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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 4 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 4, the claim positively recites a buccal surface and a lingual surface of mandibular teeth by requiring that “the lower member is positioned entirely between a buccal surface and a lingual surface of mandibular teeth”. This limitation requires the claimed oral apparatus, including the lower member, to be in an actual positional relationship with the buccal and lingual surfaces of the mandibular teeth. Thus, the mandibular teeth are not merely recited as an intended environment of use, but are part of the claimed combination necessary to satisfy the limitation. Because the mandibular teeth constitute anatomical portions of a human organism, the claimed invention as a whole encompass an oral apparatus in combination with a human organism.
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, 3-13, and 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dutertre et al (WO 02062252) herein after Dutertre.
Regarding claim 1, Dutertre teaches an oral apparatus for controlling a positional relationship between a mandible and maxilla of a patient, the oral apparatus comprising: (Claim 1, first 4 lines, "Orthodontic device for positioning and maintaining the teeth of an individual in a predetermined position, which is formed by two distinct aligners in the general shape of "U", namely a lower aligner (1), called mandibular, and an upper aligner (2), called the maxilla" and Abstract lines 2-4)
an upper tray configured (2) to receive a plurality of maxillary teeth (abstract lines 2-4, “Said device comprises two distinct, generally U-shaped splints, namely a lower
mandibular splint (1) and an upper maxillary splint (2), each of which is provided with individual tooth sockets (12, 24) having a shape that is adapted to that of the individual's teeth”),
the upper tray including an upper member (the shim 22) having an upper base portion (23/base portion of shim) coupled to the upper tray (Page 6, lines 4-5 “If necessary, the shim 22 can be removed, the element 23 projecting directly from the face 21 of the gutter 2”) and an upper interlocking member (at area 3, the interlocking members extending) extending from the upper base portion in a first direction opposite from the upper tray (as seen in figure 2), the upper interlocking member including an upper shoulder (the shoulder portion where the interlocking parts and the base of the structure 2 meets) coupled with the upper base portion and an upper arm extending (the arm extending from the base 2 then goes in the horizontal direction) from the upper shoulder (refer to labeled figure 2 below), wherein an upper recess (recesses are formed in between the interlocking parts as shown in figure 2 which the extending parts of lower tray connects to) is formed between the upper arm and the upper base portion;
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and a lower tray (1) configured to receive a plurality of mandibular teeth, the lower tray including a lower member (the combined C1 and C2 portions in area Z1 or Z2 as in Figure 3) having a lower base portion (the surface region within the boundary of Z1 or Z2, these elements C1 and C2 within the areas Z1 or Z2 are coupled with the tray as in Figures 3 and 4) coupled to the lower tray and a lower interlocking member (the lower plate 1 has interlocking areas as shown in Figure 2 towards upwards) extending from the lower base portion in a second direction opposite from the lower tray, the lower interlocking member including a lower shoulder coupled (the right side of the base towards the interlocking part there is a shoulder) with the lower base portion and a lower arm (arm extending from 1 towards the horizontal direction) extending from the lower shoulder, wherein a lower recess ( lower plate has recesses that can be interlocked with the upper plate) is formed between the lower arm and the lower base portion,
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wherein the upper arm of the upper interlocking member is received within the lower recess of the lower tray, (as seen in figure 2, the upper arm is extending towards and fit with lower plate in a recess at the left end)
and the lower arm of the lower interlocking member is received with the upper recess (the lower arm extending up and fit with the upper plate at the recess at the right) of the upper tray to adjust the positional relationship between the mandible and the maxilla of the patient.
Regarding claim 3, Dutertre teaches an oral apparatus of claim 1, wherein the upper interlocking member is positioned entirely between a buccal surface and a lingual surface of the upper tray (2) (the interlocking part as in Figure 2 situated on the biting surface which is located between the buccal and lingual surfaces, the teeth are shown by 24, and abstract lines 2-7, “Said device comprises two distinct, generally U-shaped splints, namely a lower mandibular splint (1) and an upper maxillary splint (2), each of which is provided with individual tooth sockets (12, 24) having a shape that is adapted to that of the individual's teeth. The upper (11) and lower (21) surfaces of the mandibular (1) and maxillary (2) splints respectively comprise complementarily-shaped projecting elements (3; 23) which can fit into one another in order to connect said splints (1, 2)”).
Regarding claim 4, Dutertre teaches an oral apparatus of claim 1, wherein the lower member is positioned entirely between a buccal surface and a lingual surface of mandibular teeth (figure 3, shows the lower tray (1) where the lower member is the surface area which covers the biting surfaces which is located between the lingual and mandibular surfaces).
Regarding claim 5, Dutertre teaches an oral apparatus of claim 1, first surface of the upper base portion defines an upper bite plane ( as shown in figure 2 the upper base is the surface area covering the upper bite surface plane, upper teeth shown by 24), and a second surface of the lower base portion defines a lower bite plane (such as the upper surface, the lower base is the surface covering the lower biting surface plane as in Figure 2 the lower teeth are shown by 12), wherein the upper bite plane engages the lower interlocking member, and the lower bite plane engages the upper interlocking member (the interlocking members of each planes connected as in Figure 2).
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Regarding claim 6, Dutertre teaches an oral apparatus of claim 5, wherein the lower arm slidingly engages the first surface of the upper base portion (Page 2, lines 15-19, “This device comprises two gutter-shaped shells intended to receive the upper arch and the lower arch of the patient. These two shells are held together by a system of rings provided on the first shell, cooperating with a pair of free arms arranged on the second shell. The arms are intended to come to engage and slide in the rings so as to maintain an offset of the mandible towards the front of the maxilla, while allowing lateral movements”).
Regarding claim 7, Dutertre teaches an oral apparatus of claim 6, wherein the upper bite plane is parallel with the lower bite plane (as seen in Figure 2, the two bite planes are parallel).
Regarding claim 8, Dutertre teaches an oral apparatus of claim 5, wherein the upper arm extends parallel to the upper bite plane, and the lower arm extends parallel to the lower bite plane (as seen in Figure 2, the upper and lower arms are parallel to the relative bite planes, the arms are located horizontal to each other as labelled figure 2 below).
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Regarding claim 9, Dutertre teaches an oral apparatus of claim 1, wherein the lower arm includes a corner angle of 90° and the upper arm include a corner angle of 90° (the arms are extending from each base then goes in horizontal direction thereby forming a 90 degrees angle at each corner as seen in Figure 2).
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Regarding claim 10, Dutertre teaches an oral apparatus of claim 1, wherein the upper arm includes an upper arm engagement surface, and the lower arm includes a lower arm engagement surface configured to engage with the upper arm engagement surface to control a vertical positional relationship and a distal positional relationship between the mandible and the maxilla of the patient (the engagement surfaces are the vertical extensions of the arms that engage with the interlocking as seen in Figures 2 and 4, Figure 4 highlighted vertical portions, Page 4, lines 15-17, “A device according to the invention is particularly visible in Figures 1 and 2 attached. This device for positioning and maintaining the teeth of an individual in a determined position is formed of two distinct grooves, namely a lower groove 1 called "mandibular" and an upper groove 2 called "maxilla").
Regarding claim 11, Dutertre teaches an oral apparatus of claim 10, wherein the upper arm engagement surface is parallel with the lower arm engagement surface (the vertical engagement surfaces as in Figure 2 are parallel to each other, the engagement surfaces are the vertical faces that contact with each other when interlocking).
Regarding claim 12, Dutertre teaches an oral apparatus, comprising: an upper tray configured (2) to receive a plurality of maxillary teeth (abstract lines 2-4, “Said device comprises two distinct, generally U-shaped splints, namely a lower
mandibular splint (1) and an upper maxillary splint (2), each of which is provided with individual tooth sockets (12, 24) having a shape that is adapted to that of the individual's teeth”),
the upper tray including an upper member (the shim 22) having an upper base portion (23/base portion of shim) coupled to the upper tray (Page 6, lines 4-5 “If necessary, the shim 22 can be removed, the element 23 projecting directly from the face 21 of the gutter 2”) and an upper recess (recesses are formed in between the interlocking parts as shown in figure 2 which the extending parts of lower tray connects to) is formed between the upper arm and the upper base portion;
and a lower tray (1) configured to receive a plurality of mandibular teeth, the lower tray including a lower member (the combined C1 and C2 portions in area Z1 or Z2 as in Figure 3) having a lower base portion (the surface region within the boundary of Z1 or Z2, these elements C1 and C2 within the areas Z1 or Z2 are coupled with the tray as in Figures 3 and 4) coupled to the lower tray and a lower interlocking member (the lower plate 1 has interlocking areas as shown in Figure 2 towards upwards).
wherein the lower interlocking member (which consist of the lower arm for the interlocking) is slidingly receivable with the upper recess of the upper member (which is situated on the upper base portion) to control a positional relationship between a mandible and a maxilla of a patient (Page 2, lines 15-19, “This device comprises two gutter-shaped shells intended to receive the upper arch and the lower arch of the patient. These two shells are held together by a system of rings provided on the first shell, cooperating with a pair of free arms arranged on the second shell. The arms are intended to come to engage and slide in the rings so as to maintain an offset of the mandible towards the front of the maxilla, while allowing lateral movements”).
Regarding claim 13, Dutertre teaches an oral apparatus of claim 12, wherein the lower interlocking member is positioned entirely between a buccal surface and a lingual surface of the lower tray (figure 3, shows the lower tray (1) where the lower member is the surface area which covers the biting surfaces which is located between the lingual and mandibular surfaces the interlocking is situated on the lower member/lower tray as in Figure 2, thereby the interlocking member is situated on the biting surface).
Regarding claim 16, Dutertre teaches an oral apparatus of claim 12, wherein a first surface of the upper base portion defines an upper bite plane, and a second surface of the lower base portion defines a lower bite plane, wherein the upper bite plane engages the lower interlocking member (as seen in Figure 2, the upper base contains upper bite plane, and the lower base contains a lower bite plane, where the interlocking arms of upper bite plane engage with the lower interlocking members).
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Regarding claim 17, Dutertre teaches an oral apparatus of claim 16, wherein the lower interlocking member (where the lower arm is situated) slidingly engages the first surface of the upper base portion (Page 2, lines 15-19, “This device comprises two gutter-shaped shells intended to receive the upper arch and the lower arch of the patient. These two shells are held together by a system of rings provided on the first shell, cooperating with a pair of free arms arranged on the second shell. The arms are intended to come to engage and slide in the rings so as to maintain an offset of the mandible towards the front of the maxilla, while allowing lateral movements”).
Regarding claim 18, Dutertre teaches an oral apparatus of claim 17, wherein the upper bite plane is parallel with the lower bite plane (as seen in Figure 2, the two bite planes are parallel).
Regarding claim 19, Dutertre teaches an oral apparatus of claim 18, wherein the arm of the lower interlocking member extends parallel to the upper biting surface (as seen in Figure 2, lower arm of the interlocking member is parallel to the upper bite plane).
Regarding claim 20, Dutertre teaches an oral apparatus, comprising: and a lower tray (1) configured to receive a plurality of mandibular teeth (abstract lines 2-4, “Said device comprises two distinct, generally U-shaped splints, namely a lower mandibular splint (1) and an upper maxillary splint (2), each of which is provided with individual tooth sockets (12, 24) having a shape that is adapted to that of the individual's teeth”), and a lower tray (1) configured to receive a plurality of mandibular teeth, the lower tray including a lower member (the combined C1 and C2 portions in area Z1 or Z2 as in Figure 3) having a lower base portion (the surface region within the boundary of Z1 or Z2, these elements C1 and C2 within the areas Z1 or Z2 are coupled with the tray as in Figures 3 and 4) coupled to the lower tray and a lower recess ( lower plate has recesses that can be interlocked with the upper plate) is formed between the lower arm and the lower base portion,
the upper tray including an upper member (the shim 22) having an upper base portion (23/base portion of shim) coupled to the upper tray (Page 6, lines 4-5 “If necessary, the shim 22 can be removed, the element 23 projecting directly from the face 21 of the gutter 2”) and an upper interlocking member (at area 3, the interlocking members extending) extending from the upper base portion in a first direction opposite from the upper tray (as seen in figure 2),
wherein the upper interlocking member is slidingly receivable with the lower recess of the lower member to control a positional relationship between a mandible and a maxilla of a patient (Page 2, lines 15-19, “This device comprises two gutter-shaped shells intended to receive the upper arch and the lower arch of the patient. These two shells are held together by a system of rings provided on the first shell, cooperating with a pair of free arms arranged on the second shell. The arms are intended to come to engage and slide in the rings so as to maintain an offset of the mandible towards the front of the maxilla, while allowing lateral movements”).
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.
Claim(s) 2, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dutertre et al (WO 02062252) herein after Dutertre in view of Ross (US20170035533) herein after Ross.
Regarding claim 2, Dutertre teaches an oral apparatus of claim 1, However, does not explicitly teach wherein the upper arm of the upper interlocking member is cantilevered (i.e.; there is a gap between the interlocking parts).
Ross teaches an oral apparatus for jaw manipulation wherein the upper and lower interlocking members are cantilevered (as shown in Figure 5, there is a small space/gap between the two interlocking members and not a 100% fit).
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Therefore, it would have been obvious for a person in the ordinary skill in the art before the filing date of the application to modify the interlocking parts of Dutertre’s device by using cantilevered connection as taught by Ross, in order to reduce pressure points on teeth or gingiva and to improve patient comfort while maintaining effective interlocking engagement.
Regarding claim 14, Dutertre teaches an oral apparatus of claim 13 and an arm extending in distal direction (as in Figure 2 the lower arm), however does not teach wherein the lower interlocking member includes an arm that is cantilevered.
Ross teaches an oral apparatus for jaw manipulation wherein the upper and lower interlocking members include arms that are cantilevered (as shown in Figure 5, there is a small space/gap between the two interlocking member arms and not a 100% fit).
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Therefore, it would have been obvious for a person in the ordinary skill in the art before the filing date of the application to modify the arms of the interlocking part of Dutertre’s device by using cantilevered connection as taught by Ross, in order to reduce pressure points on teeth or gingiva and to improve patient comfort while maintaining effective interlocking engagement.
Regarding claim 15, Dutertre teaches an oral apparatus of claim 14, wherein the arm includes an arm engagement surface, and the upper recess includes a recess engagement surface configured to engage with the arm engagement surface to control the positional relationship between the mandible and the maxilla of the patient (Figure 2 shows the interlocking portions, while Figure 4 shows the arm engagement surfaces with the vertical highlighted portions / sides of 3, and the recess engagement surfaces are the spaces in between arms which are C2,3,4..and abstract lines 2-7, “Said device comprises two distinct, generally U-shaped splints, namely a lower mandibular splint (1) and an upper maxillary splint (2), each of which is provided with individual tooth sockets (12, 24) having a shape that is adapted to that of the individual's teeth. The upper (11) and lower (21) surfaces of the mandibular (1) and maxillary (2) splints respectively comprise complementarily-shaped projecting elements (3; 23) which can fit into one another in order to connect said splints (1, 2)”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA N. SAMARASEKARA whose telephone number is (571)272-9653. The examiner can normally be reached Monday-Friday 8:00 am - 4:00 pm.
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/SARA N SAMARASEKARA/Examiner, Art Unit 3772
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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