`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO Box 1450
`Alexandria, Virginia 22313-1450
`w‘ww.usplo.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`1 1/232,876
`
`09/23/2005
`
`Takenari Itou
`
`027550-162
`
`9508
`
`06/02/2009
`7590
`21839
`BUCHANAN, INGERSOLLMOONEY pc
`POST OFFICE BOX 1404
`ALEXANDRIA, VA 22313-1404
`
`KOIIARSKI, CHRISTOPHER
`AR'l' UNIT
`PAPER N UMBER
`
`3763
`
`NOTIFIC ATION DATE
`
`DELIVERY MODE
`
`06/02/2009
`
`ELECTROVIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated ”Notification Date" to the
`following e-mail address(es):
`
`ADlPFDD (51? bipc.c0m
`
`PTOL-90A (Rev. 04/07)
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`Page 1
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`Medtronic Exhibit 1021
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`Page 1
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`Medtronic Exhibit 1021
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`

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`
`
`Application No.
`
`Applicant(s)
`
`ITOU ET AL.
`11/232,876
`
`
`Art Unit
`Examiner
`Office Action Summary
`
`CHRISTOPHER D. KOHARSKI 3763
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER FROM THE MAILING DATE OF THIS COMMUNICATION
`Extensions of time may be available under the provisions of 37 CFR 1. 136(a).
`In no event however may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will. by statute. cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed. may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
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`1). Responsive to communication(s) filed on 08 April 2009.
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`2a)I:I This action is FINAL.
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`2b)IZ This action is non-final.
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`3)I:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4). Claim(s) 1-15 is/are pending in the application.
`
`4a) Of the above Claim(s) fl is/are withdrawn from consideration.
`
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`5)I:I Claim(s)
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`is/are allowed.
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`6). Claim(s) M is/are rejected.
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`7)I:I Claim(s) _ is/are objected to.
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`8)I:I Claim(s) _ are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)I:I The specification is objected to by the Examiner.
`
`1mm The drawing(s) filed on 23 September 2005 is/are: mg accepted or b)I:I objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
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`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)XI Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`
`a)IZ All
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`b)I:I Some * c)I:I None of:
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`1.I:I Certified copies of the priority documents have been received.
`
`2.I:I Certified copies of the priority documents have been received in Application No.
`
`
`
`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`
`
`4) I] Interview Summary (PTO-413)
`1) E Notice of References Cited (PTO-892)
`Paper N0(S)/M3” Date. _
`2) I] Notice of Draftsperson’s Patent Drawing Review (PTO-948)
`5) I:I Notlce 0f Informal Patent Appllcatlon
`3) IZI Information Disclosure Statement(s) (PTO/SB/08)
`
`
`Paper N0(S)/Mai| Date 9/23/05 3/14/06 10/11/07.
`6) D Other: _
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20090504
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`Page 2
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`Medtronic Exhibit 1021
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`Page 2
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`Medtronic Exhibit 1021
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`Application/Control Number: 11/232,876
`Art Unit: 3763
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`Page 2
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`DETAILED ACTION
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`Election/Restrictions
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`Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b),
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`as being drawn to a nonelected group (group I selected), there being no allowable
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`generic or linking claim. Applicant timely traversed the restriction (election) requirement
`
`in the reply filed on 4/08/2009.
`
`Applicant's election with traverse of the election in the reply filed on 4/08/2009 is
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`acknowledged. The traversal is on the ground(s) that the additional group is not search
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`burden. This is not found persuasive because the additional search scope ofgroup ll
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`encompasses several addition classes specific to blood vessel insertion with a catheter
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`which encompasses thousands of addition patents.
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`The requirement is still deemed proper and is therefore made FINAL.
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`Acknowledgements
`
`The Examiner acknowledges the reply filed 4/08/2009 in which claims 1-15 are
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`pending for examination in this application with claim 15 withdrawn from a previous
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`election restriction.
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`Information Disclosure Statement
`
`The information disclosure statements (IDS) that were submitted on 9/23/2005,
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`3/14/2006, and 10/11/2007 are in compliance with the provisions of 37 CFR 1.97.
`
`Accordingly, the examiner is considering the information disclosure statements.
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`Page 3
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`Application/Control Number: 11/232,876
`Art Unit: 3763
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`Page 3
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`Claim Rejections - 35 USC § 102
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless —
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in public
`use or on sale in this country, more than one year prior to the date ofapplication for patent in the United
`States.
`
`Claims 1 and 7-12 are rejected under 35 U.S.C. 102(b) as being anticipated by
`
`Adams et al. (USPN5,385,562). Adams et al. discloses a guide catheter system for an
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`angioplasty balloon catheter.
`
`Regarding claims 1 and 7-12, Adams et al. discloses an catheter capable of
`
`being an intravascular foreign matter suction assembly (Figure 2, 14) for sucking foreign
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`matter existing in a blood vessel, comprising: a guiding catheter (12) including a distal
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`end and a proximal end and forming a lumen (27) extending from the distal end to the
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`proximal end, the guiding catheter (12) configured to be inserted into a blood vessel
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`until a position on proximal side of a target location in the blood vessel is reached; and a
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`suction catheter (32) comprising a tubular portion provided on a distal side of the
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`suction catheter with an obliquely cut shape (distal tip near 36), the tubular portion
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`including a distal tube end and a proximal tube end, and a solid wire portion (34)
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`provided at the proximal tube end of said tubular portion and having a distal end
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`embedded in a wall (portion of 32) which forms said tubular portion, and wherein said
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`suction catheter (32) is configured to be inserted in said lumen of said guiding catheter
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`(12) and said tubular portion is configured to project outwardly beyond the distal end of
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`said guiding catheter (section near 33) for removing foreign matter existing at the target
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`Application/Control Number: 11/232,876
`Art Unit: 3763
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`Page 4
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`location in the blood vessel. Adams et al. further discloses a distal end protective
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`catheter (18), wherein the suction catheter (32) having a radiopaque marker (41, 42, 43)
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`in a vicinity of the proximal tube end of said tubular portion, wherein said guiding
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`catheter has a radiopaque (41) marker in a vicinity of the distal tube end of said tubular
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`portion, wherein an outer surface of said tubular portion of said suction catheter has a
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`lubricative coating (col 4, In 55-67), and wherein said tubular portion of said suction
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`catheter is more flexible than the distal end of said guiding catheter (cols 4-5, Figure 2).
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 US. 1, 148
`
`USPQ 459 (1966), that are applied for establishing a background for determining
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`obviousness under 35 U.S.C. 103(a) are summarized as follows:
`
`99°F?
`
`Determining the scope and contents of the prior art.
`Ascertaining the differences between the prior art and the claims at issue.
`Resolving the level of ordinary skill in the pertinent art.
`Considering objective evidence present in the application indicating
`obviousness or nonobviousness.
`
`Claims 3—5 are rejected under 35 U.S.C 103(a) as being unpatentable over
`
`Adams et al. (USPN5,385,562) in view of Bagaoisan et al. (USPN6,849,068). Adams et
`
`al. meets the claim limitations as described above except for the source of negative
`
`pressure.
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`Application/Control Number: 11/232,876
`Art Unit: 3763
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`Page 5
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`However, Bagaoisan et al. teaches an aspiration catheter.
`
`Regarding claims 3-5, Bagaoisan et al. teaches an aspiration catheter (10, Figure
`
`)with a suction lumen that has a source of negative pressure (col 7, In 35—55) attached
`
`to a branched connector (14).
`
`At the time of the invention, it would have been obvious to add a source of
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`negative pressure to the device of Adams et al. in order to suction out potentially
`
`harmful emboli created during an angioplasty procedure. The references are analogous
`
`in the art and with the instant invention; therefore, a combination is proper. Therefore,
`
`one skilled in the art would have combined the teachings in the references in light of the
`
`disclosure of Bagaoisan et al. (cols 1-2).
`
`Claim Rejections - 35 USC § 103
`
`Claims 13-14 are rejected under 35 U.S.C 103(a) as being unpatentable over
`
`Adams et al. (USPN5,385,562) in view of Arney (USPN5,226,888). Adams et al. meets
`
`the claim limitations as described above except for the protective catheter having a wire
`
`and an inner guiding surface.
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`However, Arney teaches a coil perfusion balloon catheter system.
`
`Regarding claims 13-14, Arney teaches distal end protective catheter (26, Figure
`
`3 with a solid proximal wire portion (32a) wherein the catheter is configured to guide and
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`protect another catheter (18) against an inner surface (of member 46).
`
`At the time of the invention, it would have been obvious to substitute the distal
`
`catheter of Adams et al. with the distal catheter of Arney in order to perform angioplasty
`
`and maintain perfusion through the patient. The references are analogous in the art
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`Application/Control Number: 11/232,876
`Art Unit: 3763
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`Page 6
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`and with the instant invention; therefore, a combination is proper. Therefore, one skilled
`
`in the art would have combined the teachings in the references in light of the disclosure
`
`of Arney (cols 1—2).
`
`Claim Rejections - 35 USC § 103
`
`Claims 2 and 6 are rejected under 35 U.S.C 103(a) as being unpatentable over
`
`Adams et al. (USPN5,385,562). Adams et al. meets the claim limitations as described
`
`above except for the specific guiding/suction catheter lengths and the specific
`
`guiding/suction catheter diameters.
`
`Regarding claims 2 and 6, it would have been obvious to one having ordinary
`
`skill in the art at the time the invention was made to the system of Adams with the
`
`dimension as claimed by Applicant since it well known in the medical arts to change the
`
`shape and size of medicals in order to accommodate different patients and procedures,
`
`and lacking specific criticality it has been held that where the general conditions of a
`
`claim are disclosed in the prior art, discovering the optimum or workable ranges
`
`involves only routine skill in the art.
`
`In re Aller, 105 USPQ 233 (CCPA 1955).
`
`Conclusion
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`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Christopher D. Koharski whose telephone number is
`
`571-272—7230. The examiner can normally be reached on 5:30am to 2:00pm EST.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Nick Lucchesi can be reached on 571-272-4977. The fax phone number for
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`the organization where this application or proceeding is assigned is 571—273—8300.
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`Application/Control Number: 11/232,876
`Art Unit: 3763
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`Page 7
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`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`Date: 5/4/2009
`
`/Christopher D Koharski/
`Examiner, Art Unit 3763
`
`/Nicholas D Lucchesi/
`
`Supervisory Patent Examiner, Art Unit 3763
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`Page 8
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