or Foster to makethe
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`nitinol disclosed in Balko from a stress-induced martensite alloy" (Middleman Decl., ~11)_ Nitinol
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`-
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`... --
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`can only exhibit properties of a SIM material if it undergoes a treatment process to make it exhibit
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`the pr<?perties of a SIM material. Such a treatment process is time consuming and expensive and is
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`not suggested or taught by Balko. Moreover, even if the nitinol in Balko were to exhibit SIM
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`properties, there is no suggestion or teaching in the references that the SIM phenomenon is to occur
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`in the temperature range around the body temperature of a mammal (typically 35 degrees Celsius to
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`... . . . - - - - . ____ .. _ ... _____ • __ ...... - - - .... - - -... - . -...... ,....,...,.._ .......... r
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`40 degrees Celsius) (Middleman Decl., ~12). No such teaching is provided in Balko or the other cited
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`references.
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`I:\Mcdtronic, Irn:\9438-1 IFinalAMDT '{)31898_ wpd
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`Edwards Exhibit 1017, p. 6
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`PATENT
`Attorney Docket Number 9438-1
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`In addition, Balko requires a temperature change to effect a change in state utilizing SMA
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`materials, wherein such temperature change results from body heating alone, or body heating in
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`combination with external heating (see Balko, col. 5, lines 57-67). There is no suggestion in Balko
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`or' the other references to use nitinol without a t~mperature change, whether it be by heating the
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`nitinol with body heat alone, or whether it be by heating the nitinol with body heat and an external
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`heating source (Middleman Decl., ~13).·
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`There are also significant advantages provided by the present invention that are not disclosed,
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`suggested, or taught by any of the cited references. The present invention does not require any
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`external heating or cooling, is simple to operate, and is cost effective. Moreover, Lee Middleman
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`discusses the disadvantages and problems of Balko which are not found in the claimed invention, as
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`follows:
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`... For the Balko device, a doctor has to rely on heating the nitinol for it to work. If the doctor
`relies solely on body heating, this slows up the surgical procedure. Needless to say, anything
`that slows up a medical procedure is undesirable in that the chance for infection and the
`chance for adverse patient reactions increase as the length of a medical procedure increases.
`Also, a device that relies on body heating to change shape exhibits inconsistent performance
`because of the dependence on heating by the body, which rate of heating can differ from
`patient-to-patient and from operating room to operating room.
`I know from personal
`experience with sutures made of SMA materials that inconsistent heating made the sutures
`difficult to use in an operating room. If the doctor has to rely on heating the nitinol by means
`of an external heating source, an additional step is added to the procedure and the possibility .
`of overheating and injury is increased. If electric' heating is used, there is a potential for
`electrical shock or an electric bum to the patient. In spite of these disadvantages of the Balko
`procedure, there is no suggestion in Balko or the other references of a medical device where
`transformation can occur without a change in temperature.
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`(Middleman Decl., ~14).
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`Thus, in view of the foregoing, Applicant's claimed invention is not obvious over the cited
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`references and is not shown, suggested, or taught by the cited references. Moreover, the present
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`l:lMedtronic, Inc\9438·I\Fina1AMDT-031898.wpd
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`7
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`Edwards Exhibit 1017, p. 7
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`PATENT
`Attorney Docket Number 9438-1
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`claims are the result of a species election requirement in the parent application, and thus, Applicant
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`submits, if the generic invention is nonobvious, then the species likewise must be nonobvious.
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`Claims 31-33
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`In addition to the reasons set forth above why the claimed invention is not obvious over the
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`cited references, there are features in various of the narrower claims for which. Aee!~cant ~ubmits that
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`no prima facie case of obviousness has been made. With respect to claims 31, 32, and 33, the
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`invention is further limited in that removal of a restraining means or restraint from the stent
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`transforms at least a portion of the alloy from its stress-induced martensitic state so that the stent
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`transforms from its deformed relatively straightened shape towards its unstressed relatively coiled
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`shape, without any change in temperature of the restraining means or the stent being required for the
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`transformation of the alloy. These limitations are neither taught nor suggested by any of the cited
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`references, either alone or in combination. In particular, Applicant submits that Balko is deficient in
`-' -------.----
`that if the wire alloy coil of Balko is warmed up to reach body temperature as it is inserted, it can
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`prematurely expand before it is removed from the sheath, and interfere with or hinder removal. Thus,
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`Applicant submits that these claim limitations further distinguish Applicant's invention over the cited
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`references.
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`Further, with respect to the dependent claims, Applicant submits that since the independent
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`claims are nonobvious and patentably distinguishable over the cited references as discussed above,
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`it follows that the dependent claims are also nonobvious and patentably distinguishable over the cited
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`references.
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`8
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`Edwards Exhibit 1017, p. 8
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`PATENT
`Attorney Docket Number 9438·1
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`Accordingly, Applicant respectfully requests that the rejection of claims 21, 23, 25, and 2646,
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`under 35 U.S.C.§103(a), as being unpatentable over the cited references, be withdrawn.
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`DOUBLE PATENTING REJECTION
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`Claims 21 and 23 have been rejected under the doctrine of obviousness-type double patenting
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`as being unpatentable over claims 1-2 of U.S. Patent No. 5,231,989 to Middleman ("the '989
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`patent"). In particular, the Office Action sets forth at page 4 that the recitation of "placement device"
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`in claim 21 is an obvious variation over the "elongated tube" from claim 1 of the '989 patent; that the
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`recitation of "memory alloy element" of claim 21 and "stent" of claim 23 are obvious variations over
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`the "elastic member" of claims 1-2 of the '989 patent; and that the recitation of "guide wire" in claim
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`21 is an obvious variation over the "straightening means" of claims 1-2 of the '989 patent.
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`Applicant respectfully· traverses this obviousness-type double patenting rejection for the
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`following reasons and for reasons supported by the accompanying Middleman Declaration.
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`Applicant submits that claims 21 and 23 are not obvious over claims 1-2 of the '989 patent
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`because the device of the '989 patent functions very differently than the device claimed in claims 21
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`and 23 of the subject application (Middleman Decl., ~17). The device in the '989 patent uses an
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`elastic member made of SIM material to bend or unbend a bendable elongated tube ("transforming
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`the elastic member from one shape to another for correspondingly bending or unbending the distal
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`segment of the (elongate) tube" (claim 1 (c» (Middleman Decl., ~17). In contrast, the device claimed
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`in the subject application uses a non-ben~able 12~pI~ment device to bend and unbend a memory
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`'.
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`----.~----
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`alloy made ofa SIM material ("the hollow placement device stressing the memory alloy element. .. so
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`that the memory alloy element is in its deformed shape" (claim 21) (Middleman Decl., ~17). Thus,
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`--
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`9
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`Edwards Exhibit 1017, p. 9
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`PATENT
`Attorney Docket Number 9438-1
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`the concept of the invention disclosed in the '989 patent and the concept of the invention claimed in
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`the subject application, are diametrically opposed (Middleman Decl., ~17).
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`Applicant respectfully requests the Examiner to direct her attention to the drawings attached
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`as Exhibit B to the Middleman Declaration. These drawings clearly show the differences between
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`the device of claims 1 and 2 of the '989 patent and the device of claims 21 and 23 of the subject
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`application. Thus, Applicant submits that claims 21 and 23 of the subject application are not obvious
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`over claims 1 and 2 of the '989 patent (see Middleman Decl., ~19).
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`Applicant further submits that the double-patenting rejection is improper because the '989
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`patent was already previously found to be nonobVious by the Patent Office over the earlier Jervis
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`Patent No. 4,665,906, and· the present Jervis application is a continuation of Jervis Patent No.
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`4,665,906. Middleman made his invention long after Jervis made his invention, and Jervis Patent No.
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`4,665,906 is even cited as prior art on the cover page of the '989 patent (see U.S. Patent No.
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`5,231,989 and Middleman Decl., ~17). Accordingly, since the claims of the '989 patent are not
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`obvious in view of claims 21 and 23 of the present Jervis invention, Applicant respectfully requests
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`that the obviousness-type double patenting rejection of claims 21 and 23 in view of the '989 patent
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`be withdrawn.
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`REJECTION UNDER 35 U.S.C. §t02(e)
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`Applicant submits that U.S. Patent No. 5,231,989 to Middleman is not prior art under 35
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`U. S. C. § 1 02( e) to the subject application, as the subject application claims priority from application
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`serial number 06/541,852, having a filing date of October 14, 1983 (abandoned in favor of application
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`serial number 06/865,703, now U.S. Patent No. 4,665,906). The filing date of the '989 patent is
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`Edwards Exhibit 1017, p. 10
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`PATENT
`Attorney Docket Number 9438-1
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`February 15, 1991. Since all of the claims submitted under examination are supported by the
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`specification as originally submitted and contain no new matter, they are all entitled to the priority
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`date of October 14, 1983. Accordingly, Applicant respectfully requests that the rejection of claims
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`21 and 23 under 35 U.S.C. §102(e) in view of the '989 patent be withdrawn ..
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`CONCLUSION
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`In view of the foregoing remarks and in view of the accompanying declaration, Applicant
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`submits that the claim rejections are overcome and that the subject application is in condition for
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`allowance, and such action is respectfully requested.
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`Respectfully submitted,
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`SHELDON & MAK.
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`By:
`
`KCV'Um G p~
`Karin E. Peterka
`Reg. No. 35,976
`
`225 South Lake Avenue
`9th Floor
`Pasadena, California 91101
`Phone:
`(626) 796-4000
`Facsimile: (626) 795-6321
`
`EXPRESS MAIL, maiHng label no. EM262828897US
`Date of Deposit: March 18. 1998
`
`I hereby certifY that this paper is being deposited with the United
`States Postal Service "Express Mail Post Office to Addressee" under
`37 C.F.R § 1.10 on the date indicated above and is addressed to:
`Box AF, Assistant Commissioner for Patents, Washington,
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`oc~~ ~-~
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`sahdra Spencer
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`Edwards Exhibit 1017, p. 11