CTNF 18/519,330 CTNF 93875 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Drawings 06-22-07 AIA 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: #204a, #202a, #102a in Fig. 3 and #204b, #210b, #209b, #201b, #203b in Figs. 4 and/or 5 . 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. Claim Objections 07-29-01 AIA Claim s 1, 3, 5, 6, 7, 10, 11, 12, and 13 are objected to because of the following informalities: Claim 1 recites “the at least one screw element being inserted in” in line 11, although the line is written as a method step, the line does not rise to the level of being indefinite, as the line is understood by the Examiner to not be a method step, therefore, the Examiner suggests the line be amended to read “the at least one screw element insertable in” for the purpose of maintaining consistent claim language throughout; Claims 1, 3, 6, 7, and 10 recite “the screw element” in various lines, although the lines are understood by the Examiner to mean “the at least one screw element” as previously defined, the Examiner suggests the lines be amended to read “the at least one screw element” for the purpose of maintaining consistent language throughout the claims; Claim 5 recites “the sliding surface” in line 3, although the line is understood by the Examiner to mean “the proximal sliding surface” as previously defined, the Examiner suggests the line be amended to read “the proximal sliding surface” for the purpose of maintaining consistent language throughout the claims; Claim 11 recites “the mating screw element” in line 1, although the line is understood by the Examiner to mean “the at least one mating screw element” as previously defined, the Examiner suggests the line be amended to read “the at least one mating screw element” for the purpose of maintaining consistent language throughout the claims; Claim 12 recites “the fastening portion” in line 3, although the line is understood by the Examiner to mean “the distal fastening portion” as previously defined, the Examiner suggests the line be amended to read “the distal fastening portion” for the purpose of maintaining consistent language throughout the claims; Claims 12 and 13 recite one or more of “the threaded bore is introduced in” and “inserted in” in various lines, although the lines are written as method step limitations, the lines are understood by the Examiner to mean that the “threaded bore is in” the corresponding structure and “is in” corresponding structure, respectively, and that the claims are not reciting the method steps of ‘placing the threaded bore’ in the corresponding structure and the corresponding structure being ‘inserted in’ corresponding structure, the Examiner suggests the lines be amended to read “the threaded bore is in” and “is in”, respectively, for the purpose of maintaining consistent language throughout the claims; Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 7 – 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. Claim 7 recites the limitation "the insertion opening" in line 3. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the phrase renders the claim indefinite because it is unclear if Applicant is intending for claim 7 to be dependent on claim 3, which first defines the “insertion opening” or if Applicant is intending to provide antecedent basis for the “insertion opening” in claim 7. For the purpose of examination, the Examiner will read the claim to mean the latter. Regarding claim 9, the phrase "the diameter of the insertion opening is less than 80%" renders the claim indefinite because it is unclear what other structure Applicant is intending to compare the diameter of the insertion opening to. For the purpose of examination, and based on Applicant’s disclosure, the Examiner will read the claim to mean the diameter of the insertion opening is less than 80% of the diameter of the first bore portion. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1 – 5, 11, and 12 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Forte (US 5,358,527) . Regarding claim 1 , Forte discloses a knee-joint endoprosthesis (knee prosthesis 10) (abstract, col. 7 line 36 – col. 8 line 10, col. 21 line 31 – col. 22 line 41, and Figs. 1 – 12) comprising: a tibia component (tibial base component 84) comprising a distal fastening portion (underside surface 86, intramedullary stem 91, and fixation stabilizing gussets 92) and a proximal connecting portion (peripheral and centrally positioned engaging dovetail channel 83), the distal fastening portion configured for fastening to a proximal tibia (col. 27 lines 1 – 33, and Figs. 1,2,8a-11); a meniscus component (insert 57) comprising a proximal sliding surface (medial and lateral tibial plateau bearing surfaces 58 and 60) and a distal mating connecting portion (peripheral and centrally positioned engaging dovetail channel 83a / surface 77) (col. 24 lines 21 – 47 and Figs. 1,2,8a-11), the proximal sliding surface (medial and lateral tibial plateau bearing surfaces 58 and 60) configured to articulate with a femoral joint component (col. 24 lines 21 – 47 and Figs. 1,2) and the distal mating connecting portion (peripheral and centrally positioned engaging dovetail channel 83a / surface 77) configured to form a joining connection with the proximal connecting portion of the tibia component (peripheral and centrally positioned engaging dovetail channel 83) (col. 27 lines 1 – 16 and Figs. 1,2,3); and a screwed connection (screw 93 and threaded port 87) configured for additional fixation of the joining connection (col. 27 lines 1 – 16 and Figs. 1,2,3), the screwed connection (screw 93 and threaded port 87) comprising at least one screw element (screw 93) insertable in a longitudinal bore (inclined clearance hole 75) of the meniscus component (insert 57) and at least one mating screw element (threaded port 87) being assigned to the tibia component (tibial base component 84) (col. 27 lines 1 – 16 and Figs. 1,2,3), the screw element (screw 93) configured to be screwed to the at least one mating screw element (threaded port 87) to form the screwed connection (col. 27 lines 1 – 16 and Figs. 1,2,3). Regarding claim 2 , Forte discloses wherein the longitudinal bore (inclined clearance hole 75) is inclined anteriorly in a proximal direction relative to a proximodistal longitudinal axis of the meniscus component (insert 57) (Figs. 2,8b,10). Regarding claim 3 , Forte discloses wherein the longitudinal bore (inclined clearance hole 75) has an insertion opening (larger diameter opening portion of the inclined clearance hole 75) for inserting the screw element (screw 93) and/or for inserting a tool shank for driving the screw element (col. 27 lines 1 – 16 and Figs. 1,2,3). Regarding claim 4 , Forte discloses wherein the insertion opening (larger diameter opening portion of the inclined clearance hole 75) is arranged on an anterior front side of the meniscus component (insert 57) (Figs. 2, 8b, 10). Regarding claim 5 , Forte discloses wherein the insertion opening (larger diameter opening portion of the inclined clearance hole 75) is arranged with a downward offset in a distal direction relative to an anterior edge of the sliding surface (medial and lateral tibial plateau bearing surfaces 58 and 60) (Figs. 1,2,8b,10). Regarding claim 11 , Forte discloses wherein the mating screw element (threaded port 87) is a threaded bore (threaded port 87) (col. 27 lines 1 – 16 and Figs. 1,2,3,8a). Regarding claim 12 , Forte discloses wherein the threaded bore (threaded port 87) is introduced in the fastening portion (underside surface 86, intramedullary stem 91, and fixation stabilizing gussets 92) of the tibia component (tibial base component 84) (Fig. 8a) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-23-aia AIA 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. 07-22-aia AIA Claim s 6 – 9 are rejected under 35 U.S.C. 103 as being unpatentable over Forte (US 5,358,527) , as applied to claim 1 above, and further in view of Yoko et al (US 2019/0110907 A1) . Regarding claims 6 – 9 , as discussed above, Forte discloses the knee-joint endoprosthesis of claim 1. However, Forte is silent regarding (i) [claim 6] wherein the screw element is retained captively in the longitudinal bore when the meniscus component is in a state separate from the tibia component, (ii) [claim 7] wherein the longitudinal bore has a first bore portion, in which the screw element is captively retained, and a second bore portion, which has the insertion opening at a first end and leads into the first bore portion at a second end, (iii) [claim 8] wherein a diameter of the insertion opening is smaller than a diameter of the first bore portion, and (iv) [claim 9] wherein the diameter of the insertion opening is less than 80% [of the diameter of the first bore portion]. As to (i) – (iii) , Yoko teaches, in the same field of endeavor, a knee-joint endoprosthesis (assembly 210) (abstract, paragraph [0135]), and a means for coupling two elements together via a screwed connection comprising a screw element (set screw 402) in a longitudinal bore (bore 406, pocket portion 410, and opening 418 with restriction 412 ; which equates to the inclined clearance hole 75 of Forte), wherein the screw element (set screw 402) is retained captively in the longitudinal bore (bore 406, pocket portion 410, and opening 418 with restriction 412) prior to the two components being coupled (see Fig. 35A; which equates to the state wherein the meniscus component and tibia component of Forte), wherein the longitudinal bore (bore 406, pocket portion 410, and opening 418 with restriction 412) has a first bore portion (pocket portion 410), in which the screw element is captively retained (paragraphs [0174 – 0177] and Figs. 35A,35B), and a second bore portion (opening 418 with restriction 412), which has the insertion opening (opening 418 with restriction 412) at a first end and leads into the first bore portion (pocket portion 410) at a second end (paragraph [0176] and Figs. 35A,35B), wherein a diameter of the insertion opening (diameter at restriction 412) is smaller than a diameter of the first bore portion (diameter at pocket portion 410) (paragraph [0176] and Fig. 35A,35B). It should be understood that Forte and Yoko are known references in the art that teach an knee-joint endoprosthesis and a screwed connection, between components, that includes a screw within a bore (abstract, col. 7 line 36 – col. 8 line 10, col. 21 line 31 – col. 22 line 41, and Figs. 1-12 – Forte ; abstract, paragraphs [0172 – 0178], and Figs. 35A,35B – Yoko); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one screwed type connection for another, and the results of the substitution would have been predictable and resulted in the modified screw element and longitudinal bore of Forte being able to function as intended to couple the insert 57 (i.e., the meniscus component) and the tibial base component 84 (i.e., the tibia component). The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. It should be understood that the prior art makes obvious wherein the modification is such that the inclined clearance hole 75 of Forte is shaped similar to that of the longitudinal bore (bore 406, pocket portion 410, and opening 418 with restriction 412) of Yoko with the screw of Yoko captured therein. As to (iv) , although the modified device of Forte in view of Yoko is silent regarding the exact percentage difference in diameter between the first bore portion and the insertion opening, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Forte in view of Yoko to have the diameter of the insertion opening be less than 80% of the diameter of the first bore portion since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Forte in view of Yoko would not operate differently and would function appropriately with the claimed insertion opening diameter since the first bore portion is intended to have a diameter larger than that of the insertion opening the device . 07-22-aia AIA Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Forte (US 5,358,527) in view of Yoko et al (US 2019/0110907 A1) , as applied to claim 7 above, and further in view of Dees, Jr. et al (US 2011/0295377 A1) . Regarding claim 10 , as discussed above, the combination of Forte in view of Yoko teaches the knee-joint endoprosthesis of claim 7. However, the combination of Forte and Yoko is silent regarding (i) wherein the first bore portion is provided with an insert sleeve, in which the screw element is retained in a radial and axial form fit. As to the above , Dees, Jr. teaches, in the same field of endeavor, a knee-joint prosthesis (orthopedic implant) comprising a tibial component (tibial component 10) and a meniscus component (insert 40), a screwed connection (fastener 70 and threaded portion 26), wherein the screwed connection comprises a screw element (fastener 70) within a first portion (threaded portion 54; which equates to the first portion of the bore of Yoko on the device of Forte) of a bore (angled opening 50) (paragraph [0073] and Fig. 8A) and a mating element (threaded portion 26) assigned to the tibial component (tibial component 10) (paragraph [0075]), wherein the first bore portion (threaded portion 54) is provided with an insert sleeve (interference portion 78) for the purpose of reducing the loosening and pull-out of the fastener 70 (abstract, paragraphs [0065 – 0067], [0073], [0075], [0079 – 0080] and Figs. 8B,14). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Forte in view of Yoko to incorporate a sleeve insert into the first bore portion, based on the teachings of Dees, Jr., for the purpose of reducing the loosening and pull-out of the screw (paragraph [0079] – Dees, Jr.) . 07-22-aia AIA Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Forte (US 5,358,527) , as applied to claim 11 above, and further in view of Evans et al (US 6,428,577 B1) . Regarding claim 13 , as discussed above, Forte discloses the knee-joint endoprosthesis of claim 1. However, Forte is silent regarding (i) wherein the threaded bore is introduced in a threaded sleeve that is at least one of: inserted in the tibia component, and inclined relative to a proximodistal longitudinal axis of the tibia component. As to the above , Evans teaches, in the same field of endeavor, a knee-joint prosthesis (knee prosthesis 110) comprising a tibia component (tray 113) with a distal fastening portion (stem 117) and a proximal connecting portion (proximal surface 114), a meniscus component (insert 121) with a proximal sliding surface (annular surfaces 134) and a distal mating connection portion (distal surface 122), a screwed connection (locking screw 132 and threaded opening 133 in locking plug 127) comprising at least on screw member (locking screw 132) insertable into a longitudinal bore (opening 136 and slot 126) of the meniscus component (insert 121) and at least one screw mating element (threaded bore 130 in locking plug 127 – shown in Fig. 33) assigned to the tibia component (tray 113), wherein the mating element is a threaded bore (threaded bore 130 in locking plug 127) is a introduced in a threaded sleeve (locking member 127) inserted into the tibia component (tray 113) (abstract, col. 10 line 18 – col. 11 line 20, col. 16 line 10 – col. 17 line 17, and Figs. 26 – 37). It should be understood that Forte and Evans are known references in the art that teach an knee-joint endoprosthesis and a screwed connection, between components, that includes a screw within a bore (abstract, col. 7 line 36 – col. 8 line 10, col. 21 line 31 – col. 22 line 41, and Figs. 1-12 – Forte ; abstract, col. 10 line 18 – col. 11 line 20, col. 16 line 10 – col. 17 line 17, and Figs. 26-37 – Evans); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one screwed type connection for another, and the results of the substitution would have been predictable and resulted in the modified screwed connection of Forte being able to function as intended to couple the insert 57 (i.e., the meniscus component) and the tibial base component 84 (i.e., the tibia component). The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143 . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure : Nowakowski (US 2007/0260322 A1), Fabian (US 4,936,853), and Blum (US 7,998,203 B2) teach knee-joint endoprosthesis comprising a tibial component, a meniscus component, and a screwed connection coupling the two components. Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Andrew Restaino/Primary Examiner, Art Unit 3771 Application/Control Number: 18/519,330 Page 2 Art Unit: 3771 Application/Control Number: 18/519,330 Page 3 Art Unit: 3771 Application/Control Number: 18/519,330 Page 4 Art Unit: 3771 Application/Control Number: 18/519,330 Page 5 Art Unit: 3771 Application/Control Number: 18/519,330 Page 6 Art Unit: 3771 Application/Control Number: 18/519,330 Page 8 Art Unit: 3771 Application/Control Number: 18/519,330 Page 9 Art Unit: 3771 Application/Control Number: 18/519,330 Page 10 Art Unit: 3771 Application/Control Number: 18/519,330 Page 11 Art Unit: 3771 Application/Control Number: 18/519,330 Page 13 Art Unit: 3771