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 .
Response to Amendment
Applicant’s amendments of claims 1, 3-10, 12, 14-18, 21 is acknowledged by the Examiner.
Applicant’s cancelation of claims 19-20 is acknowledged by the Examiner.
Applicant’s addition of new claims 22-23 are acknowledged by the Examiner.
Applicant’s amendments of claim 21 has overcome the previous drawing objection. Therefore, the previous drawing objection is withdrawn.
Applicant’s amendments of claim 21 has overcome the previous specification objection. Therefore, the previous specification objection is withdrawn.
Applicant’s amendments of claims 1, 3-10, 12, 14-18, and 21 has overcome the previous claim objections. Therefore, the previous claim objections are/is withdrawn.
Applicant’s amendments of claim 21 has overcome the previous claim rejection under 35 U.S.C. 112(a). Therefore, the previous claim rejection under 35 U.S.C. 112(a) are/is withdrawn.
Currently claims 1-18, and 21-23 are pending in the application.
Response to Arguments
Applicant’s arguments, see remarks, filed 07/24/2026, with respect to the rejections of claims 1 under 35 U.S.C. 103 made in the previous non-final rejection have been fully considered and are persuasive. The rejections of claims 1 under 35 U.S.C. 103 and consequently the rejections under 35 U.S.C. 103 of the dependent claims thereof have been withdrawn.
Applicant’s arguments, see remarks, filed 07/24/2026, with respect to the rejection(s) of claim(s) 21 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Shim (US 2020/0222227 A1) in view of Brown CA (CA 3007171 A1).
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, “each fin segment further having a vertical thickness and each fin of the pair of immovable fins having a lingual-to-buccal thickness such that the vertical thickness of each fin segment is approximately equal to the lingual-to-buccal thickness of the respective fin of the pair of immovable fins” as recited in claim 1, and “each fin segment further having a transverse width and each immovable fin of the pair of immovable fins having a maximum transverse width such that the transverse width of each fin segment is approximately equal to the maximum transverse width of the respective immovable fin of the pair of immovable fins” as recited in claim 21 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.
Specification
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). Correction of the following is required: the specification does not provide antecedent support for the limitations of “each fin segment further having a vertical thickness and each fin of the pair of immovable fins having a lingual-to-buccal thickness such that the vertical thickness of each fin segment is approximately equal to the lingual-to-buccal thickness of the respective fin of the pair of immovable fins” recited in claim 1, and “each fin segment further having a transverse width and each immovable fin of the pair of immovable fins having a maximum transverse width such that the transverse width of each fin segment is approximately equal to the maximum transverse width of the respective immovable fin of the pair of immovable fins” recited in claim 21.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 21 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “each fin segment further having a vertical thickness and each fin of the pair of immovable fins having a lingual-to-buccal thickness such that the vertical thickness of each fin segment is approximately equal to the lingual-to-buccal thickness of the respective fin of the pair of immovable fins”. The thicknesses of each fin segment and pair of fins were not described in the originally filed specification, nor the thicknesses being approximately equal to each other. Thus, claim 1 contains new matter.
Claim 21 recites the limitation “each fin segment further having a transverse width and each immovable fin of the pair of immovable fins having a maximum transverse width such that the transverse width of each fin segment is approximately equal to the maximum transverse width of the respective immovable fin of the pair of immovable fins”. The thicknesses of each fin segment and pair of fins were not described in the originally filed specification, nor the thicknesses being approximately equal to each other. Thus, claim 21 contains new matter.
Claims 2-18 are rejected under 35 U.S.C. 112(a) as being dependent on claim 1 and thus, contain the same offending limitations.
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 1-18 and 21 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 1 recites the limitation “the pair of immovable fins” in lines 20, 22, and 26. There is insufficient antecedent basis for the limitations in the claim. For the purpose of examination, Examiner will interpret this limitation as “the pair of fins”.
The term “approximately equal” in claim 1 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 21 recites the limitation “each fin segment having a transverse width”. This limitation renders the claim indefinite because it is unclear as to which transverse dimension of the fin segments is being referred to in the claim (i.e. is the claimed width a lingual-buccal width, an inferior-superior width, or some other width). For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 21 recites the limitation “the pair of immovable fins having a maximum transverse width”. This limitation renders the claim indefinite because it is unclear as to which transverse dimension of the immovable fins is being referred to in the claim (i.e. is the claimed width a lingual-buccal width, an inferior-superior width, or some other width). For the purpose of examination, Examiner will interpret this limitation as best understood.
The term “approximately equal” in claim 21 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claims 2-18 are rejected under 35 U.S.C. 112(b) as being dependent on a rejected claim and thus, contain the same offending limitations.
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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shim (US 2020/0222227 A1) in view of Brown CA (CA 3007171 A1).
In regards to claim 1, Shim discloses a mandibular advancement device (1; see [0063]; see figure 1) comprising:
an upper tray (10; see [0063]; see figure 1) adapted to be fitted over a user's maxillary arch (see [0063]) and comprising a pair of adjustable stop members (310, 410; see [0101 and 0108]; see figures 1 and 10);
a lower tray (20; see [0063]; see figure 1) adapted to be fitted over the user's mandibular arch (see [0063]) and comprising a pair of immovable fins (250; see [0066]; see figure 1) extending from the lower tray (20), each of the immovable fins (250) being configured to engage a respective stop member (310, 410; see figures 1, 7, and 9) of the pair of adjustable stop members to inhibit posterior movement of the lower tray when worn by the user (see [0072]),
each of the upper (10) and lower trays (20) comprising a core (120, and 220; see [0083] and [0089]; see figure 3 and 5) having opposed maxilla and mandible-facing surfaces (see figure 3 that both 120 and 220 have an upper and lower surface, and therefore have opposed maxilla and mandible-facing surfaces),
each of the upper (10) and lower trays (20) comprising an outer layer (11, and 21; see [0074] and [0088]; see figure 1 and 5) positioned onto the core (120 and 220; [0074]; see figure 1), the outer layer (11 and 21) and covering the maxilla and mandible facing surfaces of, a respective one of the upper and lower tray cores (11 covers the maxilla facing surface of 120, and 21 covers the mandible facing surfaces of 220),
the outer layer (21) of the lower tray (20) comprising a pair of posterior, superior surfaces (posterior portions of 21a; see [0075]; see figure 5) that extend between buccal and lingual side margins (margins of 21 defined by the sidewalls of 21 as seen in figure 4 below)
the lower tray (20) comprising a pair of fin segments (central segments of 250 between 251 and 252 as seen in figure 2; hereinafter: central segments of 250) that extend buccally from the lower tray (20; see figure 2 that the central segment of 360 extends from a buccal side of 20 and thus, is considered to extend buccally), each fin segment (central segments of 250) having a distal end (tips of 250; see figure 2) from which each fin (each 250) of the pair of fins (250) extends towards the user’s maxilla (the tips of 250 extends towards the user’s maxilla; see figure 7), the distal end (tips of 250) extending outboard of the buccal side margins causing each fin (each 250) of the pair of fins (250) to be positioned outboard of the buccal side margin (the tips of 250 extend “to the outside of”, “on the far side of”, or away from the centre of” the buccal side margin defined by the walls of 21; thereby causing 250 to be positioned “to the outside of”, “on the far side of”, or away from the centre of” the buccal side margin defined by the walls of 21), each fin segment (central segments of 250) further having a transverse width (see annotated figure 2 below), and each immovable fin of the pair of immovable fins (250) having a maximum transverse width see annotated figure 2 below) such that the transverse width of each fin segment is approximately equal to the maximum transverse width of the respective immovable fin of the pair of immovable fins.
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Shim does not disclose the core is formed from a first material having a first softening point temperature and,
the outer layers are overmolded onto the cores, the outer layer of the upper tray covering the mandible-facing surfaces of the upper tray core, the outer layer of the lower tray covering the maxilla-facing surfaces of the lower tray core, and the outer layer being formed from a second material having a second softening point temperature that is less than the first softening point temperature.
However, Brown CA teaches an analogous oral appliance (10; see [Pg 9 ln 4-16]; see figure 1) comprising an analogous core (14t; see [pg 20 ln 28-30]; see figure 62-64) and an analogous outer layer (146; see [pg 21 ln 1-7]; see figure 62-64) wherein the core (14t) is formed from a first material having a first softening point temperature (see [pg 3 ln 1-5]) and,
an outer layer (146) overmolded onto the core (14t) and covering the maxilla and mandible-facing surfaces (see [pg 12 ln 20-26]; see figure 5), the outer layer being formed from a second material having a second softening point temperature that is less than the first softening point temperature (see [pg 3 ln 1-8]) for the purpose of providing a second material that can deform and conform to a user’s teeth during common thermosetting practices, and providing a core made from a material that has a higher temperature resistance to maintain its shape and rigidity during the forming process and being highly durable and resistant to wear caused by contact with the user's teeth during use of the dental guard (see [pg 10 ln 15-pg 12 ln 4]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the upper and lower trays as disclosed by Shim by forming the upper and lower tray cores from a first material having a first softening point temperature, and the outer layers from a second material having a second softening point temperature less than the first softening point temperature, and to have overmolded the outer layers onto the cores to cover the maxilla and mandible-facing surfaces of the cores as taught by Brown CA in order to have provided improved upper and lower trays that would add the benefit of providing a core made from a material that has a higher temperature resistance to maintain its shape and rigidity during the forming process, as well as being highly durable and resistant to wear caused by contact with the user's teeth during use of the dental guard, and a second material that can deform and conform to a user’s teeth during common thermosetting practices (see [pg 10 ln 15-pg 12 ln 4]) and that would add the benefits of the overmolding forming process known to one of ordinary skill in the art including: improved durability and shock absorption, the creation of integrated seals against environmental factors, significant cost savings by eliminating secondary assembly steps, which reduces part count, minimizes waste, and increases overall product reliability and quality.
Allowable Subject Matter
Claims 1-18 are considered free from art.
With respect to claim 1, the prior art fails to disclose the newly amended limitations of “each fin segment further having a vertical thickness and each fin of the pair of immovable fins having a lingual-to-buccal thickness such that the vertical thickness of each fin segment is approximately equal to the lingual-to-buccal thickness of the respective fin of the pair of immovable fins”.
The closest art of record is that of Shim in view of Brown CA as discussed in the rejections of claim 1 under 35 U.S.C. 103 made in the non-final rejection mailed 09/24/2025. No art could be found which reasonably made obvious a modification of the primary reference of Shim to include a distinguishable vertical thickness of each fin segment which is approximately equal to the lingual-buccal thickness of the respective fin of the pair of immovable fins. It is for at least this reason that claim 1 is considered free from art.
Claims 2-18 are considered free from art insofar as the claims depend from claim 1 and thus contain the same limitations indicated above.
Claims 22 and 23 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
With regards to claim 22, the subject matter not disclosed, suggested, or taught in the prior art, or within a combination of the prior art is: “wherein each stop member comprises a secondary slot that is laterally disposed from and substantially parallel to the adjustment slot”.
The closest art of record is that of Shim in view of Brown CA, and Brown ’10 (US 2010/0206314 A1) as discussed in the rejections of claims 1-3 under 35 U.S.C. 103 made in the non-final rejection mailed 09/24/2025.
However, Shim has been modified by Brown ‘10 to modify the stop member of Shim to include the adjustment mechanism including the post, button, and scalloped adjustment slot as taught by Brown. Therefore, any further modification to the stop member of Shim to further modify the adjustment mechanism as taught by Brown ’10 would be an impermissible hindsight modification of a modifying reference.
Thus for at least this reason, the prior art of record and combination fails to disclose the subject matter of claim 22.
With regards to claim 23, the subject matter not disclosed either singly or in combination is wherein each of the buccal sidewalls comprise a window section formed therein, wherein the window section comprises a sill that is disposed below an upper margin of the buccal sidewall, the posts extending from the buccal sidewalls below the sill.
The closest art of record is that of Shim in view of Brown CA, and Brown ’10 as discussed in the rejection of claim 2 made in the non-final rejection mailed 09/24/2025.
No art in the Examiner’s search contained any such window, indentation, or cutout section comprising a sill formed in the buccal side walls which also has a post extending from the buccal sidewall below the sill as claimed.
Thus for at least this reason, claim 23 is considered allowable.
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 DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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, Alireza Nia can be reached on 571-270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786
