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
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`DELIVERY MODE
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`03/ 14/20 1 9
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`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
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`following e—mail address(es):
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`patentdocket@ wsgr.com
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`PTOL-90A (Rev. 04/07)
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`

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`0/7709 A0170” Summary
`
`Application No.
`15/476,655
`Examiner
`Caroline Montiel
`
`Applicant(s)
`Li et al.
`Art Unit
`1748
`
`AIA (FITF) Status
`No
`
`- 7'/7e MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
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`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
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`1). Responsive to communication(s) filed on 4/3/2017.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a)D This action is FINAL.
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`2b)
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`This action is non-final.
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`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.
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`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 Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
`5)
`Claim(s)
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`20—30 is/are pending in the application.
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`5a) Of the above claim(s)
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`is/are withdrawn from consideration.
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`E] Claim(s)
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`is/are allowed.
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`Claim(s) 20—30 is/are rejected.
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`[:1 Claim(s)
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`is/are objected to.
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`) ) ) )
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`6 7
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`8
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`
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`are subject to restriction and/or election requirement
`[j Claim(s)
`9
`* If any claims have been determined aflowabie. you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
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`http://www.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPeredback@uspto.gov.
`
`Application Papers
`10)[:] The specification is objected to by the Examiner.
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`11)[:] The drawing(s) filed on
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`is/are: a)D accepted or b)l:] objected to by the Examiner.
`
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12):] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
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`a)D All
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`b)I:J Some**
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`c)C] None of the:
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`1.[:] Certified copies of the priority documents have been received.
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`2.[:] Certified copies of the priority documents have been received in Application No.
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`3.[:] Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`
`** See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1)
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`Notice of References Cited (PTO-892)
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`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) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20190306
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`

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`Application/Control Number: 15/476,655
`Art Unit: 1748
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`Page 2
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`DETAILED ACTION
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`1.
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`2.
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`3.
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`The communication dated 4/3/2017 has been entered and fully considered.
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`Claims 20—30 are pending.
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`The present application is being examined under the pre—AIA first to invent provisions.
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`Claim Rejections - 35 US C § 103
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`4.
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`In the event the determination of the status of the application as subject to AIA 35 U.S.C.
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`102 and 103 (or as subject to pre—AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the
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`statutory basis for the rejection will not be considered a new ground of rejection if the prior art
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`relied upon, and the rationale supporting the rejection, would be the same under either status.
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`5.
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`The following is a quotation of pre—AIA 35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(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.
`
`6.
`
`Claims 20-25 and 27-30 are rejected under pre-AIA 35 U.S.C. 103(a) as being
`
`unpatentable over Chen et al. (US. PGPUB 2009/0246724), hereinafter CHEN, and
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`DeSimone et al. (US. 7,641,828), hereinafter DESIMONE (CHEN and DESIMONE are
`
`provided in the IDS of 3/31/2017).
`
`7.
`
`Regarding claim 20, CHEN teaches: A method of making a dental appliance for
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`positioning a patient's teeth, the method comprising (CHEN teaches a method of making a dental
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`appliance [0014—0017]): providing a sheet comprising a hard polymer layer ofpolymeric
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`material disposed between a first soft polymer layer and a second soft polymer layer (CHEN
`
`teaches an appliance (100) with a hard inner polymer layer (132) having a hard polymer layer
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`elastic modulus [Fig. 4C; 0032;0036]. CHEN further teaches a first and second soft outer
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`

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`Application/Control Number: 15/476,655
`Art Unit: 1748
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`Page 3
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`polymer layer (134), each having soft polymer elastic modulus less than the hard polymer layer
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`elastic modulus [Fig. 4C; 0003; 0032; 0036]).
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`8.
`
`CHEN is silent as to providing a positive model of the patient’s teach in a target position
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`and fabricating an appliance as a negative of the positive model. In the same field of endeavor,
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`dental appliances, DESIMONE teaches positive tooth models of a patient's teeth using
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`intermediate and final data sets, examiner is interpreting the intermediate and final data sets as
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`target positions [Col. 3, lines 53—67—Col. 4, lines 1—7]. DESIMONE further teaches fabricating
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`positioning appliances with a molding machine that produces shells of dental appliances from a
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`thermoformable material [Col. 4, lines 3—12, examiner is interpreting the shells as negatives of
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`the positive models]. It would have been obvious to one of ordinary skill in the art at the time of
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`applicant’s invention to modify CHEN by providing a positive model of the patient’s teach in a
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`target position and fabricating an appliance as a negative of the positive model, as suggested by
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`DESIMONE, in order to progressively reposition teeth from a first initial arrangement to a final
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`tooth arrangement in the patient's mouth (Col. 3, lines 36—5 1).
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`9.
`
`Regarding claim 21, CHEN teaches: wherein the hard polymer layer comprises a layer of
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`a polyester, a co-polyester, a polycarbonate, a thermoplastic polyurethane, a polypropylene, a
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`polyethylene, a polypropylene and polyethylene copolymer, an acrylic, a cyclic block copolymer,
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`a polyetheretherketone, a polyamide, a polyethylene terephthalate, a polybutylene terephthalate,
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`a polyetherimide, a polyethersulfone, a polytrimethylene terephthalate, or a combination thereof
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`(CHEN teaches a hard polymer layer being a polycarbonate ([0036], examiner is interpreting
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`inner layers (150) as hard polymer layer)).
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`10.
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`Regarding claim 22, CHEN teaches: wherein the hard polymer layer comprises at least
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`two layers and the at least two layers are independently selected from a group consisting of a
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`

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`Application/Control Number: 15/476,655
`Art Unit: 1748
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`Page 4
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`polyester, a co-polyester, a polycarbonate, a thermoplastic polyurethane, a polypropylene, a
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`polyethylene, a polypropylene and polyethylene copolymer, an acrylic, a cyclic block copolymer,
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`a polyetheretherketone, a polyamide, a polyethylene terephthalate, a polybutylene terephthalate,
`
`a polyetherimide, a polyethersulfone, and a polytrimethylene terephthalate (CHEN teaches the
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`hard polymer layer comprises of at least two layers (Figs. 4A—4D; 5; [0031-0033; 0035—0036],
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`examiner is interpreting inner layers (132,150) as hard polymer layer). CHEN teaches a hard
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`polymer layer being a polycarbonate ([0036], examiner is interpreting inner layers (150) as hard
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`polymer layer)).
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`11.
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`Regarding claim 23, CHEN teaches: wherein each of the first soft polymer layer and the
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`second soft polymer layer independently comprises a layer of a styrenic block copolymer (SBC),
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`a silicone rubber, an elastomeric alloy, a thermoplastic elastomer (TPE), a thermoplastic
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`vulcanizate (TPV) elastomer, a polyurethane elastomer, a block copolymer elastomer, a
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`polyolefin blend elastomer, a thermoplastic co-polyester elastomer, a thermoplastic polyamide
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`elastomer, or a combination thereof (CHEN teaches the soft polymer can be a copolymer blend
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`of thermoplastics ([0036], examiner is interpreting outer layer (152) as soft polymer layer)).
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`12.
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`Regarding claim 24, CHEN teaches: wherein at least one of the first soft polymer layer
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`and the second soft polymer layer comprises at least two layers, and wherein the at least two
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`layers are independently selected from the group consisting of a styrenic block copolymer (SBC),
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`a silicone rubber, an elastomeric alloy, a thermoplastic elastomer (TPE), a thermoplastic
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`vulcanizate (TPV) elastomer, a polyurethane elastomer, a block copolymer elastomer, a
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`polyolefin blend elastomer, a thermoplastic co-polyester elastomer, or a thermoplastic
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`polyamide elastomer (CHEN teaches having at least two soft layers [Figs. 4A—4D; 0030—003 1].
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`Application/Control Number: 15/476,655
`Art Unit: 1748
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`Page 5
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`CHEN further teaches the soft polymer can be a copolymer blend of thermoplastics ([0036],
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`examiner is interpreting outer layer (152) as soft polymer layer)).
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`13.
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`Regarding claim 25, DESIMONE further teaches: wherein the hard polymer layer
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`comprises at least one of a tensile strength at yield of between about 4000 pounds psi and 6500
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`psi, an elongation at yield ofgreater than about 4%, an elongation at break ofgreater than
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`about 70%, a tensile modulus of greater than about 150,000 psi, a flexural modulus greater than
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`about 150,000 psi, a stress relaxation greater than about 10% at 24 hours testing in a wet
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`environment, and a light transmission between 400 nm and 800 nm of greater than about 75%
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`(DESIMONE teaches a transparent polymeric material preferably having a tensile strength at
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`yield of greater than 6,000 psi, which overlaps with the claimed tensile strength at yield of
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`between about 4000 psi and 6500 psi [Col. 7, lines 42—44, examiner is interpreting transparent
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`polymeric material as a hard polymer layer as DESIMONE states thermoplastic polyurethanes
`
`can be used]). It would have been obvious to one of ordinary skill in the art at the time of the
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`applicant’s invention to modify CHEN by having a tensile strength at yield of about 4000 psi and
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`6500 psi, as suggested by DESIMONE, in order for making dental appliances with improved
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`material properties [Col. 4, lines 13—16].
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`14.
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`In the alternative, it would have been obvious to one of ordinary skill in the art at the time
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`of the invention to utilize the materials of DESIMONE to form the hard polymer layer in CHEN
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`since DESIMONE teaches that such materials for the intended use of such hard layers with
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`predictable results and/or reasonable expectation of success
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`15.
`
`Regarding claim 27, DESIMONE further teaches: further comprising fabricating a
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`plurality of appliances corresponding to difi‘erent arrangements of the patient's teeth
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`(DESIMONE teaches fabricating a plurality of appliances based on different arrangements of the
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`

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`Application/Control Number: 15/476,655
`Art Unit: 1748
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`Page 6
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`patient's teeth [Col. 3, 53—67—Col. 4, lines 1—7]). It would have been obvious to one of ordinary
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`skill in the art at the time of the applicant’s invention to modify CHEN by fabricating a plurality
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`of appliances of different arrangements of the patient’s teeth, as suggested by DESHVIONE, in
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`order to progressively reposition teeth from a first initial arrangement to a final tooth
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`arrangement in the patient’s mouth (Col. 3, lines 36—51).
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`16.
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`Regarding claim 28, DESIMONE further teaches: wherein fabricating the plurality of
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`appliances comprises digitally staging a plurality of digital models of the patient's teeth and
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`generating a plurality ofphysical models from the digital models (DESIMONE teaches digitally
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`staging a plurality of digital models of the patient's teeth [Col. 3, lines 53—67] and fabricating a
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`plurality of appliances [Col. 4, lines 7—8]). It would have been obvious to one of ordinary skill in
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`the art at the time of the applicant’s invention to modify CHEN by fabricating a plurality of
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`digital models of the patient’s teeth, as suggested by DESHVIONE, in order to obtain the
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`polymeric shells of dental positioning appliances for a patient (Col. 3, lines 53—56).
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`17.
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`Regarding claim 29, CHEN teaches a sheet comprising a hard polymer layer between a
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`first and second soft polymer layer (CHEN teaches an appliance (100) with a hard inner polymer
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`layer (132) having a hard polymer layer elastic modulus [Fig. 4C; 0032; 0036]. CHEN further
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`teaches a first and second soft outer polymer layer (134), each having soft polymer elastic
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`modulus less than the hard polymer layer elastic modulus [Fig. 4C; 0003; 0032; 0036]), but is
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`silent as to making a plurality of appliances. In the same field of endeavor, dental appliances,
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`DESIMONE teaches a plurality of appliances [Col. 4, lines 7—12]). It would have been obvious to
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`one of ordinary skill in the art at the time of the applicant’s invention to modify CHEN by having
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`a plurality of appliances, as suggested by DESIMONE, in order to progressively reposition teeth
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`

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`Application/Control Number: 15/476,655
`Art Unit: 1748
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`Page 7
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`from a first initial arrangement to a final tooth arrangement in the patient's mouth (Col. 3, lines
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`36—5 1).
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`18.
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`Regarding claim 30, DESIMONE further teaches: wherein the hard polymer layer
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`comprises a plurality of co-extruded or laminated polymer layers (DESIMONE teaches
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`polycarbonate—based laminates (Col. 7, lines 30—35)). It would have been obvious to one of
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`ordinary skill in the art at the time of the applicant’s invention to modify CHEN by having
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`laminated polymer layers, as suggested by DESIMONE, in order for making dental appliances
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`with improved material properties [Col. 4, lines 13—16].
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`19.
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`In the alternative, it would have been obvious to one of ordinary skill in the art at the time
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`of the invention to utilize the materials of DESIMONE to form the hard polymer layer in CHEN
`
`since DESIMONE teaches that such materials for the intended use of such hard layers with
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`predictable results and/or reasonable expectation of success.
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`20.
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`Claim 26 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chen
`
`et al. (U.S. PGPUB 2009/0246724), hereinafter CHEN, and DeSimone et al. (U.S.
`
`7,641,828), hereinafter DESIMONE, as applied to claim 20 above, and further in View of
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`Hostettler (U.S. 4,791,156), hereinafter HOSTETTLER (HOSTETTLER is provided in the
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`IDS of 3/31/2017).
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`21.
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`Regarding claim 26, CHEN and DESIMONE teach all of the limitations of the invention
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`as stated above, but are silent as to soft layer having a hardness of about 60A to about 85D. In
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`the same field of endeavor, dental appliances, HOSTETTLER teaches a soft polyurethane
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`elastomer having a hardness not greater than about 65A (Col. 2, lines 36—44) which overlaps with
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`the claimed range of hardness of about 60A to about 85D. It would have been obvious to one of
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`ordinary skill in the art at the time of the applicant’s invention to modify CHEN and
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`

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`Application/Control Number: 15/476,655
`Art Unit: 1748
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`Page 8
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`DESIMONE by having a soft layer with a hardness not greater than 65A, as suggested by
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`HOSTETTLER, in order to provide a soft layer which provides tissue relief, is inexpensive,
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`trouble—free, and easy to keep clean (Col. 1, lines 40—41, 50—59).
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`Conclusion
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`22.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Caroline Montiel whose telephone number is (571)272—2529.
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`The examiner can normally be reached on Monday — Friday 8:30 AM. — 5:00 PM.
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`Examiner interviews are available via telephone, in—person, and video conferencing using
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`encouraged to use the USPTO Automated Interview Request (AIR) at
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`http://www.uspto.gov/interviewpractice.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Alison Hindenlang can be reached on (571) 270—7001. The fax phone number for the
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`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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`Application/Control Number: 15/476,655
`Art Unit: 1748
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`Page 9
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`/C.M./
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`Examiner, Art Unit 1748
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`/Anth0ny Calandra/
`Primary Examiner, Art Unit 1748
`
`