DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-19 and 32-33, drawn to an orthodontic appliance, classified in A61C7/08.
II. Claims 20-22, 24, 26-28, and 30-31, drawn to a method of making an orthodontic appliance, classified in B29C51/14.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as a product and a process of making it. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the orthodontic appliance can be made in another process, such as forming the first shell and the second shell separately and then stacking them and sealing the edges, or forming the first shell and then forming the second shell on top of the first shell. Examples of alternative manufacturing methods are provided in paragraph 100 of the instant application specification.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: the inventions have acquired a separate status in the art in view of their different classification and the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Richard Batt on Sept. 18, 2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-19. Affirmation of this election must be made by applicant in replying to this Office action. Claims 20-22, 24, 26-28, and 30-31 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 230.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 1012.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: “a top second surface” within the first limitation direct to “a first shell” should be “a top first surface”.
Claim 9 is objected to because of the following informalities: “the appliance, as a whole, can continue to apply force to the patient’s teeth up to 25% strain” should be changed to “the appliance, as a whole, can continue to apply force to the patient’s teeth when the appliance is strained up to 25%”.
Claim 16 is objected to because of the following informalities: “a top second surface” within the first limitation direct to “a first shell” should be “a top first surface”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 7 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The limitation “wherein the feature is located below the cementoenamel junction (CEJ) or gingival margin” positively recites the body in the form of the anatomical features of the CEJ or gingival margin. A possible alternative version of this limitation is : “wherein the feature is configured to be located below the cementoenamel junction (CEJ) or gingival margin”. Though correction should also be made to “the feature” as explained in the 112(b) rejection below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 13, 15, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation “wherein the feature is located below the CEJ or gingival margin”. There is insufficient antecedent basis for this limitation in the claim, particularly for “the feature” as the claim is dependent on claim 1. For the sake of examination, “the feature” will be considered to be “the seal”.
Regarding Claim 13, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation "does not exceed 10 hours", and the claim also recites "more preferably does not exceed 9 hours, and most preferably, does not exceed 8 hours" which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the sake of examination, the narrower language will be considered merely exemplary.
Claim 15 recites the limitation "wherein the stack comprises a sacrificial layer". There is insufficient antecedent basis for this limitation in the claim, specifically for “the stack” since the claim is dependent on claim 1 rather than claim 14, which recites “a stack”. For claim 15, the stack will be considered to be the precursor material to the appliance.
Claim 17 recites “the appliance, as a whole, can continue to apply force to the patient’s teeth when the subject to a strain up to 25%.” The claim appears to be missing words so it is unclear what is subject to a strain up to 25%. For the sake of examination, the orthodontic appliance will be considered to be subjected to up to 25% strain.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and claim 19 of U.S. Patent No. 12,433,719. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant application is fully encompassed by each claim 1 and claim 19 in US 12,433,719. The claim in the instant application is a broader genus to claims 1 and 19 in US 12,433,719.
Claim 3 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12,433,719.
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,317,992. Although the claims at issue are not identical, they are not patentably distinct from each other because if the second edge (which is on the second shell) is affixed to the top first surface (which is on the first shell), then a perimeter seal is effectively formed between a portion of the top first surface of the first shell and the bottom second surface of the second shell. Additionally, the shells are recited as being stacked by not affixed except at the second edge, therefore a chamber exists between the shells where they are not affixed, even if the chamber is just a thin amount of air between the shells.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 7, 12, 14 and 32-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Phan (US 2020/0237480).
Regarding Claim 1, Phan discloses an orthodontic appliance (orthodontic appliance 10; ¶ 51 states that the features of the individual embodiments may be readily separated or combined) comprising:
a first shell (first shell 14) adapted to receive patient teeth (Figure 2; ¶ 57), wherein the first shell has a bottom first surface for engaging the teeth (¶ 57) and a top [first] surface opposite the bottom first surface (¶ 57) and a first edge defined therebetween (the edge of the material which has a thickness and a top and opposite bottom surface);
a second shell (second shell 16; shells 18 between first shell 14 and second shell 16 are optional according to ¶ 57) stacked over the first shell (Figure 2; ¶ 57), wherein the second shell has a bottom second surface (¶ 57), a top second surface opposite the bottom second surface (¶ 57) and a second edge defined therebetween (the edge of the material which has a thickness and a top and opposite bottom surface); and
a first chamber defined between the top first surface of the first shell and the bottom second surface of the second shell (by fixing the shells together only near the edges, as shown in Figure 3A and described in ¶ 60, the rest of the space between the shells is not fixed together and therefore forms a chamber between the shells; ¶ 58 describes the shells as being substantially non-affixed because a substantially amount of the surface remains unbonded to the opposing shell, therefore this area forms a chamber which can contain a small amount of air and allow for movement, and ¶ 63 even provides for the chamber formed by the surfaces of the shells potentially containing a lubricant to decrease friction between the shells), and a first perimeter seal (dashed line in Figure 3A; ¶ 60) formed between a portion of the top first surface of the first shell and the bottom second surface of the second shell (in order to fix the shells together near the edge using one of the methods described in ¶ 66, the top surface of the first shell and the bottom surface of the second shell would be sealed together).
Regarding Claim 2, Phan discloses the orthodontic appliance as recited in claim 1 (as presented above), wherein the first perimeter seal is a mechanical seal (¶ 65 describes possible ways to create the seal and several of these create a mechanical seal).
Regarding Claim 3, Phan discloses the orthodontic appliance as recited in claim 2 (as presented above), wherein the first perimeter seal is a formed by heat (¶ 65 lists localized melting, which is done by application of heat, as a method of fixing shells together).
Regarding Claim 4, Phan discloses the orthodontic appliance as recited in claim 2 (as presented above), wherein the first perimeter seal comprises a predetermined thermal bond region and a non-anatomic shape (the thermal bond region being predetermined is a product-by-process, since the seal as shown in Figure 3A is the edge of the device, it could be predetermined before the formation of the rest of the device by the size of the plastic used to form the device, additionally the edge of the device has a non-anatomic shape because it does not follow the details of the CEJ or gingival margin but rather cuts a relatively straight line across the gums below the teeth).
Regarding Claim 7, Phan discloses the orthodontic appliance as recited in claim 1 (as presented above), wherein the feature is located below the cementoenamel junction (CEJ) or gingival margin (Figure 3A shows the seal, in the form of the dotted line, being below where the teeth and gingiva meet).
Regarding Claim 12, Phan discloses the orthodontic appliance as recited in claim 1 (as presented above), wherein the first shell and second shell are arranged together such that the appliance, as a whole, is operable to maintain clinically effective force on the patient's teeth during daily use for at least 1 week (how long the appliance maintains effective force on the patient’s teeth is a matter of design of the treatment system, which comprises multiple appliances used sequentially, therefore the appliance as taught by Phan is fully capable of applying clinically effective force to a patient’s teeth for at least 1 week if it is designed to be used for at least 1 week before switched for a the next appliance in the sequence).
Regarding Claim 14, Phan discloses the orthodontic appliance as recited in claim 1 (as presented above), made by forming a stack of layers, and arranging the stack over a dental model, and thermoforming the stack over the dental model (¶ 64).
Regarding Claim 32, Phan discloses the orthodontic appliance as recited in claim 1 (as presented above), wherein at least one of the first shell and second shell is made of polyester or polyurethane (Phan ¶ 63 lists polyester and polyurethane as potential materials for the shells).
Regarding Claim 33, Phan discloses the orthodontic appliance as recited in claim 1 (as presented above). Phan teaches the shells can be sealed by localized melting (¶ 65) and that such a seal can be around the perimeter and some distance from the CEJ (Figure 3A). While Phan does not specify the shells being trimmed and sealed by a hot tip or laser, this limitation is a product-by-process claim. Therefore the seal and trimmed edge present in the device taught by Phan is the same structure that would be created by the process recited.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Phan (US 2020/0237480) as applied to claim 1 above, in further view of Kim (WO 2021/251421).
Regarding Claims 5 and 6, Phan discloses the orthodontic appliance as recited in claim 1 (as presented above). Phan further discloses wherein the first perimeter seal comprises a localized physical deformation to key the shells together (¶ 65), but does not provide further details on such physical deformations of the shell.
However, Kim, in the same field of endeavor of orthodontic appliances (abstract), teaches joining together multiple layers of an orthodontic appliance (Figure 4; mouthpiece 1, which is a mouthpiece-type removable corrective device) with a groove (mounting portion 17 on inner surface 14 of outer cover portion 11, which is recess into the surface) and a raised protrusion (mounting protrusion 21 on the inner layer, tooth surface pad 20).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the localized physical deformation to key the shells together taught by Phan be the grove and corresponding raised protrusion taught by Kim to join to layers together. This is a substitution of the unspecified physical connection of the shells taught by Phan for the known groove and corresponding protrusion taught by Kim to connect layers or shells.
Claims 8, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Phan (US 2020/0237480) as applied to claim 1 above, in further view of Stewart et al. (WO 2022/225900).
Regarding Claims 8 and 11, Phan discloses the orthodontic appliance as recited in claim 1 (as presented above),
(Claim 8) wherein the first shell and second shell are arranged together such that the appliance, as a whole, is hyper-elastic when subjected to greater strain (¶ 59 teaches that the lack of fixation between the shells provides for increased elasticity and for the shells to move relative to each other when subjected to increased strain, resulting in hyper elasticity because the shells each have elastic behavior and then the gap between them where they are not affixed allows for movement of the shells relative to each other and provides additional elasticity) and
(Claim 11) wherein the hyper-elastic behavior arises, at least in part, from the presence of the chamber (In Phan, the height of the chamber is not specified but the chamber is created by stacking two shells and sealing around the perimeter only (dotted line in Figure 3A). In the instant application the height of the chamber is also not specified (¶ 110 says it could be uniform or varied and even have tack-less contact points), but the device could be created in the same way as Phan or could be created by having a layer of water or similar thin layer leading to thin chamber between two plastic sheets that form the shells. Therefore the chamber of the instant application and chamber of Phan have the same structure leading to the hyper-elastic behavior when the shells move relative to each other as a result of the chamber).
Phan does not explicitly teach the increased strain being greater than 5% strain, as recited in claim 8, because Phan does not explicitly teach the application of any particular strain amount.
However, Stewart, in the same field of endeavor of materials for orthodontic aligners (¶ 34), teaches that materials for orthodontic aligners, such as the polyurethanes described, must have good elastic and recovery properties at least up to 5%, as demonstrated by the testing performed at 5% strain (¶ 64, 141, 159) to determine that the material is useful for orthodontic aligners.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the orthodontic appliance as taught by Phan to have the shells arranged such that there is hyper-elastic behavior when the appliance is subjected to a greater than 5% strain, taught by Stewart as being necessary for orthodontic appliances elastic behavior. Phan teaches that the appliances with multiple shells provide greater working elasticity, which would be provided for both by the selection of material, as described in ¶ 63, and by the ability of the shells to move relative to each other except where affixed. Since Stewart teaches that orthodontic appliances must have desirable elastic behaviors up to at least 5%, it would be obvious to make an appliance intended to have greater working elasticity have desirable elastic behaviors above 5% strain.
Regarding Claim 9, Phan and Steward teach the orthodontic appliance as recited in claim 8 (as presented above). Phan further teaches wherein the first shell and second shell are arranged together such that the appliance, as a whole, can continue to apply force to the patient's teeth up to 25% strain (the device would continue to apply force to a patient’s teeth after a larger strain because the device would still be on the patient’s teeth and the elastic materials of the device would still be attempting to recover; even if the ultimate tensile strength was passed, the would still be some force exerted; the limitation does not explicitly require that the force be the desired therapeutic force or comfortable for the patient to wear or anything beyond a force being exerted on the teeth).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Phan (US 2020/0237480) and Stewart et al. (WO 2022/225900) as applied to claim 9 above, in further view of Phan et al. (US 2001/0041320), hereinafter Phan-2001.
Regarding Claim 10, Phan and Stewart teach the orthodontic appliance as recited in claim 9 (as presented above). Together they also further teaches wherein the first shell and second shell are arranged together such that the appliance, as a whole, can continue to apply force to the patient's teeth as the appliance is strained from 5 to 20%, because Phan teaches that the stack of shells with some sealed or affixed areas has a greater working elasticity than appliances with only one shell and Stewart teaches that a shell should be able to operate at least up to 5% strain, therefore the layered and partially affixed structure of Phan would work to apply force to the patient’s teeth at a strain greater than 5%. Phan and Stewart do not explicitly teach the amount of force that should be applied to the patient’s teeth.
However, Phan-2001, in the same field of endeavor of orthodontic appliances (abstract; Figure 1), teaches that “translation [of teeth] may require 70-120 gm of force” (¶ 18).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the appliance taught by Phan and Stewart deliver 100-120 gram-force as taught by Phan-2001 as being necessary for moving teeth. Such a force is known in the art to be necessary for the appliance to apply and therefore the appliance would be optimized to do so.
Claims 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Phan (US 2020/0237480) as applied to claim 1 above, in further view of Menon et al. (US 2021/0137503, published May 13, 2021).
Regarding Claim 13, Phan teaches the orthodontic appliance as recited in claim 12 (as presented above). Phan further teaches that a benefit of the appliance taught is greater break time and therefore less daily use time (¶ 46). While the example break time taught by Phan of 8-12 hours corresponds to 12-16 hours of wear, this is an example time frame and is an intended use of the appliance.
Menon, in the same field of endeavor of orthodontic appliances (abstract), teaches that aligners may be worn as little as 8 hours per day and retainers may be worn only 6-8 hours a day (¶ 106).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the orthodontic appliance taught by Phan for 10 hours or less a day, as such times for wearing aligners or retainers are known in the art and taught by Menon.
Regarding Claim 15, Phan and Menon teach the orthodontic appliance as recited in claim 13 (as presented above). Phan teaches using a stack of materials and thermoforming to fabricate the appliance (¶ 64). While the appliance taught by Phan and Menon is not explicitly made using a sacrificial layer that is converted to a gas during the thermoforming taught by Phan, this limitation is a product-by-process claim. The instant application and specifically claim 15 do not require the seal to fully enclose the chamber and/or be gas tight, therefore the gas formed during thermoforming as claimed could escape or be replaced by air after manufacturing. The claim does not require the presence of a specific gas in the chamber. Therefore the chamber present in the device taught by Phan by being a non-affixed or sealed portion of the shells is the same structure that would be created by the process recited.
Claims 16, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Phan (US 2020/0237480) in view of Stewart et al. (WO 2022/225900).
Regarding Claim 16, Phan teaches an orthodontic appliance (orthodontic appliance 10; ¶ 51 states that the features of the individual embodiments may be readily separated or combined) comprising:
a first shell (first shell 14) adapted to receive patient teeth (Figure 2; ¶ 57), wherein the first shell has a bottom first surface for engaging the teeth (¶ 57) and a top [first] surface opposite the bottom first surface (¶ 57) and a first edge defined therebetween (the edge of the material which has a thickness and a top and opposite bottom surface);
a second shell (second shell 16; shells 18 between first shell 14 and second shell 16 are optional according to ¶ 57) stacked over the first shell (Figure 2; ¶ 57), wherein the second shell has a bottom second surface (¶ 57), a top second surface opposite the bottom second surface (¶ 57) and a second edge defined therebetween (the edge of the material which has a thickness and a top and opposite bottom surface);
wherein the first shell and second shell are arranged together such that the appliance, as a whole, is hyper-elastic when subjected to greater strain (¶ 59 teaches that the lack of fixation between the shells provides for increased elasticity and for the shells to move relative to each other when subjected to increased strain, resulting in hyper elasticity because the shells each have elastic behavior and then the gap between them where they are not affixed allows for movement of the shells relative to each other and provides additional elasticity); and
wherein the hyper-elastic behavior arises, at least in part, from the presence of a first spacing defined between the top first surface of the first shell and the bottom second surface of the second shell (by fixing the shells together only near the edges, as shown in Figure 3A and described in ¶ 60, the rest of the space between the shells is not fixed together and therefore forms a spacing between the shells; ¶ 58 describes the shells as being substantially non-affixed because a substantially amount of the surface remains unbonded to the opposing shell, therefore this area forms a spacing which can contain a small amount of air and allow for movement, and ¶ 63 even provides for the spacing formed by the surfaces of the shells potentially containing a lubricant to decrease friction between the shells), and a first perimeter seal (dashed line in Figure 3A; ¶ 60) formed between a portion of the top first surface of the first shell and the bottom second surface of the second shell (in order to fix the shells together near the edge using one of the methods described in ¶ 66, the top surface of the first shell and the bottom surface of the second shell would be sealed together).
In Phan, the height of the spacing or gap between the shells is not specified, but the spacing is created by stacking two shells and sealing around the perimeter only (dotted line in Figure 3A). In the instant application the height of the spacing is also not specified (¶ 110 says it could be uniform or varied and even have tack-less contact points), but the device could be created in the same way as Phan or could be created by having a layer of water or similar thin layer leading to thin chamber between two plastic sheets that form the shells. Therefore the spacing of the instant application and chamber of Phan have the same structure leading to the hyper-elastic behavior when the shells move relative to each other as a result of the spacing.
Phan does not explicitly teach the increased strain being greater than 5% strain, because Phan does not explicitly teach the application of any particular strain amount.
However, Stewart, in the same field of endeavor of materials for orthodontic aligners (¶ 34), teaches that materials for orthodontic aligners, such as the polyurethanes described, must have good elastic and recovery properties at least up to 5%, as demonstrated by the testing performed at 5% strain (¶ 64, 141, 159) to determine that the material is useful for orthodontic aligners.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the orthodontic appliance as taught by Phan to have the shells arranged such that there is hyper-elastic behavior when the appliance is subjected to a greater than 5% strain, taught by Stewart as being necessary for orthodontic appliances elastic behavior. Phan teaches that the appliances with multiple shells provide greater working elasticity, which would be provided for both by the selection of material, as described in ¶ 63, and by the ability of the shells to move relative to each other except where affixed. Since Stewart teaches that orthodontic appliances must have desirable elastic behaviors up to at least 5%, it would be obvious to make an appliance intended to have greater working elasticity have desirable elastic behaviors above 5% strain.
Regarding Claim 17, Phan and Steward teach the orthodontic appliance as recited in claim 8 (as presented above). Phan further teaches wherein the first shell and second shell are arranged together such that the appliance, as a whole, can continue to apply force to the patient's teeth up to 25% strain (the device would continue to apply force to a patient’s teeth after a larger strain because the device would still be on the patient’s teeth and the elastic materials of the device would still be attempting to recover; even if the ultimate tensile strength was passed, the would still be some force exerted; the limitation does not explicitly require that the force be the desired therapeutic force or comfortable for the patient to wear or anything beyond a force being exerted on the teeth).
Regarding Claim 19, Phan and Stewart discloses the orthodontic appliance as recited in claim 16 (as presented above), wherein the first shell and second shell are arranged together such that the appliance, as a whole, is operable to maintain clinically effective force on the patient's teeth during daily use for at least 1 week (how long the appliance maintains effective force on the patient’s teeth is a matter of design of the treatment system, which comprises multiple appliances used sequentially, therefore the appliance as taught by Phan is fully capable of applying clinically effective force to a patient’s teeth for at least 1 week if it is designed to be used for at least 1 week before switched for a the next appliance in the sequence).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Phan (US 2020/0237480) and Stewart et al. (WO 2022/225900) as applied to claim 9 above, in further view of Phan et al. (US 2001/0041320), hereinafter Phan-2001.
Regarding Claim 18, Phan and Stewart teach the orthodontic appliance as recited in claim 9 (as presented above). Together they also further teaches wherein the first shell and second shell are arranged together such that the appliance, as a whole, can continue to apply force to the patient's teeth as the appliance is strained from 5 to 20%, because Phan teaches that the stack of shells with some sealed or affixed areas has a greater working elasticity than appliances with only one shell and Stewart teaches that a shell should be able to operate at least up to 5% strain, therefore the layered and partially affixed structure of Phan would work to apply force to the patient’s teeth at a strain greater than 5%. Phan and Stewart do not explicitly teach the amount of force that should be applied to the patient’s teeth.
However, Phan-2001, in the same field of endeavor of orthodontic appliances (abstract; Figure 1), teaches that “translation [of teeth] may require 70-120 gm of force” (¶ 18).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the appliance taught by Phan and Stewart deliver 100-120 gram-force as taught by Phan-2001 as being necessary for moving teeth. Such a force is known in the art to be necessary for the appliance to apply and therefore the appliance would be optimized to do so.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shanjani et al. (US 10,383,705) teaches monitoring devices connected to orthodontic appliances via overlying shells.
Wen (US 10,548,690) teaches a multi-layered aligner where the inner core layer can be removed, thus leaving a chamber between the remaining layers.
Sato et al. (US 11,376,101) teaches a palate expander with a chamber in the roof area adjacent to the palate.
Raby (US 11,737,854) teaches an aligner with multiple shells with a gap between.
Yamamoto et al. (US 2009/0061379) teaches an orthodontic appliance with 2 shells and a vibrating actuator running through a chamber between them.
Cios (US 2013/0157224) teaches an orthodontic appliance with 2 layers with a chamber between them on at least one side of the teeth.
Raslambekov (US 11,058,515) teaches trimming shells using a laser tool (col 17 lines 39-43), which is known to be able to generate heat (col 17 lines 19-22 describe the laser marking head as scorching the aligner), therefore it would be capable of trimming and sealing the two shells simultaneously.
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/JENNIFER P CONNELL/Examiner, Art Unit 3772
/THOMAS C BARRETT/SPE, Art Unit 3799