UNITED STA TES p A TENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria., Virginia 22313-1450
`www .uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/984,273
`
`12/30/2015
`
`Howard C. Root
`
`2005.86USREI7
`
`5700
`
`07/20/2017
`7590
`24113
`PATTERSON THUENTE PEDERSEN, P.A.
`80 SOUTH 8TH STREET
`4800 IDS CENTER
`MINNEAPOLIS, MN 55402-2100
`
`EXAMINER
`
`WILLIAMS, CATHERINE SERKE
`
`ART UNIT
`
`PAPER NUMBER
`
`3993
`
`MAIL DATE
`
`DELIVERY MODE
`
`07/20/2017
`
`PAPER
`
`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.
`
`PTOL-90A (Rev. 04/07)
`
`Page 1
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`Medtronic Exhibit 1506
`
`

`

`Application No.
`14/984,273
`
`Applicant(s)
`ROOT ET AL.
`
`Office Action Summary
`
`AIA (First Inventor to File)
`Status
`No
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`Examiner
`CATHERINE S. WILLIAMS
`
`Art Unit
`3993
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. MONTHS 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
`1 )~ Responsive to communication(s) filed on 6/12/17.
`0 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .
`2a)0 This action is FINAL.
`2b)~ This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ; the restriction requirement and election have been incorporated into this action.
`4)0 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 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)~ Claim(s) 25-45 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)~ Claim(s) 25-45 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http:ilwww.uspto.gov/patents/init events/pph/index.isp or send an inquiry to PPHfeedback(wuspto.aov.
`
`Application Papers
`10)0 The specification is objected to by the Examiner.
`11 )0 The drawing(s) filed on __ is/are: a)O accepted or b)O 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).
`
`Priority under 35 U.S.C. § 119
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)O All b)O Some** c)O None of the:
`Certified copies of the priority documents have been received.
`1.0
`Certified copies of the priority documents have been received in Application No. __ .
`2.0
`Copies of the certified copies of the priority documents have been received in this National Stage
`3.0
`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)
`1) ~ Notice of References Cited (PT0-892)
`
`2) ~ Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date 6/12117· 1124/17.
`
`3) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20170615
`
`Page 2
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`Medtronic Exhibit 1506
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`

`

`Application/Control Number: 14/984,273
`Art Unit: 3993
`
`Page 2
`
`The present application is being examined under the pre-AIA first to invent provisions. 1
`
`Reissue Applications
`
`For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251
`
`and 37 CPR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012.
`
`Where specifically designated, these are "pre-AIA" provisions.
`
`For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C.
`
`251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
`
`Applicant is reminded of the continuing obligation under 37 CPR 1.178(b ), to timely
`
`apprise the Office of any prior or concurrent proceeding in which Patent No. 8,292,850 ("the
`
`'850 patent") is or was involved. These proceedings would include interferences, reissues,
`
`reexaminations, and litigation.
`
`Applicant is further reminded of the continuing obligation under 37 CPR 1.56, to timely
`
`apprise the Office of any information which is material to patentability of the claims under
`
`consideration in this reissue application.
`
`These obligations rest with each individual associated with the filing and prosecution of
`
`this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
`
`1 It is noted that while the examination of the current reissue application falls under the pre-AIA
`first to invent provisions due to the filing date of US Patent No. 8,292,850; the application for
`reissue filing date is after September 16, 2012 and therefore is subject to the reissue rule changes
`enacted under the Leahy-Smith American Invents Act (AIA), see Federal Register, Vol. 77, No.
`157, pg. 48820, August 16, 2012.
`
`Page 3
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`Medtronic Exhibit 1506
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`

`

`Application/Control Number: 14/984,273
`Art Unit: 3993
`
`Page 3
`
`Consent of Assignee
`
`A proper Consent of Assignee is missing from the file. Applicant has filed a Declaration
`
`by the Assignee to accompany the Declaration by the Inventor; however, a Declaration by the
`
`Assignee does not fulfill the requirements of written consent of all the assignees currently
`
`owning an undivided interest in the patent. It is highly recommended that applicant use form
`
`PTO/ AIA/53 or at a minimum include language such as:
`
`The XYZ Corporation, assignee of US Pat No. 9,999,999, consents to the filing of
`reissue application No. 99/999,999 for the reissue of US Pat. No. 9,999,999.
`
`Jane Doe
`Vice President
`XYZ Corporation
`
`See MPEP § 1410.02.
`
`Application Data Sheet
`
`The Application Data Sheet ('ADS') must be updated and corrected. The Domestic
`
`Benefit section should reflect the issuance of 14/195,435 as RE46116 and the continuity type of
`
`the instant reissue application to the 14/195,435 application should be denoted as a continuation.
`
`Further, the instant application should be separately listed as a reissue of application #
`
`13/359,059 (Patent# 8,292,850). Correction is required. See MPEP § 601.05(a).
`
`Amendment to the Specification
`
`The Amendment to the Specification filed 12/30/15 is objected to as not including all
`
`current information for the priority applications listed. Specifically, the current issued Reissue
`
`Page 4
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`Medtronic Exhibit 1506
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`

`

`Application/Control Number: 14/984,273
`Art Unit: 3993
`
`Page 4
`
`Patent #s should be included in the Related Applications section of the amendment, i.e.
`
`14/195,435 filed March 3, 2015 now Reissue RE 46116. All applications listed should be
`
`updated to reflect their current status.
`
`Information Disclosure Statement
`
`The Information Disclosure Statements ('IDS') filed 1/24/17 and 6/12/17 have been
`
`entered into the file and all document have been reviewed. Any court proceedings listed on the
`
`IDS forms have been reviewed; however, they are struck through on the IDS forms since they
`
`are not documents that will be printed on the front page of a Reissued Patent.
`
`Recapture
`
`C1airns 25-45 are rejecwd under 35 U.S.C. 251 as being an irnpermissible recapture of
`
`broadened daimed subject matter surrendered in the appLication for the patent upon 'Nhich the
`
`present reissue is based. See Greenliant Systems, lne, et al v. Xiccir LLC, 692 E3d 1261, 103
`
`USPQ2d 1951 (Fed. Cir. 2012); In re Shahrmn 1Hostafazadeh and Joseph 0, Srnith, 643 F.3d
`
`1353. 98 USPQ2d 1639 {Fed. Cir. 2011 ); North Americau Cmuainer, lnc. v. Plastipak
`
`f )ncz,,., ·,1'n ·,
`.• • .... t,c);;, t.,:5~
`
`U
`
`f'IC 41SF' :Scl l :s=ss 7 5 l"''-'1)('12··! 1S4'::. (C'~.-1 C'1'r
`<_
`
`1
`
`.• ,
`
`-..-
`
`,,.._,
`
`_,.._, .... -..-
`
`., 1..
`
`)'.-..'3
`
`L
`
`......... \·CeL"
`
`...,
`
`......... \.
`
`'){)'(ls;·< JJaf"1''" ('t·o1·0• Jnc-i,"Uf1'Cl"'f"'
`
`.....
`
`'1
`
`,
`
`.. r
`
`t,z. v •
`
`.._)
`
`.
`
`~.,
`
`L}t,J
`
`.
`
`!
`
`i-
`
`.:s
`
`Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc v. Stein, Inc., 142
`
`F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); !n re Clement, 131 F.3d 1464, 45 USPQ2d 1161
`
`(Fed. Cir. 1997); Bait Corp. v .. United States. 729 F.2d 1429, 1436. 221 USPQ 289. 295 (Fed.
`
`Cir. 1984), A broadening aspect is present in the reissue which was not present in the
`
`application for patent. The record of the application for the patent shows that the broadening
`
`Page 5
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`Medtronic Exhibit 1506
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`

`

`Application/Control Number: 14/984,273
`Art Unit: 3993
`
`Page 5
`
`aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered
`
`during the prosecution of the parent application, Accordingly, the narrow scope of the claims in
`
`the patent ,,vas not an error ,,vithin the meaning of 35 U.S.C. 25L and the broader scope of claim
`
`subject rnatter surrendered in the applicalion for the patenl cannot be recaptured by the filing of
`
`the pn~sent rejssue application.
`
`Three Step Test for Recapture Analysis
`
`As stated in M.P.E.P. § 1412.02,
`
`In Clement. 131 F.3d at 1468-70, 45 USPQ2d at 1164-65, the Court of Appeals
`for the Federal Circuit set forth a three step test for recapture analysis. In North
`American Container, 415 F3cl at 1349, 75 USPQ2d at 1556, the court restated
`thjs test as follo.;vs:
`
`\Ve apply the recapture rule as a three-step process:
`
`(1) first, we detem1ine whether, and in \:vhat respect, the reissue
`claims are broader in scope than the original patent claims;
`(2) next, vve determine \Vhether lhe broader aspects of the reissue
`claims relate to subject matter surrendered in the original
`prosecution; and
`(3) finally, we determine \Vhelher the reissue claims were
`materially narrmved in other respects, so that the claims may not
`have been enlarged, and hence avoid the recapture rule.
`
`ln North American Container, the court cited Pannu, 258 F3d at 1371, 59
`USPQ2d at 1600; Hester, 142 F3d al 1482-83, 46 llSPQ2d at 1649-50; and
`Clement, 131 F.3d at 1468, 45 USPQ2d at 1164-65 as cases that lead to, and
`explain the language in, the North lunerican Contaiuer recapture test
`
`The following is the step analysis of the jmpermlssj ble recapture of broadened claimed
`
`subject matter smTenderecl in the application for the patent upon 'Nhich the present reissue is
`
`based.
`
`Page 6
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`Medtronic Exhibit 1506
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`

`

`Application/Control Number: 14/984,273
`Art Unit: 3993
`
`Page 6
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`I. The "the standard guide catheter having a continuous lumen extending for a predefined
`
`length" limitation
`
`(1) New independent claims 25 and 38 are broader in scope with respect to the limitation of "the
`
`standard guide catheter having a continuous lumen extending for a predefined length" which is
`
`present in original independent claims 1 and 11 of the '032 patent (a parent to the '850 patent
`
`under reissue examination). This limitation has been removed entirely from new independent
`
`claims 25 and 38. Therefore, the reissue claims are broader in scope than the patented claims.
`
`(2) Does the broadening aspect of the reissued claim relate to surrendered subject matter?
`
`As stated by applicant during the prosecution of application 11/416,629 ("the'629
`
`application) resulting in the '032 patent in their remarks filed 2/22/11 on pages 12-13 in response
`
`to the final office action mailed 12/21/10,
`
`The recitation of the predefined length" in the preamble must be treated as a claim
`limitation.
`
`Plainly, the reference to the "predefined length" is a limitation that limits the
`structure of the "flexible tip portion" of the claim invention. Accordingly, Niazi's
`tip portion 52 cannot satisfy this claim limitation.
`
`Subsequent to these remarks by applicant, the examiner mailed a notice of allowance.
`
`See NOA in the '629 application mailed 8/3/11. The subsequent allowance of the claims leads
`
`Page 7
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`Medtronic Exhibit 1506
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`

`

`Application/Control Number: 14/984,273
`Art Unit: 3993
`
`Page 7
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`one to conclude that applicant's comments regarding the "the standard guide catheter having a
`
`continuous lumen extending for a predefined length" resulted in the allowance of the claims.
`
`3) MPEP § 1412.02 I.B. states "that if the reissue claim(s), are broadened with respect to the
`
`previously surrendered subject matter, then recapture will be present regardless of other
`
`unrelated narrowing limitations." Clearly, step three has been obviated since applicant relied
`
`upon this claim limitation to gain allowance of the claims and the recapture analysis ends here.
`
`II. The "a substantially rigidportion ... more rigid along a longitudinal axis than. the flexible tip
`
`portion" limitation
`
`(1) New independent claims 25 and 38 are broader in scope with respect to the limitation of "a
`
`substantially rigid portion ... more rigid along a longitudinal axis than, the flexible tip portion"
`
`which is present in original independent claims 1 and 11 of the '032 patent (a parent to the '850
`
`patent under reissue examination). This limitation has been removed entirely from new
`
`independent claims 25 and 38. Therefore, the reissue claims are broader in scope than the
`
`patented claims.
`
`(2) Does the broadening aspect of the reissued claim relate to surrendered subject matter?
`
`As stated by applicant during the prosecution of the '629 application in their remarks
`
`filed 2/22/11 on page 13 in response to the final office action mailed 12/21/10,
`
`Independent claims 58 and 67 have been amended to clarify that the intended
`scope of the claims was that the "flexible tip" is less rigid than the "rigid portion"
`
`Page 8
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`Medtronic Exhibit 1506
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`

`

`Application/Control Number: 14/984,273
`Art Unit: 3993
`
`Page 8
`
`by adding the clarifying language that the "rigid portion" is "more rigid along a
`longitudinal axis than, the flexible tip portion.".
`
`Accordingly, as Niazi's distal portion is reinforced and rigid, Niazi cannot satisfy
`this claim limitation.
`
`Subsequent to these remarks by applicant, the examiner mailed a notice of allowance.
`
`See NOA in the '629 application mailed 8/3/11. The subsequent allowance of the claims leads
`
`one to conclude that applicant's comments regarding the "a substantially rigid portion ... more
`
`rigid along a longitudinal axis than, the flexible tip portion" resulted in the allowance of the
`
`claims.
`
`3) MPEP § 1412.02 I.B. states "that if the reissue claim(s), are broadened with respect to the
`
`previously surrendered subject matter, then recapture will be present regardless of other
`
`unrelated narrowing limitations." Clearly, step three has been obviated since applicant relied
`
`upon this claim limitation to gain allowance of the claims and the recapture analysis ends here.
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created doctrine
`
`grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or
`
`improper timewise extension of the "right to exclude" granted by a patent and to prevent possible
`
`harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where
`
`the conflicting claims are not identical, but at least one examined application claim is not
`
`patentably distinct from the reference claim(s) because the examined application claim is either
`
`anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg,
`
`Page 9
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`Medtronic Exhibit 1506
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`

`

`Application/Control Number: 14/984,273
`Art Unit: 3993
`
`Page 9
`
`140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d
`
`2010 (Fed. Cir. 1993); In re Langi, 759 F.2d 887,225 USPQ 645 (Fed. Cir. 1985); In re Van
`
`Ornum, 686 F.2d 937,214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`(CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CPR l.32l(c) or l.32l(d) may
`
`be used to overcome an actual or provisional rejection based on nonstatutory double patenting
`
`provided the reference application or patent either is shown to be commonly owned with the
`
`examined application, or claims an invention made as a result of activities undertaken within the
`
`scope of a joint research agreement. See MPEP § 717 .02 for applications subject to examination
`
`under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP
`
`§§ 706.02(1)(1) - 706.02(1)(3) for applications not subject to examination under the first inventor
`
`to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CPR
`
`l.32l(b).
`
`The USPTO Internet website contains terminal disclaimer forms which may be used.
`
`Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the
`
`form is filed determines what form ( e.g., PTO/SB/25, PTO/SB/26, PTO/ AIA/25, or
`
`PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely
`
`online using web-screens. An eTerminal Disclaimer that meets all requirements is auto(cid:173)
`
`processed and approved immediately upon submission. For more information about eTerminal
`
`Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-1.jsp.
`
`Claims 25-45 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 25-42 of U.S. Patent No. RE45,380. Although the claims at issue are
`
`Page 10
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`Medtronic Exhibit 1506
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`

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`Application/Control Number: 14/984,273
`Art Unit: 3993
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`Page 10
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`not identical, they are not patentably distinct from each other because both the instant reissue
`
`application and RE45,380 claim the particulars of a tip segment, a reinforced segment, a
`
`substantially rigid segment, where these segments define a length greater than the guiding
`
`catheter and also including a side opening.
`
`Claims 25-45 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 25-53 of U.S. Patent No. RE45,760. Although the claims at issue are
`
`not identical, they are not patentably distinct from each other because both the instant reissue
`
`application and RE45,760 claim the particulars of a tip segment, a reinforced segment, a
`
`substantially rigid segment, where these segments define a length greater than the guiding
`
`catheter and also including a side opening.
`
`Claims 25-45 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 25-57 of U.S. Patent No. RE45,776. Although the claims at issue are
`
`not identical, they are not patentably distinct from each other because both the instant reissue
`
`application and RE45,776 claim the particulars of a substantially rigid segment, a tubular
`
`structure, and also including a side opening.
`
`Claims 25-45 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 25-55 of U.S. Patent No. RE46,l 16. Although the claims at issue are
`
`not identical, they are not patentably distinct from each other because both the instant reissue
`
`application and RE46, 116 claim the particulars of a tip segment, a reinforced segment, a
`
`substantially rigid segment, where these segments define a length greater than the guiding
`
`catheter and also including a side opening.
`
`Page 11
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`Medtronic Exhibit 1506
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`

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`Application/Control Number: 14/984,273
`Art Unit: 3993
`
`Page 11
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`Claim Rejections - 35 USC§ 112
`
`The following is a quotation of the first paragraph of 35 U.S.C. l 12(a):
`
`(a) IN GENERAL-The specification shall contain a written description of the invention,
`and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to
`make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor
`of carrying out the invention.
`
`The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the manner and
`process of making and using it, in such full, clear, concise, and exact terms as to enable any person
`skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the
`same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
`
`Claims 25-45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first
`
`paragraph, as failing to comply with the written description requirement. The claim(s) contains
`
`subject matter which was not described in the specification in such a way as to reasonably
`
`convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the
`
`inventor(s), at the time the application was filed, had possession of the claimed invention.
`
`Regarding claim 25, the new claim term "eccentrically positioning" does not have
`
`support in the specification of the '850 patent or the '059 application resulting in the patent.
`
`Applicant points to page 15 lines 1-18 as the pertinent disclosure; however, that description does
`
`not include a teaching of an eccentric or eccentrically positioned rigid segment with respect to
`
`the reinforced segment. Appropriate correction is required.
`
`Regarding claims 26 and 38, the new claim language of "a segment having/defining a
`
`side opening" does not have support in the specification of the '850 patent or the '059 application
`
`resulting in the patent. The '850 patent is very clear that the side opening, i.e. the opening in the
`
`catheter wall made from "first full circumference portion 34, hemicylindrical portion 36 and
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`Page 12
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`Medtronic Exhibit 1506
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`

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`Application/Control Number: 14/984,273
`Art Unit: 3993
`
`Page 12
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`arcuate portion 38" is part of rigid portion 20 and not its own segment apart from rigid portion.
`
`See the '850 patent col. 6, 11. 50-65. Claim 26 further places the newly claimed "segment"
`
`"proximal of the proximal end portion of the reinforced segment." However, the substantially
`
`rigid segment is located proximal of the proximal end portion of the reinforced segment. Claim
`
`38 identifies the segment defining the side opening as a completely different structure from the
`
`rigid portion which is contrary to the '850 patent specification. Appropriate correction is
`
`required.
`
`Regarding claims 30 and 39, the claim language of "providing the substantially rigid
`
`segment and the reinforced segment includes, starting at the distal end portion of the reinforced
`
`segment and moving proximally toward the proximal end portion of the substantially rigid
`
`segment, forming or obtaining at least a first device portion having a first flexural modulus and a
`
`second device portion having a second flexural modulus" this language is not consistent with the
`
`disclosure in the '850 patent. Instead the disclosure states that the first through fourth portions
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`having different flexural modulus values are located from the distal tip to the proximal end of the
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`reinforced segment. See col. 7, 11. 14-30.
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`Claim Rejections - 35 USC § 102
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`The following is a quotation of the appropriate paragraphs of pre-AIA 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 -
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`(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 of application for patent in the
`United States.
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`Page 13
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`Medtronic Exhibit 1506
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`

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`Application/Control Number: 14/984,273
`Art Unit: 3993
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`Page 13
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`Claims 25, 29, 33-34 and 36-37 are rejected under pre-AIA 35 U.S.C. 102(b) as being
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`anticipated by US 5,527,292 to Adams et al. ("Adams").
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`Regarding independent claim 25, Adams discloses a device inserted through a guide
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`catheter (12) that includes a tip segment with a lumen (36), a reinforced segment (32) having a
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`lumen therethrough (tube), including one or more metallic elements covered with a polymer (coil
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`spring with outer coating of plastic), and extending from a proximal end portion to a distal end
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`portion (see fig. 1); the proximal end of the reinforced segment (32) is more rigid than the distal
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`tip since it has an embedded coil spring; a substantially rigid segment (19/(172 hypotube at col.
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`7, 11. 13-21) extending from a proximal end portion to a distal end portion (see fig. 1); the distal
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`end portion of the rigid segment being eccentrically positioned relative to a longitudinal axis of
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`the proximal end portion of the reinforced segment (see fig 1); and the distal and portion of the
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`reinforced segment being coaxially aligned with the proximal end portion of the tip segment (see
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`figs 1-5). The method steps of forming, providing, positioning, and aligning are considered
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`inherently necessary. Adams teaches the structure as claimed and in order to form the disclosed
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`device the method steps would have necessarily been performed. As shown in fig. 1 the distal
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`tip extend distal to the distal end of the guide catheter (12) and the proximal end of rigid segment
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`(19) extends proximal to the proximal end of the guide catheter (12). See figs. 1 and 12.
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`Regarding claims 33-34, the reinforced segment includes a lumen that is about one
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`French smaller than an inner diameter of the lumen of the guide catheter where the lumen if tge
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`reinforced segment is about 5 French and the lumen of the guide catheter is about 6 French or
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`greater. Adams discloses an intravascular device for coronary heart treatment that includes a
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`method (see cols, 4-5, lL 56-7 and col. 8, 11. 55-67) for advancing a distal end of a guide catheter
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`Page 14
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`Medtronic Exhibit 1506
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`

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`Application/Control Number: 14/984,273
`Art Unit: 3993
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`Page 14
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`(12) having a lumen (27) through a main blood vessel to an ostium of a coronary artery (''the
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`guide catheter is inserted at the femoral artery and advanced through a patient's arterial system to
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`the coronary ostium of the artery requi1ing treatment", see col. 4, 11. 56-58); advancing a distal
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`end of a guide extension catheter through, and beyond the distal end of the guide catheter (the
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`guide catheter (diameter and rigidjty) does not permit the guide catheter to advance beyond the
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`ostium into the artery requiring treatment The distal extension however is designed for insertion
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`through coronary arteries requiring treatment see col. 4, 11. 59-63)
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`Regarding claims 36-37, see coL 5, JL 39-43.
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`Claims 38 and 40-45 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by
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`US 5,578,009 to Kraus et al. ("Kraus").
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`Regarding independent claim 38, Kraus discloses a tip (18) segment with a lumen
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`(passage of 29), a reinforced segment (33) having a lumen therethrough (tube), and extending
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`from a proximal end portion to a distal end portion (see fig. 3); a substantially rigid segment
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`(push rod 34) extending from a proximal end portion to a distal end portion (see fig. 3); the distal
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`end portion of the rigid segment being eccentrically positioned relative to a longitudinal axis of
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`the proximal end portion of the reinforced segment (see fig 3); The method steps of forming,
`
`providing, positioning, and aligning are considered inherently necessary. Kraus teaches the
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`structure as claimed and in order to form the disclosed device the method steps would have
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`necessarily been performed. Kraus also teaches a side opening (Fig. 5) that provide an angled
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`entrance into the lumen of the reinforced segment 34 and 33. The opening (27) is 15cm in
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`length. See Kraus col. 6, 11. 58-61. As shown in fig. 5 the opening includes arcuate,
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`Page 15
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`Medtronic Exhibit 1506
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`

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`Application/Control Number: 14/984,273
`Art Unit: 3993
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`Page 15
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`hemicylindrical and inclined shapes and regions. The opening also includes the formation of a
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`concave track within the opening. See Kraus fig. 5.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of pre-AIA 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.
`
`Claims 25-26, 29-32 and 35-40 are rejected under pre-AIA 35 U.S.C. 103(a) as being
`
`unpatentable over US 2003/0195546 to Solar et al. ("Solar") in view of Adams.
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`Regarding independent claim 25, Solar discloses a device that includes a tip segment with
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`a lumen (open distal end 8), a reinforced segment (7) having a lumen therethrough (tubular),
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`including one or more metallic elements covered with a polymer (see <JI 0026), and extending
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`from a proximal end portion to a distal end portion (see fig. 1); a substantially rigid segment (5)
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`extending from a proximal end portion to a distal end portion (see fig. 1); the distal end portion
`
`of the rigid segment being eccentrically positioned relative to a longitudinal axis of the proximal
`
`end portion of the reinforced segment (see fig 1 annotated below); and the distal and portion of
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`the reinforced segment being coaxially aligned with the proximal end portion of the tip segment
`
`(see fig 1 annotated below). The method steps of forming, providing, positioning, and aligning
`
`are considered inherently necessary. Solar teaches the structure as claimed and in order to form
`
`the disclosed device the method steps would have necessarily been performed.
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`Page 16
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`Medtronic Exhibit 1506
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`

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`Application/Control Number: 14/984,273
`Art Unit: 3993
`
`Page 16
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`FIG. I
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`Solar meets the claim limitations as described above but fails to teach that the proximal
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`end portion of the reinforced segment is more rigid or having a flexural modulus greater than the
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`tip segment and that the device is used within a guide catheter and wherein the length of the rigid
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`segment, the reinforced segment and the tip segment is such that when positioned within a guide
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`catheter the tip segment extends distally of the guide catheter and at least part of the proximal
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`end portion of the rigid segment extends proximally from the guide catheter.
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`Solar does not explicitly disclose that the proximal end portion of the reinforced segment
`
`is more rigid or having a flexural modulus greater than the tip segment; however, this it would
`
`have been obvious to one skilled in the art that this is the case since the distal tip is shown to
`
`incorporate marker bands and the main portion of the tracking segment is disclosed to include
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`the reinforcing coil. See Solar fig. 1 and <JI 0026.
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`Additionally, Adams teaches an overall guide catheter with an internal distal extension
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`catheter. Much like the catheter of Solar, the dista