me‘
`5‘ \.
`5, UNITED STATES PATENT AND TRADEMARK OFFICE
`
`5
`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Oflicc
`Address C(:L\11\’IISSIONER FOR PATENTS
`P O Box 1
`Alexandria Virginia 22311-1480
`www uspto gov
`
`12/495,148
`
`06/30/2009
`
`Jennifer E. Tomes
`
`BPMDLOOOSJT (1005511)
`
`2300
`
`EXAMINER
`mmmmm —460 Grant Street SE P00N~ ROBhR'l‘
`
`Atlanta. GA 30312
`ART UNIT
`PAPER NUMBER
`m\10c0:
`
`MAIL DA I'E
`07/31/2013
`
`DELIVERY MODE
`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.
`
`PTOLPQOA (Rev 04/07)
`
`Medline Industries, Inc.; |PR2015-00513
`Exhibit 2009
`
`Page 1 of 13
`
`Medline Industries, Inc.; IPR2015-00513
`Exhibit 2009
`Page 1 of 13
`
`

`

`
`
`
`
`Office Action Summary
`
`
`Application No.
`Applicanl(s)
`12/495,148
`TOMES ET AL.
`
`Examiner
`Art Unit
`A|A(First Inventor to File)
`ROBERT POON
`3788
`if?“
`-- 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 g MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`- Extensions cftime may be avaiIabIe under the prowsions of 37 CFR1 136(3).
`In no event however. may a repIy be timer filed
`after SIX (6‘; MONTHS from the maiIing date of this communication.
`-
`If NO period for repIy is specified above. the maximum statutory period WIII apply and WIII expire SIX (6) MONTHS from the maiIing date ofthis communication.
`FaiIure to reply within the set or extended period for repIy wiII, by statute cause the application to become ABANDONED (35 U.S C §133).
`-
`Any reply received by the Office Iater than three months afterthe maiIing date ofthis communication, even iftimer filed, may reduce any
`earned patent term adjustment. See 37 CFR 170403).
`
`
`
`Status
`
`1 IX Responsive to communication(s) filed on 3AQri/ 2013.
`III A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`2a)IXI This action is FINAL.
`2b)|:l This action is non—final.
`3 III 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 El 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 Exparte Quayle, 1935 CD. 11, 453 QC. 213.
`
`
`
`Disposition of Claims
`5 IZI Claim(s) L59 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6 I] Claim(s)
`is/are allowed.
`7 [Z Claim(s) L59 is/are rejected.
`8
`'
`(s)
`is/are objected to.
`9 I] 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
`
`
`
`
`
`htt .:r‘/\W\rw.usoto,covi atenfsfinit events/ . h/index.'s . or send an inquiry to PPI-ffeedbackfaus top-w.
`
`
`
`Application Papers
`10)|:l "he specification is objected to by the Examiner.
`
`11)|:| “he drawing(s) filed on
`is/are: a)I:I accepted or b)|:l 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)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)|:l AII
`b)|:| Some * c)|:l None of the:
`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.|:| 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)
`
`3) D jnterview Summary (PTO-413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`2) m Information Disclosure Statement(s) (PTO/SB/08)
`4 I:I 0th _
`
`Paper No(s)/Mai| Date 4/3/2013.
`I
`e“ —-
`U 8. Patent and Trademark Office
`PTOL7326 (Rev. 0513)
`Office Action Summary
`Part of Paper No./MaiI Date 20130719
`
`
`
`Medline Industries, Inc.; |PR2015-00513
`Exhibit 2009
`
`Page 2 of 13
`
`Medline Industries, Inc.; IPR2015-00513
`Exhibit 2009
`Page 2 of 13
`
`

`

`Application/Control Number: 12/495,148
`Art Unit: 3788
`
`Page 2
`
`DETAILED ACTION
`
`Double Patenting
`
`1.
`
`A rejection based on double patenting of the “same invention” type finds its
`
`support in the language of 35 U.S.C. 101 which states that “whoever invents or
`
`discovers any new and useful process... may obtain a patent therefor...” (Emphasis
`
`added). Thus, the term “same invention," in this context, means an invention drawn to
`
`identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel,
`
`422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Ockert, 245 F.2d 467, 114 USPQ
`
`330 (CCPA 1957).
`
`A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by
`
`canceling or amending the claims that are directed to the same invention so they are no
`
`longer coextensive in scope. The filing of a terminal disclaimerm overcome a
`
`double patenting rejection based upon 35 U.S.C. 101.
`
`2.
`
`Claims 53-57 are provisionally rejected under 35 U.S.C. 101 as claiming the
`
`same invention as that of Claims 14-18 of copending Application No. 12/846675. This is
`
`a provisional statutory double patenting rejection since the claims directed to the same
`
`invention have not in fact been patented.
`
`3.
`
`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 claims at issue are not identical, but at least
`
`Medline Industries, Inc.; |PR2015-00513
`Exhibit 2009
`
`Page3 of13
`
`Medline Industries, Inc.; IPR2015-00513
`Exhibit 2009
`Page 3 of 13
`
`

`

`Application/Control Number: 12/495,148
`Art Unit: 3788
`
`Page 3
`
`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, 140 F.3d 1428, 46 USPQ2d
`
`1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQZd 2010 (Fed. Cir.
`
`1993); In re Longi, 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); and In re Thoringfon, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
`
`may be used to overcome an actual or provisional rejection based on a nonstatutory
`
`double patenting ground provided the reference application or patent either is shown to
`
`be commonly owned with this application, or claims an invention made as a result of
`
`activities undertaken within the scope of a joint research agreement. A terminal
`
`disclaimer must be signed in compliance with 37 CFR 1.321 (b).
`
`The USPTO internet Web site contains terminal disclaimer forms which may be
`
`used. Please visit http:IIwww.uspto.gov/forms/. The filing date of the application will
`
`determine what form should be used. A web-based eTerminaI Disclaimer may be filled
`
`out completely online using web-screens. An eTerminal Disclaimer that meets all
`
`requirements is auto-processed and approved immediately upon submission. For more
`
`information about eTerminaI Disclaimers, refer to
`
`http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
`
`4.
`
`Claims 19-59 are provisionally rejected on the ground of nonstatutory double
`
`patenting as being unpatentable over claims 1-18 of copending Application No.
`
`Medline Industries, Inc.; |PR2015-00513
`Exhibit 2009
`
`Page4 of13
`
`Medline Industries, Inc.; IPR2015-00513
`Exhibit 2009
`Page 4 of 13
`
`

`

`Application/Control Number: 12/495,148
`Art Unit: 3788
`
`Page 4
`
`12/846675. Although the claims at issue are not identical, they are not patentably
`
`distinct from each other because one of ordinary skill in the art would have found it
`
`obvious to remove limitations such as the contents within the tray since it has been held
`
`that omission of an element and its function is obvious if the function of the element is
`
`not desired. Ex parte Wu , 10 USPQ 2031 (Ed. Pat. App. & Inter. 1989).
`
`This is a provisional nonstatutory double patenting rejection because the
`
`patentably indistinct claims have not in fact been patented.
`
`Claim Rejections - 35 USC § 102
`
`5.
`
`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:
`
`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 of application
`for patent in the United States.
`Claim 58 is rejected under pre-AIA 35 U.S.C. 102b as being anticipated by US
`
`6.
`
`4,761,008 to Huggins.
`
`Regarding claim 58, Huggins discloses a tray (fig 1) comprising a
`
`contoured surface (16) defining at least three compartments (16, 30, 34-66)
`
`separated by barriers (24, 32) and a perimeter wall, the three compartments
`
`comprising a first compartment (34-66) having a first compartment base member
`
`having a contoured surface capable of holding syringes at different depths (Fig 5
`
`shows the compartment having different depths 44, 66), a second compartment
`
`comprising a second base member (31 ), a third compartment having a third base
`
`Medline Industries, Inc.; |PR2015-00513
`Exhibit 2009
`
`Page 5 of 13
`
`Medline Industries, Inc.; IPR2015-00513
`Exhibit 2009
`Page 5 of 13
`
`

`

`Application/Control Number: 12/495,148
`Art Unit: 3788
`
`Page 5
`
`member (26), the contoured surface non-parallel with the second or third base
`
`member.
`
`Claim Rejections - 35 USC § 103
`
`7.
`
`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.
`
`8.
`
`Claim 59 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over
`
`US 2004/0004019 to Busch.
`
`Medline Industries, Inc.; |PR2015-00513
`Exhibit 2009
`
`Page 6 of 13
`
`Medline Industries, Inc.; IPR2015-00513
`Exhibit 2009
`Page 6 of 13
`
`

`

`Application/Control Number: 12/495,148
`Art Unit: 3788
`
`Page 6
`
`
`
`Regarding claim 59, Busch discloses a catheter packaging system
`
`comprising a tray (32) having a first compartment (A, Fig. 3 above), second
`
`compartment (B), each compartment having a base member, the tray further
`
`comprising a barrier (between A and B) separating the first compartment from the
`
`second, at least one syringe (48, 50) disposed in the first compartment, a
`
`catheter assembly (46) disposed in the second compartment. Busch does not
`
`teach the first compartment member to support a syringe at a shallower depth
`
`within the tray than the depth of the second compartment base member.
`
`However, it would have been obvious to one of ordinary skill in the art to change
`
`the depths of each compartment depending on the item held. Furthermore, the
`
`Medline Industries, Inc.; |PR2015-00513
`Exhibit 2009
`
`Page 7 of 13
`
`Medline Industries, Inc.; IPR2015-00513
`Exhibit 2009
`Page 7 of 13
`
`

`

`Application/Control Number: 12/495,148
`Art Unit: 3788
`
`Page 7
`
`syringe can be placed in a configuration that is not parallel to the second
`
`compartment base member.
`
`9.
`
`Claims 53-57 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable
`
`over US 2004/0004019 to Busch in view of US Patent No. 5,031,768 to Fischer.
`
`Regarding claim 53, Busch discloses a catheter packaging system
`
`comprising a tray (32) having a first compartment (A, Fig. 3 above), second
`
`compartment (B), each compartment having a base member, the tray further
`
`comprising a barrier (between A and B) separating the first compartment from the
`
`second, at least one syringe (48, 50) disposed in the first compartment, a
`
`catheter assembly (46) disposed in the second compartment. Busch does not
`
`teach the first compartment member to support a syringe at a shallower depth
`
`within the tray than the depth of the second compartment base member.
`
`However, it would have been obvious to one of ordinary skill in the art to change
`
`the depths of each compartment depending on the item held. Furthermore, the
`
`syringe can be placed in a configuration that is not parallel to the second
`
`compartment base member. Busch further does not teach a barrier opening on
`
`the barrier. Fischer discloses a tray (Fig. 1) and in particular discloses an
`
`opening (58) on a barrier (28) separating compartments for purposes of further
`
`securing or holding various types of instruments (Fischer, col. 6, II. 25-35).
`
`It
`
`would have been further obvious to one of ordinary skill in the art to implement
`
`Medline Industries, Inc.; |PR2015-00513
`Exhibit 2009
`
`Page 8 of 13
`
`Medline Industries, Inc.; IPR2015-00513
`Exhibit 2009
`Page 8 of 13
`
`

`

`Application/Control Number: 12/495,148
`Art Unit: 3788
`
`Page 8
`
`an opening to the barrier of Busch as suggested by Fischer in order to secure or
`
`hold additional surgical instruments (Fischer, col. 6,
`
`II. 25-35).
`
`Regarding claim 54, Busch further teaches the tray comprising a third
`
`compartment (36) and a second barrier (C) separating the third and second
`
`compartments, further comprising a specimen container (34) in the third
`
`compartment.
`
`Regarding claim 55, Busch does not teach an opening on the second
`
`barrier. However, Fischer discloses a tray (Fig. 1) and in particular discloses an
`
`opening (groove adjacent 56) on a barrier (30) separating compartments for
`
`supporting instruments (Fischer, col. 6, II. 25-35).
`
`It would have been obvious to
`
`one of ordinary skill in the art to implement an opening to the barrier of Busch as
`
`suggested by Fischer in order to secure or hold additional surgical instruments
`
`(Fischer, col. 6, II. 25-35). Fischer further discloses placing a syringe (50) in the
`
`two openings (56, 58) for purposes of further securing or holding various types of
`
`instruments (Fischer, col. 6, II. 25-35).
`
`Regarding claim 56, Busch further discloses a plurality of syringes (50) in
`
`the first compartment (A), and the first compartment is capable of supporting a
`
`plurality of syringes at different depths relative to the depth of the second
`
`compartment base based on the changes in overall depths to the compartments.
`
`Regarding claim 57, Busch further discloses printed instructions (26).
`
`Medline Industries, Inc.; |PR2015—00513
`Exhibit 2009
`
`Page 9 of 13
`
`Medline Industries, Inc.; IPR2015-00513
`Exhibit 2009
`Page 9 of 13
`
`

`

`Application/Control Number: 12/495,148
`Art Unit: 3788
`
`Page 9
`
`Allowable Subject Matter
`
`10.
`
`Claims 19-52 avoid the prior art of record.
`
`1.
`
`The declarations under 37 CFR 1.132 filed 4/3/2013 is insufficient to overcome
`
`Response to Amendment
`
`the rejection of claims 19-57 based upon the 35 USC 103(a) rejection under US
`
`2004/0004019 to Busch in view of US Patent No. 6,793,078 to Roshdy and US Patent
`
`No. 4,523,679 to Paikoff et al. (Paikoff) as set forth in the last Office action because: the
`
`showing is not commensurate in scope with the claims.
`
`It refer(s) only to the system
`
`described in the above referenced application and not to the individual claims of the
`
`application. Thus, there is no showing that the objective evidence of nonobviousness is
`
`commensurate in scope with the claims. See MPEP § 716. The objective evidence
`
`provided in both declarations describes the unexpected benefits of the invention, in
`
`particular the instruction manual, but does not provide any evidence of why it would not
`
`be obvious to place an instruction manual as taught by Roshdy into a package
`
`assembly as taught by Busch.
`
`2.
`
`In view of the foregoing, when all of the evidence is considered, the totality of the
`
`rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
`
`Response to Arguments
`
`11.
`
`Applicant‘s arguments filed 4/3/2013 have been fully considered but they are not
`
`persuasive.
`
`Medline Industries, Inc.; |PR2015-00513
`Exhibit 2009
`
`Page100f13
`
`Medline Industries, Inc.; IPR2015-00513
`Exhibit 2009
`Page 10 of 13
`
`

`

`Application/Control Number: 12/495,148
`Art Unit: 3788
`
`Page 10
`
`12.
`
`In response to applicants argument that the examiner‘s conclusion of
`
`obviousness is based upon improper hindsight reasoning, it must be recognized that
`
`any judgment on obviousness is in a sense necessarily a reconstruction based upon
`
`hindsight reasoning. But so long as it takes into account only knowledge which was
`
`within the level of ordinary skill at the time the claimed invention was made, and does
`
`not include knowledge gleaned only from the applicant‘s disclosure, such a
`
`reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA
`
`1971).
`
`13.
`
`Applicant argues that the compartments of Busch does not teach supporting one
`
`syringe at a shallower depth within the tray as well as in a non-parallel configuration
`
`than a second compartment base member. This is not persuasive since the syringe is
`
`not claimed and as long as the Busch tray has the structure as claimed, then it is
`
`capable of holding a syringe in a non-parallel configation. Applicant appears to be
`
`arguing that changing the depth of the compartments would not be obvious and would
`
`in fact be hindsight; however, Busch is silent in regards to the depths of each
`
`compartment. However, Busch discloses the compartments holding different contents
`
`and each content has to be below the container rim in order for the container to be
`
`sealed. One of ordinary skill in the art would have found it obvious to change the
`
`depths of the compartment to accommodate for different size contents, especially since
`
`the contents are different. For example, US Patent 4,761,008 to Huggins discloses a
`
`tray with different compartments of various depths since the compartments hold
`
`different items of varying size. US 2006/0264822 to Nagamatsu discloses trays having
`
`Medline Industries, Inc.; |PR2015-00513
`Exhibit 2009
`
`Page 11 of13
`
`Medline Industries, Inc.; IPR2015-00513
`Exhibit 2009
`Page 11 of 13
`
`

`

`Application/Control Number: 12/495,148
`Art Unit: 3788
`
`Page 11
`
`different size compartments for holding different size syringes (Fig 2). US Patent
`
`3,851,649 to Villari discloses a catheter package (Fig 1) having different compartments
`
`holding different items, each compartment having different depths (Fig 2).
`
`14.
`
`Applicant’s arguments, see pg 22 of applicant’s remarks, filed 4/3/2013, with
`
`respect to claims 19-52 have been fully considered and are persuasive. The rejection
`
`of claims 19-52 has been withdrawn.
`
`Conclusion
`
`15.
`
`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
`
`policy as set forth in 37 CFR 1.136(a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`
`MONTHS from the mailing date of this action.
`
`In the event a first reply is filed within
`
`TWO MONTHS of the mailing date of this final action and the advisory action is not
`
`mailed until after the end of the THREE-MONTH shortened statutory period, then the
`
`shortened statutory period will expire on the date the advisory action is mailed, and any
`
`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
`
`the advisory action.
`
`In no event, however, will the statutory period for reply expire later
`
`than SIX MONTHS from the mailing date of this final action.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to ROBERT POON whose telephone number is (571)270-
`
`7425. The examiner can normally be reached on Monday thru Friday, 8:30 am to 6:00
`
`pm.
`
`Medline Industries, Inc.; |PR2015-00513
`Exhibit 2009
`
`Page 12 of13
`
`Medline Industries, Inc.; IPR2015-00513
`Exhibit 2009
`Page 12 of 13
`
`

`

`Application/Control Number: 12/495,148
`Art Unit: 3788
`
`Page 12
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Greg Pickett can be reached on (571)272-4560. The fax phone number for
`
`the organization where this application or proceeding is assigned is 571-273-8300.
`
`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.usptogov. 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.
`
`/J. Gregory Pickett/
`Supervisory Patent Examiner, Art Unit 3788
`
`/R. P./
`Examiner, Art Unit 3788
`
`Medline Industries, Inc.; |PR2015-00513
`Exhibit 2009
`
`Page130f13
`
`Medline Industries, Inc.; IPR2015-00513
`Exhibit 2009
`Page 13 of 13
`
`