DETAILED ACTION
This action is in response to the amendments filed on Apr. 23rd, 2026 A summary of this action:
Claims 1-8, 10-11, 13-17, 20-24 have been presented for examination.
Claims 21 and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement
Claim(s) 11-4, 6-8, 10-11, 13-16, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paehl et al., US 2016/0310239, either alone with an obvious rationale, or in view of Van Der Meer, Wicher J., et al. "3D Computer aided treatment planning in endodontics." Journal of dentistry 45 (2016): 67-72 (MPEP § 2120: “…In the interest of compact prosecution, such rejections should be backed up by the best other art rejections available.”)
To clarify, the below § 103 solely in view of Paehl is made premised upon there being no criticality in when the creation of the holes step is performed (MPEP § 2144.04: “If the applicant has demonstrated the criticality of a specific limitation, it would not be appropriate to rely solely on case law as the rationale to support an obviousness rejection”; see rejection to clarify); thus should it be demonstrated otherwise, a backup rejection is made.
Claim(s) 5 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paehl et al., US 2016/0310239, either alone with an obvious rationale, or in view of Van Der Meer, Wicher J., et al. "3D Computer aided treatment planning in endodontics." Journal of dentistry 45 (2016): 67-72 in further view of Herrman, DE-4116190-A1 (using the machine translation from the FIT database).
Claim(s) 17 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paehl et al., US 2016/0310239, either alone with an obvious rationale, or in view of Van Der Meer, Wicher J., et al. "3D Computer aided treatment planning in endodontics." Journal of dentistry 45 (2016): 67-72 in further view of Kim et al., US 2011/0091832.
Claims 21 and 23 are not rejected under § 103. The closest prior art is the relied upon Paehl reference taken, but it does not fairly teach what is presently claimed (to clarify on the BRI, see the below § 112(a) rejection). Should the suggested amendment to address the § 112(a) rejection be entered, Examiner notes the closest art would be the relied upon combination for dependent claim 5, however that does not fairly teach the particular location of the vent hole (i.e. facing the occlusal surface of the tooth) – rather, in Herrman, see # 13 and 10 as discussed: “So that the air in the cavity ( 6 ) can escape unhindered when the impression material is poured in, a vent groove ( 12 ) is formed in the bottom of the tray at its rear edge, from which a vent hose ( 13 ) extends outwards to the front end of the impression tray ( 1 ) is performed” – next closest references that do not fairly teach what is claimed include:
Webber, US 20170135793, fig. 3 and 5 and accompanying descriptions
Brandt et al., US 2013/0108976, ¶ 50 and fig. 5 # 530 and 528
Dingeldein et al., US 2021/0378789 – cf. 6A # 510, as discussed in ¶ 77: “In the illustrated example, door body 508a defines a vent 510, which may be an opening positioned within door body 508a, within mold body 502, partially within the mold body 502 and door body 508a, or combinations thereof. In some examples, vent 510 may be configured to allow excess restorative material to flow out of a mold cavity 520, which may be removed prior to curing (e.g., with a scalar instrument), providing for easier removal of flash. Alternatively, or in addition, vent 510 may be configured to allow air to flow out of the mold cavity.” – but again, this does not fairly teach the location of the vent opening in ¶ 154
This action is Final
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 .
Note for compact prosecution
A direction of amendment to reflect ¶ 53 first sentence was discussed during the interview. Such a direction of amendment would require further search and consideration outside of cursory review, as the state of the art per the art of record indicates that such a feature may already be known and thus a more substantial search for the yet to be claimed subject matter in ¶ 53 is required outside of cursory review. See Webber, US 2017/0135793 – see abstract, ¶ 5, ¶¶ 23-24.
Response to Arguments/Amendments
Regarding the § 112 Rejection
Withdrawn in view of amendment. New grounds as necessitated by amendment below.
Regarding the § 101 Rejection
Withdrawn in view of remarks and recent guidance updates in view of Ex parte Desjardins, as well as example 45 claims 2 and 4.
Regarding the § 102/103 Rejection
Remarks are for the newly amended subject matter. See below for how such subject matter is rejected.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21 and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The dependent claims inherit the deficiencies of the claims they depend upon.
See MPEP 2163(II)(A): "For example, in Hyatt v. Dudas, 492 F.3d 1365, 1371, 83 USPQ2d 1373, 1376-1377 (Fed. Cir. 2007), the examiner made a prima facie case by clearly and specifically explaining why applicant’s specification did not support the particular claimed combination of elements, even though applicant’s specification listed each and every element in the claimed combination. The court found the "examiner was explicit that while each element may be individually described in the specification, the deficiency was lack of adequate description of their combination" and, thus, "[t]he burden was then properly shifted to [inventor] to cite to the examiner where adequate written description could be found or to make an amendment to address the deficiency.""
Also, see MPEP 2163(I) for Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997).
Representative claim 21 recites:
The method of claim 15, wherein the portion of the molding surf ace is on a lateral side of the virtual attachment facing an occlusal surface of the virtual tooth.
Representative claim 15 recites: creating one or more virtual holes in the digital attachment template is configured to provide access for a flowable attachment material into the cavity, wherein the one or more virtual holes are positioned in a portion of the molding surface that is offset from the virtual first surface;
See ¶ 154: “For example, a vent opening may be on a lateral side (through the template width), an in particular, on a top region, facing the occlusal surface of the teeth when applied to the teeth”
Claims 21 and 23 are not sufficiently described, rather the specification conveys that the portion of the molding surface that is on a lateral side facing the occlusal surface is the one with the “vent”, not the hole “to provide access for a flowable attachment material” – to clarify, see dependent claims 5 and 22, as the “vent hole” is expressly not required in the independent claims, but rather only found in some of the dependent claims. See instant figure 2 # 207, contrast with # 252 to clarify on the distinction between the holes in the independent claims and the vent hole, i.e. these are distinct elements in both the claims and disclosure.
Examiner suggests amending these dependent claims more expressly reflect what is disclosed in ¶ 154.
The claims are interpreted in view of MPEP § 2143.03(II): “When evaluating claims for obviousness under 35 U.S.C. 103, all the limitations of the claims must be considered and given weight, including limitations which do not find support in the specification as originally filed (i.e., new matter). Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983) aff’d mem. 738 F.2d 453 (Fed. Cir. 1984)” – as such it is interpreted in view of its plain meaning.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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, if the 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.
Claim(s) 1-4, 6-8, 10-11, 13-16, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paehl et al., US 2016/0310239, either alone with an obvious rationale, or in view of Van Der Meer, Wicher J., et al. "3D Computer aided treatment planning in endodontics." Journal of dentistry 45 (2016): 67-72 (MPEP § 2120: “…In the interest of compact prosecution, such rejections should be backed up by the best other art rejections available.”)
To clarify, the below § 103 solely in view of Paehl is made premised upon there being no criticality in when the creation of the holes step is performed (MPEP § 2144.04: “If the applicant has demonstrated the criticality of a specific limitation, it would not be appropriate to rely solely on case law as the rationale to support an obviousness rejection”; see rejection to clarify); thus should it be demonstrated otherwise, a backup rejection is made.
Regarding Claim 1
Paehl teaches: A method of forming an attachment template, comprising:
placing a virtual attachment on a crown surface of a virtual tooth of a digital dental model; creating a digital attachment template from the digital dental model including the virtual attachment on the crown surface of the virtual tooth of the digital dental model, wherein the virtual attachment includes an undercut region and forms a cavity on an inner side of the digital attachment template, wherein the cavity defines a molding surface that is configured to define a shape of an attachment, wherein the molding surface includes a virtual first surface that defines an engagement surface of the attachment, the engagement surface arranged to engage with one or more aligners to apply one or more predetermined forces on a tooth corresponding to the virtual tooth; creating one or more virtual holes in the digital attachment template is configured to provide access for a flowable attachment material into the cavity, wherein the one or more virtual holes are positioned in a portion of the molding surface that is offset from the virtual first surface; and three-dimensional printing the attachment template based on the digital attachment template, wherein the attachment template includes a first surface corresponding to the virtual first surface and one or more holes corresponding to the one or more virtual holes.
(Paehl teaches this:
Paehl, abstract, teaches: “A method of making a transfer tray includes providing a physical mockup having a shape that corresponds to a positive shape of a patient's dental arch and a positive shape of one or more bracket analogs. A transfer tray may be formed over the physical mockup, with the transfer tray representing a negative replica of at least a portion of the mockup. One or more receptacles are accordingly formed in the ray, each receptacle approximating a least a portion of the shape of a bracket analog. A bracket associated with a bracket analog is placed into a receptacle of the one or more receptacles and a filler material is introduced into at least one receptacle.”
To clarify, see ¶¶ 10, 17, 19, fig. 13 and ¶ 39, then ¶ 83: “In presently preferred circumstances, the filler is at least initially flowable and is introduced into a receptacle viaa channel or other passage. The filler can be injected through the channel and allowed to flow into the cavities and voids, where it is then cured or otherwise hardened in place. In other implementations, the filler may be coated or coupled to the tray prior to introduction of the bracket into the receptacle.” [claims 1 and a few dependent claims noted below] And ¶ 85: “The channel 50 is typically, substantially cylindrical and typically features a diameter of at least 1.0 mm and no greater than 1.5 mm to provide adequate flow of the filler into the receptacle.” [e.g. claim 3] And ¶ 88: “Once the bracket is seated in the receptacle, the filler may be introduced through the channel and allowed to flow into the voids, where it is then cured or otherwise hardened in place…The filler material 60 as illustrated enters the voids 39 now defined in the receptacle 38 and is subsequently allowed to harden. Hardening may be effectuated through use of, for example, ultraviolet light, heat, or time” – as visibly depicted in fig. 13, and other figures, there is a “tray” [attachment template] for attaching “bracket[s]” (abstract) onto teeth, wherein as visibly depicted these form a cavity on an inner side of the tray with a “channel” [hole, fig. 13] for allowing a “filler material” into the cavity for bonding the bracket to the tooth (to clarify, these form braces, see ¶¶ 1 and 44 as commonly referred to) – see fig. 2 to further clarify
Wherein this was based on a 3D model from 3D printing – ¶ 47: “The manufacturing of the physical mockup in this example is based on a virtual mockup prepared in a computer system. Such a virtual mockup preferably corresponds to a mathematical representation of a three-dimensional shape which can be processed by a computer, for example by a CAD (Computer Aided Design) system. Further the virtual mockup is preferably available in the form of computer data which can be used to control an additive manufacturing machine for manufacturing the physical mockup as defined by the virtual mockup. The virtual mockup may be designed or generated from superimposing or merging a virtual dental arch of a patient with a set of virtual analogs as further described in FIG. 5.” – e.g. fig. 5, ¶ 48, wherein this was based on scan data from a scanner - ¶ 49: “The shape of a patient's dental arch may be captured by intra-orally scanning at least part of the patient's dentition including the teeth, or by scanning a physical model, for example a plaster model, of the patient's teeth. Scanning devices which allow for providing a virtual dental arch in digital data form are for example available under the designations Lava™ Scan ST and Lava™ Chairside Oral Scanner C.O.S, both from 3M Deutschland GmbH...”, note the use of STL files (¶ 50), wherein ¶ 51: “In one embodiment the method further comprises the step of positioning the virtual brackets relative to the virtual dental arch. There are a variety of treatment planning systems which allow for designing and/or placing virtual brackets relative to a virtual dental arch by computer aid. Such systems are, for example, described in U.S. Pat. Nos. 7,210,929, 7,811,087, and 7,993,133. The virtual brackets may be at least partially designed and/or retrieved from a database. Each bracket may be automatically and/or manually positioned relative to a virtual tooth comprised in the virtual dental arch.” – also see ¶ 53: “Another exemplary possibility for providing a virtual bracket with a customized pad is disclosed in U.S. Pat. No. 7,811,087” – then see ¶ 59: “A virtual mockup may be provided by combining the virtual dental arch and the set of virtual analogs, for example being merged or superimposed by computer aid”, then see ¶¶ 77-78: “As another alternative (not depicted in the Figures), a virtual transfer tray may be directly derived from the virtual mockup, using methods described in US Publication No. 2011/0091832… When virtually aligned with the virtual mockup, the virtual tray body surrounds both the teeth and analogs. The mocknp (including analogs) may then be virtually subtracted from the virtual transfer tray body to produce a virtual tray precursor. Virtual tray precursor includes a tray body which will typically have a shell-like configuration and further includes one or more receptacles [channels/holes] formed by the negative virtual imprints of the analogs. The virtual tray precursor, which is preferably present in the form of a computer processable three-dimensional data file may be transmitted to an additive manufacturing machine which manufactures the physical transfer tray based on the virtual tray precursor according to techniques discussed above.” And ¶ 84: “Alternatively, the channel 50 may be made by causing a post-like structure to protrude from the bracket body before taking the steps described above to create the transfer tray.”
To clarify on this including 3D printing see ¶ 46: “Examples of suitable additive manufacturing processes include solid freeform fabrication such as 3D printing processes, stereolithography methods, fused deposition modeling, laminated object manufacturing, laser engineered net shaping, selective laser sintering, shape deposition manufacturing, selective laser melting, and solid ground curing. An example of a suitable 3D printing machine is the Eden brand 500V printer from Objet Geometries Ltd., using FullCure 720 acrylic-based photopolymer printing material (also available from Objet Geometries Ltd.).”
With respect to the features of the molding surface with the virtual first surface for engaging with aligners to apply forces, wherein the attachment template includes a first surface correspond to the virtual first surface – see Paehl, fig. 2, wherein this photograph of the attachment of Paehl shows an intended trench for the aligner wire for the braces; similarly depicted in the CAD view in figures 3-4 – to clarify, see ¶¶ 1-3 discusses the “archwire” [example of an aligner], e.g. “The movement of teeth is typically achieved by a pre-biased elastic archwire which is attached via brackets to the teeth, and which applies a force to the teeth toward the desired position over a longer time period.” – then see ¶ 8: “As depicted in FIG. 1, such methods of creating a transfer tray result in spaces corresponding to certain brackets features (e.g., archwire slot, hooks, tiewings, etc.) that are vacant, lest the tray material interfere with the precise placement of the bracket 3 within the receptacle” and ¶ 44: “The analogs 13 represent or approximate orthodontic brackets as they are used, in combination with an archwire, to move a patient's teeth from a malocclusion toward a desired position” and ¶ 55: “Another part of the bracket, the bracket body, containing a slot for receiving an archwire and further features (e.g., hooks, tie-wings, grooves, etc.) that allow fastening the wire into the slot, may be available on the computer as predefined virtual models, for example in the form of a library of bracket bodies. To provide a virtual set of brackets for the virtual dental arch certain predefined virtual bodies may be selected. The bracket bodies are typically aligned with their slots relative to each other, for example such that a generally U-shaped virtual archwire can run through the slots of all brackets. Once the slot position of the bracket bodies have been determined the bracket bodies and the respective bracket pads may be combined, for example virtually merged to form the set of virtual brackets” – i.e. in Paehl, the attachment [the bracket/”analog”] has an engagement surface for the “archwire” wherein this is in the “virtual bracket” models, wherein the “archwire” is to apply a force to the teeth” “via the bracket” - wherein as discussed above, e.g. ¶¶ 77-78: “Virtual tray precursor includes a tray body which will typically have a shell-like configuration and further includes one or more receptacles [channels/holes] formed by the negative virtual imprints of the analogs” – i.e. the tray/template has a first surface corresponding to the location of the archwire (e.g. see figures 12-13, note top portions of the bracket where the archwire slot is have a corresponding surface in the tray) – wherein fig. 13 shows that the hole is positioned with an offset from the virtual first source (i.e. top of the bracket) as visibly depicted, see accompanying description to clarify
There is a single distinction, for when the holes/channels are created in Paehl are before the tray creation, see ¶¶ 77-78 which describes the tray creation: “In one exemplar of such a method, the derivation can proceed by defining a guidance line that extends across at least a portion of the arch and is spaced away from the arch and mounted analogs. For example, the guidance line follows a curved path that is generally parallel to the facial surfaces of the virtual analogs and generally lies in an occlusal plane. In one computer-assisted embodiment, the guidance lines are defined by tracing a line segment that connects the facial-most edges of analogs as viewed from the occlusal direction, offsetting the line segment outwardly towards the facial direction by a certain distance and then applying a smoothing operation to the line segment. If desired, the certain distance can be used to define a desired tray thickness. The process may continue by defining a series of fitted arcs, each of which extends over the lingual, occlusal, and facial surfaces of the virtual arch model and intersects each guidance line in a generally perpendicular relationship such that each fitted arc passes over, without contacting, the virtual model and virtual analogs. An exterior surface of the virtual transfer tray may be formed by fitting a surface to the set of fitted arcs. In some embodiments, the exterior surface is an open-ended shell that completely covers the occlusal, lingual, and facial sides of the virtual mockup that includes the model and analogs. Optionally, a surface smoothing operation is subsequently executed on the exterior surface. Then the remainder of a virtual tray body is derived using the exterior surface. The solid virtual tray body may be formed by defining a composite surface that includes the exterior surface and a planar surface that extends across the cavity formed by the exterior surface. When virtually aligned with the virtual mockup, the virtual tray body surrounds both the teeth and analogs. The mockup (including analogs) may then be virtually subtracted from the virtual transfer tray body to produce a virtual tray precursor. Virtual tray precursor includes a tray body which will typically have a shell-like configuration and further includes one or more receptacles formed by the negative virtual imprints of the analogs.” – note that there is no channel yet in ¶¶ 77-78 and ¶ 84: “Alternatively, the channel 50 may be made by causing a post-like structure to protrude from the bracket body before taking the steps described above to create the transfer tray.”
In summary, ¶ 84 discloses that the channel/holes for the filler material are to protrude from the bracket body before the tray is created, i.e. the creation of the holes step is performed with the creation of the digital attachment template, instead of after it is created.
However, is would have been prima facie obvious, because, per MPEP § 2144.04(IV)(c): “See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.)” – to clarify, POSITA would have found it as a simple re-arrangement of the process steps, i.e. a “Simple substitution of one known element for another to obtain predictable results” per MPEP § 2143(I), as the only distinction is when the holes were created, and POSITA would have found it a simple substitution to create the holes (#50) after creating the virtual tray, e.g. by the user simply deciding to add the holes after seeing the tray on the display of a computer and judging to add them, and thus to add the “post-like structure” (¶ 84) representing the holes after the creation of the model. To remove the post-like structure from the tray, one would simply repeat the same operation Paehl used to remove the mockup (the mockup of the teeth with the brackets) from the virtual tray body in ¶ 78, i.e.: “The mockup (including analogs) may then be virtually subtracted from the virtual transfer tray body to produce a virtual tray precursor. Virtual tray precursor includes a tray body which will typically have a shell-like configuration and further includes one or more receptacles formed by the negative virtual imprints of the analogs”. This would simply be applying the commutative property of subtraction, e.g. 5-(4+9) = (5-4)-9, and arrive at the same predictable result because it’s a mathematical equivalent calculation (by the commutative property of addition).
Should it be found that this would not have been prima facie obvious in view of Paehl for the reasons stated above, then the Examiner notes it would have been obvious to have created the holes/channels of Paehl after creating the template, when Paehl was taken in view of Meer:
As an initial matter, Paehl already describes having the ability to do Boolean operations – Paehl, ¶ 55: “Common CAD programs have capabilities (for example boolean operations) to connect existing shapes to each other” and ¶¶77-78
Then see Meer, see § 2, in particular ¶ 3: “Based on the planning, a surgical guide is digitally designed in the 3ds Max software. The guide will use the dentition for stable anatomical fixation and extends from the left first premolar to the right first premolar. The surgical guide is made to fit the dentition by first expanding the digital dentition by 0.1 mm using a “shell”- command and then digitally subtracting the dentition [arrangement of the teeth] from the guide design using a Boolean operation. Expansion of the dentition is performed to compensate for the polymerization shrinkage that occurs in almost all 3D printing technologies, thus ensuring a proper fit. Similarly, a hole is modelled with an outside diameter of 3.0 mm in the surgical guide in which a metal tube with an inside diameter of 2.40 mm could be placed” – in particular, note the modeling operations to fit the dentition (the arrangement of teeth) is to first shell/offset the dentition (i.e. expand outward), then subtract the teeth themselves with a Boolean operation, to arrive at the desired result of “Expansion of the dentition is performed to compensate for the polymerization shrinkage that occurs in almost all 3D printing technologies, thus ensuring a proper fit”, wherein any other modeling operation would follow from this one.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings from Paehl on a system which designed a similar such guide [the tray] for aiding the work of dentists and similar professions with the teachings from Meer on creating the tray of Meer by “by first expanding the digital dentition by 0.1 mm using a “shell”- command and then digitally subtracting the dentition from the guide design using a Boolean operation” The motivation to combine would have been that “Expansion of the dentition is performed to compensate for the polymerization shrinkage that occurs in almost all 3D printing technologies, thus ensuring a proper fit” (Meer, as cited above).
Meer is considered as an analogous art as being in the same field of endeavor of methods of modeling and 3D printing personalized dental apparatuses to aid dentists, and similar such professions (endodontist and orthodontist) in performing medical procedures on patients.
Regarding Claim 2
Paehl teaches:
The method of claim 1, wherein creating the one or more virtual holes comprises forming a window that is shaped to define an area of light cast onto the flowable attachment material. (Paehl, as cited above, for the channels, wherein “The channel 50 is typically, substantially cylindrical and typically features a diameter of at least 1.0 mm and no greater than 1.5 mm to provide adequate flow of the filler into the receptacle.” (¶ 85) and ¶ 88: “Once the bracket is seated in the receptacle, the filler may be introduced through the channel and allowed to flow into the voids, where it is then cured or otherwise hardened in place… Hardening may be effectuated through use of, for example, ultraviolet light, heat, or time.” And note in the instant disclosure ¶ 52: “In some embodiments, the opening(s) have a cross-sectional area ranging from about 1 square millimeters (mm2 ) to about 4 mm2”
Using A = pi*r^2 for the cross-sectional area, the holes of Paehl are range from 3.14 mm to 50.24mm in area, thus the lower-end of Paehl’s range falls into the range of ¶ 52. MPEP § 2144.04(I): “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”
Then, with those fact findings, see MPEP § 2112(IV): “In In re Schreiber, 128 F.3d 1473, 44 USPQ2d 1429 (Fed. Cir. 1997), the court affirmed a finding that a prior patent to a conical spout used primarily to dispense oil from an oil can inherently performed the functions recited in applicant’s claim to a conical container top for dispensing popped popcorn. The examiner had asserted inherency based on the structural similarity between the patented spout and applicant’s disclosed top, i.e., both structures had the same general shape. The court stated: [N]othing in Schreiber’s [applicant’s] claim suggests that Schreiber’s container is 'of a different shape’ than Harz’s [patent]. In fact, [ ] an embodiment according to Harz (Fig. 5) and the embodiment depicted in figure 1 of Schreiber’s application have the same general shape. For that reason, the examiner was justified in concluding that the opening of a conically shaped top as disclosed by Harz is inherently of a size sufficient to ‘allow [ ] several kernels of popped popcorn to pass through at the same time’ and that the taper of Harz’s conically shaped top is inherently of such a shape ‘as to by itself jam up the popped popcorn before the end of the cone and permit the dispensing of only a few kernels at a shake of a package when the top is mounted to the container.’ The examiner therefore correctly found that Harz established a prima facie case of anticipation. Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432” – and thus, Paehl teaches this limitation, for given the similar shapes (same general shape and similar dimensionalities), the holes of Paehl would have defined areas of light during the UV curing of Paehl for hardening the material
Regarding Claim 3
Paehl teaches:
The method of claim 1, wherein a cross-sectional area of the one or more holes ranges from 1 square millimeters (mm2) to 4 mm2. (Paehl, ¶ 85 as cited above, in view of MPEP § 2144.04(I) as discussed above and A=pi*r^2 for the area of a circle, i.e. it ranges from “1 mm” to “1.5 mm” “diameter”, i.e. 0.785 mm^2 to 1.767 mm^2 which at least renders obvious the claimed range – see MPEP § 2144.05(I): “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists…”)
Regarding Claim 4
Paehl teaches:
The method of claim 1, wherein creating the one or more virtual holes comprises forming an injection hole for the flowable attachment material to be injected into the cavity. (Paehl, as was cited above for # 50, e.g. ¶¶ 84-85 and the like)
Regarding Claim 6
Paehl, or Paehl in view of Meer teaches:
The method of claim 1, wherein creating the one or more holes in the digital attachment template includes placing a cut shape on the digital attachment template and subtracting the cut shape from the digital attachment template. (Paehl, as was cited above, or in view of Meer teaches this
To clarify, Paehl, ¶¶ 77-78 and 84 disclose the use of “subtraction” modeling operations to form the virtual tray, and ¶ 84 describes “causing a post-like structure to protrude from the bracket body [the attachment] before taking the steps described above to create the transfer tray” – in further view of Paehl, ¶ 55 which discusses that: “Once the slot position of the bracket bodies have been determined the bracket bodies and the respective bracket pads may be combined, for example virtually merged to form the set of virtual brackets. Common CAD programs have capabilities (for example boolean operations) to connect existing shapes to each other. Optionally the design of the virtual brackets, or parts of the brackets, may be adapted to account for a good articulation, hygiene requirements or other aspects as needed.”
In view of the above obviousness rationale of the simple substitution/changing the order of steps, wherein in doing so POSITA would have desired to have the same result with the channel (the “post-like structure to protrude from the bracket body” so it was through the tray (fig. 13 # 50), wherein to have done so in the above rationale would simply be performing a subtraction operation of the “post-like structure” in the tray model to remove the channel from tray
Or (for the should it be found above), when taken in view of Meer § 2 ¶ 3 using a digital subtraction which is “a Boolean operation” in commercially available CAD software (§ 2 ¶¶ 2-3, “3ds Max software”) - in summary POSITA would have found it obvious to arrive at this order for the rationale stated above, and the only thing needed to be done is change the order in which the modeling operations (which are in “Common CAD programs”; Paehl, ¶ 55; e.g. “3ds Max”, Meer § 2 ¶¶ 2-3) are to be performed to produce the same result.
Regarding Claim 7
Paehl, or Paehl in view of Meer teaches:
The method of claim 6, wherein the cut shape contacts the virtual attachment to create the one or more virtual holes when the cut shape is subtracted from the digital attachment template. (Same rationale as claim 6 above; not fig. 13 # 50 and # 40 of Paehl to clarify)
Regarding Claim 8
Paehl, or Paehl in view of Meer teaches:
The method of claim 6, wherein the cut shape overlaps with the digital attachment template. (Same rationale as claim 6 above, i.e. overlap the post-like structure of Paehl on top of the template, and perform a subtraction operation to form the channel)
Regarding Claim 10.
Paehl, or Paehl in view of Meer teaches:
The method of claim 1, wherein creating the one or more virtual holes comprising creating multiple virtual holes by: placing one or more cut shapes on the digital attachment template; and subtracting the one or more cut shapes from the digital attachment template to form the multiple holes. (Same rationale as claims 6-9 above, note Paehl has a “channel” per bracket (¶¶ 83-84; fig. 13) and multiple brackets/attachments (fig. 3-4) hence the “tray” of Paehl, i.e. ¶ 78: “When virtually aligned with the virtual mockup, the virtual tray body surrounds both the teeth and analogs.”)
Should it be found that this requires a plurality of holes per attachment, then the Examiner submits that this still would have been obvious when Paehl, or Paehl in view of Meer, were taken in further combination of Herrmann, as cited below for claim 5 and its accompanying rationale, wherein Herrmmann teaches having two holes, one being a vent (see the citation and rationale to combine below), wherein POSITA would have readily found it obvious that in combination of these references to have added the vent of Herrmann into the digital model of Paehl, or Paehl in view of Meer, by repeating the same operations as were performed for the first hole (MPEP § 2143 for “(A) Combining prior art elements according to known methods to yield predictable results;”, as the vent was known in combination with a hole for a material to flow through in Herrmann as cited below, and the manner of making holes in the digital was known in view of Paehl, or Paehl in view of Meer, wherein this would have been predictable as it would be merely doing a duplication of operations for a second hole (MPEP § 2144.04(VI)(B)), with POSITA motivated to add the vent in view of the rationale below for Herrmann.
Regarding Claim 11.
Paehl teaches:
The method of claim 1, wherein the digital dental model is based on a scan of a patient's dentition. (Paehl, ¶¶ 49-50 as cited above)
Regarding Claim 13.
Paehl teaches:
The method of claim 1, wherein the virtual attachment has a symmetric shape. (Paehl, fig. 2 shows it is axi-symmetric, thus it has a symmetric shape along the center axis along the length of the bracket, i.e. fig. 5 provides a cross-section)
Regarding Claim 14.
Paehl teaches:
The method of claim 1, wherein the virtual attachment has a non-symmetric shape. (Paehl, fig. 2, shows it does not have symmetry across the other center axis, i.e. fig. 5 for the cross-sectional which shows the non-symmetry in this plane; also see ¶¶ 56-58 for modifications a user may do it the attachment)
Regarding Claim 15.
Rejected under a similar rationale as claim 1 above. For the undercut region, see the discussion of Paehl, ¶ 56: “Next, the virtual brackets are used to generate the set of analogs based thereon. Each analog of the set of analogs is associated with a virtual bracket of the virtual set of brackets, and in certain cases represents a modification thereof…” then ¶¶ 57-58: “In particular the second areas 22b of the virtual analog 22 comprise reduced undercuts relative to undercuts present in the second areas 23b of the virtual bracket 23… The computer may have capabilities to determine a virtual retention strength depending on the undercuts present in one more or all of the analogs. For example, substantial and/or a high number of undercuts present in a set of analogs may lead to a relatively high virtual retention strength, whereas less substantial and/or a lower number of undercuts may lead to a lower virtual retention strength. Accordingly, the computer may be adapted to display a virtual retention strength and optionally upper and lower limits for a desired virtual retention strength to a user. The user may adjust the undercuts of the analogs accordingly by reference to the displayed or calculated virtual retention strength limits”
Regarding Claim 16.
Rejected under a similar rationale as claim 1 above.
Regarding Claim 20.
Rejected under a similar rationale as claims 1 and 15 above.
Claim(s) 5 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paehl et al., US 2016/0310239, either alone with an obvious rationale, or in view of Van Der Meer, Wicher J., et al. "3D Computer aided treatment planning in endodontics." Journal of dentistry 45 (2016): 67-72 in further view of Herrman, DE-4116190-A1 (using the machine translation from the FIT database).
Regarding Claim 5
While Paehl, either alone or in view of Meer, does not explicitly teach the following feature, this is taught when taken in further view of Herrmann:
The method of claim 4, further comprising forming a vent hole that allows excess uncured attachment material or air to flow out of the cavity during the injecting. (Paehl, as was cited above for the transfer tray (note Paehl, ¶ 83: “In other implementations, the filler may be coated or coupled to the tray prior to introduction of the bracket into the receptacle. In yet other implementations, the bracket body may be coated with a filler material prior to being seated in the receptacle.”, or in the relied upon embodiment of Paehl ¶ 84: “If the filler is to be introduced after the bracket has been coupled to the tray, a channel 50 may be formed through the tray (including position layer 36 and sheeting 35) to provide access to the receptacle 38.”
In view of Hermann, description ¶¶ 1-2 discussing impression trays for taking impressions of “human teeth”, then see: “For an impression process is first known impression material in the interior of the Spoon filled, then the spoon in the mouth of the Patients placed over the jaw part to be molded and usually with your fingers until the Impression compound held. Then the impression tray is removed the mouth and now stands with the so created Imprint available for further processing.” And ¶ 3: “This known method has a number of serious ones Disadvantage. So the inclusion of air Impression can be falsified. As a result of an insufficient Sealing at the edge of the spoon is due to the lack Backflow a desired increase in compression in the Impression material prevented. As a further consequence of the inadequate sealing often leads to uncontrolled outflow of excess Impression material in the oral cavity, in the respiratory system as well as in the saliva tube. In addition, this Method by the individually different pressure of the impression tray during curing is optimal Impression difficult. Have corresponding investigations result in impressions made in this way often imprecise and therefore for the technician are unusable. - Here the invention seeks to remedy the situation create.” - thus, Hermann is describing a similar process with a tray for teeth, wherein problems exist if the compound in the tray is pre-filled with the compound
As to Hermman’s solution, see the next few paragraphs and accompanying figures: “The invention solves this issue on the basis of one known impression tray in that at the edge of the tray a circumferential one on the inside facing the jaw elastic seal is attached that in the spoon bottom in the front area an opening with an outside connected filling hose is provided and that in the spoon bottom also in the rear area Vents are included, one of which at least one leading to the front Vent hose runs out… To generate final pressure. Through relief openings in the rear area is an optimal filling under Avoidance of air pockets guaranteed.” And “To further improve the initiation of Impression material, it is advantageous for the mouth opening the filling hose on the inside of the spoon train oval and arrange so that they are up to the bulge that extends the free ends of the Teeth is adjacent”
See the figures and descriptions of # 10, 11, 6, 12, and 13: “A suitable filling hose ( 10 ) is attached to the outside of the impression tray for the introduction of a flowable impression material. Its mouth opening ( 11 ) in the bottom of the impression tray ( 1 ) is an elongated, approximately oval opening, which extends to the ring gear bulge of the tray recess. So that the air in the cavity ( 6 ) can escape unhindered when the impression material is poured in, a vent groove ( 12 ) is formed in the bottom of the tray at its rear edge, from which a vent hose ( 13 ) extends outwards to the front end of the impression tray ( 1 ) is performed.”
In particular, fig. 1, note it’s the filler hose is a second tubular shape (# 10) from the vent (# 13)
Hermman is in the analogous art of impression trays for teeth in the same field of endeavor of trays for teeth in dentistry. Thus, Hermann is 1) in the same field of endeavor and 2) reasonably pertinent to the problem faced by the instant inventor of gases caused by the compound in the tray (¶ 68 of the instant disclosure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings from Paehl on a transfer tray which includes a channel for adding in the filler material/adhesive for bonding the bracket with the tooth with the teachings from Hermman on impression trays wherein vent cylinders were added. The motivation to combine would have been that “This known method has a number of serious ones Disadvantage. So the inclusion of air Impression can be falsified. As a result of an insufficient Sealing at the edge of the spoon is due to the lack Backflow a desired increase in compression in the Impression material prevented. As a further consequence of the inadequate sealing often leads to uncontrolled outflow of excess Impression material in the oral cavity, in the respiratory system as well as in the saliva tube. In addition, this Method by the individually different pressure of the impression tray during curing is optimal Impression difficult. Have corresponding investigations result in impressions made in this way often imprecise and therefore for the technician are unusable. - Here the invention seeks to remedy the situation create” followed by: “The invention solves this issue on the basis of one known impression tray in that at the edge of the tray a circumferential one on the inside facing the jaw elastic seal is attached that in the spoon bottom in the front area an opening with an outside connected filling hose is provided and that in the spoon bottom also in the rear area Vents are included, one of which at least one leading to the front Vent hose runs out”
Regarding claim 22
Rejected under a similar rationale as claim 5 above.
Claim(s) 17 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paehl et al., US 2016/0310239, either alone with an obvious rationale, or in view of Van Der Meer, Wicher J., et al. "3D Computer aided treatment planning in endodontics." Journal of dentistry 45 (2016): 67-72 in further view of Kim et al., US 2011/0091832.
Regarding Claim 17.
While Paehl, either alone or in view of Meer, does not explicitly teach the following feature, this is taught when taken in further view of Kim:
The method of claim 15, wherein creating the digital attachment template includes forming a frangible structure that is arranged to break away a portion of the attachment template. (Kim, abstract: “Other aspects of the tray and associated methods of bonding are directed to a frangible web that extends over the gingival portion of the receptacle and fractures to facilitate tray removal after bonding.” And ¶ 16: “The transfer tray may also include a thin frangible web of material that partially extends across gingival portions of the appliance, such that the appliance is securely retained in the tray prior to bonding. Once the appliance has been bonded to the patient's dental structure, the frangible web can then be fractured and the tray removed from the patient's mouth by urging the transfer tray in the occlusal direction. The presence of a frangible web is particularly advantageous since it provides both convenient loading and retention of the appliance into the tray, as well as easy detachment of the tray from the patient's dental structure. Detachment of the tray in the occlusal direction is convenient and comfortable for the patient since it does not involve pulling the tray outward against the cheeks or lips. Occlusal tray removal is also helps minimize the risk of accidentally debonding the newly bonded appliances, since it avoids the need to pull the appliances away from the tooth surface in the labial direction ( or lingual direction in the case of lingual appliances).” – see ¶¶ 75-76 to clarify, incl.: “The lines of weakness 83' indicate locations along which the web 81' is likely to fracture when the appliance 16' is urged towards the gingival direction with a sufficient amount of force.” As shown in fig. 13 (web is # 81’ in fig. 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings from Paehl on the tray of Paehl with the teachings from Kim on having a frangible tray structure. The motivation to combine would have been that “The presence of a frangible web is particularly advantageous since it provides both convenient loading and retention of the appliance into the tray, as well as easy detachment of the tray from the patient's dental structure. Detachment of the tray in the occlusal direction is convenient and comfortable for the patient since it does not involve pulling the tray outward against the cheeks or lips. Occlusal tray removal is also helps minimize the risk of accidentally debonding the newly bonded appliances, since it avoids the need to pull the appliances away from the tooth surface in the labial direction ( or lingual direction in the case of lingual appliances” (Kim, ¶ 16)
Also, Paehl already contemplates a combination with Kim. Paehl, ¶ 77, as relied upon above: “As another alternative (not depicted in the Figures), a virtual transfer tray may be directly derived from the virtual mockup, using methods described in US Publication No. 2011/0091832.”
Regarding claim 24
Rejected under a similar rationale as claim 17 above.
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).
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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A. HOPKINS whose telephone number is (571)272-0537. The examiner can normally be reached Monday to Friday, 10AM to 7 PM EST.
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/David A Hopkins/Primary Examiner, Art Unit 2188
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