UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
`
`15/892,181
`
`02/08/2018
`
`Kyle R. Steele
`
`098993021961
`
`4580
`
`09/28/2020
`
`75534
`B akerHostetler
`
`759°
`
`Cira Centre, 12th Floor
`2929 Arch Street
`
`Philadelphia, PA 19104
`
`SHAH” NILAY J
`
`3783
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`09/28/2020
`
`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):
`eofficemonitor @ bakerlawcom
`
`PTOL-90A (Rev. 04/07)
`
`

`

`017/09 A0170” Summary
`
`Application No.
`15/892,181
`Examiner
`NILAY J SHAH
`
`Applicant(s)
`Steele et al.
`Art Unit
`3783
`
`AIA (FITF) Status
`Yes
`
`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 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.
`|f 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 4/8/2020.
`CI A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2a)[:] This action is FINAL.
`
`2b)
`
`This action is non-final.
`
`3)[:] 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):] 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 Expade Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`
`5)
`
`Claim(s)
`
`1—24 is/are pending in the application.
`
`5a) Of the above claim(s)
`
`is/are withdrawn from consideration.
`
`
`
`Claim(ss) 3, 10 and 21—24 is/are allowed.
`
`Claim(ss) 1 —2 ,4—9 and 11 —20 is/are rejected.
`
`[:1 Claim(ss_) is/are objected to.
`
`) ) ) )
`
`S)
`are subject to restriction and/or election requirement
`C] Claim(s
`* 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://www.jjsthQQv/patents/init_events/pph/index.'sp or send an inquiry to PPeredhagk©g§ptgggm
`
`Application Papers
`
`10):] The specification is objected to by the Examiner.
`
`is/are: a)[:| accepted or b)D objected to by the Examiner.
`11):] The drawing(s) filed on
`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):] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)i:i All
`
`b)C] Some**
`
`c)C] None of the:
`
`1.1:] Certified copies of the priority documents have been received.
`
`2.[:] Certified copies of the priority documents have been received in Application No.
`
`SD 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)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`2) C] Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date_
`U.S. Patent and Trademark Office
`
`3) E] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20200413
`
`

`

`Application/Control Number: 15/892,181
`Art Unit: 3783
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AIA or AIA Status
`
`The present application, filed on or after March 16, 2013, is being examined under the
`
`first inventor to file provisions of the AIA.
`
`Response to Amendment
`
`The Amendment filed 4/8/2020 has been entered. Claims 1-24 remain pending in the
`
`application. Applicant’s amendments to the Claims have overcome each and every objection
`
`previously set forth in the Final Office Action mailed 1/8/2020.
`
`Continued Examination Under 37 CFR 1. 114
`
`A request for continued examination under 37 CFR 1.114, including the fee set forth in
`
`37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible
`
`for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has
`
`been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37
`
`CFR 1.114. Applicant's submission filed on 4/8/2020 has been entered.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness
`
`rejections set forth in this Office action:
`
`A patent for a claimed invention may not be obtained, notwithstanding that the claimed
`invention is not identically disclosed as set forth in section 102, ifthe differences between the
`claimed invention and the prior art are such that the claimed invention as a whole would have
`been obvious before the effective filing date of the claimed invention to a person having
`ordinary skill in the art to which the claimed invention pertains. Patentability shall not be
`negated by the manner in which the invention was made.
`
`Claims 1, 2, 4, 5, 7, 9, 11 and 12 are rejected under 35 U.S.C. 103 as being
`
`unpatentable over Buehler et al. (US 2008/0097310 A1) in view of Asbaghi (US 5,688,241).
`
`Regarding claim 1, Buehler discloses a tamper-evident closure assembly (figure
`
`3) for use with a medical device 4, the assembly (figure 3) com prising:
`
`

`

`Application/Control Number: 15/892,181
`Art Unit: 3783
`
`Page 3
`
`a connector 2 having a proximal end (end that comes in contact with element 3)
`
`that defines a connection interface (see “CI” in figure 6 below);
`
`a tamper element 6 removably (paragraph 0014) affixed to the connector 2 such
`
`that the tamper element 6 forms one integral piece (paragraph 0014, “break the frangible
`
`connections 7”, according to figure 6, elements 6 and 2 are only connected by element 7
`
`which is frangible and in order to separate elements 6 and 2 from each other, element 7
`
`needs to be broken therefore, it is construed that elements 6 and 2 are connected to one
`
`another via element 7 and therefore, elements 6 and 2 can be construed as one integral
`
`piece prior to breaking element 7) with the connector 2, the tamper element 6 configured
`
`to be separated (paragraph 0014) from the connector 2 upon application of a removal
`
`force; and
`
`a cap 8 having an interior surface (interior surface of element 8) defining a
`
`receptacle (hollow portion inside element 8), the cap 8 being configured to engage with
`
`the tamper element 6, such that at least a portion of the connector 2 is within the
`
`receptacle (hollow portion inside element 8),
`
`wherein upon application of the removal force (paragraph 0014), the tamper
`
`element 6 is separated from the connector 2 and retained within the receptacle (hollow
`
`portion inside element 8) of the cap 8, and the connector 2 being removable from the
`
`receptacle (hollow portion inside element 8, paragraph 0014, figure 7),
`
`wherein the interior surface (interior surface of element 8) of the cap 8 defines a
`
`retention member 9 configured to prevent the tamper element 6 from being removed
`
`from the receptacle (hollow portion inside element 8), the retention member 9 having a
`
`distally facing retaining surface (see “R8” in figure 6 below), the interior surface of the
`
`cap 8 and the retaining surface (see “R8” in figure 6 below) of the retention member 9
`
`defining a locking portion (see “LP” in figure 6 below) of the receptacle, and
`
`

`

`Application/Control Number: 15/892,181
`Art Unit: 3783
`
`Page 4
`
`wherein the tam per element 6 defines a proximally facing surface (surface of
`
`element 10 touching element “R8” in figure 6 below) that is configured to abut the
`
`retaining surface (see “R8” in figure 6 below) to prevent the tamper element from moving
`
`past the retention member 9 out of the locking portion (see “LP” in figure 6 below).
`
`Buehler is silent regarding wherein a proximal end of the tamper element defines a
`
`proximally facing surface.
`
`However, Asbaghi teaches a design of an automatic non-reusable needle guard
`
`having a proximal end (end of element 26 comprising elements 36a-36d) of an element
`
`26 defining a proximally facing surface (surface of elements 36a-36b facing towards
`
`element 16 in figure 3) for the purpose of interacting with the corresponding feature
`
`(column 4, lines 22-32).
`
`Therefore, it would have been prima facie obvious to one of ordinary skill in the
`
`art, before the effective filing of the claimed invention to modify the position of the
`
`proximally facing surface of Buehler to incorporate a proximal end of the element
`
`comprising a proximally facing surface as taught by Asbaghi for the purpose of
`
`interacting with the corresponding feature (column 4, lines 22-32).
`
`It is further construed that Buehler modified in view of Asbaghi would result into
`
`modifying the placement of element 10 of Buehler towards the proximal end of element 6
`
`of Buehler and accordingly element 9 of Buehler inside the element 8 of Buehler would
`
`also be moved to allow proper operation of the device of Buehler.
`
`

`

`Application/Control Number: 15/892,181
`Art Unit: 3783
`
`Page 5
`
`was
`
`
`
`
`Regarding claim 2, Buehler discloses wherein the tamper element 6 is affixed to
`
`the connector 2 via a protrusion 7 extending from the tamper element 6 to the connector
`
`2 such that a gap (see “G” in figure 4 below) is defined between the tam per element 6
`
`and the connector 2.
`
`Regarding claim 4, Buehler discloses wherein the retention member 9 has a
`
`sloped surface (see “88” in figure 6 above) and the retaining surface (see “R8” in figure
`
`6 above) is adjacent the sloped surface (see “88” in figure 6 above), wherein the sloped
`
`surface (see “88” in figure 6 above) is configured to allow the tam per element 6 to
`
`s|idab|y move past the retention member9 into the locking portion (see “LP” in figure 6
`
`above) .
`
`Regarding claim 5, Buehler discloses wherein the tamper element 6 in the
`
`locking portion (see “LP” in figure 6 above) is disposed closerto one end of the cap than
`
`to another end of the cap 8 (figure 6 above).
`
`

`

`Application/Control Number: 15/892,181
`Art Unit: 3783
`
`Page 6
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`Regarding claim 7, Buehler discloses wherein when the tamper element 6 is
`
`separated from the connector 2 and retained within the cap 8, the tamper element 6 is
`
`visible inside the receptacle (hollow portion inside element 8) from at least one angle
`
`(viewing straight inside element 8).
`
`Regarding claim 9, Buehler discloses the claimed invention substantially as
`
`claimed, as set forth above in claim 1. Buehler further discloses wherein the interior
`
`surface of the cap 8 further defines a post (see “P” in figure 6 above) but is silent
`
`regarding a post configured to contact the connector when the connector and the tam per
`
`element are retained in the receptacle of the cap, the post being configured to decrease
`
`movement of the connector within the cap after being inserted into the receptacle.
`
`However, Buehler shows in figure 6 small gap existing between element 2 and
`
`element “P” in figure 6 above as well as element 8 and element 6. Therefore, it is
`
`construed that if element 8 is further pushed towards element 2 such that element 2
`
`contacts element “P” in figure 6 above then element “P” in figure 6 above is configured to
`
`contact the connector 2 when the connector 2 and the tamper element 6 are retained in
`
`the receptacle of the cap 8, the post (see “P” in figure 6 above) being configured to
`
`decrease movement of the connector 2 within the cap 8 after being inserted into the
`
`receptacle for the purpose of limiting the movement of the connector within the cap 8.
`
`Regarding claim 11, Buehler discloses wherein the cap 8 further defines a fitment
`
`9 configured to engage with a housing (housing of element 4, element 8 is indirectly
`
`engaged to element 4 via element 9).
`
`

`

`Application/Control Number: 15/892,181
`Art Unit: 3783
`
`Page 7
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`Regarding claim 12, Buehler discloses wherein the tamper element 6 is a ring
`
`(element 6 can be construed as a ring).
`
`Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Buehler et
`
`al. (US 2008/0097310 A1) in view of Asbaghi (US 5,688,241) as applied to claim 1 above, and
`
`further in view of Ranalletta et al. (US 8,353,869 B2).
`
`Regarding claim 6, Buehler/Asbaghi (hereinafter referred as “modified Buehler”)
`
`discloses the claimed invention substantially as claimed, as set forth above in claims 1
`
`and 4 above. Buehler further discloses wherein the interior surface of the cap 8 further
`
`defines a projection (see “P” in figure 6 above) but is silent regarding a projection
`
`configured to contact the tamper element when the tamper element is within the locking
`
`portion of the receptacle.
`
`However, Ranalletta discloses a design of a syringe needle cap wherein the
`
`interior surface of the cap 10 (figure 5) defines a projection (see “P” in figure 5 below)
`
`configured to contact the tam per element 52 when the tamper element 52 is within the
`
`locking portion 17 of the receptacle (hollow portion inside element 10) for the purpose of
`
`providing support to the tam per element inside the receptacle (figure 5).
`
`Therefore, it would have been prima facie obvious to one of ordinary skill in the
`
`art, before the effective filing of the claimed invention to modify the projection of modified
`
`Buehler to incorporate a projection configured to contact the tamper element when the
`
`tamper element is within the locking portion of the receptacle as taught by Ranalletta for
`
`the purpose of providing support to the tamper element inside the receptacle (figure 5).
`
`Furthermore, in an alternative interpretation of Ranalletta, Ranalletta discloses
`
`projections (see “P1” in figure 5 below) to provide support to the tam per elem ent 52
`
`when the tamper element is within the locking portion of the receptacle. According to
`
`MPEP 2144.04 (V|)(A),
`
`it is obvious to one of ordinary skill in the art to reverse the parts
`
`

`

`Application/Control Number: 15/892,181
`Art Unit: 3783
`
`Page 8
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`thereby having the projections (“P1” in figure 5 below) extending from the cap 10 instead
`
`of the tamper element 52 in order to provide support to the tamper element.
`
`Thus, the cap of Buehler could also be modified to include additional projections
`
`configured to contact the tamper element when the tamper element is within the locking
`
`portion of the receptacle as taught by Ranalletta for the purpose of providing support to
`
`the tamper element inside the receptacle (figure 5).
`
`
`
`SM"
`
`F1135.
`
`Regarding claim 8, Buehler discloses the claimed invention substantially as
`
`claimed, as set forth above in claim 1. Buehler is silent regarding the connection
`
`interface includes a Luer connector.
`
`However, it can be construed that the connection interface (see “CI” in figure 6
`
`above) includes a Luer connector (connection shown by “CI” in figure 6 above).
`
`Furthermore, Ranalleta teaches the connection interface (connection interface at
`
`element 54) includes a |uer connector (column 8, lines 2-4) for the purpose of having an
`
`alternative means for the connection (column 8, lines 2-13).
`
`Therefore, it would have been prima facie obvious to one of ordinary skill in the
`
`art before the effective filing of the claimed invention to modify the connection interface
`
`

`

`Application/Control Number: 15/892,181
`Art Unit: 3783
`
`Page 9
`
`of Buehler to include a Luer connector as taught by Ranalleta for the purpose of having
`
`an alternative means for the connection (column 8, lines 2-13).
`
`Claims 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Buehler et
`
`al. (US 2008/0097310 A1) in view of Asbaghi (US 5,688,241) and further in view of Vitello (US
`
`8,864,021 B1).
`
`Regarding claim 13, Buehler discloses a kit (figure 3) for a tamper-evident
`
`closure assembly (figure 3), the kit comprising:
`
`a connector 2 having a proximal end (end that comes in contact with element 3)
`
`that defines a connection interface (see “CI” in figure 6 above);
`
`a cap 8 having an interior surface (interior surface of element 8) defining a
`
`receptacle (hollow portion inside element 8);
`
`a tamper element 6 affixed to the connector 2 such that the tamper element 6
`
`forms one integral piece (paragraph 0014, “break the frangible connections 7”, according
`
`to figure 6, elements 6 and 2 are only connected by element 7 which is frangible and in
`
`order to separate elements 6 and 2 from each other, element 7 needs to be broken
`
`therefore, it is construed that elements 6 and 2 are connected to one another via
`
`element 7 and therefore, elements 6 and 2 can be construed as one integral piece prior
`
`to breaking element 7) with the connector 2, the tamper element 6 configured to engage
`
`with the cap 8 within the receptacle (hollow portion inside element 8),
`
`wherein the interior surface (interior surface of element 8) of the cap8 defines a
`
`retention member 9 configured to prevent the tamper element 6 from being removed
`
`from the receptacle (hollow portion inside element 8), the retention member9 having a
`
`distally facing retaining surface (see “R8” in figure 6 below), the interior surface of the
`
`cap 8 and the retaining surface (see “R8” in figure 6 below) of the retention mem ber9
`
`defining a locking portion (see “LP” in figure 6 below) of the receptacle, and
`
`

`

`Application/Control Number: 15/892,181
`Art Unit: 3783
`
`Page 10
`
`wherein the tam per element 6 defines a proximally facing surface (surface of
`
`element 10 touching element “R8” in figure 6 below) that is configured to abut the
`
`retaining surface (see “R8” in figure 6 below) to prevent the tamper element from moving
`
`past the retention mem ber9 out of the locking portion (see “LP” in figure 6 below).
`
`Buehler is silent regarding wherein a proximal end of the tamper element defines a
`
`proximally facing surface.
`
`However, Asbaghi teaches a design of an automatic non-reusable needle guard
`
`having a proximal end (end of element 26 comprising elements 36a-36d) of an element
`
`26 defining a proximally facing surface (surface of elements 36a-36b facing towards
`
`element 16 in figure 3) for the purpose of interacting with the corresponding feature
`
`(column 4, lines 22-32).
`
`Therefore, it would have been prima facie obvious to one of ordinary skill in the
`
`art, before the effective filing of the claimed invention to modify the position of the
`
`proximally facing surface of Buehler to incorporate a proximal end of the element
`
`comprising a proximally facing surface as taught by Asbaghi for the purpose of
`
`interacting with the corresponding feature (column 4, lines 22-32).
`
`It is further construed that Buehler modified in view of Asbaghi would result into
`
`modifying the placement of element 10 of Buehler towards the proximal end of element 6
`
`of Buehler and accordingly element 9 of Buehler inside the element 8 of Buehler would
`
`also be moved to allow proper operation of the device of Buehler.
`
`Buehler is further silent regarding a housing configured to receive the cap, the
`
`cap being removably secured to the housing.
`
`However, Vitello teaches a design of a kit (figure 1) comprising closure assembly
`
`com prising a housing 50 configured to receive the cap 20, the cap 20 being removably
`
`secured to the housing 50 (column 11, lines 20-30) for the purpose of facilitating the
`
`storing and shipping of the closure assembly (column 9, lines 56-58) and removing the
`
`

`

`Application/Control Number: 15/892,181
`Art Unit: 3783
`
`Page 11
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`closure assembly without need of touching the closure assembly (column 11, lines 20-
`
`30).
`
`Therefore, it would have been prima facie obvious to one of ordinary skill in the
`
`art, before the effective filing of the claimed invention to modify the kit of Buehler to
`
`incorporate a housing configured to receive the cap, the cap being removably secured to
`
`the housing as taught by Vitello for the purpose of facilitating the storing and shipping of
`
`the closure assembly (column 9, lines 56-58) and removing the closure assembly
`
`without need of touching the closure assembly (column 11, lines 20-30).
`
`Regarding claim 14, Buehler is silent regarding further comprising a plurality of
`
`caps, and wherein the housing is configured to receive any one of the plurality of caps.
`
`However, Vitello teaches further comprising plurality of caps 20 and wherein the
`
`housing 50 is configured to receive any one of the plurality of caps 20 (figure 1) for the
`
`purpose of facilitating the storing and shipping of the closure assembly (column 9, lines
`
`56-58) and facilitating the use of multiple number of caps when needed for multiple
`
`syringes (column 1, lines 50-55)
`
`Therefore, it would have been prima facie obvious to one of ordinary skill in the
`
`art, before the effective filing of the claimed invention to modify the number of caps of
`
`Buehler to incorporate a plurality of caps, and wherein the housing is configured to
`
`receive any one of the plurality of caps as taught by Vitello for the purpose of facilitating
`
`the storing and shipping of the closure assembly (column 9, lines 56-58) and facilitating
`
`the use of multiple number of caps when needed for multiple syringes (column 1, lines
`
`50-55).
`
`Regarding claim 15, Buehler discloses wherein the tamper element 6 is
`
`configured to attach to a medical device 4.
`
`

`

`Application/Control Number: 15/892,181
`Art Unit: 3783
`
`Page 12
`
`Regarding claim 16, Buehler discloses wherein the tamper element is affixed to
`
`the connector 2, the connector being configured to attach to a medical device 4.
`
`Regarding claim 17, Buehler discloses wherein the tamper element 6 is
`
`configured to separate from the connector 2 when a removal force is applied (paragraph
`
`0014) to the tamper element 6 or the connector 2.
`
`Regarding claim 18, Buehler discloses wherein the tamper element 6 is
`
`configured to remain within the receptacle (hollow portion inside element 8) when the
`
`tamper element 6 is separated from the connector 2 (figure 7).
`
`Regarding claim 19, Buehler is silent regarding wherein the cap defines a fitment
`
`and the housing defines a fixture, wherein the fitment is configured to engage with the
`
`fixture, such that the cap is retained in the housing.
`
`However, Vitello teaches wherein the cap 20 defines a fitment 62 and the
`
`housing 50 defines a fixture 64, wherein the fitment 62 is configured to engage with the
`
`fixture 64, suchthat the cap 20 is retained in the housing 50 removing the closure
`
`assembly without need of touching the closure assembly (column 11, lines 20-30).
`
`Therefore, it would have been prima facie obvious to one of ordinary skill in the
`
`art, before the effective filing of the claimed invention to modify the kit of Buehler to
`
`incorporate wherein the cap defines a fitment and the housing defines a fixture, wherein
`
`the fitment is configured to engage with the fixture, such that the cap is retained in the
`
`housing as taught by Vitello for the purpose of removing the closure assembly without
`
`need of touching the closure assembly (column 11, lines 20-30).
`
`

`

`Application/Control Number: 15/892,181
`Art Unit: 3783
`
`Page 13
`
`Regarding claim 20, Buehler is silent regarding wherein the fitment includes a
`
`plurality of teeth and the fixture includes a plurality of teeth, wherein the plurality of teeth
`
`on the fitment of the cap are configured to releasably engage with the plurality of teeth
`
`on the fixture of the housing.
`
`However, Vite||o teaches wherein the fitment 62 includes a plurality of teeth 62
`
`(figure 9) and the fixture 64 includes a plurality of teeth 64, wherein the plurality of teeth
`
`62 on the fitment of the cap 20 are configured to releasably engage with the plurality of
`
`teeth 64 on the fixture of the housing 50 for the purpose of removing the closure
`
`assembly without need of touching the closure assembly (column 11, lines 20-30).
`
`Therefore, it would have been prima facie obvious to one of ordinary skill in the
`
`art, before the effective filing of the claimed invention to modify the kit of Buehler to
`
`incorporate wherein the fitment includes a plurality of teeth and the fixture includes a
`
`plurality of teeth, wherein the plurality of teeth on the fitment of the cap are configured to
`
`releasably engage with the plurality of teeth on the fixture of the housing as taught by
`
`Vite||o for the purpose of removing the closure assembly without need of touching the
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`closure assembly (column 11, lines 20-30).
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`Allowable Subject Matter
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`Claims 3, 10 and 21-24 are allowed.
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`The following is a statement of reasons for the indication of allowable subject matter:
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`The subject matter of the independent claim could either not be found or was not
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`suggested in the prior art of record. The prior art does not disclose or render obvious the
`
`combination as claimed specifically including a tamper-evident closure assembly
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`com prising a connector, a tam per element removably affixed to the connector, a cap
`
`having an interior surface defining a receptacle, wherein the tamper element is affixed to
`
`the connector via a protrusion extending from the tamper element to the connector,
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`wherein the connector further defines a groove configured to receive the protrusion
`
`

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`Application/Control Number: 15/892,181
`Art Unit: 3783
`
`Page 14
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`extending from the tamper element to the connector when the protrusion is affixed to the
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`connector in combination with other claimed limitations of claim 3.
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`The closest prior art for a tamper-evident closure assembly is Buehler et al. (US
`
`20080097310 A1) as discussed in Final Rejection mailed on 1/8/2020 including a
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`connector, a tamper element removably affixed to the connector, a cap having an interior
`
`surface defining a receptacle, wherein the tamper element is affixed to the connector via
`
`a protrusion extending from the tamper element to the connector but is silent regarding
`
`wherein the connector further defines a groove configured to receive the protrusion
`
`extending from the tamper element to the connector when the protrusion is affixed to the
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`connector.
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`Claim 23 being dependent on claim 3 is also indicated allowable.
`
`The subject matter of the independent claim could either not be found or was not
`
`suggested in the prior art of record. The prior art does not disclose or render obvious the
`
`combination as claimed specifically including a tamper-evident closure assembly
`
`com prising a connector, a tam per element, a cap, wherein the cap further includes a first
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`ratcheting ramp configured to contact a corresponding second ratcheting ramp on the
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`connector, wherein when the connector is rotated in screwing direction, the first ratching
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`ramp contacts the second ratcheting ramp on the connector, and when the connector is
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`rotated in an unscrewing direction opposite the screwing direction, the first ratcheting
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`ramp slidably contacts the second ratcheting ramp on the connector in combination with
`
`other claimed limitations of claim 10.
`
`The closest prior art for a tamper-evident closure assembly is Buehler et al. (US
`
`2008/0097310 A1) as discussed in Final Rejection mailed on 1/8/2020 including a
`
`connector, a tam per element, a cap but is silent regarding wherein the cap further
`
`includes a first ratcheting ramp configured to contact a corresponding second ratcheting
`
`

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`Application/Control Number: 15/892,181
`Art Unit: 3783
`
`Page 15
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`ramp on the connector, wherein when the connector is rotated in screwing direction, the
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`first ratching ramp contacts the second ratcheting ramp on the connector, and when the
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`connector is rotated in an unscrewing direction opposite the screwing direction, the first
`
`ratcheting ramp slidably contacts the second ratcheting ramp on the connector.
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`Seltzer et al. (US 4,740,205) discloses the closest prior art for wherein the cap
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`further includes a first ratcheting ramp configured to contact a corresponding second
`
`ratcheting ramp on the connector, wherein when the connector is rotated in screwing
`
`direction, the first ratching ramp contacts the second ratcheting ramp on the connector,
`
`and when the connector is rotated in an unscrewing direction opposite the screwing
`
`direction, the first ratcheting ramp slidably contacts the second ratcheting ramp on the
`
`connector. However, the combination of Buehler and Seltzer would require the
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`interaction between the connector and the cap which will not be possible due to
`
`presence of element 6 in Buehler.
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`Claim 24 being dependent on claim 10 is also indicated allowable.
`
`The subject matter of the independent claim could either not be found or was not
`
`suggested in the prior art of record. The prior art does not disclose or render obvious the
`
`combination as claimed specifically including a tamper-evident closure com prising a
`
`connector having a proximal end that defines a connection interface, a tamper element
`
`removably affixed to the connector, a cap having an interior surface, wherein the interior
`
`surface of the cap defines a retention member, wherein the tamper element is affixed to
`
`the connector via a protrusion extending from the tamper element to the connector, and
`
`wherein the protrusion is disposed distally of the retention member in combination with
`
`other claimed limitations of claim 21.
`
`The closest prior art for a tamper-evident closure assembly is Buehler et al. (US
`
`2008/0097310 A1) including a connector having a proximal end that defines a
`
`

`

`Application/Control Number: 15/892,181
`Art Unit: 3783
`
`Page 16
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`connection interface, a tamper element removably affixed to the connector, a cap having
`
`an interior surface, wherein the interior surface of the cap defines a retention member,
`
`wherein the tamper element is affixed to the connector via a protrusion extending from
`
`the tamper element to the connector but is silent regarding wherein the protrusion is
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`disposed distally of the retention member.
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`Claim 22 being dependent on claim 21 is indicated allowable.
`
`Response to Arguments
`
`Applicant’s arguments, see page 11, filed 4/8/2020, with respect to the rejection(s) of
`
`claim(s) 10 under Buehler et al. (US 2008/0097310 A1) in view of Seltzer et al. (US 4,740,205)
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`have been fully considered and are persuasive. The rejection of claim 10 has been withdrawn.
`
`Applicant’s arguments with respect to claim 1 have been considered but are moot
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`because the arguments do not apply in view of the present rejection.
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the examiner
`
`should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The
`
`examiner can normally be reached on IVbnday-Thursday 8:00 AM-4:30 PM EST.
`
`Examiner interviews are available via telephone, in-person, and video conferencing
`
`using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is
`
`encouraged to use the USPTO Automated Interview Request (AIR) at
`
`http://www.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Bhisma IVlehta can be reached on (571) 272-3383. The fax phone number for the
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`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
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`

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`Application/Control Number: 15/892,181
`Art Unit: 3783
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`Page 17
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`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
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