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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 22,24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Kitching 20130122448 in view of Frantz et al 6109265.
With regard to claim 22, Kitching discloses a first series of incremental adjustment appliances (see paragraphs 40 and 41) having a first series of unique appliance geometries selected to progressively reposition teeth while being worn by a patient (see fig. 3). The geometries of the first series are capable of positioning teeth in non-sleep apnea enabled adjustment appliances, and such appliances do not have button protrusions/auxiliaries. See fig. 3. Note that Kitching discloses multiple embodiments, such as a series of appliances without button protrusions (fig. 3), and also another (second) series of incremental adjustment appliances 300 (fig 4A, see paragraphs 54-56) having the geometries to provide a vertical displacement and a forward mandibular position configured to be worn by patients receiving treatment during sleep, the second series having both upper and lower appliances 300. Note that in paragraphs 57 and 59, Kitching contemplates this second series of appliances being used to treat Class II corrections while being worn by a patient. Kitching does not explicitly disclose that the second series of appliances has matching geometries to the first series of appliances. However, it would have been obvious to one skilled in the art to form the first and second series of appliances of Kitching, to have matching geometries, if one wished to be able to use both the first and second series with the same patient. Each of the second series of appliances 300 of Kitching includes a pair of button protrusions 320 (see end of paragraph 54) such that an elastic band 306 can be attached thereto. See figure 4B. Kitching does not disclose the second series of appliances 300 to include both upper and lower appliances, each having the pair of button protrusions 320 on opposite sides thereof. Frantz et al disclose an appliance 10 (fig. 1) which is used to provide a vertical displacement and a forward mandibular position. The appliance 10 includes two pair of button protrusions 13/13' and 14/14' such that elastic bands 16 can be used to provide the desired forces. With regard to applicant’s amended claim language in claim 22, such elastic bands of Kitching/Frantz et al inherently have a predetermined length and a predetermined elasticity which provide desired forces.
It would have been obvious to one skilled in the art to provide both upper and lower appliances to each have a pair of button protrusions on opposite sides that are attached with elastic bands, with the second series of Kitching appliances, as taught by Frantz et al, in view of the combined teachings of Kitching (the second series of appliances may be used to treat Class II malocclusions as well as sleep apnea disorders) and Frantz (both upper and lower appliances including opposite a pair of button protrusions on opposite sides thereof) if one wished to treat Class II malocclusions and sleep apnea disorders via buttons/bands with the appliances of Kitching. Kitching also does not explicitly disclose the lower appliances of the second series of appliances 300 to include a pair of vertical bite pads (although Kitching does disclose that the second series of appliances may include auxiliaries (ramps/blocks, which can be called "bite pads" that treat Class II malocclusions/sleep apnea), wherein at least one pair of vertical bite pads of the second series of appliances has a different size from another pair of vertical bite pads of the second series of appliances, such that each has a unique size directly dependent on the unique geometry of a respective one of the second series of appliances.
Frantz et al discloses that it is known to include vertical bite pads 15,15' (see fig. 1) on either side of a lower appliance. Frantz et al also discloses that it is known to vary the size of the bite pads. See col. 5, lines 16-25 and figs. 6A-6С.
It would have been obvious to one skilled in the art to include vertical bite pads on both sides of the lower appliances of the second series of appliances of Kitching, in view of the teaching of Kitching that the second series of appliances may be used to treat Class II malocclusions and sleep apnea disorders, as well as the teaching of Frantz et al that such bite pads allow for spacing between upper and lower appliances, and allow them to slide relative to each other. See col. 3, lines 43-49 of Frantz et al. It also would have been obvious to one skilled in the art to form the bite pads on the second series of appliances of Kitching/Frantz et al such that at least one pair of bite pads has a different size from another pair of bite pads, in view of the teaching of Frantz et al that it is known to vary the size of bite pads on an intraoral dental appliance (col. 5, lines 16-25).
With regard to claim 24, it is noted that the first and second series of appliances of Kitching/Frantz et al are configured (capable of being used with) for treating patients with malocclusions and sleep apnea.
With regard to claim 25, the limitation of the first and second series of appliances being configured to incrementally adjust patients' teeth based on a plurality of thermoform molds of the patients' teeth, is considered to be a product by process limitation, as it recites how the appliances are formed. Itis held that the appliances of Kitching/Frantz et al could be formed via a such an apparatus. Such method steps, in an apparatus claim, are considered to be product by process limitations that only limit the claim to the final product required by the claim. Since the final appliance of Kitching/Frantz et al is disclosed in claim 25, Kitching/Frantz et al is considered to meet this claim.
With regard to claim 26, the limitation of the forward mandibular position is configured via scanner data of the patient, is considered to be a method step, which carries no patentable weight in an apparatus claim.
With regard to claim 27, note that the bands 306 of Kitching are elastic bands. Furthermore, the newly presented limitation in this claim of the pair of bands being "chosen from a plurality of pairs of elastic bands..." is considered to be a method step, that does not carry patentable weight in this apparatus claim.
With regard to claim 28, with regard to the limitation of each series of appliances being three dimensional printed appliances, it is noted that this limitation recites a method step how the appliances were formed, and is not given structural weight in this claim, which is an apparatus claim. It is held that the appliances of Kitching/Frantz et al could be formed via a such an apparatus. Such method steps, in an apparatus claim, are considered to be product by process limitations that only limit the claim to the final product required by the claim. Since the final appliance of Kitching/Frantz et al is disclosed in claim 22, Kitching/Frantz et al is considered to meet this claim.
Response to Arguments
Applicant's arguments filed 10/23/25 have been fully considered but they are not persuasive.
Applicant’s arguments appear to center on the assertion that Kitching does not disclose the use of auxiliary devices such as the disclosed elastic band to effect mandibular advancement to treat sleep apnea, but rather for tongue guidance purposes to treat sleep apnea. This is not found persuasive.
While Kitching does disclose in paragraphs 55 and 57 that such auxiliaries (elastic band/button) can effect tongue guidance to treat sleep apnea, such tongue guidance is effectuated by mandibular advancement. In other words, that is exactly how sleep apnea correction devices operate…bands/buttons are used to advance the mandible, which in turn guides the tongue forward and prevents tissues in the throat from collapsing, opening the airway. See fig. 4A of Kitching.
Applicant also argues (page 9 of response) that there would be no reason to incorporate the bite pads disclosed by Frantz et al with the device of Kitching because Kitching does not disclose upper and lower appliances requiring a spacing. This is not found persuasive.
It is clear that Kitching contemplates that ramps (thickened portions) can be utilized to treat sleep apnea. See paragraph 21 of Kitching. Frantz et al discloses that the size of bite pads on an appliance may be varied and can be provided on both sides of a lower appliance. It is the examiner’s position that one skilled in the art would recognize that the teachings of Frantz et al could be combined with the teachings of Kitching, such that varied sized bite pads could be utilized on both sides of the lower appliances disclosed by Kitching.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS D LUCCHESI whose telephone number is (571)272-4977. The examiner can normally be reached M-F 800-430.
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/NICHOLAS D LUCCHESI/Primary Examiner, Art Unit 3772