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 .
DETAILED ACTION
Status of the Claims
Claims 1-25 are pending. Claims 1-15 are the subject of this NON-FINAL Office Action. This is the first action on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-15) in the reply filed on 04/16/2026 is acknowledged. The species election is withdrawn.
Claims 16-25 are withdrawn as drawn to unelected inventions and species.
Claim Rejections - 35 USC § 112- Indefiniteness
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.
Claims 1-15 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The resin required by the claims is too ambiguous to apply prior art without conjecture as to its scope. When the claims become so ambiguous that one of ordinary skill in the art cannot determine their scope absent speculation, such claims are invalid for indefiniteness. see In re Steele, 305 F.2d 859, 862 (CCPA 1962). Claim 1 is representative and recites:
1. A method of manufacturing an orthodontic appliance, the method comprising:
providing a mold including one or more projections representing a patient's teeth and comprising a resin;
deforming a worksheet over the one or more projections, wherein the deformed worksheet includes the orthodontic appliance;
exposing the resin to a fluid whereby at least one material property of the resin changes; and
during or after a change in the at least one material property, removing the orthodontic appliance from the mold.
The mold is made of a fluid-altered resin that causes the cured mold resin to change a “material property.” This encompasses any resin that changes in any way. However, the only “material property” that changes in response to fluid exposure disclosed in the specification and claims is swelling via water absorption (Spec., paras. 0018, 0026, 0033, 0040-41 & 0050-67; claims 2-13). In other words, the only resin possibly disclosed that meets the claimed functions is water-swelling resin. Yet, critically, no species are disclosed (i.e. chemical compositions). At best, the specification discloses that “[b]y way of example only, and not limitation, the mold material tested was Perfect Cast WS1 Water Soluble for SLA, DLP & LCD Printers from 3Dresyns” (Example 1). However, the ingredients for this are never disclosed. Moreover, Perfect Cast WS1 is proprietary (see Bing Copilot Search, Perfect Cast WS1 ingredients, attached, 06/17/2026 (“Important note: The exact proprietary chemical composition is not disclosed by 3Dresyns, as it is a professional manufacturing material.”)). Thus, it is impossible to determine what resins are being claimed because Applicants fail to disclose any species.
Claim Rejection - 35 USC § 112 – Written Description
The following is a quotation 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.
Claims 1-15 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the full scope of the claimed invention.
The specification fails to demonstrate possession of any resins with the claimed fluid-altering characteristics; rather, Applicants present a wish or plan to develop them. The specification completely fails to describe the structure or composition of the claimed resin. The claims are very generic and broad: any resin can be used with any fluid, to cause any resin change. As an initial matter, the specification fails to provide written description support for any and all “material property” alterations by any and all “fluids” in any and all steps of a dental thermoforming process. Instead, the specification discloses a single example, which fails to support any other species that fall within the huge genus of possible resins, fluids and resin changes. For example, the specification never discloses “material property”/resin change of shrinking, exploding, dissolving, color change, hardening, curing, etc.
Within this breadth, the specification provides one possible generic example. At most, the specification states the following:
The mold 14 is manufactured of a material that is capable changing properties in such a way to facilitate separation of the aligner 12 from the mold 14. One exemplary material is a resin that reacts with a fluid. As an example, the resin may absorb water into its molecular structure. As it does, the molecular structure expands, much like a sponge. Volumetric expansion may be referred to herein as swelling and refers to the capability of the mold material to absorb a fluid, and in doing so, the mold increases along one or more dimensions and/or changes shape. In this exemplary embodiment, the mold 14 has a dual purpose. First, it forms a base over which the worksheet 16 is deformed. Second, after deforming the worksheet 16, the mold is capable of assisting in the separation of itself from the deformed worksheet. Material property modification may be selectively initiated by an activation process.
[ . . . ]
Example 1
With continued reference to FIG. 5, to measure the rate of swelling, volume measurements of a cube of mold material were made at time intervals following submersion. By way of example only, and not limitation, the mold material tested was Perfect Cast WS1 Water Soluble for SLA, DLP & LCD Printers from 3Dresyns. Three 11 mm by 11 mm by 11 mm cubes of 3Dresyns material were 3D printed under standard machine parameters on an ELEGOO Mars 3 Pro 4K 6.66″ MONO LCD MSLA Resin 3D Printer. The Chitubox parameters were as follows: Resolution X: 4098 px; Y: 2560 px; Machine Type Mirror: LCD_mirror; Size X: 143.430 mm; Size Y: 89.6 mm; Size Z: 175 mm; Exposure Time 30 s; Lift Distance 5 mm; Lift Speed 65 mm/min; Bottom Exposure Time 80 s; Layer Height 0.05 mm; and Retract Speed 150 mm/min.
Each cube was submerged in 80° C. water (submersion is shown, for example, in FIG. 5). At predetermined time intervals of 5 minutes 30 seconds, one side of each cube was measured. The volume of each cube was calculated from the measured dimensional data. Calculated volume is plotted against time in FIG. 6A. An enlarged view of a selected range of FIG. 6A is shown in FIG. 6B. From the data, a swelling rate of at least 0.96 cc/hr was calculated by least squares analysis of the data plotted in FIG. 6A. It is noted that the mold material is dissolvable in water. This is illustrated by the rapid increase in the volume at about 11,000 seconds in FIG. 6A. The exemplary material therefore swells and then eventually dissolves when submerged in water.
In particular, with reference to FIG. 6B, in an exemplary embodiment, the mold material swells by at least 20% after submersion in water for 5 minutes and 30 seconds. For example, from FIG. 6B, with an initial calculated volume of 1,250 mm3, after submersion, the cube has a calculated volume of 1,500 mm3. Not being bound by theory, swelling (i.e., volume expansion) may be due to absorption of the fluid by the mold material. Property changes were not limited to swelling, for example, in addition to the mold material softened and was pliable and elastic when removed from the water.
(paras. 0040 & 0053-55). This single example of manufacturing a dental article requires a water-swelling resin mold, over which a thermoforming sheet is heated and molded, followed by subjecting the mold with the thermoformed sheet to water to swell and remove the mold. Critically, Applicants never actually test a resin that falls within the claims, much less this single disclosed thermoforming orthodontic manufacturing method. Instead, Example 1 only describes testing a cube of proprietary Perfect Cast WS1 in a glass of water to determine its swelling. This alone evinces a wish or a plan to later try using Perfect Cast WS1 in the claimed method.
Moreover, Perfect Cast WS1 is proprietary, meaning a skilled artisan would not know what ingredients are in it (see Bing Copilot Search, Perfect Cast WS1 ingredients, attached, 06/17/2026 (“Important note: The exact proprietary chemical composition is not disclosed by 3Dresyns, as it is a professional manufacturing material.”)). In other words, the disclosure of a single example, Perfect Cast WS1, fails to provide any written description support for the resin ingredients.
Finally, this single possible species is far from enough to cover the genus of all resins capable of forming a dental product thermoforming mold that is later subject to a “material property” alteration after the thermoforming. Whether the disclosure of a patent satisfies the written description requirement is a question of fact. See Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The test for sufficiency of the written description support is “whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date sought.” Id. This “possession” test “requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. Possession shown by evidence “outside of the specification is not enough,” and “a description that merely renders the invention obvious does not satisfy the requirement.” Id. at 1352. Instead, it is the specification itself that must demonstrate possession. Id. “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997) (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993))). Further:
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.
University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 926 (Fed. Cir. 2004). Here, the specification never discloses a species of resin, much less one used in the claimed dental product thermoforming process. The specification mentions Perfect Cast WS1, which is a trade name. However, as explained above, this product is proprietary; thus, the chemical composition is secret. In other words, at most the specification discloses a single species (Perfect Cast WS1); at worst, zero. A single species fails to satisfy the genus; and zero species certainly fails. Further, as explained in Ariad, possession of any and all species of the claimed resin shown by evidence “outside of the specification is not enough,” and “a description that merely renders the invention obvious does not satisfy the requirement.” 598 F.3d at 1352. Finally, the claimed function of the resin “merely draw[s] a fence around the outer limits of a purported genus [and] is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” See Ariad, 598 F.3d at 1350; see also 598 F.3d at 1349 (Where a genus is claimed using functional language to define a desired result, “the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.”). In sum, the specification fails to disclose any species of resin that achieve the claimed functions.
Possible Prior Art
The following potential prior art may be relevant: JP 2019217770 A; KR 20230105722 A.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELODY TSUI whose telephone number is (571)272-1846. The examiner can normally be reached Monday - Friday, 9am - 5pm.
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/YUNG-SHENG M TSUI/ Primary Examiner, Art Unit 1684
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