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 .
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 “set of differently sized spacers” of claim 17 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.
Specification
The disclosure is objected to because of the following informalities: The priority data should be listed on page 1, line 1 of the specification. No new incorporation by reference should be made.
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 1-18 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 1, the term “the internal threaded connection of the second end the spacer” is indefinite, as it is unclear whether or not a threaded connection is intended to be required. Specifically, in the fourth paragraph of the claim the second end is only recited to include an internal connection, with “threaded” removed. It is unclear which instance of the internal connection is in error. Correction is required.
Regarding claims 3 and 4, the term “for example” is indefinite as it is unclear whether or not the claims intend to positively recite the material listed thereafter, or if it is merely exemplarily and preferable. Clarification is required.
Regarding claim 7, the term “high density polymer” is a term of degree, and as such it is unclear what would or would not specifically be considered “high density”. What one person may consider high density may be different than another’s opinion. As such the meets and bounds of the term is indefinite. Clarification is required.
Regarding claim 12, the term “comprise a tool carry function to carry the cap and/or spacer” is indefinite as it is unclear what specifically the term corresponds to. For example, it is unclear if the term intends to require some kind of structure that allows carrying, or if it is merely a functional recitation; that is that the components can be carried. Further, the Examiner notes that the carrying function at least in part depends on the tool, which is not positively recited, required or part of the claim. As such it is unclear what is specifically required of the spacer and cap to meet the claim language. Clarification is required.
Regarding claim 13, the term “the internal threaded connection” is indefinite for the same reasons as explained above in regards to claim 1. Clarification is required.
Regarding claim 14, the term “at least partially axially coincident” is indefinite as it is unclear what specifically the term encompasses. As best understood by the Examiner, it appears the term states that the tool connection region and internal threaded connection are at least partially coaxial. Clarification is required.
Regarding claim 15, the term “sufficiently equal in size and/or shape” is indefinite as it is unclear what would or would not specifically be considered specific. The term is a term of degree and variable based on personal opinion. It is unclear if any particular structure is required by the term. Further the ability to be lifted depends, at least in part on the screwdriver used, which is not positively recited, required or part of the claim. Clarification is required.
Regarding claims 16 and 18, the claims recites a spacer “for use with the assembly of claim 1” and “for use in the dental implant assembly of claim 1”, respectively, which already recites the spacer and barrier. The claims appear to refer back to claim 1, however, reintroduces all features and components of the spacer and barrier. It is unclear if the terms attempt to refer back and/or incorporate the limitations of claim 1. 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) 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaneko et al (US 6171106 B1).
Regarding claim 16, Kaneko et al discloses a spacer (3) for use in the dental implant assembly of claim 1 (capable of being used in a dental implant assembly, as best understood by the Examiner), comprising a first end (end of 3a) comprising a threaded connection (3a) configured to engage with the dental implant (configured to be used as such), and a second end (end of 3b) comprising an internal threaded connection (3c) configured to engage with the cap (configured to be used as such), said second end further comprising a tool connection region for receiving a screwdriver (e.g. tool connection region interpreted as region between spacer and implant as shown in Fig. 2; approximately at 3d, as a screwdriver can be wedged or inserted therein to lift the cap when at least partially unscrewed).
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) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kaneko et al in view of Lazzara et al (US 4856994).
Regarding claim 17, Kaneko discloses all the features of the spacer of claim 16, but does not teach a set of different sized spacers as required.
Lazzara et al, however, teaches a similar implant system comprising spacers (30) provided as a set with different sizes from which the dentist can choose based on the gum thickness of a particular patient (see col 3, lines 5-12). 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 Kaneko to include a set of differently sized spacers, as taught by Lazzara, as such modification would allow for improved fit, aesthetics and/or customization of the spacer for a particular patient with a particular gum height.
Claim(s) 1-8, 10-15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kaneko et al in view of Engman (US 2017/0239051 A1).
Regarding claim 1, Kaneko et al discloses a dental implant assembly (see Figs. 1-2) comprising: a spacer (3) removably attachable to a dental implant (1), a cap (4) removably attachable to the spacer, and a surgical barrier (5) for preventing ingress of bacteria and soft tissue (capable of being used as such, at least to some degree; “seals”, see abstract and citations below), said barrier at least partially disposed between the cap and the spacer (see Fig. 1); wherein the spacer comprises a first end (end of 3a) comprising a connection (3a) configured to engage with the dental implant, and a second end (end of 3b) comprising an internal connection (3c) configured to engage with the cap (see Fig. 2), said second end further comprising a tool connection region for receiving a screwdriver (e.g. tool connection region interpreted as region between spacer and implant as shown in Fig. 2; approximately at 3d, as a screwdriver can be wedged or inserted therein to lift the cap when at least partially unscrewed); wherein the cap (4) comprises a head (4a) and a body (4c), said head comprising a lower surface configured to engage with the surgical barrier (see Fig. 2); said body comprising a threaded profile engageable with the internal threaded connection of the second end of the spacer (see Figs. 1-2); and said head further comprising a tool connection region (4b) for receiving a screwdriver (see col 6, lines 34-44), and wherein at least part of said surgical barrier is sandwiched between the spacer and the lower surface of the cap (see Figs) and wherein the barrier includes an aperture whose diameter is greater than an outer diameter of the body of the cap (implicitly in order to fit therethrough; see col 6, line 64 through col 7, line 8). See also col 5, line 53 through col 6, line 33; and abstract. Kaneko further discloses wherein the second end of the spacer further comprises an upper supporting surface for supporting the barrier thereon (see Figs. 1-2; per claim 2); wherein the barrier is at least partially resorbable (see col 6, lines 64 through col 7, line 30; per claim 5); wherein the outer surface of the barrier comprises an opening for receiving the body of the cap (implicitly in order to fit thereon; per claim 8); wherein the tool connection region of the spacer and cap comprise a tool carry function to carry the cap and/or the spacer (e.g. as best understood by the Examiner, an appropriately sized and shaped tool can be used to engage the tool connection regions to carry the devices if so desired; tool not positively recited, required or part of claim; per claim 12); wherein the tool connection region of the spacer is located axially below the internal threaded connection towards an apical or lower end of the spacer (at least in part, see Fig. 2; per claim 13); wherein the tool connection region of the spacer is at least partially axially coincident with the internal threaded connection (e.g. tool connection region extends circumferentially around implant, see Figs; per claim 14); and wherein the tool connection region of the spacer and cap are sufficiently equal in size and/or shape to be lifted by the same screwdriver (e.g. a sufficiently sized and shaped screwdriver can be used to lift spacer and unscrew cap, if so desired; screwdriver/tool not positively recited, required or part of claimed assembly; per claim 15).
Kaneko, while disclosing the surgical barrier, does not teach wherein the surgical barrier comprises an outer membrane and an inner mesh, said inner mesh being enclosed within the outer membrane and wherein said inner mesh provides the surgical barrier with a configurable structure, by being bendable into a desired shape as required.
Engman, however, teaches a dental surgical barrier (Fig. 1) for preventing the ingress of bacteria and soft tissue (see citations below), the barrier comprises an outer membrane (1 and 4) and an inner mesh (2), the inner mesh being fully enclosed within the outer membrane and wherein the inner mesh provides the barrier with a configurable structure by being bendable into a desired shape (see abstract, [0005], [0007], [0013]-[0017], [0027]). Engman further discloses wherein the mesh comprises titanium or PEEK ([0013]; per claims 3-4); and wherein the outer membrane comprises PTFE or a high density polymer impenetrable to bacteria (see [0014]-[0015]; per claims 6-7). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the barrier of Kaneko to include Engman’s barrier with outer membrane and inner mesh, as such modification would provide improved support to the tissue, allow easy shaping of the barrier, improve customization of the 3D shape of the barrier, reduce the risk of contamination and adhesion on the bone, and allow gas and liquid to permeate through the barrier (see Engman, citations above). The Examiner notes that should the barrier of Kaneko be modified to include the structure of Engman, as combined above, the barrier of the modified device (including the mesh and the membrane) would have the hole/aperture therethrough to receive the cap threaded portion extending therethrough as required.
Regarding claims 10-11, Kaneko/Engman, as combined above, teaches wherein the head of the cap has a heigh (implicitly has a height in 3D space), but does not teach wherein the height is either no more than 1 mm or 1-7 mm tall as required. However, the Examiner notes that the specific head height is a result effective variable dependent on the gum thickness of desired graft size for a particular patient. Further, the Examiner notes that Applicant describes the height at [0018] and [0037] of the instant disclosure as being merely exemplary, and lacking any particular criticality. Therefore, it would have been obvious to modify the device of Kaneko/Engman, as combined above, to have a cap heigh of no more than 1 mm, or between 1-7 mm, as required, as such modification would merely involve the optimization of a result effective variable, which has been held to be within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results (see MPEP 2144.05 (II)(A)).
Regarding claim 18, Kaneko/Engman, as combined above, discloses a surgical barrier for use in the dental implant assembly of claim 1 (see above), comprising an outer membrane and an inner mesh, the inner mesh being fully enclosed within the outer membrane wherein the inner mesh provides the barrier with a configurable structure, by being bendable into a desired shape and wherein the inner mesh includes an aperture for receiving the body of the cap (see explanation above; all limitations addressed above in combination of Kaneko/Engman in regards to claim 1).
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kaneko et al in view of Engman, as combined above, further in view of Chen (US 2019/0110870 A1).
Regarding claim 9, Kaneko/Engman, as combined above, discloses all the features of the claimed invention, except wherein the mesh comprises at least one elongated slot in a bend region of the barrier as required.
Chen, however, teaches a surgical barrier mesh (10) comprising an elongated slot (41) in a bend region of the barrier. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the barrier mesh of Kaneko/Engman, as combined above, to include Chen’s elongated slots, as such modification would provide improved and controlled flexibility along a bend line to provide a desired bend in a given direction.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see attached PTO892 form.
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