DETAILED ACTION
In Applicant’s Response filed 5/26/26, Applicant has amended claims 1, 4-6, 8 and 10; submitted a replacement abstract; and submitted replacement drawing sheets. Currently, claims 1-13 are pending.
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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because in line 2, “…device. from the device…” should be amended to recite “…device. The device…” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawings
The drawings were received on 5/26/26. These drawings are acceptable.
Claim Objections
Claim 6 is objected to because of the following informalities which require appropriate correction:
In claim 6 line 2: a comma “,” should be added between the words “adjustable” and “the”.
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 1-13 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.
Regarding claim 1, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 2-13 depend directly or indirectly from claim 1 and, therefore, contain the same deficiencies.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-7 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mauclaire (WO 2018008002) in view of Gribb et al (US 9474483).
With respect to claim 1, Mauclaire discloses a method for treating dysphagia (FIGS. 18A-D show an exemplary treatment plan for treating a tongue condition associated with persistent atypical swallowing; see pgs 47-48; atypical swallowing is interpreted as including difficulty swallowing or dysphagia), comprising: fitting a patient afflicted with dysphagia with a TRP oral retainer-based device (the attachment mechanism that attaches the appliance onto the top dental arcade – see pg 21—29) for wearing at night starting at about bedtime and during sleep (duration of treatment includes wearing for several hours during the day and then during sleep; pgs 47-48);
providing instructions to the patient to wear the device nightly for a wearing period that is a period of time from about 2 to about 18 months or longer (3-10 months which is within the claimed range of 2-18 months); monitoring the patient's tongue pressure at one or
more time points during the wearing period (pg 5 lines 24-25);
wherein the wearing period includes wearing the device at night starting at about bedtime and during sleep (duration of treatment includes wearing for several hours during the day and then during sleep; pgs 47-48), the wearing period being free of active tongue training such as tongue exercise (it is inherent that the user does not actively engage in tongue exercises while they are asleep); and
wherein the TRP device is for limiting movement of a posterior or anterior zone of the tongue and stimulating the tongue, while allowing respectively an anterior or posterior zone and lateral edges of the tongue to perform movements necessary for speech and swallowing (pg 3 lines 13-16) and comprises:
an attachment mechanism adapted to releasably attach the TRP device teeth of the patient (pg 3 lines 20-29, pgs 7-9; pgs 21-29) the attachment mechanism comprising a first surface adapted to be positioned on a vestibular side of upper teeth of the dental arcade of the patient and a pair of second surfaces, comprising a left second surface and a right second surface, each second surface in opposition to the first surface and adapted to be seated along at least one and up to four posterior teeth of the wearer on the lingual side of the posterior
teeth (pg 7 line 28 – pg 8 line 6) and
a connector for joining a left end of the first surface with the left second surface and a connector for joining a right end of the first surface with the right second surface (pg 8 lines 7 and 31; the connector joins or connects the first surface and the second surface at the rearmost tooth on each side of the top dental arcade – pg 24 line 25-27);
a tongue-constraining mechanism having a first and second end wherein each end of the constraining mechanism is optionally removably secured to a corresponding
second surface of the attachment mechanism (pg 8 lines 7-8; forward-oriented constraining mechanisms described on pages 31-36) and
a component transverse to and spanning between the first and second surfaces and having a forward or rearward orientation (pg 8 lines 9-10), the component being configured to sit at the occlusal plane of the patient or at an angle thereto (pg 8 lines 10-11) the angle being within the range from + 0 to - 30 degrees lower than the occlusal plane (being seated at “approximately an occlusal plane” as described in page 8 lines 10-11 is interpreted to be a position that is 0 degrees lower than the occlusal plane) and to limit movement of the corresponding zone of the tongue thereby confining the range of motion of the tongue to a more limited three-dimensional space within the mouth of the patient than in the
absence of the device (pg 8 lines 12-14).
Mauclaire does not, however, explicitly disclose wearing the device preferably for at least 8 hours. However, Mauclaire does teach that the duration of treatment includes wearing for several hours during the day and then during sleep (pgs 47-48). The average sleep time for adults is 7-9 hours, which overlaps with the claimed range of 8 or more hours. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to wear the device of Mauclaire for at least 8 hours during sleep in order to maximize wear time while the patient is at rest and not aware of or impacted by use of the device, and, because, discovering the optimum or workable ranges involves only routine skill in the art.
Mauclaire also does not disclose that the wearing period is indicated based
on strength of the patient's tongue or disclose the step of measuring a baseline tongue pressure before or at the beginning of the wearing period wherein tongue pressure represents tongue strength, wherein an increase in tongue strength, as determined by an increase in tongue pressure at one or more time points compared to baseline, or compared to a prior monitored tongue pressure during the wearing period, indicates that the patient receives a benefit from wearing the device or continues to receive a benefit from wearing the device and the patient's dysphagia is thereby treated, wherein, based on the increase in tongue pressure, the wearing period is continued or the tongue right positioner oral retainer-based device is adjusted or replaced to enhance treatment of the oropharyngeal dysphagia.
Gribb, however, teaches a method for assessing and altering swallowing (col 1 lines 12-17) using an intraoral component (col 2 lines 17-20) wherein therapeutic protocols instruct a subject to use the intraoral device over a period of time (col 16 lines 11-16) to improve functions such as strength (col 16 lines 36-45) and the specific protocol selected for the subject may be based on an initial screening or diagnostic test and performance over time is monitored (col 16 lines 11-45). Gribb further teaches monitoring of lingual strength to treat dysphagia (col 18 lines 43-47) and that typical therapy for dysphagia involves strengthening therapy to increase muscle tone and augment oropharyngeal swallow (col 1 lines 49-53). Gribb further teaches that the wearing period is continued or the tongue right positioner oral retainer-based device is adjusted or replaced to enhance treatment of the oropharyngeal dysphagia (col 12 lines 27-44).
Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the method of Mauclaire so that the wearing period is indicated based on strength of the patient's tongue wherein the method further includes the step of measuring a baseline tongue pressure before or at the beginning of the wearing period wherein tongue pressure represents tongue strength, wherein an increase in tongue strength, as determined by an increase in tongue pressure at one or more time points compared to baseline, or compared to a prior monitored tongue pressure during the wearing period, indicates that the patient receives a benefit from wearing the device or continues to receive a benefit from wearing the device and the patient's dysphagia is thereby treated, wherein, based on the increase in tongue pressure, the wearing period is continued or the tongue right positioner oral retainer-based device is adjusted or replaced to enhance treatment of the oropharyngeal dysphagia, as taught by Gribb, in order to custom tailor the treatment protocol to the specific needs of the patient and ensure that the treatment is progressing in a manner which provides a positive therapeutic benefit to the patient.
With respect to claim 2, Mauclaire in view of Gribb discloses the method substantially as claimed (see rejection of claim 1) and Mauclaire further discloses that the dysphagia is oropharyngeal dysphagia (the device is used for treating tongue conditions associated with atypical swallowing and, specifically, with respect to oropharyngeal disorders – pg 20 lines 14-15).
With respect to claim 3, Mauclaire in view of Gribb discloses the method substantially as claimed (see rejection of claim 1) and Mauclaire further discloses that tongue strength is assessed by measuring tongue pressure (TP) (the method includes measurement of tongue pressure – pg 5 lines 24-25).
With respect to claim 4, Mauclaire in view of Gribb discloses the method substantially as claimed (see rejection of claim 1) and Mauclaire further discloses that the TRP is forward-oriented (pg 6 lines 13-14).
With respect to claim 5, Mauclaire in view of Gribb discloses the method substantially as claimed (see rejection of claim 1) and Mauclaire further discloses that the TRP device is adjustable and the method further comprises adjusting the TRP during the wearing period by removing the constraining mechanism and replacing the constraining mechanism by a second constraining mechanism having different geometry and/or orientation than the first constraining mechanism, to enhance the effect of the TRP device on tongue strength and
thereby enhance the treatment of dysphagia (series of different constraining mechanisms used for treatment - pg 29 lines 16-24; pg 48 lines 16-19).
With respect to claim 6, Mauclaire in view of Gribb discloses the method substantially as claimed (see rejection of claim 1) and Mauclaire further discloses that the TRP device is not adjustable and the method further comprises replacing the entire TRP device with one having a
constraining mechanism with a different orientation and/or geometry, to enhance the effect of the TRP on tongue strength and thereby enhance the treatment of dysphagia (series of different constraining mechanisms used for treatment - pg 29 lines 16-24; pg 48 lines 16-19).
With respect to claim 7, Mauclaire in view of Gribb discloses the method substantially as claimed (see rejection of claim 1) but Mauclaire does not explicitly disclose that the wearing period extends from 6 to 18 months. Mauclaire does, however, teach that the duration of treatment is typically between 3-10 months (pg 48 lines 6-7) which overlaps with the claimed range of 6-18 months. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to use the device of Mauclaire for, specifically, 6-18 months since discovering the optimum or workable ranges involves only routine skill in the art.
With respect to claim 9, Mauclaire in view of Gribb discloses the method substantially as claimed (see rejection of claim 1) and Mauclaire further discloses that the component is an arch (as shown in fig 18A).
With respect to claim 10, Mauclaire in view of Gribb discloses the method substantially as claimed (see rejection of claim 9) and Mauclaire further discloses that the arch has an apex (fig 18C shows positioning of the apex of the component – see pg 47 lines 22-25).
With respect to claim 11, Mauclaire in view of Gribb discloses the method substantially as claimed (see rejection of claim 9) but Mauclaire does not disclose that the embodiment of figs 18A-D includes an arch with a central bead. Mauclaire does, however, teach other embodiments wherein elements are encased in a “bead” or coating of resinous material for added comfort (pg 33 lines 12-15; figs 6A-C). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the method of Mauclaire in view of Gribb so that the arch on the device of figures 18A-D includes a central bead, as taught in the embodiment of figs 6A-C of Mauclaire, in order to provide added comfort to the central part of the arch.
With respect to claim 12, Mauclaire in view of Gribb discloses the method substantially as claimed (see rejection of claim 1) and Mauclaire further discloses that the attachment mechanism is a circumferential retainer band (see abstract).
With respect to claim 13, Mauclaire in view of Gribb discloses the method substantially as claimed (see rejection of claim 1) and Mauclaire further discloses that the connector is integrated to the first and second surfaces (the connector can be an extension of the first surface and integrating with the second surface – pg 18 lines 13-15).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mauclaire (WO 2018008002) in view of Gribb et al (US 9474483) and further in view of Lin (US 20200352765).
With respect to claim 8, Mauclaire in view of Gribb discloses the method substantially as claimed (see rejection of claim 1) but Mauclaire does not disclose that the wearing period continues until TP reaches and maintains a normal value of at least 30 and up to 55kPa.
Lin, however, teaches an oral appliance used for treating dysphagia (para [0026]) wherein after a period of time of training, the maximum tongue pressure is measured to determine if the pressure is larger than 30 kPa without wearing the oral appliance as an auxiliary device, and to evaluate whether or not the patient no longer needs to wear the auxiliary device and is able to swallow by themselves (para [0006]). Lin further teaches that people with ideal swallowing function can achieve a maximum tongue pressure of 30 kPa to 90 kPa or higher (para [0003]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the method of Mauclaire in view of Gribb so that the wearing period continues until TP reaches and maintains a normal value of at least 30 and up to 55kPa as taught by Lin in order to ensure that the patient has achieved ideal swallowing function, no longer needs to wear the appliance, and can swallow by themselves.
Response to Amendments/Arguments
Applicant’s amendments filed 5/26/26 have been fully considered as follows:
Regarding the objections to the abstract, Applicant’s replacement abstract was fully considered and is sufficient to overcome the objections, but new objections have been given as necessitated by Applicant’s amendments to the claims.
Regarding the objections to the drawings, Applicant’s replacement drawing sheets have been reviewed and are sufficient to overcome the objections which, accordingly, have been withdrawn.
Regarding the objections to the claims, Applicant’s amendments have been fully considered and are sufficient to overcome some objections (which have been withdrawn) while objections which have not been addressed have been maintained.
Regarding the claim rejections under 35 USC 112, Applicant’s amendments have been fully considered and are sufficient to overcome the rejections (which have been withdrawn) while new rejections have been made as necessitated by Applicant’s amendments to the claims.
Regarding the claim rejections under 35 USC 103, Applicant’s arguments on pages 9-17 have been fully considered but are rendered moot in view of the modified grounds of rejection presented above which were necessitated by Applicant’s amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
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