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 “fin-type” and “wing members” of Claim 1 must be shown or the feature(s) canceled from the claim. 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 specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the “fin-type” of Claim 1 is not found in the specification.
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, 4-7, and 9-10 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, it is unclear what is meant by “fin-type” in line 13 of the amended claim. The specification is silent as to the term “fin-type” and it is also unclear what structure is required to be “fin-type” or what shape “fin-type” would encompass.
Regarding Claim 10, it is unclear what is meant by the “bone formation inducers a provided in the plurality of grooves.” The bone formation inducers are described in paragraph [0063] of the specification as “corresponding to the plurality of grooves” which is not the same thing as “in the plurality of grooves.” It is not clear from the specification or the figures how the bone formation inducers are provided in the plurality of grooves.
All claims not specifically addressed above are rejected based on their dependency on Claim 1.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “the bone formation inducers” in claims 1, 4, and 9-10, the “first type inducer” in Claim 4, and the “second type inducer” of Claim 4.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Gilgenbach Blume et. al. (WO 2020/099334 A2, hereinafter “Gilgenbach Blume”).
Regarding Claim 1, Gilgenbach Blume discloses an implant fixture (Figure 1) capable of reducing periodontitis comprising a body part (Figures 1 and 3) which is implanted into bone tissue to form an artificial tooth root (abstract), where the an outer surface of the body part has a predetermined roughness to enhance fixing force of the body part to the bone tissue (roughness as seen in Figure 3 and described on pages 37-40), and at least a portion of the outer surface of the body part is provided with bone formation inducers attached to be released gradually to the bone tissue to enable effective osseointegration (as described on page 39, where the osteointegration via bone formation in vivo via hydroxylated titanium surfaces is described), where an upper portion of the body part (coronal portion 2) has a machined surface with smoother surface characteristics compared to the outer surface of the body part to improve adhesion with soft tissue, where the body part comprises a first body part (transitional region 3) corresponding to a predetermined depth section downwards from the machined surface, and a second body part corresponding to the a lower end of the fixture (apical region 4). Gilgenbach Blume further discloses that the first body part is provided in a fin-type including a plurality of wing members (as seen in Figure 3, the threads of the transitional region can be considered a fin type with wing members), and the second body part is provided in a screw-type with threads formed on the outer surface thereof so that the first body part and the second body part can have distinct outer surface characteristics (as the second part has cut out sections in the treads as seen in Figure 3, it would have distinct outer surface characteristics from the first body part).
Gilgenbach Blume discloses the invention substantially as claimed but does not specifically disclose that the wing members are made of a material with higher strength compared to the material of the second body part. However, as seen in Figure 3, the materials of the members of the body parts comprise different density as exhibited by the porosity size. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to utilize a stronger, more dense material for the wing members in order to prevent breakage and since such modification would merely involve choosing from one of a finite number of identified predictable solutions (e.g. higher, lower or the same strength), which has been held to be within the skill of the ordinary artisan (see MPEP 2143).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Gilgenbach Blume in view of Collins et al. (US 2013/0022943 A1, hereinafter “Collins”).
Regarding Claims 4 and 5, Gilgenbach Blume discloses the implant fixture according to claim 1, but does not disclose that the that bone formation inducer provided on the outer surface of the first body part is a first type inducer and the bone formation inducer provided on the outer surface of the second body part is a second type inducer made of a material different from the first type inducer, nor does Gilgenbach Blume disclose that the first type of inducer includes
includes poly lactic-co glycolic acid (PLGA), and the second type inducer includes bone morphogenetic protein (BMP).
In the same art of dental implants, Collins teaches an implant with a first type of bone formation inducer (porous structure of shaft 12 as described in [0052]) that includes poly lactic-co glycolic acid (PLGA) (as described in [0057]), and a second type of inducer (channel structure 50 as seen in Figures 5A and 5B) that includes a bone morphogenetic protein (BMP) ([0072] describes that BMP can be used as the flowable material 54). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to utilize PGLA in conjunction with the first body part of Gilgenbach Blume, and BMP with the second body part of Gilgenbach Blume in order to provide materials that are well known as biocompatible and effective for adding strength and stability and assisting in bone growth in the field of implants as is taught by Collins.
Claims 6-7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gilgenbach Blume in view of Wysocki et al. (US 2022/0387143 A1, hereinafter “Wysocki”).
Regarding Claim 6, Gilgenbach Blume discloses the implant fixture of Claim 1 but does not disclose a cavity formed by recessing upwards from the lower end of the body part where after the implant fixture is implanted, the implant fixture is configured to draw a portion of a bone tissue into the cavity ([0021]). Wysocki teaches an implant fixture with a cavity (Figure 5, channel 8) formed by recessing upwards from the lower end of the body part (channel starts at outlet 10 in the lower end of the body part), where after the implant fixture is implanted, at least a portion of bone tissue is drawn into the cavity ([0021]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the implant fixture of Gilgenbach Blume with a cavity from the lower end of the body part as taught by Wysocki in order to provide a cavity for additional bone growth and osteointegration.
Regarding Claim 7, Gilgenbach Blume in view of Wysocki discloses the implant fixture according to claim 6, and Wysocki further discloses that at least one through-hole (Figure 5, lateral channels 9) is formed to allow communication between the cavity and the outside of the body part. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the implant fixture of Gilgenbach Blume with at least one through-hole as taught by Wysocki in order to provide a cavity for additional bone growth and osteointegration.
Regarding Claim 9, Gilgenbach Blume discloses the implant fixture of Claim 1 but does not disclose that the bone formation inducers are provided at a plurality of different positions on the outer surface, each at a predetermined distance from each other. Wysocki teaches that bone formation inducers are provided at a plurality of different positions on the outer surface, each at a predetermined distance from each other (as seen in Figure 5, and as described in [0030] the endings of channels open at a predetermined location in the concave grooves 6). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the implant of Gilgenbach Blume with the bone formation inducers of Wysocki in order to provide a for additional bone growth and osteointegration.
Regarding Claim 10, Gilgenbach Blume in view of Wysocki discloses the implant fixture according to claim 9, and Wysocki further discloses a plurality of grooves (6) formed on the outer surface of the body part (as seen in Figure 5), and that the bone formation inducers are provided corresponding to the plurality of grooves (as described in [0030]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the implant of Gilgenbach Blume with grooves of Wysocki with corresponding bone formation inducers in order to provide a for additional bone growth and osteointegration.
Response to Arguments
Claim amendments filed on December 23, 2025 have overcome the prior drawing objections, claim objections, previous 35 U.S.C. 112(b) rejections, and the previous 35 U.S.C. 101 rejection. Please see newly added drawing and specification objections and 35 U.S.C. 112(b) rejections in response to the applicant’s amendments to the claims.
Applicant’s arguments with respect to claims 1, 4-7, and 9-10 have been considered but are moot because the new ground of rejection does not rely on the references as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Amended Claim 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gilgenbach Blume.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE L NELSON whose telephone number is (571)270-5368. The examiner can normally be reached M - F 7:30-4:30 PT.
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.
/CHRISTINE L NELSON/Examiner, Art Unit 3772
/EDWARD MORAN/Primary Examiner, Art Unit 3772
Prosecution Insights