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 Objections
Claim 15 is objected to because of the following informalities: On lines 2-3 of the claim “the second connecting member” is believed to be in error for -a connecting member-. Appropriate correction is required.
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.
Claims 1-8 and 10-19 are 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). The limitation including “the remaining member is secured between an outer gum surrounding lower teeth of the user’s mouth and a lower lip of the use’s mouth” claims the human anatomy. It is suggested that the applicant amend the claim to functorially claimed how the device is to be placed in the mouth. For example, -the remaining member is configured to be secured- in order to overcome the rejection.
The same issue applies to claim 16 and it is suggested that the applicant amend the claim in the same manner. For example -the arc-shaped supporting member and the remaining member is configured to sandwich a lower tooth inside of the user’s mouth therebetween- in order to overcome the rejection.
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.
Claims 1-8 and 10-19 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. Claim 1 has been amended to include the limitation of “the remaining member being secured between an outer gum surrounding lower teeth of the user’s mouth and a lower lip of a user’s mouth without either contacting outer surfaces of the user’s lower teeth, or being bitten by the user’s upper teeth on the intra-buccal mounting device”. It is noted that support for the remaining member not contacting outer surface of the user’s lower teeth is not provided in the originally filed application. It is noted that support cannot be found in the figures or the specification. While the applicant does have support for securing it between an outer gum of a lower tooth and a lower lip, specific support for it NOT contacting the outer surface of the teeth is not provided.
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.
Claims 2 and 17 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.
With respect to claim 2, it is noted that the applicant has amended claim 1 to include the limitation of the remaining member, which comprises the retaining members, being configured to be placed in the user’s mouth, therefore the limitation of the curved shaped retaining members configured to be placed inside the mouth is unclear as to how it is it further limiting the limitation of claim 1.
The limitation of “the intra-buccal mounting device is secured on the elongated holding member and is displaced outside the user’s mouth” is unclear. It is noted that the claims are directed to “An intra-buccal mounting device” which comprises the claimed remaining member and elongated holding member. Therefore, it is unclear how the entire device, including the elongated holding member is secured to the elongated holding member and further what is displaced outside the mouth. It is noted that due to the applicant claiming the remaining member being secured in the mouth in the independent claim, the limitation is being interpreted as the elongated holding member being displaced outside the mouth when the device is in use, however, the applicant should amend the claims to clarify what is being claimed.
Claim Rejections - 35 USC § 102
(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) 1-8 and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DE 202020002528.
DE discloses with respect to claim 1, an intra-buccal mounting device for holding a device outside a user's mouth (such that a device, sensor can be connected to element 3, see par. 22, lines 226-228 of translation), comprising a remaining member 1/2 and an elongated holding member 5/3 integrally extended from the remaining member 1/2 (see fig. 3); wherein the remaining member comprises a first curve-shaped retaining member outwardly extended from the elongated holding member and a second curved-shaped retaining member outwardly extended from the elongated holding member (see figs. 2-3, annotated figure below), wherein the remaining member is configured to be secured between an outer gum surrounding lower teeth of the user’s mouth and a lower lip of the user’s mouth without either contacting outer surface of the user’s lower teeth, or being bitten by the user’s upper teeth on the intra-buccal mounting device (pars. 8, 10, 21). It is noted that the limitations are functional, such that the device is capable of being placed in the mouth as claimed, specifically since the limitations are claimed in the alternative and only 1 of them is required. It is noted that the device, when placed in the mouth will not be bitten by the user’s upper teeth as the device does not extend over any occlusal surfaces. Further the device is capable of being placed in the mouth so that it does not contact outer surfaces of the teeth. Such that it can be placed on the gum rather than the teeth. Therefore, since the structure is capable of functioning as claimed all the claimed limitations are met.
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With respect to claim 2, DE further discloses wherein the first curve-shaped retaining member and the second curve-shaped retaining member are configured to be placed inside the user's mouth, and the elongated holding member is configured to be placed outside the user's mouth (see fig. 5).
With respect to claim 3, DE further discloses, wherein the elongated holding member comprises a protruded holding member 3, and an exhaust member (portion of element 5) integrally extended from the protruded holding member and formed between the protruded holding member and the retaining member 1 (see figs. 2-3).
With respect to claim 4, DE further discloses, wherein the exhaust member is placed inside the user's mouth (see fig. 5, par. 22, lines 226-228, the exhaust member is the portion of element that extends from the retaining member in the mouth and extends outside the mouth, such that it is inside the mouth, the portion outside the mouth is the holding member)
With respect to claim 5, DE discloses, the first curve-shaped retaining member and the second curve-shaped retaining member are integrally extended from a front portion of the elongated holding member towards a direction, and the elongated holding member is integrally extended from the front portion towards an opposite direction (see figs. 2-3, pars. 13, par. 16, ll. 141-142, par. 22, ll. 218-220).
With respect to claim 6, DE discloses, wherein the elongated holding member is extended towards the opposite direction to form a free end (see annotated figure below, such that the arrows show the extension direction being in opposite directions).
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With respect to claim 7, DE discloses wherein the remaining member and the elongated holding member form a one-piece configuration (see figs. 2-3, pars. 13, par. 16, ll. 141-142, par. 22, ll. 218-220).
With respect to claim 8, DE discloses the remaining member comprises an upper peripheral edge and a lower peripheral edge, wherein the elongated holding member is integrally extended from the upper peripheral edge, and the lower peripheral edge is located on an opposite side of the upper peripheral edge (see annotated figure below, see figs. 2-3, pars. 13, par. 16, ll. 141-142, par. 22, ll. 218-220).
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With respect to claim 17, DE further discloses, wherein the elongated holding member of the intra-buccal mounting device is displaced outside the user’s mouth when in use (see fig. 5).
With respect to claim 18, DE further discloses, wherein the first curve-shaped retaining member is symmetrical to the second curve-shaped retaining member with respect to a central line of the elongated holding member (see figs. 2-3).
Claim(s) 1-7 and 10-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heo (KR 20080094279).
Heo discloses with respect to claim 1, an intra-buccal mounting device 200 for holding a device outside a user's mouth (see figs. 2-3, such that it holds device 253 outside the mouth), comprising a remaining member 402 and an elongated holding member 251/252 integrally extended from the remaining member 402 (see figs. 2-3, pg. 14 of translation, Second full paragraph “Next, the ends of the support members (151, 251) of the marker members (152, 251) are attached to the outer central portions of the resin patter”, such that they are attached to form an integral structure); wherein the remaining member comprises a first curve-shaped retaining member outwardly extended from the elongated holding member and a second curved-shaped retaining member outwardly extended from the elongated holding member (see annotated figure below), wherein the remaining member is configured to be secured between an outer gum surrounding lower teeth of the user mouth and a lower lip for the user’s mouth, without either contacting outer surfaced of the users lower teeth or being bitten by the upper teeth on the intra-buccal mounting device (see figs. 2-3, see page 5, fourth paragraph of translation, pg. 9, second full paragraph of translation. “or may be formed to cover only a part of the gums without covering the teeth”).
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With respect to claim 2, Heo further discloses wherein the first curve-shaped retaining member and the second curve-shaped retaining member are configured to be placed inside the user's mouth (see annotated figure above, fig. 3), and the elongated holding member is configured to be placed outside the user's mouth (fig. 3).
With respect to claim 3, Heo further discloses wherein the elongated holding member comprises a protruded holding member, and an exhaust member integrally extended from the protruded holding member and formed between the protruded holding member and the retaining member (see annotated figure below, such that the exhaust member is the portion extending from the remaining member to the curved portion).
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With respect to claim 4, Heo further discloses wherein the exhaust member is configured to be placed inside the user's mouth (such that exhaust member extends from the gum towards the lip when placed in the mouth which is inside the user’s mouth, the protruding member comprises the curved region to the distal end which extends over the lip and outside the mouth).
With respect to claim 5, Heo discloses the first curve-shaped retaining member and the second curve-shaped retaining member are integrally extended from a front portion of the elongated holding member towards a direction, and the elongated holding member is integrally extended from the front portion towards an opposite direction (see annotated figure).
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With respect to claim 6, Heo discloses, wherein the elongated holding member is extended towards the opposite direction to form a free end (see annotated figure above).
With respect to claim 7, Heo discloses, wherein the remaining member and the elongated holding member form a one-piece configuration (see fig. 2).
With respect to claim 8, Heo discloses, wherein the remaining member comprises an upper peripheral edge and a lower peripheral edge, wherein the elongated holding member is integrally extended from the upper peripheral edge, and the lower peripheral edge is located on an opposite side of the upper peripheral edge (see annaoted figure below).
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With respect to claim 10, Heo discloses the intra-buccal mounting device further comprising a hanger 401/403 connected with the retaining member and configured to hook on a lower tooth of the user's mouth (see figs. 2-3, such that elements 403 are configured to hook on a lower tooth).
With respect to claim 11, Heo discloses the intra-buccal mounting device further comprising a hanger 401/403 comprising an arc-shaped supporting member 401 configured to contact with an inner gum of a lower tooth in the user's mouth and a pair of connecting members 403 connected to the retaining member (see fig. 2, page 12, first paragraph of translation, see page 9, second full paragraph of translation regarding the arch member contacting the inner gum, see fig. 3).
With respect to claim 12, Heo discloses the intra-buccal mounting device further comprising a hanger 401/403 comprising a pair of connecting members 403 having a first connecting member and a second connecting member (see fig. 2, such that it has two connecting member 403), wherein the first connecting member is connected to the first curve-shaped retaining member and the second connecting member is connected to the second curved-shaped retaining member (see annotated figure below).
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With respect to claim 13, Heo discloses the intra-buccal mounting device further comprising a hanger 401/403 comprising an arc-shaped supporting member 401, a first connecting member 403 integrally extended from one edge of the arc-shaped supporting member, and a second connecting member 403 integrally extended from an opposite edge of the arc-shaped supporting member (see annotated figure above).
With respect to claim 14, Heo discloses wherein the arch shaped supporting member 401 comprises a top peripheral edge and a bottom peripheral edge, wherein the first connecting member is integrally extended from the bottom peripheral edge to from a first receiving cavity and the second connecting member is integrally extends from the bottom peripheral edge to from a second receiving cavity, wherein the one edge and the opposite edge of the arch shaped supporting member are integrally extended from the bottom peripheral edge of the arch shaped supporting member (see annotated figure below, such that both of the claimed edges are integral with the arc-shaped member).
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With respect to claim 15, Heo discloses the intra-buccal mounting device further comprising a hanger 401/403 connected to the first curve-shaped retaining member and the second connecting member to form a slot (see annotated figure below).
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With respect to claim 16, Heo discloses the intra-buccal mounting device further comprising a hanger 401/403 comprising an arc-shaped supporting member 401, wherein the arc-shaped supporting member and the retaining member (see fig. 3).
With respect to claim 17, Heo discloses the elongated holding member of the intra-buccal mounting device is displaced outside the user’s mouth (see fig. 3).
With respect to claim 18, Heo discloses wherein the first curve-shaped retaining member is symmetrical to the second curve-shaped retaining member with respect to a central line of the elongated holding member (see fig. 2, annotated figures above).
With respect to claim 19, Heo discloses the intra-buccal mounting device further comprising a hanger 401/403 comprising an arc-shaped supporting member 401 having a middle portion inwardly extended towards a front portion of the elongated holding member (see annotated figure, such that the front portion is inwardly extended relative to the opposite ends of the arc-shaped supporting member).
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Response to Arguments
Applicant’s arguments with respect to the claim(s) 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 August 20, 2025 have been fully considered but they are not persuasive. The applicant argues that the prior art of DE528 does not teach the limitations including “wherein the remaining member is configured to be secured between an outer gum surrounding lower teeth of the user mouth and a lower lip for the user’s mouth, without either contacting outer surfaced of the users’ lower teeth or being bitten by the upper teeth on the intra-buccal mounting device”. However, it is noted that first the limitations are claimed in the alternative, such that only one of them has to be satisfied in order to meet the claimed limitations. In this case, DE528 teaches that the retaining member is configured such that it is not bitten by the upper teeth as seen in the figures, such that it does not have any surfaces which extend over the occlusal surfaces of the teeth.
Second, the limitations are functional and if the prior art is capable of functioning as claimed then the limitations are met. In this case, the device of DE528 is capable of being placed in the mouth so that it does not contact the teeth as claimed. Such that it is capable of being inserted lower in the mouth so that it is contacting the gingival tissue and not the teeth when installed. It is noted that the application is not modified to teach this limitation, since it is capable of functioning as claimed and therefore, the art does not teach away from what is being claimed. It is noted that the applicant is claiming the device and NOT the method of using. Since the prior art of DE528 is capable of functioning as claimed, it is noted that the claimed limitations are met and therefore, the applicant’s arguments are moot.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEIDI MARIE EIDE whose telephone number is (571)270-3081. The examiner can normally be reached Mon-Fri 9:00-4:00.
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/HEIDI M EIDE/Primary Examiner, Art Unit 3772 6/6/2025