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 7/2/26.
The amendments to the abstract, specification and drawings filed 7/2/26 have been entered.
Additionally, all previous claim interpretation under 35 USC 112, F is maintained herein.
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 1-19, 21-29 and 31 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 claims 1, 12 and 22, the term “and are not configured for fixation in bone” lacks support in the original disclosure and as such is deemed new matter and must be removed. Specifically, while the original disclosure supports that the lateral extensions do not require any fixation in bone, the original disclosure is silent to the extensions “not being configured for fixation in bone”. In other words there is a difference between “not being required” and specifically “not configured” to be used in bone, the latter implying some structure or configuration that prohibits or stops the extensions from being fixated to bone, and is not supported by the original disclosure. In the instant case, for example, while the extensions may not be required to be fixed by bone, they could be adhered thereto, if so desired, and thereby do not support a disclosure of “not being configured” to be fixation in bone. Deletion is required.
All other claims not specifically addressed above are rejected based on their dependency on a previously rejected claim.
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 1-19, 21-29 and 31 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 1, 12 and 22, the term “do not comprise any orifice configured for positioning of a fixing screw and are not configured for fixation in bone” is indefinite for several reasons. First, the term “do not comprise any orifice configured for positioning of a fixing screw” is indefinite as it is unclear if the term prohibits all orifices or only those configured to receive a fixing screw. For example, it is unclear if a small hole configured to bone ingrowth would be permitted or excluded from the claim. Still further, the term “are not configured for fixation in bone” is indefinite as the term is not supported in the original disclosure and it is unclear what specific structure, if any, is required or specifically prohibited by the term. It is unclear what the meets and bounds of the claim term actually encompass. Further, the term “and whose axes intersect perpendicularly” is indefinite as it is unclear what axes of the extensions the term corresponds too. Specifically, in cross section, the extensions extend both laterally and vertically (see Fig. 1-2) and it is unclear which axes the term corresponds too. Clarification is required.
Regarding claim 2, 13, and 23, the terms “from which extend the flexible elongated lateral extensions, or flexible elongated vestibular lateral extensions”, lack antecedent basis in the claims. Specifically, the claim does not first specify that at least one of the flexible elongated vestibular lateral extensions extend from the vestibular side. Further it is unclear if the “flexible elongated vestibular lateral extensions” intend to refer back to some or all of the flexible elongated lateral extensions. Similarly, the term “the flexible elongated lateral extensions extending from the other half of the central part…. Of flexible elongated palatal lateral extensions” is indefinite for the same reasons. Further, the terms “the practitioner”, “the vestibular side” and “the palatal side” lack antecedent basis in claims 13 and 23. Clarification is required.
Regarding claim 6, and 17, the term “has one or more comprises one or more” is indefinite as it appears a typographical error has occurred. It is unclear which term is intended to be used. Clarification is required.
Regarding claim 29, the term “at least one cover membrane” is indefinite as it is unclear if the term intends to refer back to the previously recited membrane in claim 22, or another membrane. As best understood it is intended to refer back. 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 § 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) 1-4, 7-15, 18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Badih (WO 2019/081059, see attached Machine Translation) in view of Reggie (US 2006/0154205 A1).
Regarding claims 1 and 12, Badih discloses a bone regeneration system (see Figs. 1-4; and device (per claim 1); see below) for a bone defect site in a jaw bone of a patient with a bone regeneration substitute allowing the filling of said bone defect (capable of being used as such), which comprises: 1. at least one anchor foot (3) suitable for endosteal installation in the jaw bone (capable of being used as such)); 2. at least one device (5) configured to ensure the maintenance of a bone regeneration substitute over a bone defect in a jaw bone of a patient (configured of being used as such) comprising: a. at least one external pillar (4) configured to be fixed in the anchor foot (via screw 12), which external pillar (4) comprises anti-rotational means (4a2) making it possible to inhibit/resisting the relative movements of the external pillar (4) relative to the anchor foot (3) once the external pillar (4) is placed in the anchor foot (3); and b. at least one cover piece (6/7) disposed above the at least one external pillar (at least in part), which is placed on the bone regeneration substitute (capable of being used as such) and, optionally, on a cover membrane (the Examiner choses to not include the cover membrane; e.g. optional), so as to delimit the volume of bone regeneration at said bone defect site in combination with said bone regeneration substitute (capable of being used as such) and, optionally, said cover membrane (not required, see above)), which cover piece (6/7) forms a single piece with the external pillar (see Fig. 1) and comprises/presents: i. a central part (6), extending from and positioned above the external pillar (4), and ii. at least two flexible elongated lateral extensions (7/7V/7P) extending from this i) central part, and whose axes intersects perpendicularly a central axis of the central part and the anchor foot ( see Fig. 1 and 3; prior to placement).
Badih further discloses wherein the a central part has two distinct halves for facilitating differentiation by a practitioner of a vestibular side and a palatal side (e.g. vestibular and palatal halves thereof), with a half of the central part facing the vestibular side when placed by the practitioner (i.e., towards the outside the mouth) from which extend the flexible elongated lateral extensions, or flexible elongated vestibular lateral extensions (7V), have a greater length than the flexible elongated lateral extensions extending from the other half of the central part (12) which faces the palatal side when placed by the practitioner (i.e. towards the palate) or flexible elongated palatal lateral extensions (7P; see machine translation (MT) page 9, par 3; per claims 2 and 13); wherein the flexible elongated vestibular lateral extensions (7V) have a length of between 4 and 10 mm, and the flexible elongated palatal lateral extensions (7P) have a length of between 3 and 6 mm (see MT page 6, par 4; per claims 3 and 14); wherein the device comprises 2 to 5 flexible elongated vestibular lateral extensions, and 1 to 4 flexible elongated palatal lateral extensions (see MT page 5; paragraph 5; higher number of extensions would require the particular number of vestibular and palatal extensions in the claimed range; per claims 4 and 15); wherein the device comprises an intermediate pillar (11; and/or upper most portion of 4, just below where it joins 6) between the external pillar and the cover piece, and wherein the external pillar, the intermediate pillar, and the cover piece form a single piece (see Figs; pe claims 7 and 18); wherein the height of said intermediate pillar is in the range from 0.5 to 5 mm (see MT pg. 4, par 7; per claim 8); wherein the cover piece has a thickness of between 0.3 and 3 mm and the flexible elongated lateral extensions have a thickness of between 0.1 and 1.5 mm (see page 6, par 4 and Fig. 1 showing the lateral extensions having the same thickness as the cover piece, which is within the claimed range; per claim 9); wherein the central part is circular (see Fig. 3; per claim 10); wherein said device is made of titanium (see page 4; par 5; per claim 11); and wherein said bone regeneration system further comprises at least one screw (12) having a head (wider top of screw) and an external thread (12a) at its distal end; wherein the external pillar of the device has an internal cavity (cavity of 4) allowing the passage of said screw but not of its head (see Fig. 1); and wherein the anchor foot has a cavity (central hole in 3) in which is provided a tapping (3c), which can cooperate with the thread (12a) of said screw (12) to allow the assembly of the at least one anchor foot (3) and of the at least one device (see Fig. 1; per claim 21).
Badih, however, does not explicitly teach wherein the lateral extensions do not comprise any orifice configured for positioning of a fixing screw and are not configured for fixation in bone as required.
Reggie, however, teaches a similar device (150) attached to an implant (100) comprising a central section (152) and lateral extensions (154/156/158) which can alternatively comprise barbs instead of holes for screws (see [0057]) and as such would not comprise any orifice configured for positioning of a fixing screw as required. 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 Badih to include barbs instead of holes and screws as taught by Reggie, as such modification would provide for easier and faster installation, reduce the risk of loss of small separate screws, and would merely involve the simple substitution of one known element for another, which has been held to be within the skill of the ordinary artisan (see MPEP 2143). The Examiner notes that should the device of Badih be modified with the teachings of Reggie, as combined above, the resultant extensions would comprise barbs, not holes for screws, meeting the limitations of “do not comprise any orifice configured for positioning of a fixing screw” as required. Regarding the limitation of wherein the at least two flexible elongated lateral extensions “are not configured for fixation in bone” the Examiner maintains that the device of Badih/Reggie, as combined above, meets all required limitations of the term, as the barbed extensions, as combined above, would not be specifically configured for fixing in bone, if so desired, as they are configured to be mounted into or onto the gum, a bone regeneration substitute, a mesh, a plate, a membrane or a cover (as best understood by the Examiner as it is unclear what specific structure makes the extensions not configured for fixation in bone and the term is interpreted as intended use of the recited extensions).
Claim(s) 5-6 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Badih in view of Reggie, as combined above, further in view of Rostami (US 2014/0248583 A1).
Regarding claims 5-6 and 16-17, Badih/Reggie, as combined above, does not teach wherein the lateral extensions have one or more predetermined breaking points or one or more weakened regions, facilitating folding, positioned along its length as required.
Rostami, however, teaches an implant extension plate (100) with lateral extensions (216a/b) which have comprise punch grooves for bending (see [0074]). 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 Badih/Reggie, to include Rostami’s punch grooves, as such modification would provide easier and more consistent shaping of the extensions (see Rostami, citations above). The Examiner notes that should the device of Badih/Reggie be modified with the teachings of Rostami, as combined above, the lateral extensions would comprise the punch grooves along their length, which the Examiner interprets as breaking points (per claims 5 and 16) as repeated folding at the groove can cause breakage, or alternatively as weakened regions facilitating folding (per claims 6 and 17) as they are disclosed to aid in folding.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Badih in view of Reggie, as combined above, further in view of Kim (KR 1020140128896, see attached Machine Translation).
Regarding claim 19, Badih/Reggie, as combined above, does not teach wherein said bone regeneration system further comprises: said cover membrane, which is of resorbable or non-resorbable nature, and whose surface makes it possible to cover at least the entire bone defect as required.
Kim et al, however, teaches an implant system with an implant (110), a maintenance device (340) with 2 elongated lateral extensions (340) and a cover membrane (121; implicitly either resorbable or non-resorbable), whose surface covers an entire bone defect and bone graft substitute (60; see Figs. 3-5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the system of Badih/Reggie, as combined above, to include Kim’s cover membrane, as such modification would aid in maintaining the bone graft material in place and aid in shaping the newly developing bone.
Claim(s) 22-25, 28-29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Badih in view of Reggie in view of Kim.
Regarding claim 22 and 29, Badih discloses a bone regeneration kit (see Figs. 1-4; and device (per claim 1); see below) for a bone defect site in a jaw bone of a patient (capable of being used as such), which comprises at least one anchor foot (3) suitable for endosteal installation in the jaw bone (capable of being used as such)); at least one device (5) configured to ensure the maintenance of a bone regeneration substitute over a bone defect in a jaw bone of a patient (configured of being used as such) comprising: a. at least one external pillar (4) configured to be fixed in the anchor foot (via screw 12), which external pillar (4) comprises anti-rotational means (4a2) making it possible to inhibit/resisting the relative movements of the external pillar (4) relative to the anchor foot (3) once the external pillar (4) is placed in the anchor foot (3); and b. at least one cover piece (6/7) disposed above the at least one external pillar (at least in part), which is placed on the bone regeneration substitute (capable of being used as such) and, optionally, on a cover membrane (the Examiner choses to not include the cover membrane; e.g. optional), so as to delimit the volume of bone regeneration at said bone defect site in combination with said bone regeneration substitute (capable of being used as such) and, optionally, said cover membrane (not required, see above)), which cover piece (6/7) forms a single piece with the external pillar (see Fig. 1) and comprises/presents: i. a central part (6), extending from and positioned above the external pillar (4), and ii. at least two flexible elongated lateral extensions (7/7V/7P) extending from this i) central part, and whose axes intersects perpendicularly a central axis of the central part and the anchor foot ( see Fig. 1 and 3; prior to placement).
Badih further discloses wherein the a central part has two distinct halves for facilitating their differentiation by the practitioner of the vestibular side and the palatal side (e.g. vestibular and palatal halves thereof), with a half of the central part facing the vestibular side when placed by the practitioner (i.e., towards the outside the mouth) from which extend the flexible elongated lateral extensions, or flexible elongated vestibular lateral extensions (7V), have a greater length than the flexible elongated lateral extensions extending from the other half of the central part (12) which faces the palatal side when placed by the practitioner (i.e. towards the palate) or flexible elongated palatal lateral extensions (7P; see machine translation (MT) page 9, par 3; per claim 23); wherein the flexible elongated vestibular lateral extensions (7V) have a length of between 4 and 10 mm, and the flexible elongated palatal lateral extensions (7P) have a length of between 3 and 6 mm (see MT page 6, par 4; per claim 24); wherein the device comprises 2 to 5 flexible elongated vestibular lateral extensions, and 1 to 4 flexible elongated palatal lateral extensions (see MT page 5; paragraph 5; higher number of extensions would require the particular number of vestibular and palatal extensions in the claimed range; per claim 25); wherein the device comprises an intermediate pillar (11; and/or upper most portion of 4, just below where it joins 6) between the external pillar and the cover piece, and wherein the external pillar, the intermediate pillar, and the cover piece form a single piece (see Figs; pe claim 28); and wherein said bone regeneration system further comprises at least one screw (12) having a head (wider top of screw) and an external thread (12a) at its distal end; wherein the external pillar of the device has an internal cavity (cavity of 4) allowing the passage of said screw but not of its head (see Fig. 1); and wherein the anchor foot has a cavity (central hole in 3) in which is provided a tapping (3c), which can cooperate with the thread (12a) of said screw (12) to allow the assembly of the at least one anchor foot (3) and of the at least one device (see Fig. 1; per claim 31).
Badih, however, does not explicitly teach wherein the lateral extensions do not comprise any orifice configured for positioning of a fixing screw and are not configured for fixation in bone, or the kit comprising the bone regeneration substitute and cover membrane (per claim 29) as required.
Reggie, however, teaches a similar device (150) attached to an implant (100) comprising a central section (152) and lateral extensions (154/156/158) which can alternatively comprise barbs instead of holes for screws (see [0057]) and as such would not comprise any orifice configured for positioning of a fixing screw as required. 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 Badih to include barbs instead of holes and screws as taught by Reggie, as such modification would provide for easier and faster installation, reduce the risk of loss of small separate screws, and would merely involve the simple substitution of one known element for another, which has been held to be within the skill of the ordinary artisan (see MPEP 2143). The Examiner notes that should the device of Badih be modified with the teachings of Reggie, as combined above, the resultant extensions would comprise barbs, not holes for screws, meeting the limitations of “do not comprise any orifice configured for positioning of a fixing screw” as required. Regarding the limitation of wherein the at least two flexible elongated lateral extensions “are not configured for fixation in bone” the Examiner maintains that the device of Badih/Reggie, as combined above, meets all required limitations of the term, as the barbed extensions, as combined above, would not be specifically configured for fixing in bone, if so desired, as they are configured to be mounted into or onto the gum, a bone regeneration substitute, a mesh, a plate, a membrane or a cover (as best understood by the Examiner as it is unclear what specific structure makes the extensions not configured for fixation in bone and the term is interpreted as intended use of the recited extensions).
Kim et al, however, teaches an implant kit with an implant (110), a maintenance device (340) with 2 elongated lateral extensions (340) and a cover membrane (121; implicitly either resorbable or non-resorbable), whose surface covers an entire bone defect and bone graft/regeneration substitute (60; see Figs. 3-5), and the bone graft substitute (60) filling a bone defect. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the kit of Badih/Reggie, as combined above, to include Kim’s bone graft/regeneration substitute and cover membrane, as such modification would improve recovery time and new bone quality and aid in maintaining the bone graft material in place and aid in shaping the newly developing bone (respectively). The Examiner notes that should the kit of Badih/Reggie be modified with the teachings of Kim, as combined above, the bone graft/regeneration substitute can be used to fill a bone defect, with the device ensuring maintenance of the bone regeneration substitute, with the cover piece and cover membrane capable of being placed over the bone regeneration substitute so as to delimit the volume of bone regeneration at the defect site in combination with the regeneration substitute as required.
Claim(s) 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Badih in view of Reggie in view of Kim, as combined above, further in view of Rostami (US 2014/0248583 A1).
Regarding claims 26-27, Badih/Reggie/Kim, as combined above, does not teach wherein the lateral extensions have one or more predetermined breaking points or one or more weakened regions, facilitating folding, positioned along its length as required.
Rostami, however, teaches an implant extension plate (100) with lateral extensions (216a/b) which have comprise punch grooves for bending (see [0074]). 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 Badih/Reggie/Kim, to include Rostami’s punch grooves, as such modification would provide easier and more consistent shaping of the extensions (see Rostami, citations above). The Examiner notes that should the device of Badih/Reggie/Kim be modified with the teachings of Rostami, as combined above, the lateral extensions would comprise the punch grooves along their length, which the Examiner interprets as breaking points (per claim 26) as repeated folding at the groove can cause breakage, or alternatively as weakened regions facilitating folding (per claim 27) as they are disclosed to aid in folding.
Response to Arguments
Applicant's arguments filed 7/2/26 have been fully considered but they are not persuasive and additionally do not address the new grounds of rejection and/or interpretation above necessitated by Applicant’s amendments.
Applicant argues that it would not have been obvious to modify the hole and fixation means of Badih to instead comprise the integrated barbs of Reggie as relied on above. Applicant argues that as Badih is concerned with fixation of the device through the holes, modifying such construction to include the barbs would destroy its function. However, the Examiner disagrees as Reggie explicitly discloses that the barbed embodiment is an alternative to a hole and fixation means embodiment, demonstrating the equivalency between the embodiments. Although Applicant argues that this modification, and the barbs of Reggie, would render Badih unsuitable for its intended use, no evidence is provided to support such claim. Additionally, although Applicant alleges unexpected results due to the claimed invention, no such evidence is provided.
Further, Applicant argues that Badih/Reggie, as combined above, does not teach the newly added limitations of “are not configured for fixation to bone”, however the Examiner disagrees. First, as explained above, it is unclear what specific structure the term imparts to the claim as the specific negative limitation is unsupported by the original disclosure. The Examiner notes that it is unclear how the device of the instant invention is not configured for fixation to bone as, in the least, it could be adhered thereto. Further, the Examiner maintains that the deice of Badih/Reggie, as combined above, can be interpreted as not being configured for fixation to bone as the device could instead be fixated to a bone regeneration substitute/graft, gums, a mesh, membrane, cover, etc., dependent on its desired intended use.
Therefore, Applicant’s arguments have been fully considered but are not persuasive and additionally do not address the new grounds of rejection and/or interpretation above necessitated by Applicant’s amendments.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EDWARD MORAN/Primary Examiner, Art Unit 3772
