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 .
Response to Amendment
This action is in response to Applicant’s amendment filed 3/5/26.
Response to Arguments
Applicant's arguments filed 3/5/25 have been fully considered but they are not persuasive and additionally do not address the new grounds of rejection and/or interpretation below necessitated by Applicant’s amendments.
Briefly, the Examiner notes that Applicant argues that the prior art of Jessop does not teach the newly added limitations to the claims, however the Examiner respectfully disagrees in view of the new interpretation below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "126", “215”, “210” and "224" have both been used to designate the structure of the cradle with an enlarged diameter, referred to as a “base”. “apex”, “sublingual buffer” and “a central region” (see Figs. 1-3). It is unclear what the differences are in said structures listed above. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 32-34 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. Regarding claim 32, the claim states that the rear edge is configured to be placed “against the floor of the mouth of the user” which is unsupported by the original disclosure and as such is deemed new matter and must be removed. Specifically, as supported in the original disclosure and the claims, the rear edge is positioned against the lower surface of the tongue and spaced from the floor of the mouth. Deletion is required. Claims 33-34 are rejected based on their dependency on claim 32.
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 29-35, 41-43, 46, and 53 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.
Regarding claims 29-30, the term “sublingual buffer” is indefinite as it is unclear what the structural difference is between the claimed “base” of claim 28 and the sublingual buffer. Based on a review of the original disclosure and figures, the base and sublingual buffer appear to be directed to the same structure and will be interpreted as such. This is further supported by the figures which point to the same structure when describing each term. Clarification is required.
Regarding claim 31, the term “curved engagement surface” is indefinite as it is unclear whether or not the term intends to refer back to the previously recited engagement surface, or another structure. Claim 28 does not require the engagement surface to be curved, and as such it is unclear if the term attempts to further define the engagement surface to be curved. As best understood by the Examiner, the term intends to refer back and further limit the shape of the engagement surface. Clarification is required.
Regarding claims 32 and 41, the term “wherein the rear edge configured to be positioned…against the floor of the mouth of the user” is indefinite as it is unclear how the rear edge would contact the tongue and be positioned against eh floor of the mouth of the user. Further, the original disclosure shows in Figs. 3 and 5, that the rear edge would contact the tongue of the user with the base or buffer contacting the floor of the mouth. As such it is unclear how the rear edge is capable of contacting the floor of the mouth. Clarification is required.
Regarding claims 35 and 46, the claims state that the first and second curved portions are substantially planar to engage the floor of the mouth of the user. However, claims 28 and 40 already recite that the base is planar to do so. Accordingly the claim limitations appear to refer to the structure of the base, arranged on the first and second curved portions and will be interpreted as such. This is supported by Fig. 1d which shows the base, not the curved portions having the planar surfaces. Clarification is required.
Regarding claims 42-43 and 53, the term sublingual buffer is indefinite, as it is unclear what structure the term refers to in light of claim 40 which already recites a base. As best understood by the Examiner and supported by the original figures, the base and buffer appear to be directed to the same structure and will be interpreted as such. Clarification is required.
All other claims not specifically addressed above are rejected based on their dependency on a previously rejected claim.
Claim Rejections - 35 USC § 102
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) 28-29, 31-42, 44-50, and 52-53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jessop et al (US 20160008094 A1).
Regarding claim 50, Jessop discloses a dental retraction device (see Figs. 1-2) configured for placement in a mouth of a user, the dental retraction device comprising: a first arced member (102); a second arced member (104); a right connection (116a) connecting the first arced member and the second arced member; a left connection (116b) connecting the first arced member and the second arced member; and a tongue retractor (128a/b, 129a/b, 124a/b, 126,134) connected to the right connection and the left connection, the tongue retractor configured for placement below a tongue of the user to raise the tongue away from a floor and towards a roof of the mouth of the user (configured to be used as such; user may place the tongue over 134, with 134 pressing on the underside thereof; Examiner notes that entire device and the tongue are flexible and as such are configured for such positioning), the tongue retractor comprising: first and second curved portions (124a/b), the first and second curved portions meeting at an apex (D, below), and engagement surface (134) extending between the first and second curved portion (see Fig. 1), a first side of the engagement surface connected to an elongated side of the first curved portion (at E, below), and a second side of the engagement surface connected to an elongated side of the second curved portion (at F, below; curved surfaces are elongated members), the engagement portion configured to engage an underside of a tongue of a user during use of the device (see above), the engagement surface including a rear edge (see below) connected to the first and second curved portion (e.g. at ends of curved rear edge of 134); and a sublingual buffer (B) disposed on at least a portion of the first and second curved portions (see Figs), the buffered capable of being placed in contact with or adjacent to a lower arch of the user to distribute pressure to a sublingual floor of the user while lifting the tongue of the user from the floor during use (capable of being used as such, see explanation above). For example as Jessop discloses that the device is flexible, and the tongue is repositionable, if the tongue or an instrument and/or fingers are used to depress the buffer to engage the floor of the mouth, then the tongue would be prevented from being placed thereunder.
Regarding claims 52-53, Jessop discloses a tongue retractor (see Figs. 1-2) sized and configured to be positioned below a tongue of a user to position the tongue in an upwardly displaced configuration in which the tongue is disposed towards a top of a mouth of the user (configured to be used as such; user may place the tongue over 134, with 134 pressing on the underside thereof; Examiner notes that entire device and the tongue are flexible and as such are configured for such positioning), the tongue retractor comprising: a first arced member (102); a second arced member (104); a first connection region (116a) where the first arced member and the second arced member are connected; a second connection region (116b) where the first arced member and the second arced member are connected; a transpalatal element (128a/b, 129a/b, 124a/b, 126,134) connected to the first connection region and the second connection region, the transpalatal element including a cradle (124a/b, 134) the cradle comprising: a first curved portion (124a) and a second curved portion (124b), the first and second curved portions connected in a central area (area where 126/134 is located); an engagement surface (upper surface of 134) at least partially disposed between the first curved portion and the second curved portion (see Fig. 2), a first side of the engagement surface connected to an elongated side of the first curved portion and a second side of the engagement surface connected to an elongated side of the second curved portion (e.g. at E and F, below), the engagement surface configured to engage or at least partially contact a lower portion of the tongue of the user when the tongue retractor is being used (e.g. as explained above tongue is configured to be placed on top of 134); a base (B) disposed at least proximate a floor of the mouth of the user during use (configured to be positioned proximate the floor of the mouth); and a rear edge (e.g. rear edge of 134) connected to the first and second curved portions (e.g. where right and left edge of 134 contact 124a/b), the rear edge having an arched shaped configuration (e.g. curving downwards from a central portion of the rear edge, see below), the rear edge disposed at least proximate the floor of the mouth of the user, the rear edge spaced apart from the floor of the mouth of the user by a distance the distance separating the rear edge from the floor of the mouth and configured to prevent the tongue of the user from being placed underneath the transpalatal element (rearmost edge of 134 configured to prevent tongue movement at least to some degree and configured to be spaced apart from floor by a distance separating the rear edge from the floor; see explanation below per claim 28); and further comprising a sublingual buffer (e.g. base, as best understood by the Examiner) connected to at least a portion of the cradle (see Figs. 1-2).
Regarding claims 40-42, and 44-49, Jessop et al discloses a tongue retractor (see Figs. 1-2) configured to be placed below a tongue of a user and against a floor of a mouth of the user (configured to be used as such; user may place the tongue over 134, with 134 pressing on the underside thereof; Examiner notes that entire device and the tongue are flexible and as such are configured for such positioning), the tongue retractor configured to lift the tongue from the floor of the mouth of the user towards a roof of the mouth of the user (configured to be used as such, see above), the tongue retractor comprising: a cradle (128a/b, 129a/b, 124a/b, 126,134) comprising: a first curved member (124a); a second curved member (124b), the curved members extending towards one another to meet at a central region (e.g. where 124a-b, 126 and 134 meet; e.g. D below); a base (B) configured to be disposed within a lower dental arch of the user (configured to be placed in the lower arch), the base configured to contact the floor of the mouth of the user during use of the retractor (configured to be placed as such, see above), at least a portion of the base including a substantially planar bottom surface (e.g. bottom surfaces of base fall in a plane (as seen in Fig. 4) which is engaged with the upper plane of the tongue (as seen in Fig. 5); e.g. bottommost surface of base B lies in a plane which contacts the tongue); and an engagement surface (134) configured to contact a lower surface of the tongue (configured to be positioned as such, see explanation above and below), a first side of the engagement surface connected to an elongated portion of the first curved member and a second side of the engagement surface connected to an elongated portion of the second curved member (e.g. at E and F, below; see explanation above) and a rear edge (e.g. rearmost edge of 134, see below) connected to the first and second curved members (see explanation above), the rear edge having an arched shaped configuration (see below and explanation above), the rear edge is spaced apart from the floor of the mouth of the user by a distance, the distance configured to prevent the tongue of the user from being placed underneath the cradle (e.g. configured to be positioned as such; for example as Jessop discloses that the device is flexible, and the tongue is repositionable, the rear edge of 134 as identified above and below is configured to be placed a distance from the floor of the mouth of the user (for example by depression via the tongue or fingers), the distance separating the rear edge from the floor of the mouth and configured to prevent the tongue from being placed underneath the cradle, for example when the distance is less than the tongue thickness; configured to be placed as such if so desired). Jessop et al further discloses the rear edge is configured to be positioned below the tongue of the user and against the floor of the mouth of the user ( as best understood by the Examiner, the rear edge is placed against the tongue and the base/buffer is placed on the floor of the mouth; configured to be placed as such, see explanation above; per claim 41); further comprising a sublingual buffer (e.g. base, as best understood by the Examiner) disposed along at least a portion of the curved members, (per claim 42); wherein: the first curved member (124a) includes a first end at a first connection region (116a/128a); the second curved member (124b) includes a second end at a second connection region (116b/128b); and the curved members are curved in a first direction (e.g. rearward) relative to the first end and the second end and then curved in an opposing second direction towards the central region (e.g. forwards as 124a/b transition to 126; per claim 44); wherein the first curved member is rotatably flexible at the first connection region and the second curved member is rotatably flexible at the second connection region to allow the cradle to rotate relative to the first connection region and the second connection region (see [0059]; per claim 45); wherein the base is at least partially formed by a portion of the first and second curved members (see below; B is formed by portions of curved members), wherein one or more portions of the first curved member is substantially planar (e.g. a bottom most tangential line of 124a forming a line shaped surface; extends in a plane at least in part); wherein one or more portions of the second curved member is substantially planar (e.g. a bottom most tangential line of 124b forming a line shaped surface; extends in a plane at least in part), wherein the first side of the engagement surface is connected to a substantially planar portion of the first curved member (portion where it is connected has a planar surface); and wherein the second side of the engagement surface is connected to a substantially planar portion of the second curved member (portion where it is connected has a planar surface; base is formed by portions of curved members; per claim 46); wherein the base is at least partially formed by a portion of the first and second curved members (see above); and wherein the engagement surface extends between the central region and the rear edge (see Fig. 1 and area D, below; per claim 47); wherein the first curved member, the second curved member, and the engagement surface are integrally formed as part of a unitary, one- piece structure (see Figs. 1-2; additionally [0072] and [0086]; per claim 48); and wherein the cradle includes an apex (forward most portion of 134/126, for example at D), at least a portion of the cradle curves upwardly between the rear edge and the apex (see Fig. 2; per claim 49).
Regarding claim 28, Jessop et al discloses a dental retraction device (see Figs. 1-2), comprising: a first arced member (102); a second arced member (104); a right connection (116a) connecting the first arced member and the second arced member; a left connection (116b) connecting the first arced member and the second arced member; a cradle (124a/b, 126, 134) connected to the right connection and the left connection, the cradle comprising: a first curved portion (124a); a second curved portion (124b), the first and second curved portions meeting at an apex (e.g. at D); an engagement surface (134) extending between the first and second curved portion (see Fig. 1), a first side of the engagement surface connected to an elongated side of the first curved portion (at E, below), and a second side of the engagement surface connected to an elongated side of the second curved portion (at F, below; curved surfaces are elongated members), the engagement portion configured to engage an underside of a tongue of a user during use of the device (see above), the engagement surface including a rear edge (see below) connected to the first and second curved portion (e.g. at ends of curved rear edge of 134), the rear edge having an arched shaped configuration (see below and explanation above); and a base (B) configured to be disposed within a lower dental arch of a user during use (configured to be used as such, see below), the base configured to contact and distribute pressure to a floor of a mouth of the user when a tongue of the user is being lifted away from the floor by the cradle (see explanation below; when in contact pressure is configured to be distributed via said contact), the base including a substantially planar bottom surface at least partially disposed between the apex (D) of the first and second curved portions and the rear edge (e.g. bottom surfaces of base fall in a plane (as seen in Fig. 4) which is engaged with the upper plane of the tongue (as seen in Fig. 5); e.g. bottommost surface of base B lies in a plane which contacts the tongue). For example as Jessop discloses that the device is flexible, and the tongue is repositionable, the engagement surface as identified above and below is configured to be placed a distance from the floor of the mouth of the user (for example by depression via the tongue or fingers), the distance configured and sized to prevent the tongue from being placed underneath the cradle, for example when the distance is less than the tongue thickness; configured to be placed as such if so desired). Jessop et al further discloses wherein the device further comprises a sublingual buffer (e.g. base, as best understood) located along at least a portion of the cradle (configured to be placed and used as such; see explanation above per claim 29); wherein the curved engagement surface includes a portion that extends between the first curved portion and the second curved portion (see curved surface shape of 134 in Figs. 1-2; per claim 31); wherein the rear edge is configured to be positioned below the tongue of the user and against the floor of the mouth of the user (e.g. the rear edge is configured to be positioned below the tongue and the base is configured to be placed against the floor of the mouth, as best understood by the Examiner; configured to be positioned as claimed, see citations above; per claim 32); wherein the rear edge of the engagement surface extends inwardly towards a central portion of the first curved portion and the second curved portion (e.g. at A, see below; per claim 33); wherein at least a portion of the rear edge of the engagement surface includes a curvature sized and configured to at least partially engage the lower surface of the tongue (rear edge is curved and tongue can be pressed into a shape to correspond therewith; per claim 34); wherein a portion of the first curved portion is substantially planar (e.g. a bottom most tangential line of 124a forming a line shaped surface; extends in a plane at least in part); wherein a portion of the second curved portion is substantially planar (e.g. a bottom most tangential line of 124b forming a line shaped surface; extends in a plane at least in part) wherein the planar portions of the first curved portion and second curved portion are configured to engage the floor of the mouth of the user (e.g. bottom surface of 124a/b is configured to contact the bottom surface of the mouth when the tongue is positioned as explained above per claim 35); wherein the cradle is disposed in an inner volume at least partially defined by the second arced member (at least in part, see Figs. 1-3; per claim 36); wherein the cradle is disposed in an inner volume at least partially defined by the first arced member and the second arced member (at least in part, see Figs. 1-3; per claim 37); further comprising a first flexible region (128a/b) disposed between the first curved portion and the right connection and a second flexible region (129a/b) disposed between the second curved portion and the left connection, the first flexible region and the second flexible region enabling movement of the cradle independent of the first arced member and the second arced member (see [0059]; per claim 38); and wherein at least a portion of the cradle curves upwardly between the lower/rear edge and the apex (see curvature of 134, Figs. 1-3; per claim 39).
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Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 30, 43, and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Jessop et al.
Regarding claims 30, 43 and 51, Jessop et al teaches a sublingual buffer (as explained above) but does not teach wherein the thickness thereof is greater than a thickness of remaining portions of the curved portions as required. However, the Examiner notes that such modification would merely involve a change of size of a known components of the device, which has been held to be within the skill of the ordinary artisan. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the sublingual buffer of the device of Jessop to be larger than portions of 124a/b, as such modification would merely involve a change in size of a known component of the device which has been held to be within the skill of the ordinary artisan (see MPEP (IV)(A)).
Conclusion
THIS ACTION IS MADE FINAL. 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 EDWARD MORAN whose telephone number is (571)270-5349. The examiner can normally be reached Monday-Friday 7 AM-4 PM EST.
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, Eric Rosen can be reached at 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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/EDWARD MORAN/Primary Examiner, Art Unit 3772
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