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 .
Election/Restrictions
Claims 14-21, 24, 39, 40, and 74-76 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/24/25.
Applicant’s election without traverse of 1-2, 6-8, and 77-83 in the reply filed on 10/24/25 is acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/124,62, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claims 1-2, 6-8, and 77-81 receive the priority date of 12/11/2020.
Claims 82-83 receive the priority date of 12/11/2021
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 82-83 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.
Claim 82 recites the limitation "the treatment" in line 5. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1 and 79 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pope et al. (US 4553549, hereinafter Pope).
Regarding claim 1, Pope discloses a device for treating a congenital oral defect or condition (figures 1-5; abstract), comprising: a palatal plate (10; figures 1-5) configured to be positioned within a subject's oral cavity (figures 105; column 3, lines 45-62) and comprising an anterior region (at 11; figure 1) and a posterior region (at 19; figure 1) opposite one another (figure 1) and defining an axis therebetween (figure 1); a curved pharyngeal extension (20; figures 1-5; column 5, line 59 – column 6, line 17 discloses that 20 is in communication with the oral-pharyngeal cavity) extending from the posterior region along the axis (figure 1) configured to extend into the subject's pharynx to direct the subject's tongue and/or lower jaw anteriorly when the palatal plate is positioned within the oral cavity (column 2, lines 56-65, column 5, line 59 – column 6, line 17); and a screw mechanism (14; figure 1) coupled to the palatal plate (Figure 1), wherein the palatal plate is configured to be split along the axis to create two palatal plate side portions (column 4, lines 30-45), and wherein the screw mechanism is actuatable to direct the two palatal plate side portions away from one another to increase a size of the palatal plate or to direct the two palatal plate side portions towards one another to close the gap and decrease a size of the palatal plate (column 4, lines 30-45).
Regarding claim 77, Pope discloses a device for treating a congenital oral defect or condition (figures 1-5; abstract), comprising: a palatal plate (10; figures 1-5) configured to be positioned within a subject's oral cavity (figures 105; column 3, lines 45-62) and comprising an anterior region (at 11; figure 1) and a posterior region (at 19; figure 1) opposite one another (figure 1) and defining an axis therebetween (figure 1); a curved pharyngeal extension (20; figures 1-5; column 5, line 59 – column 6, line 17 discloses that 20 is in communication with the oral-pharyngeal cavity) extending from the posterior region along the axis (figure 1) configured to extend into the subject's pharynx to direct the subject's tongue and/or lower jaw anteriorly when the palatal plate is positioned within the oral cavity (column 2, lines 56-65, column 5, line 59 – column 6, line 17); and a screw mechanism (14; figure 1) coupled to the palatal plate (Figure 1), wherein the palatal plate is configured to be split along the axis to create two palatal plate side portions (column 4, lines 30-45), and wherein the screw mechanism is actuatable to direct the two palatal plate side portions away from one another to increase a size of the palatal plate or to direct the two palatal plate side portions towards one another to close the gap and decrease a size of the palatal plate (column 4, lines 30-45).
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.
Claims 2 and 78 are rejected under 35 U.S.C. 103 as being unpatentable over Pope et al. (US 4553549, hereinafter Pope) in view of Martinez (US 20120073581).
Regarding Claim 2 and Claim 78, Pope discloses the device as claimed in Claim 1 and Claim 77. Pope does not disclose one or more anterior wires extending from the anterior region of the palatal plate for securing the device on the face relative to the oral cavity.
Martinez discloses an oral device (Figure 3 and 4) with a palatal plate (Figures 3-4), and one or more anterior wires (18; figures 3-4) extending from the anterior region of the palatal plate for securing the device on the face relative to the oral cavity (paragraph [0016]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device of Pope with the anterior wires of Martinez in order to have the device secured outside of the oral cavity for the comfort of the patient.
Claims 6-7 and 79-80 are rejected under 35 U.S.C. 103 as being unpatentable over Pope et al. (US 4553549, hereinafter Pope) in view of Staples (US 5904479).
Regarding Claim 6 and Claim 79, Pope discloses the device as claimed in Claim 1 and Claim 77, respectively. Pope does not disclose the screw mechanism is at least partially embedded within material of the palatal plate such that an actuator of the screw mechanism is exposed.
Staples discloses an oral device (figures 5-6) with a palatal plate (124 and 126; figure 5) and a screw mechanism (120; figures 5-7), the screw mechanism is at least partially embedded within material of the palatal plate such that an actuator of the screw mechanism is exposed (figures 5-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the screw mechanism of Pope have the screw mechanism is at least partially embedded within material of the palatal plate such that an actuator of the screw mechanism is exposed taught by Staples in order to easily adjust the device without fear the screw mechanism would detach from the plate.
Regarding Claim 7 and Claim 80, Pope discloses the device as claimed in Claim 6 and claim 79. Pope discloses the screw mechanism comprises a jackscrew embedded in the material of the palatal plate (figure 1; column 4, lines 30-45), the jackscrew defining a screw axis orthogonal to the axis of the palatal plate (figure 1).
Pope does not disclose wherein the actuator comprises a lead screw.
Staples discloses an oral device (figures 5-6) with a palatal plate (124 and 126; figure 5) and a screw mechanism (120; figures 5-7) that comprises a jackscrew (142; figure 6) embedded in the material of the palatal plate (figures 6-8) and wherein the actuator comprises a lead screw (122; figures 5-8), the jackscrew defining a screw axis orthogonal to the axis of the palatal plate (figures 6-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the actuator of Pope have a lead screw as taught by Staples in order to cause rotation of the jackscrew about its longitudinal axis (column 8, lines 53-65).
Claims 8 and 81 are rejected under 35 U.S.C. 103 as being unpatentable over Pope et al. (US 4553549, hereinafter Pope) in view of Yousefian (US 20160270883).
Regarding Claim 8 and Claim 81, Pope discloses the device as claimed in Claim 1 and Claim 77. Pope discloses the palatal plate is formed from acrylic.
Pope does not disclose the palatal plate is formed from acrylic resin.
Yousefian discloses an oral device (figures 11-12) with a palatal plate (1110 and 1150; figure 12) formed from acrylic resin (paragraph [0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the material of the device of Pope to be acrylic resin as taught by Yousefian in order to have a more hygienic design (paragraph [0067]).
Claims 82-83 are rejected under 35 U.S.C. 103 as being unpatentable over Pope et al. (US 4553549, hereinafter Pope) in view of Kuo et al. (US 20110159451, hereinafter Kuo).
Regarding Claim 82, Pope discloses the device as claimed in Claim 77. Pope does disclose an oral appliance for treating a condition in an individual subject (abstract) comprising: an initial oral appliance comprising the device of claim 1.
Pope does not disclose a set of sequential oral appliances for treating a congenital oral defect or condition in an individual subject comprising: one or more additional oral appliances formed based at least in part on a model reflecting changes in anatomical configuration of the subject’s oral cavity at the onset of the treatment or during a course of treatment for the congenital defect or condition.
Kuo discloses a set of subsequential oral appliance (figure 9-10) comprising: an initial oral appliance (paragraph [0066]-[0068] and [0072]), and one or more additional oral appliances formed based at least in part on a model reflecting changes in anatomical configuration of the subject’s oral cavity at the onset of the treatment or during a course of treatment for the condition (paragraph [0066]-[0068] and [0072]).
It would have been obvious to one of ordinary skill in the art to have modified the oral appliance of Pope to have a set of subsequential oral appliances following the initial oral appliance and one or more additional oral appliances formed based at least in part on a model reflecting changes in anatomical configuration of the subject’s oral cavity at the onset of the treatment or during a course of treatment for the congenital defect or condition as taught by Kuo in order to ensure the end result is what is desired by the patient.
Regarding Claim 83, Pope as modified by Kuo discloses the device as claimed in Claim 82. Pope discloses each of the oral appliances (Figures 1-5) comprises a palatal plate (10; figure 1-5) including an anterior region (near 11; figure 1) and a posterior region (near where 19 and 20 connect; figure 1) opposite one another along an axis (Figure 1), and a curved pharyngeal extension (20; figure 1; column 5, line 59 – column 6, line 17 discloses that 20 is in communication with the oral-pharyngeal cavity) extending from the posterior region along the axis (Figure 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sydney J Pulvidente whose telephone number is (571)272-8066. The examiner can normally be reached Monday - Thursday, 7:30 a.m. - 3:30 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached at (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SYDNEY J PULVIDENTE/ Examiner, Art Unit 3772 /ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772