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’s filed 3/11/26.
All previous claim interpretation under 35 USC 112, F are maintained herein.
Additionally, the amendments to the specification filed 3/11/26 have been entered.
Response to Arguments
Applicant's arguments filed 3/11/26 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, regarding Applicant’s arguments against Mommaerts, the Examiner notes that language added to the claims regarding the term “without being fixed into the maxillary bone” is functional language. The Examiner asserts that the device of Mommaerts could be used without fixing to the maxillary bone if so desired, for example by only securing the device to the zygoma, if so desired. Further, as explained below, the interpreted elongate element (9) is not fixed to the maxilla, but is instead connected to structure that is interpreted as the zygomatic fixation part, meeting the limitations of the claims. The Examiner additionally notes that portion 9 can be separable (initially) from the portion 8 (see citations below). Regarding Applicant’s arguments to the argued structure of a “zygomatic implant” being distinct from the device of Mommaerts, the Examiner notes that the term itself does not provide distinction between the implants. Further, no structural limitations are present which would exclude the device of Mommaerts from being interpreted as a zygomatic implant, as it is capable of being secured only to the zygoma. Additionally, the Examiner notes that there are no reasons in the claims why structure 8 of Mommaerts (as explained below) cannot be interpreted as an “end” of the zygomatic fixation part (as identified below). Still further, there are no structural components in the claim which would exclude the Examiner’s interpretation of the “zygomatic fixation part” as explained below. Applicant’s arguments against Mommaerts appear to be based on Applicant’s own interpretation of the prior art, and not the relied on interpretation as explained below. Therefore, Applicant’s arguments have been fully considered but respectfully are not persuasive and additionally do not address the new grounds of rejection and/or interpretation below necessitated by Applicant’s amendments.
In order to move the Application forward, the Examiner suggests Application a) add more structure regarding the zygomatic fixation part and/or maxillary part and elongate element (for example where the elongate element is connected to the maxillary part in regards to the anatomy) and/or b) recite that the elongate element extends along the jugal face of the maxillary bone, or the like.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the convex internal face with at least one relief projecting with respect to said internal face must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Objections
Claim 1 is objected to because of the following informalities: there is an apostrophe following the period at the end of the claim. Appropriate correction is required.
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.
Claims 10-11 and 13 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 claim 10, the term “wherein one end of the at least one fixation means is intended to be fixed in the at least one fixation means” is indefinite as it is unclear how the fixation means is fixed to itself. As best understood by the Examiner the term should read “wherein one end of the elongate element is intended to be fixed in the at least one fixation means” and will be interpreted as such. Clarification is required.
Claims 11 and 13 are rejected based on their dependency on claim 10.
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.
Claim(s) 1, 3-4, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Mommaerts (US 2018/0161129 A1) in view of Strauss (US 5201736).
Regarding the above claims Mommaerts discloses a zygomatic implant (Fig. 6a or C for example), for supporting a dental prosthesis (capable of being used as such as shown in Fig, 6c) and for being fixed only to the jugal face of the zygomatic bone of a patient (capable of being used as such as a device with one or more extensions adapted to be attached to the zygomatic bone at [0054] and that the specific location and arrangement of such extensions is customized for the particular patient (see [0121]-[0123]), this implant comprising: a zygomatic fixation part (11a/b/2/8) arranged to be fixed to the jugal face of the zygomatic bone of a patient (via 11a/b), forming a plate, (see Figs. 6a, c for example), in which there is defined at least one fixation opening (13) which extends through the plate and which is configured to receive a fixation element (e.g. screw, not positively recited, required or part of claimed implant) so as to fix the plate to the jugal face of the zygomatic bone of a patient (see [0102]-[0105]), said plate having an end portion (8) spaced apart from the at least one fixation opening (see Figs); a maxillary part comprising at least one elongate element (9) wherein one end of which is connected to the end portion of the zygomatic fixation part (via 8), and the other end of which is free and is intended to be connected to a connection interface with said dental prosthesis (e.g. opposite free end, see Fig. 6c and 5b), said at least one elongate element, when the zygomatic fixation part is fixed to the jugal face of the zygomatic bone of a patient, facing the jugal face of the maxillary bone of the patient without being fixed into said maxillary bone (e.g. 9 is not fixed to the bone and the end of 9 connected to 8 faces and/or points to the maxillary bone, including the jugal face, at least in part; additionally, the specific angulation of 9 (and 8) is variable based on a particular patient and as such 9 is capable of being arranged to be more or less facing the jugal face of the maxillary bone, dependent on a particular patient; see Fig. 6c). See also [0018], [0027], [0028], and abstract).
Mommaerts further discloses wherein the implant is made in at least two independent parts, wherein the zygomatic part (at 8) defines at least one fixation means for the at least one elongate element (e.g. where elongate element 9 and part 8 are joined; see [0100]; per claim 3); wherein the plate comprises a single fixation opening (e.g. a single extension with a single opening is within the scope of the custom implant of Mommaerts as disclosed in [[0027] and [0054]; per claim 4); wherein the plate comprises at least two fixation openings (see Fig. 6a,c, for example; per claim 6); and wherein the zygomatic part is pre-operatively pre-formed in order to correspond to the external shape of the zygomatic bone of the patient (see citations above and [0027]-[0028], [0121]-[0123]; per claim 8).
Mommaerts, however, does not explicitly teach wherein the zygomatic fixation part has a cross section concave towards the zygomatic bone as required.
Strauss, however, teaches a similar zygomatic implant with a zygomatic fixation part (see Figs. 6-7 and col 4, lines 22-40; 14) which has a cross section concave towards the zygomatic bone (see Fig. 7) and is curved having the concave inner face and a convex external face (see Fig. 7). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Mommaerts to include Strauss’ concave/convex arrangement of the zygomatic fixation part, as such modification would provide a closer anatomical fit of the fixation part, batter matching the contours of the human face and cheek bones.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mommaerts et al in view of Strauss, as combined above, further in view of Lodde (FR 2631813, as evidenced by its Machine Translation).
Regarding claim 5, Mommaerts/Strauss, teaches wherein the zygomatic fixation part is curved and has a concave internal face intended to be in contact with the jugal face of the zygomatic bone and a convex external face intended to be in contact with the soft tissues of the cheek (see above), but does not teach wherein the internal concave face has at least one relief projecting with respect to the internal face as required.
Lodde, however, teaches a similar dental implant which has at least one relief (7) projecting with respect to the inner face (see Fig. 1). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the concave inner face of Mommaerts/Strauss to include Lodde’s at least one relief, as such modification would aid in stabilize the implant and distribute forces (see Lodde, 8th to last paragraph).
Claim(s) 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Mommaerts et al in view of Strauss, as combined above, further in view of Waizenegger et al (US 2020/0261189 A1).
Regarding claims 7 and 9, Mommaerts/Strauss discloses wherein the maxillary part comprises at least two elongate elements (9, see Fig. 6a, c), but does not teach wherein the elongate elements form an acute angle between them or wherein the elongate element is preoperatively pre-formed in order to correspond to the shape and dimensions of the jugal face of the maxillary bone of the patient as required.
Waizenegger et al, however, teaches a similar dental implant, comprising a maxillary part comprising at least two elongate elements (4) wherein the elongate elements form an acute angle between them (see Fig. 8 and also Figs. 6-7), and wherein the elongate element is pre-operatively pre-formed in order to correspond to the shape and dimensions of the jugal face of the maxillary bone of the patient (e.g. elongate elements are designed to correspond to the shape and dimensions of the jugal face in order to achieve the desired design, see [0056], [0103], [0023]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Mommaerts/Strauss to include Waizenegger’s acute angle between elongate elements and custom shape/size/arrangement of the elongate elements, as such modification would allow for optimum positioning of the final prosthesis and support thereof based on a particular patient (see Waizenegger, citations above).
Claim(s) 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Mommaerts et al in view of Strauss and in view of Robichaud (US 2018/0289454 A1).
Regarding claim 10, Mommaerts discloses a kit for producing a zygomatic implant (e.g. comprising the separate components as described at [0100], prior to joining, see Fig. 6a, c), intended to receive a dental prosthesis (capable of being used as such as shown in Fig, 6c) and to be fixed only to the jugal face of the zygomatic bone of a patient (capable of being used as such as a device with one or more extensions adapted to be attached to the zygomatic bone at [0054] and that the specific location and arrangement of such extensions is customized for the particular patient (see [0121]-[0123]), comprising: a zygomatic fixation part (11a/b/2/8) arranged to be fixed to the jugal face of the zygomatic bone of a patient (via 11a/b), forming a plate, (see Figs. 6a, c for example), in which there is defined at least one fixation opening (13) which extends through the plate and which is configured to receive a fixation element (e.g. screw, not positively recited, required or part of claimed implant) so as to fix the plate to the jugal face of the zygomatic bone of a patient (see [0102]-[0105]), said plate having an end portion (8) spaced apart from the at least one fixation opening (see Figs), and defining at least one fixation means for an elongate element (where elongate element 9 and part 8 are joined; see [0100]) in which said elongate element can be fixed (see [0100]); at least one elongate element (9) adapted to the at least one fixation means (in order to be connected thereto, see explanation above in regards to claim 3 above) wherein one end of which is connected to the fixation means of the zygomatic fixation part (via 8), and the other end of which is free and is intended to be connected to a connection interface with said dental prosthesis (e.g. opposite free end, see Fig. 6c and 5b), said at least one elongate element, when the zygomatic fixation part is fixed to the jugal face of the zygomatic bone of a patient, facing the jugal face of the maxillary bone of the patient without being fixed into said maxillary bone (e.g. 9 is not fixed to the bone and the end of 9 connected to 8 faces and/or points to the maxillary bone, including the jugal face, at least in part; additionally, the specific angulation of 9 (and 8) is variable based on a particular patient and as such 9 is capable of being arranged to be more or less facing the jugal face of the maxillary bone, dependent on a particular patient; see Fig. 6c). See also [0018], [0027], [0028], and abstract). Mommaerts further discloses wherein the zygomatic part is pre-operatively pre-formed in order to correspond to the external shape of the zygomatic bone of the patient (see citations above and [0027]-[0028], [0121]-[0123]; per claim 11).
Mommaerts, however, does not explicitly teach wherein the zygomatic fixation part has a cross section concave towards the zygomatic bone, or wherein the elongate element and the zygomatic part are removably fixed as required.
Strauss, however, teaches a similar zygomatic implant with a zygomatic fixation part (see Figs. 6-7 and col 4, lines 22-40; 14) which has a cross section concave towards the zygomatic bone (see Fig. 7) and is curved having the concave inner face and a convex external face (see Fig. 7). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Mommaerts to include Strauss’ concave/convex arrangement of the zygomatic fixation part, as such modification would provide a closer anatomical fit of the fixation part, batter matching the contours of the human face and cheek bones.
Robichaud, however, teaches a similar dental implant (Fig. 14a-b) with a base part (Fig. 14a) having a fixation means (180/184) and an elongate element (Fig. 14b) which are removably fixed (see [0213]; e.g. adhesive connection between components can be dissolved or fractured to remove; additionally, prior to cementing together the components are removably fixed). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Mommaerts/Strauss to include Robichaud’s removable fixation between a base and elongate element, as such modification would allow for repair and/or replacement of the elongate element as needed.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Mommaerts et al in view of Strauss in view of Robichaud, further in view of Waizenegger et al.
Regarding claim 13, Mommaerts/Strauss/Robichaud, as combined above, does not teach wherein the elongate element is preoperatively pre-formed in order to correspond to the shape and dimensions of the jugal face of the bone of the patient as required.
Waizenegger et al, however, teaches a similar dental implant, comprising a maxillary part comprising at least two elongate elements (4) (see Fig. 8 and also Figs. 6-7), wherein the elongate element is pre-operatively pre-formed in order to correspond to the shape and dimensions of the jugal face of the maxillary bone of the patient (e.g. elongate elements are designed to correspond to the shape and dimensions of the jugal face in order to achieve the desired design, see [0056], [0103], [0023]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Mommaerts/Strauss/Robichaud, as combined above, to include Waizenegger’s custom shape/size/arrangement of the elongate elements, as such modification would allow for optimum positioning of the final prosthesis and support thereof based on a particular patient (see Waizenegger, citations above).
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.
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/EDWARD MORAN/Primary Examiner, Art Unit 3772
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