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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/20/2026 has been entered.
Response to Amendment
Applicant’s amendments of claims 1, 4, 8, 11, 14, and 16 are acknowledged by the Examiner.
Applicant’s amendments of claims 1, 4, 8, 11, 14, and 16 has overcome most of the claim objections. Thus, the objections are mostly withdrawn and the remaining claim objections are described below.
Currently claims 1-20 are pending in the current application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 under 35 U.S.C. 102(a)(1) as being anticipated by Orrico (US 2009/0308401 A1) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 02/20/2026 with respect to the rejection of claim 8 under 35 U.S.C. 102(a)(1) as being anticipated by Orrico have been fully considered but they are not persuasive. Applicant argues that Orrico does not disclose "wherein insertion of the first projection and the second projection into the first recess and the second recess, respectively, maintains a gap between superior incisors and inferior incisors and maintains an opening of the mouth.". Examiner respectfully disagrees. It can clearly be seen in Orrico figure 18 that upon insertion of the first and second projection into their recesses, a gap between the superior and inferior incisors is maintained.
Applicant's arguments filed 02/20/2026 with respect to the rejection of claim 11 under 35 U.S.C. 102(a)(1) as being anticipated by Orrico have been fully considered but they are not persuasive. Applicant presents similar arguments with respect to the angle of the projection that were addressed in the final rejection mailed 09/26/2025 on pages 3-4. With respect to Applicant’s arguments that one of ordinary skill in the art would not interpret the projection of claim 11 to be a portion of the projection in light of the specification, and that “the entire projection is angled, and not a portion thereof”. It is noted that the features upon which applicant relies (i.e., the entire projection is angled, and not a portion thereof) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). With respect to Applicant’s arguments regarding design choice, Examiner has not relied on a design choice rationale to modify the structure of Orrico to reject any claims, thus, Applicant’s arguments are moot.
In response to Applicant’s arguments that to rely on design choice, there must be presented a simple rearrangement of parts citing MPEP 2144.04 VI C. This assertion is incorrect. When absent any form of criticality, a design choice may also be the result of obvious changes in size (MPEP 2144.04 IV A), changes in shape (MPEP 2144.04 IV B), or any of the other situations recited in MPEP 2144.04 IV-VI.
In response to Applicant’s arguments that Orrico does not disclose the same features, nor does it achieve the same function of the recited elements of claim 11. Claim 11 amended to include features previously found in claim 20. Both claims were anticipated by Orrico, and thus, Orrico discloses the same features, and the same function of creating mandibular advancement as discussed in the previous final rejection mailed 09/26/2025.
In response to Applicant’s arguments regarding claim 14, of how Orrico does not “cause” mandibular advancement when 42 is inserted into 44, these arguments were addressed in the final rejection mailed 09/26/2025 on page 3, and are not persuasive for the same reasons.
Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8 recites the limitation “an oral device insertable” in line 1. This limitation should be amended to recite “an oral device configured to be insertable”.
Claim 8 recites the limitation “a second guard insertable” in line 14. This limitation should be amended to recite “a second guard configured to be insertable”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by LeBlanc et al. (US 2019/0021901 A1) (hereinafter LeBlanc).
In regards to claim 1, LeBlanc discloses oral device (50; see [0021]; see figure 2) for use by a patient during sleep (see [abstract]), the oral device comprising:
a first guard (12; see [0021]; see figure 2) configured for insertion into an oral cavity of the patient (see figure 5e), the first guard (12) comprising:
a first body (body of 12) configured to engage a first set of a dentition of the patient (see figure 5e); and
a first recess (gap between 58 of 52r; see figure 3) extending into the first body (body of 12 includes 52r and thus, the gap between 58 extends into the body of 12), the first recess configured to align with a first set of occlusal surfaces of the first set of the dentition upon insertion of the first guard (12; see figure 5e); and
a second guard (14; see [0021]; see figure 2) configured for insertion into the oral cavity of the patient (see figure 5e), the second guard comprising:
a second body (body of 14) configured to engage a second set of the dentition (see figure 5e); and
a first projection (62 of 54r; see [0027]; see figure 3) extending from the second body (see figure 5a), the first projection (62) configured to align with a first set of occlusal surfaces of the second set of the dentition upon insertion of the second guard (14; see figure 5e), and the first projection (62) configured to not extend laterally beyond the first dentition (see figure 5e), and wherein the first projection (62) is insertable into the first recess (gap between 58; see [0040-0044]; see figures 5a-d) to position the second guard (14) with respect to the first guard (12) and to position the first set of the dentition with respect to the second set of the dentition (see [0024]), and wherein the first projection (62) is insertable into the first recess (gap between 58) to cause mandibular advancement when the first body (12) is engaged with the first set of the dentition and the second body (14) is engaged with the second set of the dentition (see [abstract] and [0024]).
In regards to claim 2, LeBlanc discloses the invention as discussed above.
LeBlanc further discloses wherein the first set of the dentition is a superior set of the dentition and wherein the second set of the dentition is an inferior set of the dentition (see figure 5e).
In regards to claim 3, LeBlanc discloses the invention as discussed above.
LeBlanc further discloses wherein the first set of the dentition is an inferior set of the dentition and wherein the second set of the dentition is a superior set of the dentition (12 and 14 are capable of being placed in a configuration such that 12 engages a user’s inferior dentition, and 14 engages a user’s superior dentition).
In regards to claim 4, LeBlanc discloses the invention as discussed above.
LeBlanc further discloses wherein the first guard (12) includes a second recess (gap between 58 of 52L; see figure 3) configured to align with a second set of occlusal surfaces of the first set of the dentition upon insertion of the first guard (12; see figure 5e), and wherein the second guard (14) includes a second projection (62 of 54L; see [0027]; see figure 3) see to align with a second set of occlusal surfaces of the second set of the dentition upon insertion of the second guard (14; see figure 5e), and wherein the second projection (62 of 54L) is insertable into the second recess (gap between 58 of 52L) to position the second guard (14) with respect to the first guard (12) and to, together with the first projection (62 of 52r) and the first recess (gap between 58 of 52r), position the first set of the dentition with respect to the second set of the dentition (see [abstract] and [0024]).
In regards to claim 5, LeBlanc discloses the invention as discussed above.
LeBlanc further discloses wherein the first projection (62) is angled posteriorly with respect to the oral cavity (see figure 3 that 62 is in the form of a dovetail, and thus, the posterior portion of 62 is angled posteriorly with respect to the oral cavity).
In regards to claim 6, LeBlanc discloses the invention as discussed above.
LeBlanc further discloses wherein the first projection (62) is angled anteriorly with respect to the oral cavity (see figure 3 that 62 is in the form of a dovetail, and thus, the anterior portion of 62 is angled anteriorly with respect to the oral cavity).
In regards to claim 7, LeBlanc discloses the invention as discussed above.
LeBlanc further discloses wherein the first projection (62) and the first recess (gap between 58) are configured to maintain a gap between superior incisors and inferior incisors of the dentition (see figure 5e).
Claim(s) 8-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Orrico et al. (US 2009/0308401 A1) (hereinafter Orrico).
In regards to claim 8, Orrico discloses an oral device (20; see [0035]; see figure 1) insertable into an oral cavity to engage a dentition of a patient (see [0035]), the oral device (20) comprising:
a first guard (22a; see [0035]; see figure 1) configured to be inserted into the oral cavity (see [0035]), the first guard (22a) comprising:
a first lateral extension (portion of 22a to the left of midline 8 as seen in figure 6; hereinafter left 22a) configured to engage with a first set of occlusal surfaces of a first set of the dentition (see [0035] in reference to 22a engaging an upper dentition of the user, thus left 22a engages a first set of occlusal surfaces of a left set of the user’s upper dentition) and a second lateral extension (portion of 22a to the right of midline 8 as seen in figure 6; hereinafter right 22a) configured to engage with a second set of occlusal surfaces of the first set of the dentition (see [0035] in reference to 22a engaging an upper dentition of the user, thus right 22a engages a second set of occlusal surfaces of a right set of the user’s upper dentition);
a first recess (left 44a; see [0040]; see figures 8, 10, and 23) extending into the first lateral extension (left 22a; see figures 8 and 9 that left 44a extends into left 22a) and a second recess (right 44a; see [0040]; see figures 8, 10, and 23) extending into the second lateral extension (right 22a; see figures 8 and 9 that right 44a extends into right 22a), the first recess (left 22a) and the second recess (right 22a) configured to align with the first set of occlusal surfaces and the second set of occlusal surfaces of the first set of the dentition, respectively, upon insertion of the first guard (22a; see figures 4, 6, and 9 that 44a is positioned on an inferior surface of 22a, is positioned to align with left and right portions of the user’s upper teeth positioned within 22a; therefore, left and right 44a aligns with the first and second set of occlusal surfaces of the left and right portions of the user’s upper teeth); and
a second guard (22b; see [0035]; see figure 1) insertable into the oral cavity (see [0035]), the second guard (22b) comprising:
a third lateral extension (portion of 22b to the left of midline 8 as seen in figure 6; hereinafter left 22b) configured to engage a first set of occlusal surfaces of a second set of the dentition (see [0035] in reference to 22b engaging a lower dentition of the user, thus left 22b engages a first set of occlusal surfaces of a left set of the user’s lower dentition) and a fourth lateral extension (portion of 22b to the right of midline 8 as seen in figure 6; hereinafter right 22b) configured to engage a second set of occlusal surfaces of the second set of the dentition (see [0035] in reference to 22b engaging a lower dentition of the user, thus right 22b engages a second set of occlusal surfaces of a right set of the user’s lower dentition);
a first projection (left 42b; see [0040]; see figures 8, 10, and 23) extending from the third lateral extension (left 22b) and a second projection (right 42b; see [0040]; see figures 8, 10, and 23) extending from the fourth lateral extension (right 22b), the first projection (left 42b) and the second projection (right 42b) configured to align with the first set of occlusal surfaces and the second set of occlusal surfaces of the second set of the dentition, respectively, upon insertion of the second guard (22b; see figures 4, 6, and 9 that 42b is positioned on a superior surface of 22b, is positioned to align with left and right portions of the user’s lower teeth positioned within 22b; therefore, left and right 42b aligns with the first and second set of occlusal surfaces of the left and right portions of the user’s lower teeth), and the first projection (left 42b) and the second projection (right 42b) configured to be inserted into the first recess (left 44a) and the second recess (right 44a), respectively, to position the second guard (22b) with respect to the first guard (22a) and to position the first set of the dentition (upper teeth) with respect to the second set of the dentition (lower teeth) to cause mandibular advancement (see [abstract], [0002], [0007], [0009], and [0043]; see figure 5), and wherein insertion of the first projection (left 42b) and the second projection (right 42b) into the first recess (left 44a) and the second recess (right 44a) respectively, maintains a gap between superior incisors and inferior incisors and maintains an opening of the mouth (See figure 18).
In regards to claim 9, Orrico discloses the invention as discussed above.
Orrico further discloses wherein the first set of the dentition is a superior set of the dentition and wherein the second set of the dentition is an inferior set of the dentition (see [0036] in reference to one of the members 22a, 22b will be mounted on the user's upper jaw while the other will be mounted on the user's lower jaw; thus 22a and 22b are considered to be interchangeably placed on the user’s upper and lower jaw respectively due to their common configurations, thereby defining the first set of the dentition as a superior set of the dentition and the second set of the dentition as an inferior set of the dentition).
In regards to claim 10, Orrico discloses the invention as discussed above.
Orrico further discloses wherein the first set of the dentition is an inferior set of the dentition and wherein the second set of the dentition is a superior set of the dentition (see [0036] in reference to one of the members 22a, 22b will be mounted on the user's upper jaw while the other will be mounted on the user's lower jaw; thus 22a and 22b are considered to be interchangeably placed on the user’s upper and lower jaw respectively due to their common configurations, thereby defining the first set of the dentition as an inferior set of the dentition and the second set of the dentition as a superior set of the dentition).
In regards to claim 11, Orrico discloses an oral device (20; see [0035]; see figure 1) configured for insertion into an oral cavity to engage a dentition of a patient (see [0035]), the oral device (20) comprising:
a first guard (22a; see [0035]; see figure 1) configured for insertion into the oral cavity of the patient (see [0035]), the first guard (22a) comprising:
a first lateral extension (portion of 22a to the left of midline 8 as seen in figure 6; hereinafter left 22a) configured to engage a first set of occlusal surfaces of a first set of the dentition (see [0035] in reference to 22a engaging an upper dentition of the user, thus left 22a engages a first set of occlusal surfaces of a left set of the user’s upper dentition) and a second lateral extension (portion of 22a to the right of midline 8 as seen in figure 6; hereinafter right 22a) configured to engage with a second set of occlusal surfaces of the first set of the dentition (see [0035] in reference to 22a engaging an upper dentition of the user, thus right 22a engages a second set of occlusal surfaces of a right set of the user’s upper dentition);
a first plurality of recesses (left 44a; see [0040]; see figures 8, 10, and 23) extending into the first lateral extension (left 22a; see figures 8 and 9 that left 44a extends into left 22a) and a second plurality of recesses (right 44a; see [0040]; see figures 8, 10, and 23) extending into the second lateral extension (right 22a; see figures 8 and 9 that right 44a extends into right 22a); and
a second guard (22b; see [0035]; see figure 1) configured for insertion into the oral cavity (see [0035]), the second guard (22b) comprising:
a third lateral extension (portion of 22b to the left of midline 8 as seen in figure 6; hereinafter left 22b) configured to engage a first set of occlusal surfaces of a second set of the dentition (see [0035] in reference to 22b engaging a lower dentition of the user, thus left 22b engages a first set of occlusal surfaces of a left set of the user’s lower dentition) and a fourth lateral extension (portion of 22b to the right of midline 8 as seen in figure 6; hereinafter right 22b) configured to engage a second set of occlusal surfaces of the second set of the dentition (see [0035] in reference to 22b engaging a lower dentition of the user, thus right 22b engages a second set of occlusal surfaces of a right set of the user’s lower dentition);
a first projection (left 42b; see [0040]; see figures 8, 10, and 23) extending from the third lateral extension (left 22b) and a second projection (right 42b; see [0040]; see figures 8, 10, and 23) extending from the fourth lateral extension (right 22b), the first projection (left 42b) and the second projection (right 42b) configured for insertion into one recess of the first plurality of recesses (left 44a) and one recess of the second plurality of recesses (right 44a; see figure 8 that each 42b is insertable into any one of the plurality of 44a), respectively, to position the second guard (22b) with respect to the first guard (22a) and to position the first set of the dentition (upper teeth) with respect to the second set of the dentition (lower teeth) to cause mandibular advancement (see [abstract], [0002], [0007], [0009], and [0043]; see figure 5) wherein the first projection (left 42a) is angled anteriorly to posteriorly with respect to the oral cavity (see annotated figure 23 above) at an angle between 30 and 45 degrees (as (left) 42a is a round, semicircular bulb as can be seen in figure 23 below; left 42a has a portion which is angled anteriorly to posteriorly at an angle of 30 degrees, 45 degrees, and every degree therebetween with respect to the anterior to posterior direction of the user’s oral cavity).
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In regards to claim 12, Orrico discloses the invention as discussed above.
Orrico further discloses wherein the first plurality of recesses (left 44a) and the second plurality of recesses (right 44a) are alignable with the first set of occlusal surfaces and the second set of occlusal surfaces of the first set of the dentition, respectively, upon insertion of the first guard (22a; see figures 4, 6, and 9 that left and right 44a is positioned on a left and right inferior surface of 22a, and is therefore positioned to align with a left and right portion of the user’s upper teeth positioned within 22a).
In regards to claim 13, Orrico discloses the invention as discussed above.
Orrico further discloses wherein the first projection (left 42b) and the second projection (right 42b) are alignable with the first set of occlusal surfaces and the second set of occlusal surfaces of the second set of the dentition, respectively, upon insertion of the second guard (22b; see figures 4, 6, and 9 that left and right 42b is positioned on a left and right superior surface of 22b, and is therefore positioned to align with a left and right portion of the user’s lower teeth positioned within 22b).
In regards to claim 14, Orrico discloses an oral device (20; see [0035]; see figure 1) for use by a patient during sleep (see [0002]), the oral device (20) comprising:
a first guard (22a; see [0035]; see figure 1) configured for insertion into an oral cavity of the patient (see [0035]), the first guard (22a) comprising:
a first body (body of 22a) configured to engage a first set of a dentition of the patient (see [0035]); and
a first projection (left 42a; see [0040]; see figures 8, 10, and 23) extending from the first body (body of 22a; see figures 8 and 9 that left 42a extends from the body of 22a), the first projection (left 42a) configured to align with a first set of occlusal surfaces of the first set of the dentition upon insertion of the first guard (22a; see figures 4, 6, and 9 that left 42a is positioned on a left inferior surface of 22a, is positioned to align with a left portion of the user’s upper teeth positioned within 22a, and therefore aligns with a first set of occlusal surfaces of the left portion of the user’s upper teeth); and
a second guard (22b; see [0035]; see figure 1) configured for insertion into the oral cavity of the patient (see [0035]), the second guard (22b) comprising:
a second body (body of 22b) configured to engage a second set of the dentition (see [0035]); and
a second projection (left 42b; see [0040]; see figures 8, 10, and 23) extending from the second body (body of 22b), the second projection (left 42b) configured to align with a first set of occlusal surfaces of the second set of the dentition upon insertion of the second guard (22b; see figures 4, 6, and 9 that left 42b is positioned on a left superior surface of 22b, is positioned to align with a left portion of the user’s lower teeth positioned within 22b, and therefore aligns with a first set of occlusal surfaces of the left portion of the user’s lower teeth), and the first projection (left 42a) and the second projection (left 42b) configured to engage each other (see figure 8), upon insertion of the second guard (22b), to position the second guard (22b) with respect to the first guard (22a) and to position the first set of the dentition (upper teeth) with respect to the second set of the dentition (lower teeth) to cause mandibular advancement (see [abstract], [0002], [0007], [0009], and [0043]; see figure 5; upon insertion of 22b, left 42a and left 42b engage one another to cause mandibular advancement as claimed).
In regards to claim 15, Orrico discloses the invention as discussed above.
Orrico further discloses wherein the first projection (left 42a) and the second projection (left 42b) are configured to interlock (see figure 8 and 23) to cause or promote mandibular movement of displacement (see [abstract] and [0007]; see figure 5) when the first guard (22a) and the second guard (22b) are inserted to engage the first set of the dentition and the second set of the dentition (see [abstract], [0007], [0009], and [0043]), respectively.
In regards to claim 16, Orrico discloses the invention as discussed above.
Orrico further discloses wherein the first guard (22a) includes a third projection (right 42a; see [0035]; see figures 8, 10, and 23) configured to align with a second set of occlusal surfaces of the first set of the dentition upon insertion of the first guard (22a; see figures 4, 6, and 9 that right 42a is positioned on a right inferior surface of 22a, is positioned to align with a right portion of the user’s upper teeth positioned within 22a, and therefore aligns with a second set of occlusal surfaces of the right portion of the user’s upper teeth), and wherein the second guard (22b) includes a fourth projection (right 42b; see [0040]; see figures 8, 10, and 23) to align with a second set of occlusal surfaces of the second set of the dentition upon insertion of the second guard (22b; see figures 4, 6, and 9 that right 42b is positioned on a right superior surface of 22b, is positioned to align with a right portion of the user’s lower teeth positioned within 22b, and therefore aligns with a second set of occlusal surfaces of the right portion of the user’s lower teeth), and the third projection (right 42a) configured to engage with the fourth projection (right 42b; see figure 4, 6, 8, 9, and 10) to position the second guard (22b) with respect to the first guard (22a) and to, together with the first projection (left 42a) and the second projection (left 42b), position the first set of the dentition with respect to the second set of the dentition (see [abstract], [0007], [0009], and [0043]).
In regards to claim 17, Orrico discloses the invention as discussed above.
Orrico further discloses wherein the third projection (right 42a) is engageable with the fourth projection (right 42b) to, together with the first projection (left 42a) and the second projection (left 42b), cause or promote anterior mandibular movement or displacement when the first guard (22a) and the second guard (22b) are inserted to engage the first set of the dentition and the second set of the dentition (see [abstract], [0007], [0009], and [0043]; see figure 5 and 9), respectively.
In regards to claim 18, Orrico discloses the invention as discussed above.
Orrico further discloses wherein the first projection (left 42a) and the second projection (right 42a) are configured to form and maintain a gap between superior incisors and inferior incisors of the dentition when the first guard (22a) and the second guard (22b) are inserted to engage the first set of the dentition and the second set of the dentition (see figure 18), respectively.
In regards to claim 19, Orrico discloses the invention as discussed above.
Orrico further discloses wherein the second set of the dentition an inferior set of the dentition (see [0036] in reference to one of the members 22a, 22b will be mounted on the user's upper jaw while the other will be mounted on the user's lower jaw; the second set of the dentition engaged by 22b is considered an inferior set of the dentition), wherein the second guard (22b) is configured to engage the inferior dentition (see [0036]), and wherein the first projection (left 42a) is angled anteriorly to posteriorly with respect to the oral cavity (see annotated figure 23 below).
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In regards to claim 20, Orrico discloses the invention as discussed above.
Orrico further discloses wherein the first projection (left 42a) is angled anteriorly to posteriorly with respect to the oral cavity (see annotated figure 23 above) at an angle between 30 and 45 degrees (as (left) 42a is a round, semicircular bulb as can be seen in figure 23 above; left 42a is considered to have a portion which is angled anteriorly to posteriorly at an angle of 30 degrees, 45 degrees, and every degree therebetween with respect to the anterior to posterior direction of the user’s oral cavity).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kownacki (US 2004/0177853 A1) which discloses a similar projection and recess engagement as seen in Applicant’s figure 5.
Garabadian et al. (US 2011/0005526 A1) which discloses a similar projection and recess engagement as seen in Applicant’s figures 2, 4b and 4c.
Buzzard et al. (US 5,570,704) which discloses a similar projection and recess engagement as seen in Applicant’s figure 4a.
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 at 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
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