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 is 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).
Claim 4 recites “the protruding piece is set… of the first orthodontic mouthpiece… such that the bonding surface faces a front surface of the orthodontic target tooth” and “the protruding piece is set… of the second orthodontic mouthpiece… such that the bonding surface faces a front surface of the orthodontic target tooth”. This appears to positively claim the bonding surface as facing a part of the human organism (the tooth) and therefore encompasses a human organism within the scope of the claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 4, the last line of the claim recites “another the first orthodontic mouthpiece”. It is unclear if this is referencing another of the first orthodontic mouthpiece, as in a third orthodontic mouthpiece that has a structure the same as the first orthodontic mouthpiece. It is further unclear if this is instead referencing “the first orthodontic mouthpiece” and the inclusion of the term “another” is in error. It is further unclear if this is instead meant to mean something different. As best understood, this should read “
Claim 4 recites “the protruding piece is set in the first recessed portion of the first orthodontic mouthpiece” and “the protruding piece is set in the recessed portion of the second orthodontic mouthpiece”. It is unclear if this is meant to positively claim the protruding piece set in the recessed portion of both the first and the second orthodontic mouthpiece at the same time or if this is meant to refer to a functional capability of the devices. The first interpretation appears to contradict other functional recitations of the claim and the specification. For the purpose of the application of prior art, the claim is interpreted as “the protruding piece is configured to be set in the first recessed portion” and “the protruding piece is configured to be set in the second recessed portion”.
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) 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Phan et al (US 20020106604 A1).
Regarding Claim 4, Phan discloses orthodontic mouthpiece system comprising:
a protruding piece 100/101 (figure 4A, 4, 6) having a hemispherical shape and a base portion 102 configured to be bonded to an orthodontic target tooth, a rear side of the base portion is a bonding surface having an adhesive (paragraph 0023);
an auxiliary mouthpiece (paragraph 0058: may be identical to an elastic repositioning appliance 105; figure 6) including a recessed portion (figure 6) that accommodates the protruding piece in the recessed portion of the auxiliary mouthpiece (figure 6), and the auxiliary mouthpiece bonds the protruding piece to the orthodontic target tooth such that when the bonding surface of the protruding piece set in the recessed portion of the auxiliary mouthpiece is brought into contact with a front surface of the orthodontic target tooth, the protruding piece is caused to be bonded to the orthodontic target tooth at a predetermined position (paragraph 0058),
an orthodontic mouthpiece 105 including a recessed portion that corresponds to the protruding piece (figure 6; 105 is the repositioning appliance and paragraph 0058 discloses a positioning appliance also be provided that has the same shape as 105), the recessed portion of the orthodontic mouthpiece has a shape that accommodates the protruding piece in the recessed portion of the orthodontic mouthpiece, and the protruding piece is set in the recessed portion of the orthodontic mouthpiece such that the bonding surface faces a front surface of the orthodontic target tooth, the orthodontic mouthpiece being separate and distinct from the auxiliary mouthpiece (figure 6; 105 is the repositioning appliance and paragraph 0058 discloses a positioning appliance also be provided that has the same shape as 105); and
a plurality of contact points (figure 6) provided to the recessed portion of the orthodontic mouthpiece, the plurality of contact points that come into direct contact with the protruding piece having the hemispherical shape configured to be bonded to the orthodontic target tooth, thus generating orthodontic forces applied to the orthodontic target tooth in a direction toward the orthodontic target tooth (figure 6);
a second orthodontic mouthpiece including a recessed portion that corresponds to the protruding piece, the recessed portion of the second orthodontic mouthpiece has a shape that accommodates the protruding piece in the recessed portion of the second orthodontic mouthpiece, and the protruding piece is set in the recessed portion of the second orthodontic mouthpiece such that the bonding surface faces the front surface of the orthodontic target tooth, the second orthodontic mouthpiece being separate and distinct from the first orthodontic mouthpiece and the auxiliary mouthpiece (claims 13-17 and 19 of the reference disclose that a plurality of appliances can be provided “wherein at least some of said appliances has a receptacle positioned to receive an attachment device”; note that claim 19 recites that “each of the appliances has a receptacle for receiving the attachment device” -emphasis added-; see citations above for first orthodontic mouthpiece); and
a plurality of contact points provided to the recessed portion of the second orthodontic mouthpiece, the plurality of contact points of the second orthodontic mouthpiece that come into direct contact with the protruding piece having the hemispherical shape configured to be bonded to the orthodontic target tooth, thus generating orthodontic forces applied to the orthodontic target tooth in the direction toward the orthodontic target tooth (claims 13-17 and 19 of the reference disclose that a plurality of appliances can be provided “wherein at least some of said appliances has a receptacle positioned to receive an attachment device”; note that claim 19 recites that “each of the appliances has a receptacle for receiving the attachment device” -emphasis added- see citations above for first orthodontic mouthpiece), wherein
the plurality of contact points of the first orthodontic mouthpiece and the second orthodontic mouthpiece are formed into a convex shape (figure 6),
each contact point of the plurality of contact points of the first orthodontic mouthpiece and the second orthodontic mouthpiece comes into direct contact with a protrusion of the protruding piece (figure 6),
after the protruding piece is caused to be bonded to the orthodontic target tooth at the predetermined position, the auxiliary mouthpiece is removed from the orthodontic target tooth and the protruding piece is separated from the auxiliary mouthpiece (at least capable of being used in the claimed manner; note that this sets forth an intended use of the device and even if the prior art does not explicitly disclose the claimed steps, the disclosed devices are capable of being used as claimed),
a direction and a magnitude of the orthodontic force is adjusted by changing a position and a size of the contact points of the first orthodontic mouthpiece and the second orthodontic mouthpiece and the predetermined position where the protruding piece is bonded (at least capable of being used in the claimed manner; note that this sets forth an intended use of the device and even if the prior art does not explicitly disclose the claimed steps, the disclosed devices are capable of being used as claimed; paragraph 0050: “Additionally, the elastic appliance 105 and/or the attachment device 100 may change in shape, stiffness or orientation to implement such anchoring. These changes may be the result of state changes of one or more layers of the material when subjected to a certain environmental condition, such as non-physiologic pH, temperature, ionic strength or external stimulus” showing that changes in size and shape and contact points is able to be conducted),
when the protruding piece is caused to be separated from the orthodontic target tooth, the auxiliary mouthpiece again accommodates the protruding piece in the recessed portion of the auxiliary mouthpiece, and the auxiliary mouthpiece again bonds the protruding piece to the orthodontic target tooth such that when the bonding surface of the protruding piece set in the recessed portion of the auxiliary mouthpiece is again brought into contact with the front surface of the orthodontic target tooth, the protruding piece is again caused to be bonded to the orthodontic target tooth at the predetermined position (at least capable of being used in the claimed manner; note that this sets forth an intended use of the device and even if the prior art does not explicitly disclose the claimed steps, the disclosed devices are capable of being used as claimed), and
after the protruding piece is again caused to be bonded to the orthodontic target tooth at the predetermined position, the direction and the magnitude of the orthodontic force is adjusted by changing the position and the size of the plurality of contact points provided to the recessed portion of the second orthodontic mouthpiece (at least capable of being used in the claimed manner; note that this sets forth an intended use of the device and even if the prior art does not explicitly disclose the claimed steps, the disclosed devices are capable of being used as claimed; paragraph 0050: “Additionally, the elastic appliance 105 and/or the attachment device 100 may change in shape, stiffness or orientation to implement such anchoring. These changes may be the result of state changes of one or more layers of the material when subjected to a certain environmental condition, such as non-physiologic pH, temperature, ionic strength or external stimulus” showing that changes in size and shape and contact points is able to be conducted),
the position and the size of the plurality of contact points provided to the recessed portion of the second orthodontic mouthpiece are different from the position and the size of the plurality of contact points provided to the recessed portion of another the first orthodontic mouthpiece (at least capable of being used in the claimed manner; note that this sets forth an intended use of the device and even if the prior art does not explicitly disclose the claimed steps, the disclosed devices are capable of being used as claimed; note that once the teeth are moved using the first appliance, the second appliance will fit differently and result in different contact points; also see paragraph 0050: “Additionally, the elastic appliance 105 and/or the attachment device 100 may change in shape, stiffness or orientation to implement such anchoring. These changes may be the result of state changes of one or more layers of the material when subjected to a certain environmental condition, such as non-physiologic pH, temperature, ionic strength or external stimulus” showing that changes in size and shape and contact points is able to be conducted).
Response to Arguments
Applicant's arguments filed 1/5/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the direction and the magnitude of the orthodontic force M can be easily adjusted; possible to precisely and flexibly set the orthodontic forces M) 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).
Applicant’s arguments are directed to methods of use of the claimed structures. The functional recitations of the claimed device claim are not given the same patentable weight as if in the form of a method claim.
In response to applicant's argument that the methods of Phan are not the same as the functional limitations claimed (i.e. after the protruding piece is again caused to be bonded…), a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.]
As set forth above, the devices disclosed by Phan are of a structure that would allow them to be used in the claimed manner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC J ROSEN whose telephone number is (571)270-7855. The examiner can normally be reached Monday-Friday 930am-6pm.
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/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772
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