Status under America Invents Act
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Withdrawal from Consideration of non-elected claims
Claims 1-7, 9, 11, 21, 22, 25-27, 29 and 31-34 have been withdrawn from further consideration as being directed to a non-elected invention as set forth in the restriction requirement of October 5, 2023 and the election by applicant on April 5, 2024.
The amendment to claim 12 that limits the “implantable object . . . comprises a bone engaging element and a guiding device” appears to be an attempt to claim the “kit” of claim 1 that is comprised of an “implantable object” and a “guiding device.” The “kit” was not elected in the April 5, 2024 response. Claim 12, however, confusingly claims the “guiding device” as an element of the “implantable object.” Because claim 12 on its face indicates that it is only directed to “an implantable object,” it is herein treated as being directed solely to the “implantable object” where a “guiding element” is an element of the “implantable object” and not a collection of two different devices (“implantable object” and a “guiding device”). If the claim is further amended or interpreted to make it clear that it is directed to two different devices, then the claim and its dependents will be withdrawn from consideration in accordance with the restriction requirement of October 5, 2023.
Newly presented claims 47-53, directed solely to a “guiding device” are identical (or nearly identical) to claims 21, 22, and 25-27 previously presented and currently pending which have been previously withdrawn from further consideration pursuant to the restriction requirement of October 5, 2023 and the election by applicant on April 5, 2024. Accordingly, claims 47-53 are withdrawn from further consideration as being directed to a nonelected invention.
Objection to Amendment
At least the amendment to claim 12 is objected to under 37 CFR 1.121(c)(2) for failing to indicate that the previously presented text referring to the “transition zone” limitation has been deleted. Future amendments that fail to comply with the amendment procedures of 37 CFR 1.121 will be held nonresponsive.
Rejection based on 35 U.S.C. 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 12, 15, 36-40 and 42-46 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Independent claims 12 and 46 are directed to an implantable object that “is adhered to the implantation site by an adhesive composition.” The claims positively require the claimed device to be “adhered to the implantation site” which includes within its scope a living human’s bone (note claim 42 identifying the implantation site as a “bone or bone socket”). The “implantation site” is a required element of the claim and includes a living human patient. Accordingly, the claims do not present patentable subject matter and are nonstatutory under 35 U.S.C. 101.
Additionally, it is noted that the written description indicates that the adhesive material is added to the implantation site (e.g. page 62, lines 3-20), as opposed to being formed on the implantable object – i.e. the implantable object and the adhesive are not disclosed as being formed together except when fixed together in an implantation site. The “implantation site” is a disclosed necessary element for the combination of the disclosed implant and adhesive.
Rejections based on 35 U.S.C. 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(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 12, 15 36-40 and 42-45 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.
In claim 12, it is unclear how the “implantable object” can comprise both “a bone-engaging element and a guiding device” as required in element “(i).” According to the written description, the identified “guiding device” (identified in applicant’s Figure 1) is a distinct and different device from the identified “implantable object” (Figures 15G, 15H). It is confusing and indefinite to refer to two completely different and distinct devices as a single device.
Rejection based on Prior Art
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.
Claims 12, 15, 36-40 and 42-46 are rejected under 35 U.S.C. 103 as being unpatentable over Rubbert (US 2008/0090207).
In regard to claim 12, Rubbert at least in Figures 13, 15, 16, 31, 35, 36 discloses an “implantable object” (dental implant 12000) free of threads that includes a bone engaging element (outer post surface) and a “guiding device” 12020 (the stem of element 12020 guides the pin into position). The Rubbert “implantable object” (dental implant 12000) is custom shaped to match an implantation site (e.g. tooth socket 500, Figure 14) and has a smooth surface with a changing contour and which further comprises an opening (12010, 21000 (Fig 31)). In regard to the limitation requiring the implant to be adhered to the implantation with an adhesive composition, the present rejection interprets the claimed invention as not requiring the adhesive/patient as an element of the implantable object, but rather as an “implantable object” being intended/constructed for use with the adhesive and implantation site. Accordingly, the intended use of a cement with the claimed “implantable object” fails to impose any objectively ascertainable structural limitations on the claimed “implantable object” itself. Furthermore, it is noted that Rubbert discloses the use of cement (9000 Figure 9; paragraphs [0123]-[0126]) for securing the dental implant when in use.
In regard to the limitation requiring the implantable object have a diameter between about .1mm and about 50mm, Rubbert does not appear to explicitly disclose any particular sizes for the dental implant, however, the construction of a dental implant to within the wide range (0.1mm – 50mm diameter) of sizes claimed such that it fits with a typical patient’s tooth socket would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
In regard to claims 15 and 43, the Rubbert implant is custom produced (see e.g. paragraph [0002]). In regard to claims 36, 42, 44 and 45 the custom produced Rubbert implant is a patient’s tooth. In regard to claim 37, the construction of a Rubbert dental implant to within the wide range (0.5mm – 25mm diameter) of sizes claimed such that fits with a typical patient’s tooth socket would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. In regard to claim 39 and 40, the composition of the adhesive that applicant intends for the implant to be used with fails to impose any objectively ascertainable structural distinctions from the Rubbert device.
Claims 12, 15, 36-40 and 42-46 are rejected under 35 U.S.C. 103 as being unpatentable over Rubbert (US 2008/0090207) in view of Garigapati et al (US 2011/0277931).
To the limited extent that the present claims are interpreted as requiring the adhesive as an element of the “implantable device” then the following rejection applies. Rubbert meets all the limitations of the present claims as identified above, with the exception of that directed to the particular adhesive used to secure the implant to the patient’s bone. Rubbert discloses that the implantable object is adhered to the implantation site by a bone cement 9000 (Figure 9). The Rubbert bone adhesive does not appear to meet the limitations set forth regarding the particularly claimed bone cement. At least the bone cement “Formula (I)” is known in the art as taught by Garigapati et al (see paragraph [0010]). Garigapati et al further disclose that the cement composition has capacity to enhance the fixation of a prosthesis to a bone and may be used to support new bone growth in dental sockets (see paragraph [0021]). To have substituted the enhanced bone growth cement of Garigapati et al for the bone cement disclosed in Rubbert for an enhanced fixation would have been obvious to one of ordinary skill in the art.
Action Made Final
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 Ralph Lewis whose telephone number is (571)272-4712. The examiner can normally be reached Monday-Friday from 9AM-4PM.
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/RALPH A LEWIS/Primary Examiner, Art Unit 3772 (571) 272-4712
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