www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`16/853,399
`
`04/20/2020
`
`Dean HU
`
`P001428US11DIV
`
`1627
`
`60402
`
`7590
`
`05/08/2024
`
`KINETIC CONCEPTS, INC.
`c/o Harness Dickey & Pierce
`5445 Corporate Drive
`Suite 20
`Troy, MI 48098
`
`EXAMINER
`
`SU, SUSAN SHAN
`
`Para NONE
`
`3781
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`05/08/2024
`
`ELECTRONIC
`
`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):
`
`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 STATUTORYPERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensionsof 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 2/5/2024.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`2a)[¥) This action is FINAL.
`2b) (J This action is non-final.
`3) 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)(2) 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*
`1-20 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`C} Claim(s)__ is/are allowed.
`Claim(s) 1-20 is/are rejected.
`(] Claim(s)__ is/are objectedto.
`C] Claim(s
`are subjectto restriction and/or election requirement
`)
`* 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://www.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)0) The drawing(s) filedon__ is/are: a)(J accepted or b)( 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)7) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)Z None ofthe:
`b)() Some**
`a)C All
`1.1.) Certified copies of the priority documents have been received.
`2.2) Certified copies of the priority documents have been received in Application No.
`3.1.) 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)
`
`4)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20240503
`
`

`

`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.
`
`Status of Claims
`
`Claims 1-25 are pending, of which claims 1, 7 & 9 are amended and claims 21-25
`
`remain withdrawn. No new matter is found.
`
`Response to Arguments
`
`3.
`
`Applicant's arguments with respect to the claims have been considered but are moot
`
`because the new ground of rejection does not rely on any reference applied in the prior rejection
`
`of record for any teaching or matter specifically challenged in the argument.
`
`4.
`
`The amendmentsto claim 1 necessitate a new ground of rejection in view of Miyasaka
`
`(US 2008/0103487) and Peters (US 6,267,754).
`
`Claim Objections
`
`5.
`
`Claim 9 objected to because of the following informalities:
`
`Re Claim 9, Examiner recommendsadding “is” or “being” immediately in front of
`
`“configured to.”
`
`Appropriate correction is required.
`
`Claim Rejections - 35 USC § 103
`
`6.
`
`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
`andthe 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
`
`marrer pertains. Patentability shall not be negated by the mannerin which the invention was
`
`7.
`
`The factual inquiries for establishing a background for determining obviousness under
`
`pre-AlA 35 U.S.C. 103(a) are summarized asfollows:
`
`

`

`Application/Control Number: 16/853,399
`Art Unit: 3781
`
`Page 3
`
`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.
`
`8.
`
`Claims 1-18 are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over
`
`Miyasaka (US 2008/0103487) in view of Peters (US 6,267,754).
`
`Re Claim 1, Miyasaka 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, and a second conduit (outer tube part
`
`7) including a proximal segment(the end that is closer to introduction part 3) and a distal
`
`segment (the end having retaining hole 8, Fig. 1a), wherein the first conduit resides within the
`
`proximal segmentof the second conduit (also see Fig. 1a).
`
`Miyasaka doesnot teach that the second conduit’s proximal segment has a reduced
`
`diameter comparedto the distal segment.
`
`Peters discloses a coupling (Fig. 1) used for medical purposes wherea first connector
`
`(male member2) has an inner conduit residing within a segment reduced diameter of an outer
`
`conduit (sleeve 24, see annotated figure below). Given that Peters’ first connectoris similar in
`
`structure to the injection tube 2 of Miyasaka and performsa similar function (to be connected to
`
`a corresponding connector to establish fluid flow therethrough), one skilled in the art at the time
`
`distal segment
`
`.
`proximal segment
`
`.
`
`‘
`
`4,
`
`2
`
`:
`
`12
`
`$3
`
` MSELLLLSSLLY ta
`
`
`OULTLULETITITTETETILLEYTITLE
`
`
`
`
`
`
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`Wg §SS .
`s
` }
`14 NS \
`Bs
`FIGURE|
`ab
`_first/inner conduit
`
`

`

`Application/Control Number: 16/853,399
`Art Unit: 3781
`
`Page 4
`
`offiling would find it obvious to modify the second/outer conduit of Miyasaka with the
`
`second/outer conduit shape taught in Peters as the enlarged portion can providebetter finger
`
`grip.
`
`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 end of 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 openedby the distal opening of the first conduit (shown in Fig. 4, whereas non-
`
`deformed connector seal is shownin Fig. 2b).
`
`Re Claim 6, Miyasakaalso 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).
`
`Re Claim 7, Miyasakaalso discloses that the second conduit (outer tube part 7)is
`
`attached to the chamber(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, Miyasaka also discloses the second conduit being configured to receive the
`
`second end of the connector (Fig. 4).
`
`

`

`Application/Control Number: 16/853,399
`Art Unit: 3781
`
`Page 5
`
`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 between retained 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 12, Miyasaka and Peters do not teach that 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 knownoptions (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 connectedfor fluid flow), it is likely that
`
`product was notof innovation but of ordinary skill and common sense. In that instant the fact
`
`that a combination was obvious to try might show that it was obvious under § 103. See MPEP
`
`2143(E).
`
`Re Claim 13, Miyasaka also discloses wherein the first conduit (4) and the second
`
`conduit (7) are configured to receive the second end of the connector between an inner surface
`
`of the second conduit and an outer surfaceof the first conduit (Fig. 4).
`
`Re Claim 14, Miyasaka and Peters combine to disclose the invention of claim 9 but are
`
`mute to the position of the distal opening of the first conduit relative to a distal opening of the
`
`second conduit. Miyasaka appears to show that the distal opening of the first conduit is slightly
`
`moredistal to the distal opening of the second conduit (see Fig. 1) or may beflush with the
`
`distal opening of the second conduit (see Fig. 4). However, changing the axial length of the
`
`

`

`Application/Control Number: 16/853,399
`Art Unit: 3781
`
`Page 6
`
`second conduit such thatits distal opening would be moredistal than that of the first conduit is
`
`merely a change in a 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.
`
`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).
`
`Re Claim 18, Miyasaka also 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”).
`
`9.
`
`Claims 19-20 are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over
`
`Miyasaka and Peters as applied to claim 1 or 2 above, andfurtherin view of Vaillancourt (US
`
`2003/0060804).
`
`Re Claim 19, Miyasaka and Peters disclose the invention of claim 1 but do 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 connectorsare 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 asaslit 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
`
`

`

`Application/Control Number: 16/853,399
`Art Unit: 3781
`
`Page 7
`
`Vaillancourt since the simple substitution of a known element for another to obtain predictable
`
`results establishes a prima facie case of obviousness (MPEP 21438(I) (B)).
`
`Re Claim 20, Miyasaka and Peters disclose the invention of claim 2 but do not expressly
`
`disclose tubing attached to the first end of the connector. Miyasaka’s device is for use in a
`
`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 transportfluid in a
`
`medicalsetting.
`
`Conclusion
`
`10.
`
`Applicant's amendment necessitated the new ground(s) of rejection presentedin this
`
`Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 eventa first replyis 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 shortenedstatutory 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 date of this
`
`final action.
`
`11.
`
`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.
`
`

`

`Application/Control Number: 16/853,399
`Art Unit: 3781
`
`Page 8
`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
`/SUSAN S$ SU/
`Primary Examiner, Art Unit 3781
`3 May 2024
`
`