DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/11/2026 has been entered.
Response to Arguments
3. Applicant’s arguments regarding the amendment filed 03/11/2026 have been fully considered. Claims 1-10, 12-14, and 19-22, are allowable as indicated herein.
The amendment to claim 23 fails to overcome Kopelman et al. and also raise new issues which are rejected under 35 USC 101, 35 USC 112(a), and 35 USC 112(b). Claims 15-18 and 23 are rejected as detailed herein below. Applicant’s remarks are held to be responded to in the grounds of rejection as detailed herein below.
Allowable Subject Matter
4. Claims 1-10, 12-14, and 19-22, are allowed.
Claim Rejections - 35 USC § 101
5. 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.
6. Claims 23 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 23 recites “an attachment secured to a patient’s tooth” (lines 7-8), which is attempting to claim the invention in combination with human anatomy, i.e. “a patient’s tooth”. (see In re Rohrbacher, 128 USPQ 117 (CCPA 1960)). Claims that are directed to or include within their scope a human being are not considered patentable subject matter under 35 U.S.C. 101 since the grant of a limited, but exclusive property right in a human being is prohibited by the constitution. See 1077 OG 24 (April 21, 1987).
Applicant is suggested to recite the underlined language as intended use or functional claim language, e.g. "adapted to be secured to a patient’s tooth”, “configured for attaching to a patient’s tooth", etc., in order to avoid positively reciting/claiming the human anatomy.
Claim Rejections - 35 USC § 112(a)
7. 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.
8. Claims 15-18 and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
For reference, the application’s Drawings Figs. 6, 7A, and 7C, are reproduced herein:
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For reference, the application’s Written Description paragraph [0057] is reproduced herein (emphasis added):
[0057] In the exemplary embodiment shown, the window 50 is defined by a through-thickness surface or wall 64 that intersects or connects an outer surface 70 and an inner surface 78 of the integral hook 22. In the example shown in FIG. 7A, the opposing through wall portions 64a, 64b of the wall 64 trace a mouth-shaped configuration with a largest distance between opposing lingual 64a and labial portions 64b of the through wall 64 being at the occlusal wall 60. The mouth-shaped configuration is concave with respect to the labial portion 42. This largest distance defines a width of an opening 68 for the window 50 at the occlusal wall 60. Around the perimeter of the integral hook 22, the through wall 64 extends from the mesial wall 56 to the distal wall 58 over the occlusal wall 60. In essence, the through wall 64 is in three of four sides of the integral hook 22. The through wall 64 extends around each of the mesial wall 56 and the distal wall 58 toward the gingival wall 62 to a gingival-most end 66. A distance between opposing lingual and labial through-wall portions 64a, 64b gradually decreases toward each of the ends 66 of the through wall 64 along each wall 56, 58, respectively. In the example, there is one end 66 at one or both the mesial wall 56 and the distal wall 58. The ends 66 represent the furthest distance that the window 50 extends along the mesial wall 56 and along the distal wall 58. At each end 66, the lingual and labial wall portions 64a, 64b meet or merge.
Claim 23 recites in lines 16-20:
“the through-thickness wall has opposing through-thickness wall portions that extend from a first end to a second end,
wherein the first end is on a first side of the outer wall and the second end is on a second opposing side of the outer wall”
In light of the specification, such recitations are interpreted that the through-thickness wall 64 has opposing through-thickness wall portions 64a, 64b that extend horizontally from a first end 56 to a second end 58, the first end being on the mesial side wall 56 and the second end 58 being on the opposing distal side wall 58. See Fig. 6, [0057] “the through wall 64 extends from the mesial wall 56 to the distal wall 58 over the occlusal wall 60. In essence, the through wall 64 is in three of four sides of the integral hook 22”.
Claim 23 further recites in lines 25-30:
“wherein the opposing wall portions are spaced apart by a distance
(i) that is constant from the first end to the second end, or
(ii) that increases from the first end to a maximum width between the first end and the second end and decreases from the maximum width to the second end in the absence of the attachment and in the absence of the elastic band”
Such recitations do not have support from the originally filed disclosure and therefore are considered to be new matter.
Note that the original disclosure does not describe a distance that is constant or increases from the first end to the second end horizontally (mesial-distal) from first side mesial end 56 to second side distal end 58. Instead, the original disclosure describes the distance between the wall portions 64a, 64b in term of their extending vertically (occlusal-gingival) from occlusal opening 68 to gingival end 66. See Figs. 7A and 7C, [0057] “The through wall 64 extends around each of the mesial wall 56 and the distal wall 58 toward the gingival wall 62 to a gingival-most end 66. A distance between opposing lingual and labial through-wall portions 64a, 64b gradually decreases toward each of the ends 66 of the through wall 64 along each wall 56, 58, respectively”.
Furthermore, note that the original disclosure does not describe an increases from the first end to a maximum width. Instead, the original disclosure describes a maximum width at the opening and decreases toward end 66. There is no increase to a maximum width as claimed. See Figs. 7A and 7C, [0057] “This largest distance defines a width of an opening 68 for the window 50 at the occlusal wall 60… A distance between opposing lingual and labial through-wall portions 64a, 64b gradually decreases toward each of the ends 66…”
All dependent claims are rejected herein based on dependency on the rejected base claim.
Claim Rejections - 35 USC § 112(b)
9. 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.
10. Claims 15-18 and 23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23 recites in the preamble “A system for orthodontic treatment including an attachment secured to a patient’s tooth and an elastic band for contact with the attachment” (lines 1-2). Note that since the limitations “an attachment” and “an elastic band” are recited in the preamble as parts of an orthodontic treatment, they are not considered to be positively claimed elements of the claimed system.
Claim 23 then recites “an orthodontic aligner for orthodontic treatment of a patient’s teeth” (line 3, emphasis added), which is indefinite because it is unclear whether the underlined features are the same or different from the similar recitations “orthodontic treatment… a patient’s tooth” in the preamble.
Claim 23 further recites “in the absence of the attachment and in the absence of the elastic band” (lines 29-30), which is indefinite because it is unclear how or when the attachment and the elastic band are present or absent in the system. There appears to be an omission of structural cooperative connection(s) of the attachment and the elastic band with the claimed system. Note that the base claim 23 has been amended to delete “
Likewise, claim 15 recites “wherein the attachment does not fill the interior space of the integral hook..” (lines 1-2), which is indefinite because it is unclear what is the structural cooperative connection between the attachment and the integral hook.
Claim 23 recites “the through-thickness wall has opposing through-thickness wall portions that extend from a first end to a second end, wherein the first end is on a first side of the outer wall and the second end is on a second opposing side of the outer wall” (lines 16-20)
Claim 15 recites “the side wall” (line 3) which lacks antecedent basis. Note that the base claim 23 has been amended to no longer recite a side wall.
Claim 16 recites “a through wall that intersects an outer surface and an inner surface of the side wall and the through wall has opposing portions…” (lines 1-3), which is indefinite because it appears to repeat some elements already defined in the base claim 23 “a through-thickness wall that intersects the outer surface and the inner surface… has opposing through-thickness wall portions” (claim 23 lines 13-17). Are the elements in claim 16 the same as, different from, or part of, the similarly recited limitations in claim 23?
Likewise, claim 17 recites “a through wall…” (lines 1-3), which is indefinite because it appears to repeat some elements already defined in the base claim 23 lines 13-17. Are the elements in claim 17 the same as, different from, or part of, the similarly recited limitations in claim 23?
Claim 16 recites “the through wall has opposing portions that define a first width at the opening of the window and that define a second width near an end of the opposing portions of the through wall, the first width being greater than the second width” (lines 3-5), which is indefinite because it appears to contradict the features “a distance (i) that is constant from the first end to the second end, or (ii) that increases from the first end to a maximum width between the first end and the second end and decreases from the maximum width to the second end in the absence of the attachment and in the absence of the elastic band” recited in the base claim 23 (lines 25-30).
Likewise, claim 17 recites “the through wall… the first width being less than the second width” (lines 3-5), which is indefinite because it appears to contradict the corresponding features recited in the base claim 23 (lines 25-30).
Claim 18 recites “the end of the opposing portions” which lacks proper antecedent basis in the claims. Note that claim 23 has been amended to recite “opposing through-thickness wall portions that extend from a first end to a second end” (lines 16-17).
All dependent claims are rejected herein based on dependency on the rejected base claim.
Claim Rejections - 35 USC § 102
11. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
12. Claims 15-18 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kopelman (2015/0216627).
Regarding claim 23, Kopelman discloses a system (Figs. 12A-12B and 15A-15F) for orthodontic treatment comprising: an orthodontic aligner for orthodontic treatment of a patient's teeth, the orthodontic aligner 1206 comprising: a shell 1206 that defines at least one tooth cavity configured to receive at least one of the patient's teeth and an edge that defines an opening through which the at least one tooth cavity receives the at least one of the patient's teeth (Figs. 12A-12B; paragraph [0152]). The shell has wall portions and an integral hook 1204 extends outwardly from one of the wall portions adjacent the at least one tooth cavity and is spaced occlusally apart from the edge (Figs. 12A-12B).
Regarding the newly recited limitations, Kopelman Figs. 12A-12B show the integral hook 1204 has an outer wall 1204/1208 which has an inner surface and an outer surface, the inner surface defining an interior space (receptacle interior 1204) that opens to the at least one tooth cavity, and a through-thickness wall (opening between 1204 and flap 1208) that intersects the outer surface and the inner surface to define a window (opening best pointed to by 1202 in Fig. 12B) in the outer wall 1204/1208, the through-thickness wall (opening 1202) has opposing through-thickness wall portions that extend from a first/upper end 1204 to a second/lower end 1208.
The first/upper end 1204 is on a first upper side of the outer wall 1204/1208 and the second/lower end is on a second, opposing/lower side of the outer wall 1204/1208 (Figs. 12A-12B).
Fig. 14A shows the opposing wall portions are spaced apart by a distance (i) that is constant from the first end to the second end.
Fig. 15D shows the distance (ii) that increases from the first end to a maximum width 1522 (protrusion 1522 makes a maximum width of the window between hook and flap) between the first end and the second end and decreases from the maximum width 1522 to the second/lower end in the absence of the attachment and in the absence of the elastic band.
As to claim 15, Kopelman further discloses the attachment 1574/1580 does not fill the interior space of the integral hook (receptacle/relief 1572/1578) so that an unfilled portion of the interior space between the attachment (at 1580) and the side wall of the integral hook is accessible through the window (Fig. 15; paragraph [0157] “the relief 1578 can be larger than the protrusion 1580, such that the relief 1578 includes sufficient space to accommodate movement of the protrusion 1580 within the relief 1578”). That is, Kopelman discloses the interior space (relief 1578) of the integral hook is larger than the attachment protrusion 1580; therefore, the attachment does not fill the interior space 1578 as claimed.
As to claim 16, the embodiment of Figs. 15A-15F shows the window (defined by protruding receptacle and flap 1572) includes a through wall that intersects an outer surface and an inner surface of the side wall and the through wall has opposing portions that define a first width at the opening (side opening of 1578) of the window and that define a second width (lower end) near an end of the opposing portions of the through wall, the first width (at 1578) being greater than the second width (lower end of window 1578).
As to claim 17, wherein the window includes a through wall that intersects an outer surface and an inner surface of the side wall and the through wall has opposing portions that define a first width at the opening (side opening of 1578) of the window and that define a second width (upper end) near an end of the opposing portions of the through wall, the first width being less than the second width at the upper opening end (see Figs. 15E-15F).
As to claim 18, a depth of the window from the opening 1578 to the end of the opposing portions of the through wall is greater than a distance measured from the opening to a surface of the attachment when the orthodontic aligner is placed on the patient's teeth (Figs. 15E-15F).
Conclusion
13.. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner HAO D. MAI whose telephone number is (571)270-3002. The examiner can normally be reached on Mon-Fri 8:00-4:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached on (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAO D MAI/
Examiner, Art Unit 3772
Prosecution Insights