UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
`
`15/476,655
`
`03/31/2017
`
`Chunhua LI
`
`22773-826401
`
`5936
`
`WSGR / Ahgn Technology , Inc.
`650 Page Mill Road
`Palo Alto, CA 94304
`
`MONTIEL' CAROLINE
`
`ART UNIT
`
`1748
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`12/12/2019
`
`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):
`
`patentdocket@ wsgr.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`017/09 A0170” Summary
`
`Application No.
`15/476,655
`Examiner
`CAROLINE MONTIEL
`
`Applicant(s)
`Li et al.
`Art Unit
`1748
`
`AIA (FITF) Status
`No
`
`- 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 g 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 9/16/2019.
`CI A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2a). This action is FINAL.
`
`2b) D 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)
`
`20—39 is/are pending in the application.
`
`5a) Of the above claim(s)
`
`is/are withdrawn from consideration.
`
`
`
`[:1 Claim(ss)
`
`is/are allowed.
`
`8)
`Claim(s 2_0—39 Is/are rejected
`
`D Claim(ss_) is/are objected to.
`
`) ) ) )
`
`S)
`are subject to restriction and/or election requirement
`[:1 Claim(s
`* If any claims have been determined aflowable. 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.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPeredback@uspto.gov.
`
`Application Papers
`
`10)|:I The specification is objected to by the Examiner.
`
`11). The drawing(s) filed on 3/31/2017 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)D 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.[:] Certified copies of the priority documents have been received.
`
`2C] Certified copies of the priority documents have been received in Application No.
`
`3D 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)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date 3/12/2109: 9/16/2019.
`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 20190924
`
`

`

`Application/Control Number: 15/476,655
`Art Unit: 1748
`
`Page 2
`
`DETAILED ACTION
`
`1.
`
`2.
`
`3.
`
`The communication dated 9/ 16/2019 has been entered and fully considered.
`
`Claims 20—24, 26, and 29 have been amended. Claims 31—39 are new.
`
`The present application is being examined under the pre—AIA first to invent provisions.
`
`Response to Amendment and Arguments
`
`4.
`
`The reference is a statutory bar under pre—AIA 35 U.S.C. 102(b) and thus cannot be
`
`overcome by an affidavit or declaration under 37 CFR 1.131(a).
`
`5.
`
`The declaration under 37 CFR 1.132 filed 9/16/2019 is insufficient
`
`to overcome the
`
`rejection of claim 20 and 37 based upon DESIMONE as set forth in the current Office action
`
`below because: facts presented are not germane to the rejection below and DESIMONE is in the
`
`same field of endeavor, dental appliances, and teaches the desirable properties.
`
`6.
`
`Furthermore, DESIMONE is 102(b) for claims 20 and 37, but regarding the dependent
`
`claims, the Examiner would add the following:
`
`a.
`
`The Applicant has not shown EX30, the standard, is commensurate in scope with
`
`DESIMONE and CHEN because DESIMONE and CHEN teach at least two layer devices
`
`compared to the EX30, which is a single polyurethane [paragraph 4 of declaration]. In
`
`paragraphs 4 and 5 of the declaration,
`
`it is stated that none of the materials generically or
`
`specifically described in DESIMONE or CHEN would have yielded an orthodontic
`
`device having sufficient elongation,
`
`time stress—relaxation, durability, and thermoform
`
`ability; however, there is not data shown in regards to these properties.
`
`b.
`
`Furthermore, Applicant argues there is a sole exemplified multilayer material
`
`described in CHEN; however, CHEN further teaches that the various inner and outer
`
`

`

`Application/Control Number: 15/476,655
`Art Unit: 1748
`
`Page 3
`
`layers can be made from a homopolymer, cross—linked homopolymer, copolymer,
`
`polycarbonate, cross—linked copolymer, a copolymer blend of thermoplastics, and/or
`
`similar material [0036]. Also, the Applicant argues that the PVC and polycarbonate
`
`layers of CHEN are unsuitable, but has not provided any evidence supporting that it is
`
`unsuitable. How are these layers inadequate?
`
`c.
`
`ST30 shows improved results, but it is not clear what the polymer layers are
`
`composed of or what physical properties they have. The Applicant has provided no
`
`evidence to support ST30 being commensurate in scope to the claimed invention.
`
`Furthermore, while Applicant tried many combinations, one of ordinary skill
`
`in the art
`
`would have had the benefit of the disclosure of CHEN and DESIMONE, which teaches
`
`multilayered devices and various properties. Applicant has provided no specific scientific
`
`evidence or evidence of laboratory hardship to support that one of ordinary skill
`
`in the art
`
`would have expected failure and has further provided no evidence that the skilled artisan
`
`would have expected failure given the benefit of the teachings of CHEN and
`
`DESIMONE. Also, it is not clear that the layers of CHEN and DESIMONE would not
`
`have given the same results of ST30 as no data was given regarding the composition of
`
`ST30. One of ordinary skill would have been motivated and have tried a soft layer and a
`
`hard layer device based on DESIMONE and CHEN teachings, and the Applicant has
`
`provided no evidence to refute that the motivation provided by CHEN and DESIMONE
`
`would have been inadequate to support combining elements as presented in the rejection.
`
`There is nothing in DESIMONE and CHEN that would lead one of ordinary skill
`
`in the
`
`art to expect that undue experimentation would be necessary to combine the teachings set
`
`

`

`Application/Control Number: 15/476,655
`Art Unit: 1748
`
`Page 4
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`forth in the rejection as both DESIMONE and CHEN teach exemplified layers and
`
`suitable materials for each layer.
`
`d.
`
`The Applicant argues that ST30 as a single hard layer and single soft layer would
`
`also exhibit beneficial functions, as stated in paragraphs 15 and 18, but offers no
`
`evidence. ST30 is a construction of a hard layer disposed between two soft layers. At
`
`best, the Applicant has shown that this provides improvements over a single polyurethane
`
`layer. Furthermore, the declaration states that one would also expected an appliance with
`
`layers of a single hard polymer material and a single soft polymer material to exhibit
`
`beneficial performance relative to EX30 appliances; therefore, DESIMONE would be
`
`expected to have beneficial performance and also the same properties as ST30 [paragraph
`
`18 of the declaration].
`
`Claim Rejections - 35 USC § 102
`
`1.
`
`In the event the determination of the status of the application as subject to AIA 35 U.S.C.
`
`102 and 103 (or as subject to pre—AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the
`
`statutory basis for the rejection will not be considered a new ground of rejection if the prior art
`
`relied upon, and the rationale supporting the rejection, would be the same under either status.
`
`2.
`
`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.
`
`

`

`Application/Control Number: 15/476,655
`Art Unit: 1748
`
`Page 5
`
`3.
`
`Claim(s) 20-21, 23, 25-30 and 37-39 are rejected underpre-AIA 35 U.S.C. 102(b) as
`
`being anticipated by De Simone et al. (US. 7,641,828), hereinafterDESIMONE, considered
`
`With Pudleiner et al. (US. PGPUB 2015/0140300), hereinafter PUDLEINER.
`
`4.
`
`Regarding claim 20,DESIMONE teaches: A method ofmaking a dental appliancefor
`
`positioning a patient's teeth (DESIMONE teaches methods of making dental appliances for
`
`moving patient’s teeth [Abstract]), the method comprising: providing a sheet comprising
`
`(DESIMONE teaches providing a sheet [Col 1, lines 64—67 — Col. 2, lines 1—3; claim 1]): a hard
`
`polymer layer ofa hardpolymeric material comprising aflexural modulus greater than about
`
`I 5 0, 000 psi (DESIMONE teaches a hard polymer layer (first transparent material: Col. 9, lines
`
`30—37) comprising aflexural modulus greater than 200,000 psi [Col 2, lines 16—29], which is
`
`within the claimed range); and a softpolymer layer ofa softpolymeric material (DESIMONE
`
`teaches a soft polymer layer (the coating of a second transparent material) [Col 2, lines 42—48].)
`
`comprising an elongation at break ofgreater than about 200% (DESIMONE teaches the soft
`
`polymer layer has an elongation at break of greater than 80%, which encompasses the claim
`
`[Col 2, lines 5065]), and a hardnessfrom about 60 A to about 85 D (DESIMONE teaches using
`
`a layer of the second transparent material, which Examiner is interpreting as the soft polymer
`
`layer includes ISOPLAST 2530 [Col 10, lines 14—20], which has a hardness of 82D, which is
`
`within the claimed range, shown by PUDLEINER [0142]); providing a positive model of the
`
`patient ’s teeth in a targetposition (DESIMONE teaches positive tooth models of a patient's teeth
`
`using intermediate and final data sets, examiner is interpreting the intermediate and final data
`
`sets as target positions [Col 3, lines 53—67—Col. 4, lines l—7]); and fabricating an appliance as a
`
`negative of the positive model comprising thermoforming the sheet over the positive model
`
`(DESIMONE further teaches fabricating positioning appliances with a molding machine that
`
`

`

`Application/Control Number: 15/476,655
`Art Unit: 1748
`
`Page 6
`
`produces shells of dental appliances from a thermoformable material [C01, 4, lines 3—12,
`
`examiner is interpreting the shells as negatives of the positive models]).
`
`5.
`
`Regarding claim 21,DESIMONE teaches: wherein the hardpolymer layer comprises a
`
`layer ofa polyester, a co-polyester, apolycarbonate, a thermoplastic polyurethane, a
`
`polypropylene, apolyethylene, apolypropylene andpolyethylene copolymer, an acrylic, a cyclic
`
`block copolymer, apolyetheretherketone, apolyamide, apolyethylene terephthalate, a
`
`polybutylene terephthalate, apolyetherimide, apolyethersulfone, apolytrimethylene
`
`terephthalate, or a combination thereof (DESIMONE teaches the hard polymer layer (first
`
`transparent layer) used may be polyesters [C01, 9, lines 10— 17]).
`
`6.
`
`Regarding claim 23, DESIMONE teaches: wherein the soft polymeric material comprises
`
`a styrenic block copolymer, a silicone rubber, an elastomeric alloy, a thermoplastic elastomer, a
`
`thermoplastic vulcanizate elastomer, apolyurethane elastomer, a block copolymer elastomer, a
`
`polyolefin blend elastomer, a thermoplastic co-polyester elastomer, a thermoplastic polyamide
`
`elastomer, or a combination thereof (DESIMONE teaches the soft polymeric material (second
`
`transparent material) can be silicone, which Examiner is interpreting as silicone rubber [C01, 9,
`
`lines 66—67 — Col. 10, lines 1—5]).
`
`7.
`
`Regarding claim 25,DESIMONE further teaches: wherein the hard polymer layer
`
`comprises at least one ofa tensile strength atyield ofbetween about 4000pounds psi and 6500
`
`psi, an elongation at yield ofgreater than about 4%, an elongation at break ofgreater than
`
`about 70%, a tensile modulus ofgreater than about 150, 000psi, aflexural modulus greater than
`
`about 150,000 psi, a stress relaxation greater than about 10% at 24 hours testing in a wet
`
`environment, and a light transmission between 400 nm and 800 nm ofgreater than about 75%
`
`(DESIMONE teaches a transparent polymeric material preferably having a tensile strength at
`
`

`

`Application/Control Number: 15/476,655
`Art Unit: 1748
`
`Page 7
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`yield of greater than 6,000 psi, which overlaps with the claimed tensile strength at yield of
`
`between about 4000 psi and 6500 psi [Col. 7, lines 42—44, examiner is interpreting transparent
`
`polymeric material as a hard polymer layer as DESIMONE states thermoplastic polyurethanes
`
`can be used]).
`
`8.
`
`Regarding claim 26, DESIMONE teaches: wherein the soft polymer layer comprises at
`
`least one ofan ultimate tensile strength ofgreater than about 5000psi, a compression set at
`
`about 70 OC ofgreater than 40% after 24 hours, aflexural modulus ofgreater than about 35, 000
`
`psi, and a light transmission between 400 nm and 800 nm ofgreater than about 75%
`
`(DESIMONE teaches the coating (soft polymer layer) has a flexural modulus of greater than
`
`200,000 psi, which is Within the claimed range [Col. 2, lines 50—56]).
`
`9.
`
`Regarding claim 27, DESIMONE further teaches: further comprising fabricating a
`
`plurality ofappliances corresponding to different arrangements of the patient's teeth
`
`(DESIMONE teaches fabricating a plurality of appliances based on different arrangements of the
`
`patient's teeth [Col. 3, 53—67—Col. 4, lines l—7]).
`
`10.
`
`Regarding claim 28, DESIMONE further teaches: wherein fabricating the plurality of
`
`appliances comprises digitally staging a plurality ofdigital models of the patient's teeth and
`
`generating aplurality ofphysical modelsfrom the digital models (DESIMONE teaches digitally
`
`staging aplurality of digital models of the patient's teeth [Col 3, lines 53—67] and fabricating a
`
`plurality of appliances [Col 4, lines 7—8]).
`
`ll.
`
`Regarding claim 29, DESIMONE teaches: wherein two or more ofthe plurality of
`
`appliances comprise a sheet comprising the hardpolymer layer of the hardpolymeric material
`
`and the softpolymer layer of the softpolymeric material (DESIMONE teaches a plurality of
`
`appliances [Col. 4, lines 7—12]. DESIMONE further teaches the appliance has ahard polymer
`
`

`

`Application/Control Number: 15/476,655
`Art Unit: 1748
`
`Page 8
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`layer made of polymeric material [first transparent material: Col. 9, lines 30—37] and a soft
`
`polymer layer (coating of a second transparent material) [Col 2, lines 42—48]).
`
`12.
`
`Regarding claim 30,DESIMONE further teaches: wherein the hard polymer layer
`
`comprises aplurality ofco-extruded or laminatedpolymer layers (DESIMONE teaches other
`
`materials that can be formed and annealed include laminates and/or blends of transparent
`
`polymeric material [Col 7, lines 24—35]).
`
`13.
`
`Regarding claim 37,DESIMONE teaches: A method ofmaking aplurality ofdental
`
`appliancesfor positioning a patient ’s teeth (DESIMONE teaches methods of making dental
`
`appliances for moving patient’s teeth [Abstract]), the method comprising: providing a sheet
`
`(DESIMONE teaches providing a sheet [Col 1, lines 64—67 — Col. 2, lines 1—3; claim 1])
`
`comprising: a hardpolymer layer ofa hardpolymeric material comprising aflexural modulus
`
`greater than about I 5 0,000 psi (DESIMONE teaches a hard polymer layer (first transparent
`
`material: Col. 9, lines 30—37) comprising a flexural modulus greater than 200,000 psi [Col 2,
`
`lines 16—29], which is within the claimed range); and a softpolymer layer ofa softpolymeric
`
`material (DESIMONE teaches a soft polymer layer (the coating of a second transparent material)
`
`[Col 2, lines 42—48]) comprising an elongation at break ofgreater than about200%
`
`(DESIMONE teaches the soft polymer layer has an elongation at break of greater than 80%,
`
`which encompasses the claim [Col 2, lines 50—55]), and a hardnessfrom about 60A to about 85
`
`D (DESIMONE teaches using a layer of the second transparent material, which Examiner is
`
`interpreting as the soft polymer layer includes ISOPLAST 2530 [Col 10, lines 14—20], which has
`
`a hardness of 82D, which is within the claimed range, as evidenced by PUDLEINER [0142]);
`
`providing a plurality ofpositive models ofthe patient ’s teeth, each in a targetposition
`
`(DESIMONE teaches positive tooth models of a patient's teeth using intermediate and final data
`
`

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`
`Page 9
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`sets, examiner is interpreting the intermediate and final data sets as target positions [Col. 3, lines
`
`53—67—Col. 4, lines l—7]); andfabricating the plurality ofdentalappliances, each as a negative of
`
`at least one of the plurality ofpositive models comprising thermoforming the sheet over the at
`
`least one positive model (DESIMONE teaches fabricating positioning appliances with a molding
`
`machine that produces shells of dental appliances from a thermoformable material [Col. 4, lines
`
`3—12, examiner is interpreting the shells as negatives of the positive models]. DESIMONE
`
`further teaches aplurality of appliances [Col. 4, lines 7—12].).
`
`14.
`
`Regarding claim 38, DESIMONE teaches: wherein the hard polymeric material
`
`comprises a polyester, a co-polyester, apolycarbonate, a thermoplasticpolyurethane, a
`
`polypropylene, apolyethylene, apolypropylene andpolyethylene copolymer, an acrylic, a cyclic
`
`block copolymer, apolyetheretherketone, apolyamide, apolyethylene terephthalate, a
`
`polybutylene terephthalate, apolyetherimide, apolyethersulfone, apolytrimethylene
`
`terephthalate, or a combination thereof (DESIMONE teaches the hard polymer layer (first
`
`transparent layer) used may be polyesters [Col. 9, lines 10— 17]).
`
`15.
`
`Regarding claim 39,DESIMONE teaches: styrenic block copolymer (SBC), a silicone
`
`rubber, an elastomeric alloy, a thermoplastic elastomer, a thermoplastic vulcanizate elastomer,
`
`a polyurethane elastomer, a block copolymer elastomer, apolyolefin blend elastomer, a
`
`thermoplastic co -polyester elastomer, a thermoplastic polyamide elastomer, or a combination
`
`thereof (DESIMONE teaches the soft polymeric material (second transparent material) can be
`
`silicone, which Examiner is interpreting as silicone rubber [Col. 9, lines 66—67 — Col. 10, lines 1—
`
`5]).
`
`

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`Application/Control Number: 15/476,655
`Art Unit: 1748
`
`Page 10
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`Claim Rejections - 35 USC § 103
`
`16.
`
`In the event the determination of the status of the application as subject to AIA 35 U.S.C.
`
`102 and 103 (or as subject to pre—AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the
`
`statutory basis for the rejection will not be considered a new ground of rejection if the prior art
`
`relied upon, and the rationale supporting the rejection, would be the same under either status.
`
`17.
`
`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, 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.
`
`18.
`
`Claims 22, 24 and 31-36 are rejected under pre -AIA 35 U.S.C. 103(a) as being
`
`unpate ntable over De Simone et al. (U.S. 7,641,828), hereinafter DESIMONE, considered
`
`With Pudleineret al. (U.S. PGPUB 2015/0140300), hereinafterPUDLEINER, in Viewof
`
`Chen et al. (U.S. PGPUB 2009/0246724), hereinafter CHEN (DESIM ONE and CHEN are
`
`provided in the IDS of 3/3 1/2017).
`
`19.
`
`Regarding claim 22,DESIMONE teaches all the limitations of the claimed invention as
`
`stated above, but fails to teach wherein the hard polymer layer comprises at least two layers. In
`
`the same field of endeavor, dental appliances, CHEN teaches: wherein the hard polymer layer
`
`comprises at least two layers and the at least two layers are independently selectedfroma group
`
`consisting ofa polyester, a co -polyester, a polycarbonate, a thermoplastic polyurethane, a
`
`polypropylene, apolyethylene, apolypropylene andpolyethylene copolymer, an acrylic, a cyclic
`
`block copolymer, apolyetheretherketone, apolyamide, apolyethylene terephthalate, a
`
`polybatylene terephthalate, apolyetherimide, apolyethersnlfone, and apolytrimethylene
`
`terephthalate (CHEN teaches the hard polymer layer comprises of at least two layers (Figs. 4A—
`
`

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`
`Page 11
`
`4D; 5; [0031—0033; 0035—0036], examiner is interpreting inner layers (132,150) as hard polymer
`
`layer). CHEN further teaches a hard polymer layer being a polycarbonate ([0036], examiner is
`
`interpreting inner layers (150) as hard polymer layer)). It would have been obvious to one of
`
`ordinary skill in the art at the time of the filing date of applicant’s invention to modify
`
`DESIMONE with two hard layers, as suggested by CHEN, in order to have variable glass
`
`transition temperatures and various orientations and configurations to suit the modulus and
`
`application requirements [0031].
`
`20.
`
`Regarding claim 24, DESIMONE teaches: wherein at least one of the first soft polymer
`
`layer and the second softpolymer layer comprises at least two layers, and wherein the at least
`
`two layers are independently selectedfrom the group consisting ofa styrenic block copolymer
`
`(SBC), a silicone rubber, an elastomeric alloy, a thermoplastic elastomer (TPE), a thermoplastic
`
`vulcanizate (TPV) elastomer, apolyurethane elastomer, a block copolymer elastomer, a
`
`polyolefin blend elastomer, a thermoplastic co-polyester elastomer, or a thermoplastic
`
`polyamide elastomer (DESIMONE teaches the soft polymer layer (second transparent material)
`
`is made of silicone, which Examiner is interpreting as silicone rubber [Col. 9, lines 66—67 —Col.
`
`10, lines 1—5]. It would have been obvious to one of ordinary skill
`
`in the art at the time of the
`
`effective filing date of applicant’s invention to duplicate the soft layer into two layers, since it
`
`has been held that a mere duplication of working parts of a device involves only routine skill in
`
`the art. In re Harza,274 F.2d 669, 124 USPQ 378 (CCPA 1960)).
`
`21.
`
`In the alternative, CHEN teaches having at least two soft layers [Figs. 4A—4D; 0030—
`
`0031]. CHEN further teaches the soft polymer can be a copolymer blend of thermoplastics
`
`[0036], examiner is interpreting outer layers (152, 134) as soft polymer layer. CHEN further
`
`teaches thermoplastic elastomer can be used for the appliance [0025; Figs. 4A—4C, 5]. It would
`
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`
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`have been obvious to one of ordinary skill
`
`in the art at the time of the filing date of applicant’s
`
`invention to modify DESIMONE with two layers in the soft polymer layer, as suggested by
`
`CHEN, in order to have variable glass transition temperatures and various orientations and
`
`configurations to suit the modulus and application requirements [0031].
`
`22.
`
`Regarding claim 31,DESIMONE teaches all the limitations of the claimed invention as
`
`stated above, but fails to teach wherein the appliance comprises three or more polymer layers. In
`
`the same field of endeavor, dental appliances, CHEN teaches: wherein the appliance comprises
`
`three or more polymer layers, the three or more layers comprising the hardpolymer layer and
`
`the soft polymer layer (CHEN teaches an appliance with three or more polymer layers [Fig. 4A—
`
`4C]. CHEN further teaches the layers comprise a hard polymer layer and a soft polymer layer
`
`[0026]). It would have been obvious to one of ordinary skill in the art at the time of the filing
`
`date of applicant’s invention to modify DESIMONE with several polymer layers in the
`
`appliance, as suggested by CHEN, in order to have variable glass transition temperatures and
`
`various orientations and configurations to suit the modulus and application requirements [0031].
`
`23.
`
`Regarding claims 32-33, DESIMONE teaches all the limitations of the claimed invention
`
`as stated above, but fails to teach wherein the layers alternate. In the same field of endeavor,
`
`dental appliances, CHEN teaches the layers alternate between the soft layers (outer layers) and
`
`the hard layer (inner layers) [Figs. 4A—4C] and the hard layer is adjacent to the polymer layers
`
`[Figs 4A—4C; 0032; 0036]. It would have been obvious to one of ordinary skill
`
`in the art at the
`
`time of the filing date of applicant’s invention to modify DESIMONE with several polymer
`
`layers in the appliance and alternate the layers, as suggested by CHEN, in order to have variable
`
`glass transition temperatures and various orientations and configurations to suit the modulus and
`
`

`

`Application/Control Number: 15/476,655
`Art Unit: 1748
`
`Page 13
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`application requirements [0031] and for the harder segment to control the restoration of an
`
`original shape [0026].
`
`24.
`
`Regarding claim 34,DESIMONE teaches all the limitations of the claimed invention as
`
`stated above, including a hard layer and a soft layer comprising an elongation at break of greater
`
`than about 200% [Col. 2, lines 50—55] and a hardness from about 60 A to about 85 D (soft
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`polymer layer includes ISOPLAST 2530 [Col. 10, lines 14—20], which has a hardness of 82D,
`
`which is within the claimed range, as shown by PUDLEINER [0142]). Furthermore, It would
`
`have been obvious to one of ordinary skill
`
`in the art at the time of the effective filing date of
`
`applicant’s invention to duplicate the soft layer into two layers with the same properties, since it
`
`has been held that a mere duplication of working parts of a device involves only routine skill in
`
`the art. In re Harza,274 F.2d 669, 124 USPQ 378 (CCPA 1960).
`
`25.
`
`DESIMONE fails to teach wherein the hard polymer layer is disposed between the soft
`
`polymer layer and a second soft polymer layer. In the same field of endeavor, dental appliances,
`
`CHEN teaches wherein the hardpolymer layeris disposed between the softpolymer layer and a
`
`second soft polymer layer [Figs. 4A—4C]. It would have been obvious to one of ordinary skill
`
`in
`
`the art at the time of the filing date of applicant’s invention to modify DESIMONE with a hard
`
`layer disposed between two soft layers, as suggested by CHEN, in order to have variable glass
`
`transition temperatures and various orientations and configurations to suit the modulus and
`
`application requirements [0031].
`
`26.
`
`Regarding claim 35,DESIMONE teaches all the limitations of the claimed invention as
`
`stated above, but fails to teach wherein the appliance comprises a co—extruded material. In the
`
`same field of endeavor, dental appliances, CHEN teaches the layers may be formed by a process,
`
`such as thermoforming or similar process, such as co—extrusion, lamination or any other process
`
`

`

`Application/Control Number: 15/476,655
`Art Unit: 1748
`
`Page 14
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`where layers are formed [0031]. It would have been obvious to one of ordinary skill in the art at
`
`the time of the effective filing date of the applicant’s invention to have the layers co—extruded
`
`since it is known in the art that layers can be made by co—extrusion.
`
`"The combination of familiar elements according to known methods is likely to be
`
`obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127
`
`S.Ct. 1727, 82 USPQ2d 1385 (2007).
`
`27.
`
`Regarding claim 36,DESIMONE teaches all the limitations of the claimed invention as
`
`stated above, but fails to teach wherein the hard polymer layer comprises at least two layers. In
`
`the same field of endeavor, dental appliances, CHEN teaches: wherein the appliance comprises a
`
`thickness between 500 pm and 1200pm (CHEN teaches an appliance with three or more layers
`
`and that the inner layers (132) as well as the outer layers (134) may each have different
`
`thicknesses, such as 5 or 10 mils [0030—0031]. Fig. 4C shows an appliance with two inner layers
`
`and two outer layers. If each layer is 10 mils, then all the layers together form the appliance and
`
`the appliance would have a thickness of 1016 um (10 mils = 254 pm), which meets the claimed
`
`range). It would have been obvious to one of ordinary skill
`
`in the art at the time of the filing date
`
`of applicant’s invention to modify DESIMONE by having the appliance thickness about 1016
`
`pm, as suggested by CHEN, in order to have variable glass transition temperatures and various
`
`orientations and configurations to suit the modulus and application requirements [0031] and have
`
`variable thickness depending on the modulus requirements [0036].
`
`Conclusion
`
`Applicant's amendment necessitated the new ground(s) of rejection presented in 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).
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`

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`Application/Control Number: 15/476,655
`Art Unit: 1748
`
`Page 15
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`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 l.l36(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.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to CAROLINE MONTIEL whose telephone number is (571)272—
`
`2529. The examiner can normally be reached on MONDAY — FRIDAY 8:30 A.M. — 5:00 P.M.
`
`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
`
`htth/www.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, ABBAS RASHID can be reached on (571) 270—7457. The fax phone number for the
`
`organization where this application or proceeding is assigned is 571—273—8300.
`
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`
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`
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`
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