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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the gap and support structure must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 18 is objected to because of the following informalities: On line 2 of the claims "along has a transparent appearance" is believed to be in error for -alone has a transparent appearance-. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: On line 6 of the claim “edge are sealed are sealed at one” are believed to be in error for -edge are sealed at one-. Appropriate correction is required.
Claim 31 is objected to because of the following informalities: On line 2 of the claim “release of agent” is believed to be in error for -the release of the first agent-. Appropriate correction is required.
Claim 45 is objected to because of the following informalities: On line 1 of the claimed “of claim 34” is believed to be in error for -of claim 44-. Appropriate correction is required.
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 24-25 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.
In each of claims 24 and 25, the applicant claims “a polyurethane”. It is noted that the claims depend from claim 23 in which the applicant has claimed that the laminate comprises “a polyurethane or a maleic anhydride grafted polyethylene”. It is unclear if the claimed polyurethane in claims 24-25 is the claimed polyurethane of claim 23 or a different one. It is noted that for examination purposes, the limitation is being interpreted as the same polyurethane, however, the applicant should amend the claims to clarify.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 12-15, 26-27, 34-35, 38, and 44 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qiu (CN 113616363).
Qiu discloses with respect to claim 1,a device comprising a first polymer shell 6 contoured to fit at least a portion of a subject’s upper or lower teeth (see fig. 1, pars. 7, 8, 17, 28), the first polymer shell having an inner surface, an outer surface, and a fist shell edge member (see annaoted figure below), a second polymer shell 3 (par. 27) dimensioned to receive the first polymer shell 6 (see fig. 1) having an inner receiving surface and an outer external surface, and a second shell edge member (see annotated figure below), wherein the first edge member and the second edge members are jointed to form a first gap between the inner surface and inner receiving surface (see fig. 1, such that the gap is filled with the hydrogel 4, the edges are jointed together such that they form the combined structure, par. 29 such that the hydrogel is inserted in an embodiment in which the insert is NOT removable from the base) and a first agent 4 disposed in the first gap (pars. 11-13) wherein the device is configured for insertion into an oral cavity of a subject for delivery of the first agent for controlled release over a time period (pars. 7-9, 11-13, see fig. 1).
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Qiu further discloses with respect to claim 12, wherein one or more of the first and second polymer shells has an opening (pars. 8, 15, 29, 31, such that the opening is an injection hole on the base or the pores on the first shell).
Qiu further discloses with respect to claim 13, wherein the device wherein inserted into an oral cavity of a subject is further configured to apply force to the teeth for a wear period, for movement of the teeth from an existing position to a next position (pars. 19, 29, 33).
Qiu further discloses with respect to claim 14, wherein the device is a retainer, the retainer not configured to apply force to teeth to reach a final tooth position but to maintain teeth in a final tooth position, wherein the retainer is designed to be worn in the mouth for a wear period. It is noted that the aligner of Qui is capable of being a retainer, such that once the teeth have been moved by the alinger to the final position of that alinger, the alinger will no longer apply a tooth moving force to the teeth and will function as a retainer. It is noted that the limitation is a functional limitation and since the prior art is capable of functioning as claimed, then the claimed limitations are met.
Qiu further discloses with respect to claim 15, wherein the device is designed to be worn in the mouth (see fig. 1), and wherein a wear period of the device is longer than the release period, or wherein the release period is longer than the wear period, or wherein the wear period and the release period are essentially the same. It is noted that the device of Qiu has a wear period as it is to be worn in the mouth for a period for orthodontic treatment and the wear period is inherently longer, shorter, or the same as the release period.
Qiu further discloses with respect to claim 26, comprising an amount of the first agent for release at a controlled rate for the release period (see pars. 13, 30, such that the composition includes sustained release agents to control the release of the agent).
Qiu further discloses with respect to claim 27, wherein the device comprises a second agent, a third agent, and/or a fourth agent (see par. 30, such that is contained active peptides, silver nanoparticles, and antioxidants).
Qiu further discloses with respect to claim 34, wherein one or more of the first and second polymer shells is a porous shell member (par. 9, 21, 31, see fig. 1, such that the first shell is a porous shell).
Qiu further discloses with respect to claim 35, wherein the first agent is a breath freshener, a nutritional agent or nutritional supplement, an oral or dental wellness agent, or a therapeutic agent with activity for tissue remodeling (par. 30, such that the agent is a dental wellness agent).
Qiu further discloses with respect to claim 38, wherein the first agent is selected from a group consisting of vitamins, minerals, antioxidants, and sleep agents (par. 30, such that it is an antioxidant).
Qiu further discloses with respect to claim 44, wherein a support member 4 (the support being the hydrogel) is positioned in the first gap, wherein the support member is configured to releasably carry the first agent (par. 30).
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.
Claim(s) 3 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Qiu (CN 113616363).
Qiu discloses with respect to claim 2, the first and second shell edge members comprise of an inner edge, an outer edge or both an inner edge and an outer edge (see annaoted figure below). Qiu teaches the invention as substantially claimed and discussed above however, is silent to wherein one or both of the inner edge and outer edge of the first and second shell edges form an arch. However, Qiu teaches the device is an orthodontic aligner for accepting the teeth of the patient to perform orthodontic treatment (see par. 7) and the upper and lower aligners having upper and lower alveoli that match the patient’s teeth (see par. 26). Therefore, Qiu obviously teaches the inner edge and the outer edge form an arch since the alveoli of the patients’ teeth are an arch shape. In the alternative it would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Qiu to provide the alinger with the inner and outer edges in an arch shape in order to fit on the teeth of the patient in order to provide the orthodontic treatment.
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Qiu further teaches with respect to claim 7, wherein the inner edge and the outer edge of the second shell each form an arch length (see explanation above, such that each the inner and outer edge follows the arch shape of the jaw), respectively of L2-inner and l2-outer, and the inner edge and the outer edge of the first shell each form an arch with a length, (see explanation above, such that each the inner and outer edge follows the arch shape of the jaw), respectively of l1-inner and l1-outer, and the first shell inner edge and second shell inner edge are sealed along the lengths l1-inner and l2- inner and the first shell outer edge and the second shell outer edge are sealed along the lengths l1-outer and l-2 outer, to form a peripheral edge seal (see fig. 1, such that the shells are connected and the edges are sealed in that the agent in the gap is expelled through the openings in the inner shell, par. 29 such that in the embodiment in which the layers are formed connected together).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qiu (CN 113616363) as applied to claim 3 above, and further in view of Gaglio et al. (5,326,685).
Qiu teaches the invention as substantially claimed and discussed above, including wherein the inner edge and the outer edge of the second shell each form an arch length (see explanation above, such that each the inner and outer edge follows the arch shape of the jaw), respectively of L2-inner and l2-outer, and the inner edge and the outer edge of the first shell each form an arch with a length, (see explanation above, such that each the inner and outer edge follows the arch shape of the jaw), respectively of l1-inner and l1-outer, and the first shell inner edge and second shell inner edge are sealed along the lengths l1-inner and l2- inner and the first shell outer edge and the second shell outer edge are joined together along the lengths l1-outer and l-2 outer, to form a peripheral edge (see fig. 1, such that the shells are connected and the edges are sealed in that the agent in the gap is expelled through the openings in the inner shell, par. 29 such that in the embodiment in which the layers are formed connected together). Qiu teaches the invention as substantially claimed and discussed above including the edges being connected together in a form fitting manner, however, does not specifically teach the edge is seal.
Gaglio teaches a device comprising a first layer 30, as second layer 40 and a gap (occupied by element 32) wherein a first agent is disposed (see fig. 9).
Gaglio further teaches with respect to claim 7, wherein the edges are sealed (38-54). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Qiu with the seal at the edges as taught by Gaglio in order to ensure that the agent is only delivered through the first polymer shell.
Claim(s) 16-17, 20 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qiu (CN 113616363) as applied to claim 1 above, and further in view of Martino (WO 2013/190580).
Qiu teaches the invention as substantially claimed and discussed above including the second shell made of a transparent polyurethane (see par 27), however, does not specifically teach wherein one or more of the first and second polymer shells is a laminate of at least two polymeric materials, wherein the laminate is a di-laminate or tri—laminate comprised of a first thermoplastic material and a second thermoplastic material, wherein the second thermoplastic material is a copolyester, and wherein the laminate comprises a polyurethane or maleic anhydride grafted polyethylene.
Martino teaches a device comprising a polymer shell contoured to fit at least a portion of a subjected upper or lower teeth (see fig. 2).
Martino further teaches with respect to claim 16, wherein the polymer shell is a laminate of at least two polymeric materials (pg. 9, ll. 21-30, pg. 10, ll. 1-5).
Martino further teaches with respect to claim 17, wherein the laminate is a di-laminate comprised of a first thermoplastic material and a second thermoplastic material (pg. 9, ll. 21-30, pg. 10, ll. 1-5).
Martino further teaches with respect to claim 20, wherein the second thermoplastic material is a copolyethylene (pg. 9, ll. 21-30, pg. 10, ll. 1-5, specifically, PETG).
Martino further teaches with respect to claim 23, wherein the laminate comprises a polyurethane or a maleic anhydride grafted polyethylene (pg. 9, ll. 21-30, pg. 10, ll. 1-5, specifically a polyurethane).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Qiu with the laminate material taught by Martino in order to deliver the desired force to the teeth. Further it is noted that is has been held to be within the general skill of a worker in the art to selece a known material on the basis of its suitability for the intended use as a matter of obvious design choice (MPEP 2144.07).
Claim(s) 18-19, 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qiu (CN 113616363) in view of Martino (WO 2013/190580) as applied to claims 16-17 above, and further in view of Raslambekov (2020/0315743).
Qiu/Martino teaches the invention as substantially claimed and discussed above including Qiu teaching the device being made of a transparent polyurethane (see par. 27), however, does not specifically teach the first thermoplastic material along has a transparent appearance, the second thermoplastic material is translucent, the copolyester is transparent.
Raslambekov teaches a device comprising a polymer shell (see fig. 1, par. 91).
Raslambekov further teaches with respect to claim 18, wherein a first thermoplastic material has a transparent appearance (par. 91, such that a thermoplastic polyurethane being the first thermoplastic material and is disclosed being able to be transparent).
Raslambekov further teaches with respect to claim 19, wherein the second thermoplastic material is translucent (par. 91, such that the second thermoplastic material is PETG which is disclosed as being able to be translucent).
With respect to claim 20, Martino teaches the second thermoplastic material is a copolyester (pg. 9, ll. 21-30, pg. 10, ll. 1-5, specifically, PETG), however, does not specifically teach it is transparent.
Raslambekov further teaches the copolyester is transparent (par. 91).
Raslambekov further teaches with respect to claim 22, wherein the transparent copolyester is polyethylene terephthalate glycol-modified (PETG) (par. 91).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the first and second thermoplastic materials taught by Qiu/Martino to be either transparent or translucent as taught by Raslambekov in order to provide the dental alinger of the desired esthetic properties. It is noted that the thermoplastics taught by Raslambekov as being transparent or translucent as the same as those disclosed by Martino.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qiu (CN 113616363) in view of Martino (WO 2013/190580) as applied to claim 23 above, and further in view of Kim et al. (2016/0157962).
Qiu/Martino teaches the invention as substantially claimed and discussed above, however, does not specifically teach the laminate is a tri-laminate comprises of a middle layer of a polyurethane disposed between first and second layer of PETG.
Kim teaches a device comprising a polymer shell (see fig. 1) being made of a laminate material including a soft thermoplastic polyurethane and a hard layer of PETG (par. 132).
Kim further teaches with respect to claim 24, wherein the laminate is a tri-laminate comprised of a middle layer of a polyurethane disposed between first and second layer of PETG (see par. 132, 201, such that it teaches the laminar structure being hard material-soft material-hard material). It would have been obvious to one having ordinary skill in the art before the effective filling date of Qiu/Martino to modify the di-laminate structure with the tri-laminate structure taught by Kim in order to provide the desired forces to the teeth. It is further noted that Kim teaches the shell can be made of a di-laminate structure as taught by Martino (see par. 201). Further it is noted that is has been held to be within the general skill of a worker in the art to selece a known material on the basis of its suitability for the intended use as a matter of obvious design choice (MPEP 2144.07).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qiu (CN 113616363) in view of Martino (WO 2013/190580) as applied to claim 23 above, and further in view of Gagnon et al. (2024/0050197).
Qiu/Martino teaches the invention as substantially claimed and discussed above, however, does not specifically teach the laminate is a tri-laminate comprised of a middle layer of PETG disposed between first and second layers of polyurethane.
Gagnon teaches a polymer shell made of a laminate material.
Gagnon further teaches with respect to claim 25, wherein the laminate is a tri-laminate material comprised of a middle layer of PETG disposed between first and second layer of a polyurethane (see pars. 8-9, 26 77, 79). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Qiu/Martino with tri-laminate taught by Gagnon in order to deliver the desired forces to the teeth (see abstract). Further it is noted that is has been held to be within the general skill of a worker in the art to selece a known material on the basis of its suitability for the intended use as a matter of obvious design choice (MPEP 2144.07).
Claim(s) 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qiu (CN 113616363) as applied to claims 1 and 7 above, and further in view of Heller et al. (2016/0278899).
Qiu teaches the invention as substantially claimed and discussed above, including first agent includes a sustained release agent, however, does not specifically teach the first agent is formulated with one more excipients to obtain a formulation, and the formulation controls release of the first agent from the device.
Heller teaches a device comprising a polymer shell (par. 239, see figs) and a first agent (see abstract, such that the agent is a drug).
Heller further teaches with respect to claim 30, wherein the first agent is formulated with one or more excipients to obtain a formulation, and the formulation controls release of the first agent from the device (pars. 79, 135, 161, 233, 259, 338).
With respect to claim 31, Qiu further teaches wherein the release of the agent from the device is controlled by the first polymer shell (par. 31, such that the pores in the polymer shell control the release of the agent). Heller further teaches with respect to claim 31, wherein the first agent is formulated with one or more excipients to obtain a formulation (pars. 79, 135, 161, 233, 259, 338).
With respect to claim 32, Qiu further teaches wherein the release of the first agent from the device is controlled by the peripheral edge seal (par. 31, such that the pores in the polymer shell control the release of the agent and the sealed edge controls the release such that it prevents it from being release out of the edge). Heller further teaches with respect to claim 31, wherein the first agent is formulated with one or more excipients to obtain a formulation (pars. 79, 135, 161, 233, 259, 338).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Qiu to includes an excipient as taught by Heller in order to control the release of the active agent or improve the taste of the formulation.
Claim(s) 39, 41, 43 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qiu (CN 113616363) as applied to claims 35, 38, and 44 above, and further in view of Zegarelli (2009/0136893).
Qiu teaches the invention as substantially claimed and discussed above, however, does not specifically teach the first agent is melatonin or 5-hydroxytryptophan, the first agent is stannous fluoride or sodium fluoride, wherein ethe first agent is release over a period of at least 6 hours, 8 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, or 72 hours, and wherein the support member is foam, a population of microporous particles or a fabric.
Zegarelli teaches a shell comprising a first agent (see abstract).
Zegarelli further teaches with respect to claim 39, wherein the first agent is melatonin (pars. 108, 110).
Zegarelli further teaches with respect to claim 41, wherein the first agent is stannous fluoride or sodium fluoride (par. 102).
Zegarelli further teaches with respect to claim 43, wherein the release agent is release over a period of 24 hours or more (par. 77).
Zegarelli further teaches with respect to claim 45, wherein the support member is a polymer hydrogel which is a foam (see par. 64).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the first agent taught by Qiu with the different agents taught by Zegarelli in order to deliver the desired treatment to the patient’s teeth over the desired amount of time. Further it would have been obvious to one having ordinary skill in the art before the effective filling date of the invention that the PEG hydrogel is a foam as taught by Zegarelli in order to hold the first agent.
Claim(s) 48-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qiu (CN 113616363) in view of Peter (GB 2,584,471).
Qiu teaches a device comprising a first polymer shell 6 contoured to fit at least a portion of a subject’s upper or lower teeth (see fig. 1, pars. 7, 8, 17, 28), the first polymer shell having an inner surface, an outer surface, and a fist shell edge member (see annaoted figure below), a second polymer shell 3 (par. 27) dimensioned to receive the first polymer shell 6 (see fig. 1) having an inner receiving surface and an outer external surface, and a second shell edge member (see annotated figure below), wherein the first edge member and the second edge members are jointed to form a first gap between the inner surface and inner receiving surface (see fig. 1, such that the gap is filled with the hydrogel 4, the edges are jointed together such that they form the combined structure, par. 29 such that the hydrogel is inserted in an embodiment in which the insert is NOT removable from the base) and an agent 4 configured for insertion into the gap (pars. 11-13, such that it is inserted by injecting) wherein the device is configured for insertion into an oral cavity of a subject for delivery of the first agent for controlled release over a time period (pars. 7-9, 11-13, see fig. 1). Qiu teaches the invention as substantially claimed and discussed above, however, does not specifically teach the device is a included in a kit.
Peter teaches a kit comprising a device comprising a first shell to fit at least a portion of a subject’s upper or lower teeth and an agent configured for insertion on the device (see fig. 1 showing the device, see claim 1 regarding the kit). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Qiu with the kit taught by Peter in order to provide everything the user needs in one location.
Qiu/Peter teaches the invention as substantially claimed and discussed above including with respect to claim 49, Peter further teaching wherein the kil further comprising one or more refiles of the agent (see claim 5). It would have been obvious to one having ordinary skill in the art to modify Qiu with the refill kit taught by Peter in order to replenish the agent as needed during treatment.
Allowable Subject Matter
Claims 8-9, 28-29 and 33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/HEIDI M EIDE/Primary Examiner, Art Unit 3772 11/24/2025