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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/27/2025 has been entered.
Terminal Disclaimer
The terminal disclaimer filed on 08/27/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Pat. No. 11,191,664 B2, and US Pat. No. 11,896,518 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
In response to the acceptance of the terminal disclaimer, the non-statutory double patenting rejections made in the final rejection mailed 02/28/2025 are withdrawn.
Response to Amendment
Applicant’s amendments of claims 1 and 21 is acknowledged by the Examiner.
Currently claims 1-21 are pending in the application.
Response to Arguments
Applicant's arguments filed 08/27/2025 have been fully considered but they are not persuasive.
In regards to Applicant’s arguments that Shim does not teach each fin segment extends outboard of the buccal side margin. Examiner respectfully disagrees. Examiner first notes that Applicant has not relied upon the same interpretation of “buccal side margin” between Applicant’s figure 8 where buccal side margin is considered as extending into the center of the device, and Shim’s figure 4 where Applicant only interprets the very outer edge of 20 (which is the interpreted “lower tray” not the outer layer) of Shim as being a “buccal side margin”. Examiner notes that this interpretation is erroneous as the Applicant relies solely on the edge of 20, not a margin (the outside limit and adjoining surface of something, i.e. a buffer space and the edge). A correct interpretation of the buccal margin defined by the sidewalls of Shim’s structure 21 can be seen in figure 2 below. Examiner also notes that the US colloquial definition (as every other definition is drawn to a boat or other irrelevant definition not pertinent to the claimed invention) for outboard provided by the Oxford English Dictionary is “To the outside of something; on the far side or away from the centre” (see https://www.oed.com/dictionary/outboard_adj?tab=meaning_and_use#33123539). Thus, given that Shim’s fin structure is situated “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 (as defined in figure 2 below, and can be seen in figures 4, and 7-9), Shim discloses that each fin segment extends outboard of the buccal side margin as claimed in claim 1.
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In regards to Applicant’s arguments that Shim does not disclose the buccally extending fin segments extending through the outer layer that is overmolded, Examiner respectfully disagrees. Examiner asserts that: if the lower core (220) of Shim were to be overmolded by an outer layer (such as 21) such that both the maxilla and mandible-facing surfaces of the lower core (220) were overmolded and covered by the outer layer as taught by Brown CA; then the fin (250 which extends out from the maxilla facing surface of the lower core) of Shim would extend through the modified outer layer (21) which covers the maxillary surface of the lower core (220) as claimed.
In regards to Applicant’s arguments that Shim does not disclose the newly amended limitations of claim 21 of “wherein each stop member of the pair of stop members is configured so that when engaged with a respective fin of the pair of fins is located entirely outboard of the buccal side margin”. Examiner agrees that Shim does not disclose this feature. However, Shim was not relied upon to teach this feature.
The Examiner asserts that Bedford discloses the limitation of “wherein each stop member of the pair of stop members is configured so that when engaged with a respective fin of the pair of fins is located entirely outboard of the buccal side margin” as recited in claim 21 as will be discussed below.
With regards to the limitation of “wherein each stop member of the pair of stop members is configured so that when engaged with a respective fin of the pair of fins is located entirely outboard of the buccal side margin”: Examiner first notes that Applicant’s figures and specification do not provide explicit support for “the stop member…located entirely outboard of the buccal side margin” which excludes any portion of the stop member being within the buccal side margin defined by the lower tray. As can be seen in figure 2 of Applicant’s drawings below, it would appear that the stop member (76) at most overlies the buccal side margin (defined by 130) of the outer layer (124) of the lower tray, thereby residing inboard of the buccal side margin. Furthermore, no recitation of “entirely can be found anywhere in Applicant’s specification. Thus, this limitation will be addressed under 35 U.S.C. 112(a) as will be discussed below.
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Furthermore, Examiner asserts that the reference of Bedford teaches this limitation as it can be seen in figure 7 of Bedford, the entirety of the fin (34; intended to engage with the stop member 32) lies outside of the buccal margin (defined by 38 as seen in figure 7), thus, the stop member (32) is similarly considered to extend entirely outboard of the buccal side margin as well.
In regards to Applicant’s arguments that Bedford does not disclose an immovable fin. Examiner respectfully disagrees. Bedford teaches in [0015] that “the lower flange is fixed to the lower part”, and thus, discloses an embodiment of an immovable fin.
Therefore, the rejections will be maintained as discussed below.
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, the “wherein each stop member of the pair of stop members is configured so that when engaged with a respective fin of the pair of fins is located entirely outboard of the buccal side margin” of claim 21 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. As discussed above, it would appear based on figure 2 that at least a portion, if not the entirety of Applicant’s stop members lie inboard of Applicant’s defined buccal side margin.
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:
Applicant’s specification does not provide explicit support for the exclusory limitation of “wherein each stop member of the pair of stop members is configured so that when engaged with a respective fin of the pair of fins is located entirely outboard of the buccal side margin” which excludes any portion of the stop member from residing within the buccal side margin defined by the outer layer of the lower tray’s posterior, superior surfaces.
Claim Objections
Claims 1, 3-10, 12, 14-18, and 21 are objected to because of the following informalities:
Claim 1 recites the limitation “each of the fins being configured to engage a respective stop member”. This limitation, while not unclear should be amended to recite “a respective stop member of the pair of adjustable stop members” to maintain consistency in the claims.
Claim 1 recites the limitation “an outer layer overmolded onto the core and covering the maxilla and mandible-facing surfaces”. This limitation, while not unclear should be amended to recite “an outer layer overmolded onto, and covering the maxilla and mandible-facing surfaces of each of the upper and lower tray cores” to maintain consistency in the claims.
Claim 3 recites the limitation “an adjustment slot formed in the stop members, the adjustment slot comprising”. This limitation, while not unclear should be amended to recite “an adjustment slot formed in each of the adjustable stop members, each of the adjustment slots comprising” to maintain consistency in the claims.
Claim 4 recites the limitation “wherein each stop member comprises a secondary slot that is laterally disposed from and substantially parallel to the adjustment slot”. This claim, while not unclear should be amended to recite “wherein each adjustable stop member comprises a secondary slot that is laterally disposed from and substantially parallel to each of the adjustment slots” to maintain consistency in the claims.
Claim 5 recites the limitation “the scalloped margins”. this limitation should be amended to recite “the opposed scalloped inner margins” to maintain consistency in the claims.
Claim 6 recites the limitation “wherein the posts and buttons are not overmolded with the outer layer”. This limitation while not unclear as to which outer layer Applicant is referring to because the posts and buttons are only recited as being formed from the upper tray core, should be amended to recite “wherein the pair of posts and buttons are not overmolded with the outer layer of the upper tray” to maintain clarity and consistency in the claims.
Claim 7 recites the limitation “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 claim, while not unclear, should be amended to recite “wherein each of the respective buccal sidewalls comprise a window section formed therein, wherein each of the window sections comprises a sill that is disposed below a respective upper margin of each of the buccal sidewalls, each of the posts extending from the respective buccal sidewall below the sills” to maintain consistency and clarity in the claims.
Claim 8 recites the limitation “wherein each button comprises a parting line that is substantially even with the sill, wherein a length of the button is the greatest at the parting line and decreases above and below the parting line”. The claim, while not unclear, should be amended to recite “wherein each button comprises a parting line that is substantially even with the sills, wherein a length of each of the buttons are the greatest at the parting line and decreases above and below the parting line” to maintain consistency and clarity in the claims.
Claim 9 recites the limitation “wherein each button slopes inwardly toward the buccal sidewall”. The claim, while not unclear, should be amended to recite “wherein each button slopes inwardly toward the respective buccal sidewalls.” to maintain consistency in the claims.
Claim 10 recites the limitation “wherein the upper tray core comprises an arch and buccal and lingual lattice segments extending from the arch, wherein the buccal lattice segments are positioned to an anterior of the buccal sidewalls, and the lingual lattice segments are positioned opposite the buccal sidewalls”. The claim, while not unclear, should be amended to recite “wherein the upper tray core comprises an arch, (at least one/a plurality of/multiple) buccal lattice segments and (at least one/a plurality of/multiple) lingual lattice segments extending from the arch, wherein the buccal lattice segments are positioned to an anterior of the respective buccal sidewalls, and the lingual lattice segments are positioned opposite the respective buccal sidewalls” to properly present the buccal and lingual lattice segments and to maintain consistency in the claims.
Claim 12 recites the limitation “wherein the lingual lattice segments extend from the bite pad segment, and the buccal lattice segments extend from the anterior arch segment”. The claim, while not unclear, should be amended to recite “wherein the (at least one/plurality of/multiple) lingual lattice segments extend from the pair of posterior bite pad segments, and the (at least one/plurality of/multiple) buccal lattice segments extend from the anterior arch segment” depending on Applicant’s amendments of claim 10 above to maintain consistency and clarity in the claims.
Claim 14 recites the limitation “an anterior stop tab located in between adjacent buccal lattice segments”. The claim, while not unclear, should be amended to recite “an anterior stop tab located in between adjacent buccal lattice segments of the (at least one/plurality of/multiple) buccal lattice segments” depending on Applicant’s amendments of claim 10 above to maintain consistency and clarity in the claims.
Claim 15 recites the limitation “wherein each fin comprises a posterior margin that is configured to engage an anterior side edge of the stop member”. The claim, while not unclear, should be amended to recite “wherein each fin comprises a posterior margin that is configured to engage an anterior side edge of each respective adjustable stop member” to maintain consistency and clarity in the claims.
Claim 16 recites the limitation “wherein the fins are not overmolded with the outer layer”. This claim, while not unclear as to which outer layer Applicant is referring to because the fins are only recited as being formed from the lower tray core, should be amended to recite “ wherein the pair of fins are not overmolded with the outer layer of the lower tray” to maintain clarity and consistency in the claims.
Claim 17 recites the limitation “wherein the lower tray core comprises an arch segment and buccal and lingual lattice segments extending therefrom” The claim, while not unclear, should be amended to recite “wherein the lower tray core comprises an arch segment, (at least one/a plurality of/multiple) buccal lattice segments extending the arch segment and (at least one/a plurality of/multiple) lingual lattice segments extending the arch segment” to properly present the buccal and lingual lattice segments, and to maintain consistency and clarity in the claims.
Claim 18 recites the limitation “the lower tray core comprising at least one buccal lattice segment positioned to each side of the anterior stop tab along the arch segment”. This limitation, while not unclear should be amended to recite “the lower tray core comprising a first and second buccal lattice segment of the (at least one/a plurality of/multiple) buccal lattice segments positioned to each side of the anterior stop tab along the arch segment” to maintain consistency and clarity in the claims.
Claim 21 recites the limitation “each of the fins being configured to engage a respective stop member”. This limitation, while not unclear, should be amended to recite “each of the immovable fins being configured to engage a respective stop member of the pair of adjustable stop members” to maintain consistency in the claims.
Claim 21 recites the limitation “an outer layer overmolded onto the core and covering the maxilla and mandible-facing surfaces”. This limitation, while not unclear should be amended to recite “an outer layer overmolded onto, and covering the maxilla and mandible-facing surfaces of each of the upper and lower tray cores” to maintain consistency in the claims.
Appropriate correction is required.
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.
Claim 21 is 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 21 recites the limitation “wherein each stop member of the pair of stop members is configured so that when engaged with a respective fin of the pair of fins is located entirely outboard of the buccal side margin” as discussed above, the specification and figures do not provide sufficient support for this limitation. Therefore, the newly amended limitation of claim 21 is considered to be new matter.
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 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 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shim (US 2020/0222227 A1) in view of Brown (CA 3007171 A1) (hereinafter Brown CA).
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
a pair of fins (250; see [0066]; see figure 1) extending from the lower tray (20), each of the fins (250) being configured to engage a respective stop member (310, 410; see figures 1, 7, and 9) 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) the cores (120 and 210) and,
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 (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).
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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.
In regards to claim 15, Shim as now modified by Brown CA discloses the invention as discussed above.
Shim further discloses wherein each fin (250) comprises a posterior margin (252; see [0091]; see figure 2) that is configured to engage an anterior side edge of the stop member (310, 410; see figure 1).
In regards to claim 16, Shim as now modified by Brown CA discloses the invention as discussed above.
Shim further discloses wherein the fins (250) are not overmolded with the outer layer (11 and 21; see figure 2 that 250 is a part of 220, not 11 and 21).
In regards to claim 17, Shim as now modified by Brown CA discloses the invention as discussed above.
Shim further discloses wherein the lower tray core (220) comprises an arch segment (240; see [0089]; see figure 2).
Shim as now modified by Brown CA does not disclose buccal and lingual lattice segments extending therefrom.
However, Brown CA further teaches buccal and lingual lattice segments (148, 150; see [page 21 ln 8-30]; see figures 62 and 63) extending therefrom for the purpose of providing structural integrity to the outer layer (see [pg 20 ln 26-pg 21 ln 7]).
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 arch segment as disclosed by Shim as now modified by Brown CA and to have included buccal and lingual lattice segments as further taught by Brown CA in order to have provided an improved arch segment that would add the benefit of providing structural integrity to the outer layer (see [pg 20 ln 26-pg 21 ln 7]).
In regards to claim 18, Shim as now modified by Brown CA discloses the invention as discussed above.
Shim as now modified by Brown CA does not disclose wherein the lower tray core comprises an anterior stop tab extending from the arch segment, the lower tray core comprising at least one buccal lattice segment positioned to each side of the anterior stop tab along the arch segment.
However, Brown CA further teaches wherein the lower tray core (14t capable of being used in both lower and upper trays and is therefore considered a lower tray core) comprises an anterior stop tab (see annotated figure 62 below) extending from the arch segment (40t), the lower tray core (14t) comprising at least one buccal lattice segment (152; see [pg 21 ln 8-30]; see figure 62) positioned to each side of the anterior stop tab along the arch segment (40t) for the purpose of providing structural integrity to the outer layer (see [pg 20 ln 26-pg 21 ln 7]).
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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 arch segment as disclosed by Shim as now modified by Brown CA and to have included the anterior stop tab and the at least one buccal lattice segment positioned to each side of the anterior stop tab along the arch segment as further taught by Brown CA in order to have provided an improved arch segment that would add the benefit of providing additional structural integrity to the outer layer (see [pg 20 ln 26-pg 21 ln 7]).
In regards to claim 19, Shim as now modified by Brown CA further discloses a method of treating obstructive sleep apnea (see Shim [Abstract]) comprising;
fitting the mandibular advancement device of claim 1 (1; see discussion above for teaching) to the maxillary and mandibular arches of a user (see Shim [0063]),
the fitting step comprising heating the upper (10) and lower trays (20) to a temperature of about 40 °C to about 80 °C thereby causing the overmolded outer layer of each tray to soften, molding the softened outer layer of the upper tray to at least some of the user's maxillary teeth, and molding the softened outer layer of the lower tray to at least some of the user's mandibular teeth (see Brown CA [pg 14 ln 29-pg 15 ln 11]);
permitting the softened outer layer of the upper and lower trays (10 and 20) to harden within the user's mouth (see Brown CA [pg 15 ln 11-pg 16 ln 5]); and
adjusting the pair of adjustable stop members (310 and 410) to maintain the mandible in an advanced position when the device (1) is being worn by the user (see Shim [0095]).
In regards to claim 20, Shim as now modified by Brown CA discloses the invention as discussed above.
Shim further discloses wherein the step of adjusting the pair of adjustable stop members (310 and 410) comprises sliding an adjustment slot (312, 412; see [0087]; see figure 2) of each stop member (310 and 410) in an anterior or posterior direction (anterior to disengage, posterior to engage 310 and 410) across a post (152; see [0086]; see figure 2) extending laterally from respective buccal sidewalls of the upper tray core (120; see figure 3), the adjustment slot (312 and 412) and the post (152) comprising interlocking surfaces (see figure 2) configured to maintain the relative position of the stop members (310 and 410) and posts (152) when the upper tray (10) is being worn by the user.
Claim(s) 2, 3, 5, 6, and 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shim in view of Brown CA as applied to claims 1, and 15-20 above, and further in view of Brown (US 2010/0206314 A1) (hereinafter Brown ’10).
In regards to claim 2, Shim as now modified by Brown CA discloses the invention as discussed above.
Shim as now modified by Brown CA does not disclose wherein the upper tray comprises a pair of posts extending laterally from respective buccal sidewalls of the upper tray core, each post including a button disposed at an outboard end thereof.
However, Brown ’10 teaches an analogous oral device (10; see [0026]; see figure 1) for the analogous purpose of creating mandibular advancement (see [0026]) comprising an analogous stop member (16 and 18; see [0027]; see figure 1) and an analogous tray (24; see [0028]; see figure 1; 28 engages a user’s upper teeth and therefore is considered an upper tray); wherein the tray (24) is formed using a core (26; see [0028]; see figure 3) and an overmolded layer (28; see [0028]; see figure 6); wherein the upper tray (24) comprises a pair of posts (32; see [0028]; see figure 2) extending laterally from respective buccal sidewalls of the upper tray (24; see figure 1 that 32 extends laterally on each side from 24), each post (32) including a button (34; see [0028]; see figure 3) disposed at an outboard end thereof (see figure 2) for the purpose of providing an adjustment mechanism that is both rotatably and longitudinally adjustable (see [0038]).
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 tray as disclosed by Shim as now modified by Brown CA by including the pair of posts with buttons disposed at an outboard end thereof for adjusting the stop members as taught by Brown ’10, thereby substituting through simple substitution the multiple pairs of different sized stop members and the adjustment mechanism of said stop members as taught by Shim to be the single pair of stop members adjusted by a translational movement of the stop members about the pair of posts with buttons disposed at an outboard end thereof in order to have provided an improved mandibular advancement device that would add the benefits of providing an adjustment mechanism of the stop members that is both rotatably and longitudinally adjustable (see [0038]) thereby allowing the device to provide its therapeutic benefit when the user’s jaw is in multiple different positions during sleep, while also simplifying the adjustment of the stop members, and reducing the number of parts needed for the mandibular advancement device to function.
Furthermore, such a modification is held to be obvious since it has been held that “(w)here a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509 (BPAI, 2007) (citing KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1396 (2007). Accordingly, Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1395 (2007). In the instant case the claimed improvement on a device or apparatus is no more than the simple substitution of one known adjustment element for another, and the combination of those elements yields the predictable results of advancing a user’s jaw.
In regards to claim 3, Shim as now modified by Brown CA and Brown ’10 discloses the invention as discussed above.
Shim as now modified by Brown ’10 further discloses wherein each post (32 of Brown ’10) comprises superior and inferior surfaces (see Brown ’10 figure 3) adapted to engage an adjustment slot (64 of Brown ‘10; see Brown ’10 [0041] and figures 1 and 8) formed in the stop members (310 and 410 of Shim as now modified by Brown ‘10), the adjustment slot (64 of Brown ‘10) comprised opposed scalloped inner margins (see Brown ’10 figure 8) configured to mate with the superior and inferior surfaces of each post (32 of Brown ’10; see Brown ’10 figure 1).
In regards to claim 5, Shim as now modified by Brown CA and Brown ’10 discloses the invention as discussed above.
Shim as now modified by Brown CA and Brown ’10 does not explicitly disclose wherein the scalloped margins have a period of approximately 1mm. However, Brown ’10 further teaches “The shaft preferably has a diameter which is large enough to provide sufficient strength to avoid breakage under the aforementioned chewing pressure, but which is also small enough to avoid requiring an opening in the receiver so large that retention of the assembly is jeopardized” (see [0039]). Additionally, Applicant has placed no criticality on the claimed size dimensions of the device stating “preferred increments of 1 mm” with respect to the adjustment of the stop members (see pg 17) thereby disclosing the period of approximately 1mm is a preferred embodiment thereby implying the sizes are not more than design choices.
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 formed the scalloped margins as disclosed by Shim as now modified by Brown CA and Brown ’10 from the claimed range of approximately 1mm in order to have provided an improved scalloped margin that would add the benefit of allowing the receiver to be a reasonable size (see Brown ’10 [0039]).
Further such a modification would have been obvious to one of ordinary skill in the art since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (see MPEP 2144.04 IV A).
In regards to claim 6, Shim as now modified by Brown CA and Brown ’10 discloses the invention as discussed above.
Shim as now modified by Brown ’10 further discloses wherein the posts (32 of Brown ’10) and buttons (34 of Brown ’10) are not overmolded with the outer layer (10 of Shim; see Brown ’10 [0028] in reference to the core (26) being covered by an overmold (28) and not the post (32); thus, as now combined 32 of Brown ’10 is not overmolded with the 21 of Shim as now modified by Brown CA).
In regards to claim 9, Shim as now modified by Brown CA and Brown ’10 discloses the invention as discussed above.
Shim as now modified by Brown ’10 further discloses wherein the button slopes (34 of Brown ’10) inwardly toward the buccal sidewall (see Brown 10’ that 34 slopes inwardly and thus as now combined would slope inwardly towards the buccal sidewall of Shim).
In regards to claim 10, Shim as now modified by Brown CA and Brown ’10 discloses the invention as discussed above.
Shim as now modified by Brown CA and Brown ’10 does not disclose wherein the upper tray core comprises an arch and buccal and lingual lattice segments extending from the arch, wherein the buccal lattice segments are positioned to an anterior of the buccal sidewalls, and the lingual lattice segments are positioned opposite the buccal sidewalls.
However, Brown CA further teaches wherein the upper tray core (14t capable of being used in both lower and upper trays and is therefore considered an upper tray core) comprises an arch (40t; see [pg 20 ln 26-pg 21 ln 7]; see figure 62) and buccal and lingual lattice segments (148 and 150; see [pg21 ln 8-30]; see figure 62-63]) extending from the arch (40t), wherein the buccal lattice segments (150) are positioned to an anterior of the buccal sidewalls (see figure 64), and the lingual lattice segments (148) are positioned opposite the buccal sidewalls (see figure 64) for the purpose of providing structural integrity to the outer layer (see [pg 20 ln 26-pg 21 ln 7]).
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 tray core as disclosed by Shim as now modified by Brown CA and Brown ‘10 and to have included the buccal and lingual lattice segments as further taught by Brown CA in order to have provided an improved arch segment that would add the benefit of providing additional structural integrity to the outer layer (see [pg 20 ln 26-pg 21 ln 7]).
In regards to claim 11, Shim as now modified by Brown CA and Brown ’10 discloses the invention as discussed above.
Shim as now modified by Brown CA and Brown ’10 does not disclose wherein the arch comprises a pair of posterior bite pad segments interconnected by an anterior arch segment.
However, Brown CA further teaches wherein the arch (40t) comprises a pair of posterior bite pad segments (38t; see [pg 20 ln 26-pg 21 ln 7]; see figure 62) interconnected by an anterior arch segment (see figure 62) for the purpose of reinforcing the occlusal surfaces of the guard to prevent the user's teeth from penetrating through the guard during custom-fitting and usage of the guard (see [pg 1 ln 11-19]).
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 arch as disclosed by Shim as now modified by Brown CA and Brown ’10 and to have included the bite pad segments as further taught by Brown CA in order to have provided an improved arch that would add the benefit of reinforcing the occlusal surfaces of the guard to prevent the user's teeth from penetrating through the guard during custom-fitting and usage of the guard (see [pg 1 ln 11-19]).
In regards to claim 12, Shim as now modified by Brown CA and Brown ’10 discloses the invention as discussed above.
Shim as now modified by Brown CA further discloses wherein the lingual lattice segments (148 of Brown CA) extend from the bite pad segment (38t of Brown CA), and the buccal lattice segments (150 of Brown CA) extend from the anterior arch segment (see Brown CA figure 62).
In regards to claim 13, Shim as now modified by Brown CA and Brown ’10 discloses the invention as discussed above.
Shim as now modified by Brown CA and Brown ’10 does not disclose wherein the anterior arch segment comprises a sloped bite surface.
However, Brown CA further teaches wherein the anterior arch segment (40t; see [pg 20 ln 26-pg 21 ln 7]; see figure 62) comprises a sloped bite surface (see figure 64).
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 anterior arch segment as disclosed by Shim as now modified by Brown CA and Brown ’10 by forming the anterior arch segment with a sloped surface as further taught by Brown CA in order to have provided an improved anterior arch segment that would add the benefit of providing a wider arch segment that would accommodate different sizes of dental arches.
In regards to claim 14, Shim as now modified by Brown CA and Brown ’10 discloses the invention as discussed above.
Shim as now modified by Brown CA and Brown ‘10 does not disclose wherein the anterior arch segment comprises an anterior stop tab located in between adjacent buccal lattice segments.
However, Brown CA further teaches wherein the anterior arch segment (40t) comprises an anterior stop tab (see annotated figure 62 above) located in between adjacent buccal lattice segments (left and right 150; see Figure 62 and 63) for the purpose of providing structural integrity to the outer layer (see [pg 20 ln 26-pg 21 ln 7]).
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 anterior arch segment as disclosed by Shim as now modified by Brown CA and Brown ’10 by including the anterior stop tab located in between adjacent buccal lattice segments that would add the benefit of providing structural integrity to the outer layer (see [pg 20 ln 26-pg 21 ln 7]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bedford (US 2018/0360646 A1) in view of Brown CA.
Bedford discloses A mandibular advancement device (26; see [0049]; see figure 1) comprising:
an upper tray (28; see [0049]; see figure 1) adapted to be fitted over a user's maxillary arch (see figure 1) and comprising a pair of adjustable stop members (32; see [0049]; see figure 9 that there are a pair of 32); and
a lower tray (30; see [0049]; see figure 1) adapted to be fitted over the user's mandibular arch (see figure 1) and comprising a pair of fins (34; see [0049]; see figure 5 that there are a pair of 34) extending from the lower tray (30; see figure 1), each of the fins (34) being configured to engage a respective stop member (32) to inhibit posterior movement of the lower tray (30) when worn by the user (see [0055]; see figure 1),
each of the upper and lower trays (28 and 30) comprising a core (36; see [0050]; see figure 7; see [0054] in reference to 28 comprising a similar core) having opposed maxilla and mandible- facing surfaces (see figures 7 and 8 that 36 comprises mandible and maxilla facing surfaces), the cores (36) being formed from a first material (polyamide; see [0050]) having a first softening point temperature (polyamide has a first softening point temperature),
each of the upper and lower trays (28 and 30) further comprising an outer layer (38; see [0050]; see figure 7; see [0054] in reference to 28 comprising a similar outer layer) overmolded onto the core (36; see [0050] in reference to 38 being injection molded onto 36 (considered overmolding since overmolding is a type of injection molding) and covering the maxilla and mandible-facing surfaces (see figure 10 that 38 of 28 covers the maxilla facing surface of 36 of 28, and that 38 of 30 covers the mandible facing surface of 36 of 30), the outer layer (38) being formed from a second material (PCL (polycaprolactone) and EVA or polyurethane; see [0050]) having a second softening point temperature that is less than the first softening point temperature (as per applicant’s specification page 14; applicant’s outer layer can be a blend of PCL (polycaprolactone) and EVA (lines [1-5]), and core can be Nylon or polyamide (lines [13-15]); thus, 38 is considered to have a second softening point which is lower than the first softening point of 36),
the outer layer (38 of 30) of the lower tray (30) comprising a pair of posterior superior surfaces (see figure 5) that extend between buccal and lingual side margins (See annotated figure 5 below)
wherein each stop member (32) of the pair of stop members (pair of 32) is configured so that when engaged with a respective fin (34) of the pair of fins (pair of 34) is located entirely outboard of the buccal side margin (see figure 5 that 34 is positioned entirely outboard of the buccal side margin of 38 of 30; see figure 9 that 32 is similarly positioned entirely outboard of the buccal side margin of 38 of 28; and see figure 10 that 32 and 34 are intended to abut one another; therefore, each 32 is considered to be located entirely outboard of the buccal side margin of 38 of 30).
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Bedford does not disclose the pair of fins are a pair of immovable fins; and
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.
However, Bedford teaches a second embodiment of the pair of fins wherein the pair of fins are immovable fins (see [0015]).
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 adjustable pair of fins as disclosed by the first embodiment of Bedford by making the pair of fins immovable as taught by the second embodiment of Bedford in order to have provided an improved pair of fins that would add the benefit of fixedly attaching the pair of fins to the lower part (see [0015]) thereby simplifying the means of adjusting the mandibular advancement device.
Bedford still does not disclose 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.
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) overmolded onto the core (14; see [pg 12 ln 1-3]); the outer layer (146) covering the maxilla and mandible-facing surfaces (see [pg 12 ln 20-26]; see figure 5) of the core (14t) for the purpose of providing a covering of the rigid core which is formed from a softer and more pliable material (see [pg 15 ln 20-25]).
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 outer layer of the upper and lower trays as disclosed by Bedford, and to have overmolded the outer layers to cover the maxilla and mandible-facing surfaces of the cores as taught by Brown CA in order to have provided an improved mandibular advancement device that would add the benefit of providing a covering of the rigid core which is formed from a softer and more pliable material (see [pg 15 ln 20-25]) thereby increasing patient comfort when using the device.
Allowable Subject Matter
Claims 4 and 7-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and rewritten to address the claim objections as discussed above.
The following is a statement of reasons for the indication of allowable subject matter:
With regards to claim 4, 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 as discussed above in the rejection of claim 3 above.
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 4.
With regards to claim 7, 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 above in the rejection of claim 2 above
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 7 is considered allowable.
Claim 8 is considered allowable insofar that the claim depends from claim 7 and therefore contains the same allowable subject matter.
Conclusion
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/DANIEL A MILLER/Examiner, Art Unit 3786
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