Status under America Invents Act
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Improper claim as a Continuation Application
Applicant indicates on page 1 of the written description (12/13/2024) and Application Data Sheet (12/13/2024) that the present application is a continuation application of prior-filed applications 18/477,513; 17/304,904 and 16/003,841. A continuation application cannot include matter not originally presented in the prior filed applications. Applicant is required to delete the benefit claim or change the relationship (continuation) to continuation-in-part because this application contains matter not disclosed in the prior-filed application. The matter for which there is no support in the prior filed applications are the limitations directed to the method (claims 1-11) and series of dental appliances (claims 12-17, 19, 20) requiring the initial use of an expandable dental appliance followed by the use of a series of a plurality of non-expandable appliances to be worn sequentially over a plurality of treatment stages in a treatment plan.
Objection to the Written Description
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP 608.01(o). The specification provides no apparent basis for the limitations directed to the method (claims 1-11) and series of dental appliances (claims 12-17, 19, 20) that require the initial use of an expandable dental appliance followed by the use of a series of a plurality of non-expandable appliances to be worn sequentially over a plurality of treatment stages in a treatment plan.
Rejections based on 35 U.S.C. 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.
Claim 19 is 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 claim 19, it is unclear how the “one dental appliance of a plurality of dental appliances” relates to the “series of dental appliances” in the parent claim 12. It appears as though claim 19 (and 20) were intended to depend from claim 18.
Rejections based on Prior Art
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 18 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al (US 2017/0007367).
In regard to claim 18, Li et al disclose a method of using a series of dental appliances for expanding a patient’s palate comprising positioning an expandable dental appliance is over a patient’s upper dental arch (e.g. Figure 8D, 8E) wherein the expandable dental appliance comprises a left portion including a left palatal region and a left tooth engagement region that are customized to a left side of the patient’s upper dental arch (note Figures 8D, 8E and paragraph [0139] describing customized fit) and a right portion including a right palatal region and a right tooth engagement region that are customized to a left side of the patient’s upper dental arch (note Figures 8D, 8E and paragraph [0139] describing customized fit). The left and right portions are distinct and separate parts coupled by a sliding expansion feature 831, 842 to laterally translate the left and right portions toward or away from each other (note movement/force vectors 836, 843). Note annotated Figure 8E below.
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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 1-17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al (US 2017/0007367).
In regard to claim 1, Li et al disclose a method of using a series of dental appliances for expanding a patient’s palate comprising positioning an expandable dental appliance is over a patient’s upper dental arch (e.g. Figure 8D, 8E) wherein the expandable dental appliance comprises a left portion including a left palatal region and a left tooth engagement region that are customized to a left side of the patient’s upper dental arch (note Figures 8D, 8E and paragraph [0139] describing customized fit) and a right portion including a right palatal region and a right tooth engagement region that are customized to a left side of the patient’s upper dental arch (note Figures 8D, 8E and paragraph [0139] describing customized fit). The left and right portions are distinct and separate parts coupled by a sliding expansion feature 831, 842 to laterally translate the left and right portions toward or away from each other (note movement/force vectors 836, 843). Li et al further disclose non-expandable dental appliances (Figures 9A, 9C, 9D, 10, 16) for positioning over the patient’s upper dental arch.
Li et al does not appear to explicitly disclose that an expandable dental appliance (e.g. Figure 8A, 8E) be first used in a treatment plan followed by a plurality of non-expandable dental appliances (e.g. Figures 9A, 9C, 9D, 10, 16) in a sequential manner corresponding to treatment stages of a treatment plan as required by claim 1. Li et al, however, does disclose that the practitioner may choose “palatal expanders capable of applying large forces for rupturing the palatal suture and/or causing rapid expansion of the palate” followed by “[s]ubsequent appliance stages can be designed to apply different amounts of force, such as first applying a large force to break the suture, and then applying smaller forces to keep the suture separated or gradually expand the palate.” (paragraph [0114]). Accordingly, one of ordinary skill in the art at the time of applicant’s invention would have found it obvious to have first used an expandable dental appliance (e.g. Figure 8A, 8E) to apply a large first large force to rupture and cause rapid expansion of a patient’s palate suture followed by a plurality of non-expandable appliances (e.g. Figures 9A, 9C, 9D, 10, 16) to gradually expand the patient’s palate in view of the suggestion that such a treatment may be desirable.
In regard to claim 2, note Figures 8D, 8E (including annotated Figure 8E above).
In regard to claims 3 and 4, the activating the expansion feature includes compressing the expansion feature and then allowing to expand/decompress when installed.
In regard to claim 5, the use of the Li et al non-expandable appliances for distinct periods of time is implicit in the teaching.
In regard to claim 6, the use of a non-expandable palatal expander prior to an expandable palatal expander in order to determine if the expandable palatal expander is necessary would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
In regard to claims 7, 10 and 15, note Figures 8D, 8E of Li et al.
In regard to claims 9, 16 and 19, non-expandable appliances (e.g. Figures 9A, 9C, 9D, 10, 16) to gradually expand the patient’s palate in view of the suggestion that such a treatment may be desirable would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and is implicit in the rejection based on Li et al.
In regard to claim 11, Li et al teach that the palatal expanders may include portions (1001 in Figure 10 for example) that are used to secure the expander to the patient’s teeth.
In regard to claim 12, note the discussion above with respect to method claim 1; merely providing the expandable and non-expandable palatal expanders of Li et al as a “series” to perform the method of claim 1, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
In regard to claims 13, 14 and 20, note paragraph [0153].
In regard to claim 17, the identified expansion feature in Li et al is flexible and elastic.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ralph Lewis whose telephone number is (571)272-4712. The examiner can normally be reached Monday-Friday from 9AM-4PM.
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/RALPH A LEWIS/Primary Examiner, Art Unit 3772 (571) 272-4712