www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`16/853,399
`
`04/20/2020
`
`Dean HU
`
`P001428US 11 DIV
`
`1627
`
`60402
`
`7590
`
`10/05/2023
`
`KINETIC CONCEPTS, INC.
`c/o Harness Dickey & Pierce
`5445 Corporate Drive
`Suite 300
`
`Troy, MI 48098
`
`EXAMINER
`
`SU, SUSAN SHAN
`
`3781
`
`10/05/2023
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`Thetime 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):
`
`dgodzisz@hdp.com
`troymailroom @hdp.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Office Action Summary
`
`Application No.
`16/853,399
`Examiner
`SUSAN S SU
`
`Applicant(s)
`HU etal.
`Art Unit
`3781
`
`AIA (FITF) Status
`No
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom 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) MONTHSfrom 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, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`
`
`1) Responsive to communication(s)filed on 6/23/2023.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)() This action is FINAL. 2b)¥)This action is non-final.
`3)02 An election was madeby the applicant in responseto 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 Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`1-25 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) 21-25 is/are withdrawn from consideration.
`[) Claim(s)__ is/are allowed.
`Claim(s) 1-20 is/are rejected.
`S)
`) © Claim(s)____is/are objected to.
`C] Claim(s
`are subjectto restriction and/or election requirement
`)
`S)
`“If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http:/Awww.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) )
`
`Application Papers
`10) The specification is objected to by the Examiner.
`11)M The drawing(s) filed on 4/20/2020 is/are: a)¥) accepted or b)C) 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:
`c)() None ofthe:
`b)( Some**
`a)C) All
`1.2 Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have beenreceived in Application No.
`3.2.) Copies of the certified copies of the priority documents have been receivedin 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)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) (J Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20230929
`
`

`

`Application/Control Number: 16/853,399
`Art Unit: 3781
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AlA or AIA Status
`
`1.
`
`2.
`
`The present application is being examined under the pre-AlA first to invent provisions.
`
`Election/Restrictions
`
`Applicant’s election without traverse of Group | (Claims 1-20) in the reply filed on
`
`6/23/2023 is acknowledged. Applicant has withdrawn Claims 21-25.
`
`Double Patenting
`
`
`
`3. The nonstatutory double patenting rejection is based onajudicially created doctrine
`
`groundedin public policy (a policy reflected in the statute) so as to prevent the unjustified or
`
`impropertimewise 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 wherethe 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, 140 F.3d 1428, 46 USPQe2d 1226 (Fed. Cir. 1998); In re Goodman,11 F.3d
`
`1046, 29 USPQ2d 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); In re Thorington, 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 nonstatutory double patenting
`
`provided the reference application or patent either is shown to be commonly ownedwith the
`
`examined application, or claims an invention made as a result of activities undertaken within the
`
`scopeof a joint research agreement. See MPEP § 717.02 for applications subject to
`
`examination underthe first inventor to file provisions of the AIA as explained in MPEP § 2159.
`
`See MPEP § 2146 et seq.for applications not subject to examination underthe first inventor to
`
`

`

`Application/Control Number: 16/853,399
`Art Unit: 3781
`
`Page 3
`
`file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR
`
`1.321(b).
`
`The filing of a terminal disclaimerbyitself is not a complete reply to a nonstatutory
`
`double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be
`
`accompanied by a reply requesting reconsideration of the prior Office action. Even where the
`
`NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection |.B.1.
`
`For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action,
`
`see 37 CFR 1.113(c). A requestfor reconsideration while not provided for in 37 CFR 1.113(c)
`
`maybefiled after final for consideration. See MPEP §§ 706.07(e) and 714.13.
`
`The USPTOInternet website contains terminal disclaimer forms which may be used.
`
`Please visit www.uspto.gov/patent/patents-forms. The actualfiling date of the application in
`
`whichthe 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 maybefilled 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 eTerminal
`
`Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
`
`4.
`
`Claims 1, 2, & 16-20 are rejected on the ground of nonstatutory double patenting as
`
`being unpatentable over claims 1, 4, 13-17, and 30 of U.S. Patent No. 9,283,307. Although the
`
`claims at issue are notidentical, they are not patentably distinct from each other because the
`
`patented claims recite the same limitations as the current claims as shownin the chart below.
`
` corresponding claim #|1, 13, or 15|4, 17, or 30
`
`in 9,283,307
`
`Claim Rejections - 35 USC § 102
`
`5.
`
`The following is a quotation of the appropriate paragraphs of pre-AlA 35 U.S.C. 102 that
`
`form the basis for the rejections underthis section madein this Office action:
`
`

`

`Application/Control Number: 16/853,399
`Art Unit: 3781
`
`A person shall be entitled to a patent unless —
`
`Page 4
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`(bo) 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 yearprior to the date of application
`for patent in the United States.
`
`6.
`
`Claims 1-11, 13, & 15-18 are rejected underpre-AlA 35 U.S.C. 102(b) as being
`
`anticipated by Miyasaka (US 2008/0103487).
`
`Re Claim 1, Mlyasaka discloses a device, comprising a chamber(introduction part 3 of
`
`injection tube 2, see [0023)), a first conduit (injection part 4 of injection tube 2) with a distal
`
`opening (5) and a proximal opening in communication with the chamber, and a conduit sealing
`
`member(protective shutter 6) sealing the distal opening.
`
`Re Claim 2, Miyasakaalso discloses a connector (female connector 20) comprising a
`
`first end (the end with injection tube 23, see Fig. 2b) and a second end (the end with septum 27)
`
`configured to retract the conduit sealing memberfrom the distal opening ofthe first conduit (see
`
`Fig. 5 where the conduit sealing member/protective shutter 6 is non-retracted, and Fig. 4 where
`
`the conduit sealing member/protective shutter 6 is retracted, also see [0028]).
`
`Re Claim 3, Miyasaka also discloses that the connector further comprises a connector
`
`seal (holding portion 25 in combination with septum 27, because septum 27is retained in place
`
`by holding portion 25, [0027]) at the second endof the connector.
`
`Re Claim 4, Miyasaka also discloses that the connector seal is configured to deform into
`
`the second end of the connector (as shownin Fig. 4, where septum 27 is compressed by
`
`leading end injection portion 4b).
`
`Re Claim 5, Miyasaka also discloses that the connector seal is configured to be
`
`deformably openedbythe distal opening of the first conduit (shown in Fig. 4, whereas non-
`
`deformed connector seal is shown in Fig. 2b).
`
`Re Claim 6, Miyasaka also discloses that the conduit sealing member(6) is configured
`
`to retract from the distal opening of the first conduit along an outer surface of the first conduit
`
`([0028], Figs. 4-5 showsthe retracted and non-retracted states, respectively).
`
`

`

`Application/Control Number: 16/853,399
`Art Unit: 3781
`
`Page 5
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`Re Claim 7, Miyasaka also discloses a second conduit (outer tube part 7) attached to the
`
`chamber (Fig. 1a), wherein the first conduit resides within the second conduit (also see Fig. 1a).
`
`Re Claim 8, Miyasaka also discloses that the connector seal is configured to seal
`
`against the second conduit (Fig. 4, the holding portion 25 is sealing against the second conduit).
`
`Re Claim 9, Miyasakaalso discloses a second conduit (outer tube part 7) in which the
`
`first conduit resides (Fig. 1a), the second conduit configured to receive the second end of the
`
`connector (Fig. 4).
`
`Re Claim 10, Miyasaka also discloses wherein the connector is configured to form a
`
`mechanicalinterfit with an outer surface of the second conduit (since retaining hole 8 penetrates
`
`through the entire thickness of the second conduit wall, see e.g., Figs. 1, 4, & 5, the mechanical
`
`engagement betweenretained portion 22 and retaining hole 8 can be broadly interpreted as an
`
`interfit with both an inner and an outer surface of the second conduit).
`
`Re Claim 11, Miyasaka also discloses that wherein the mechanicalinterfit comprises as
`
`least one latch structure (see e.g., Figs. 1 & 5 clearly showing retaining hole 8 having a slot into
`
`which the retained portion 22 canslide, thus forming a latch structure that latches onto the
`
`retained portion 22).
`
`Re Claim 13, Miyasaka also discloses wherein the first conduit (4) and the second
`
`conduit (7) are configured to receive the second endof the connector between an inner surface
`
`of the second conduit and an outer surfaceof the first conduit (Fig. 4).
`
`Re Claim 15, Miyasaka also discloses wherein the connector seal comprises a
`
`slit seal configuration (slit 27a, [0027]).
`
`Re Claims 16-17, Miyasaka also discloses a connector housing (outer tube part
`
`21, Fig. 2b) that comprises at least one button member (the retained portion 22 can be
`
`broadly interpreted as a button).
`
`

`

`Application/Control Number: 16/853,399
`Art Unit: 3781
`
`Page 6
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`Re Claim 18, Miyasakaalso discloses that the conduit sealing member(6) has a
`
`normally closed position ([0031] “the protective shutter 6 is returned to the leading end
`
`portion side byits elastic force”).
`
`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
`
`obviousnessrejections 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, 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 obviousat the
`time the invention was madeto a person having ordinaryskill in the art to which said subject
`matter pertains. Patentability shall not be negated by the manner in which the invention was
`made.
`
`8.
`
`The factual inquiries for establishing a background for determining obviousness under
`
`pre-AlA 35 U.S.C. 103(a) are summarized asfollows:
`
`1. Determining the scope and contents of the prior art.
`2. Ascertaining the differences between the prior art and the claims at issue.
`3. Resolving the level of ordinary skill in the pertinentart.
`4. Considering objective evidence presentin the application indicating obviousness or
`nonobviousness.
`
`9.
`
`Claims 12 & 14 are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over
`
`Miyasaka.
`
`Re Claim 12, Miyasaka discloses the invention of claim 11 but does not teachesthat the
`
`latch structure is located on the connector. Miyasakainstead discloses that the latch structure
`
`is on the second conduit. However, a person of ordinary skill has good reason to pursue the
`
`known options (having the latch structure on the second conduit or switch the latch structure to
`
`the connector side of the mechanicalinterfit) within his or her technical grasp.
`
`If this leads to
`
`the anticipated success (the connector and the first/second conduits are securely connected for
`
`fluid flow), it is likely that product was notof innovation but of ordinary skill and common sense.
`
`

`

`Application/Control Number: 16/853,399
`Art Unit: 3781
`
`Page 7
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`In that instant the fact that a combination was obvious to try might show that it was obvious
`
`under § 103. See MPEP 2148(E).
`
`Re Claim 14, Miyasaka discloses the invention of claim 9 but is mute to the position of
`
`the distal opening of the first conduit relative to a distal opening of the second conduit.
`
`Miyasaka appearsto showthatthe distal opening of the first conduit is slightly more distal to the
`
`distal opening of the second conduit (see Fig. 1) or may be flush with the distal opening of the
`
`second conduit (see Fig. 4). However, changing the axial length of the second conduit such
`
`that its distal opening would be moredistal than thatof the first conduit is merely a change ina
`
`dimension/size of a structure and requires only routine skills in the art. There would be benefit
`
`to such a modification, e.g., for preventing accidental contact of a user with the first conduit,
`
`which is wheresterile fluid would need to flow through.
`
`10.
`
`Claims 19-20 are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over
`
`Miyasakain view of Vaillancourt (US 2003/0060804).
`
`Re Claim 19, Miyasaka discloses the invention of claim 1 but does not teach that the
`
`conduit sealing member comprisesa slit seal configuration. Vaillancourt discloses a connector
`
`assembly comprising two connectors (see Fig. 3), wherein one of the connectors (adaptor 10)
`
`has a septum (12) that closes a fluid passage (15) when the connectors are disconnected (see
`
`Figs. 1 & 2), and when the connectors are joined, the septum would be pushed back/retracted
`
`(see Fig. 5) to open the fluid passage. The operation of the septum in Vaillancourt is similar to
`
`the conduit sealing member in Miyasaka, which is also pushed back/retracted to expose an
`
`opening that allowsfluid to pass through. The Vaillancourt septum is further configured asa slit
`
`seal (13, Fig. 1).
`
`It would have been obvious to one skilled in the art at the time of invention to
`
`modify Miyasaka with the type of seal/septum taught in Vaillancourt since the simple substitution
`
`of a known element for another to obtain predictable results establishes a prima facie case of
`
`obviousness (MPEP 2143(I) (B)).
`
`

`

`Application/Control Number: 16/853,399
`Art Unit: 3781
`
`Page 8
`
`Re Claim 20, Miyasaka discloses the invention of claim 2 but does not expressly
`
`disclose tubing attachedto the first end of the connector. Miyasaka’s deviceis for use ina
`
`transfusion line (Abstract) and thereforeis likely to be connected between two segmentsof
`
`tubing. Vaillancourt discloses a connector assembly for connecting tubing (e.g., [0005]), thus
`
`both ends of the connector assembly are connected to tubing.
`
`It would have been obvious to
`
`one skilled in the art at the time of invention to modify Miyasaka with the knowledge from
`
`Vaillancourt such that the invention of Miyasaka can be usedto effectively transport fluid in a
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`medical setting.
`
`Conclusion
`
`11.
`
`The prior art made of record and not relied upon is considered pertinent to applicant's
`
`disclosure.
`
`Diodati et al. (US 2008/0185056) discloses a device, comprising a chamber(e.g., tubing
`
`540 or container 650, Fig. 11), a first conduit (stem 230) with a distal opening (covered by valve
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`250, see Fig. 1) and a proximal opening (see Fig. 11) in communication with the chamber, and a
`
`conduit sealing memberhavingaslit seal configuration (valve 250) sealing the distal opening.
`
`Diodati also discloses a connector (connector 10) that has a connector seal (valve 150), the
`
`connector configured to retract the conduit sealing memberfrom the distal opening of the first
`
`conduit (once connector 10 is pushed toward connector 20 and makes housing 200 to slide
`
`along stem 230, the valve 250 is retracted as shownin Fig. 3).
`
`12.
`
`Anyinquiry concerning this communication or earlier communications from the examiner
`
`should be directed to SUSAN S SU whosetelephone numberis (408)918-7575. The examiner
`
`can normally be reached M-F 9:00 - 5:00 Pacific.
`
`Examiner interviews are available via telephone, in-person, and video conferencing
`
`using a USPTO supplied web-basedcollaboration tool. To schedule an interview, applicant is
`
`encouraged to use the USPTO AutomatedInterview Request(AIR) at
`
`http://www.uspto.gov/interviewpractice.
`
`

`

`Application/Control Number: 16/853,399
`Art Unit: 3781
`
`Page 9
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Nicholas J Weiss can be reached on 571-270-1775. The fax phone numberfor the
`
`organization where this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of published or unpublished applications may be
`
`obtained from Patent Center. Unpublished application information in Patent Centeris available
`
`to registered users. To file and manage patent submissions in Patent Center, visit:
`
`https://patentcenter.uspto.gov. Visit https:/;www.uspto.gov/patents/apply/patent-center for more
`
`information about Patent Center and https:/Awww.uspto.gov/patents/docx for information about
`
`filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at
`
`866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service
`
`Representative, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/SUSAN S SU/
`Primary Examiner, Art Unit 3781
`1 October 2023
`
`