DETAILED ACTION
The following is a non-final office action is response to communications received on 04/27/2023. Claims 27-48 are currently pending and addressed below. Claims 27-38 are withdrawn.
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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 27-38, drawn to method for inserting an implant, classified in A61F2/28.
II. Claims 39-48, drawn to an implant system, classified in A61F2/4637.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the process for using the product as claimed can be practiced with another materially different product (e.g., a device without a driver and associated driver receptacle).
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because the inventions require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries). As Invention I is drawn to a method, Invention I would require searching in additional classifications, including but not limited to 128 (Surgery) & 606 (Surgery), not required for the device of Invention II.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Edmund Pfleger on 09/16/2025 a provisional election was made without traverse to prosecute the invention of Group II, claims 39-48. Affirmation of this election must be made by applicant in replying to this Office action. Claims 27-38 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 60 (Figs 3 & 4) and 103 (Fig 3). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
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 limitation:
Of claim 48, wherein the implant system is configured to replace an entire articular surface of the bone, must be shown or the feature(s) canceled from the claim(s). As illustrated in at least Fig 1, the implant is nested within a portion of the articular cartilage and there are no drawings directed towards an entire articular resurfacing. Nor is it clear how the round articular surface shown in Fig 2 is capable of replacing the entire surface of a femoral condyle.
Of claim 43, wherein the first fixation element is configured to connect to the second fixation element with a positive mechanical engagement connection.
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 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.
Claim(s) 39-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ek (US 7,618,462) in view of Miniaci et el. (US 7,896,885).
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Regarding Claim 39, Ek discloses the invention substantially as claimed. Ek teaches an implant system for securing an implant (40) to a bone, the implant system comprising:
an implant anchor (10’) comprising:
an implant fixation portion (shown) having a first fixation element (shown) configured to couple the implant anchor with the implant (40);
a bone fixation portion (shown) distal to the implant fixation portion, the bone fixation portion having one or more external screw threads (shown) disposed around an outer surface thereof and configured to secure the implant anchor to the bone (Fig 1);
A driver receptacle (15) disposed on the implant fixation portion and configured to receive a drive member (2);
the implant comprising a load bearing surface (41), a bone facing surface (42), and a second fixation element (45) extending from the bone facing surface, the first fixation element (shown) configured to mate with the second fixation element (45); and a driver (2) (Fig 7a & 7b) comprising a body portion (handle) and the driving member (2), wherein the driving member is configured to rotate the implant anchor via driver receptacle (Col 13: lines 54-57), so as to threadably engage the one or more external screw threads to the bone (Fig 1).
However, Ek does not disclose wherein the driver receptacle is disposed at least partially within the implant fixation portion.
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Miniaci teaches an articular resurfacing implant in the same field of endeavor. Said implant (Fig 1) anchored via an implant anchor (screw 33) comprising an internal drive feature (34) (receptacle) engaged by a driver (35) to rotate and anchor the threads within the bone (Fig 5a & 5b).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the driver receptacle (15), as taught by Ek, with the internal driver receptacle, as taught by Miniaci, in order to provide alternative driving means for the bone anchor device. As both the Ek and Miniaci are constructed and designed in order to effectively anchor a prosthetic device within joint surface, it would have been obvious to one of ordinary skill to substitute the design of one anchor driver mechanism for the other. The proposed combination would involve no more than the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement. “Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious.” Id. at 301, 213 USPQ at 536.
Regarding Claim 40, the combination teaches wherein the first fixation element (shown) is a tapered protrusion (14) narrowing towards a proximal tip of the implant anchor (Fig 2B).
Regarding Claim 41, the combination teaches wherein the tapered protrusion (14) includes a tapered sidewall configured to contact and abut against at least a portion of a corresponding implant tapered sidewall (44) of the second fixation element to form a frictional connection therebetween (Col 13: lines 1-10).
Regarding Claim 42, the combination teaches wherein the first fixation element is configured to connect to the second fixation element with a friction fit connection (Col 13: lines 1-10).
Regarding Claim 43, the combination teaches wherein the first fixation element is configured to connect to the second fixation element with a positive mechanical engagement connection (Col 13: lines 1-10).
Regarding Claim 44, the combination teaches wherein at least one of the first fixation element and second fixation element is deformed (if fabricated form one of the materials taught in Col 24: lines 30-39) against the other fixation element.
Regarding Claim 45, the combination teaches wherein at least one of the first fixation element and second fixation element have an overlapping surface (shown assembled in Fig 1).
Regarding Claim 46, the combination teaches wherein the implant comprises polyether ether ketone, polyethylene, and/or ultrahigh molecular weight polyethylene (Col 24: lines 30-39).
Regarding Claim 47, the combination teaches wherein at least a portion of the implant comprises stainless steel, titanium, aluminum, chromium cobalt, and/or any alloy thereof (Col 24: lines 30-39).
Regarding Claim 48, the combination teaches wherein the implant system is configured to replace an entire articular surface of the bone (Fig 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774