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 .
This Office action is in response to the amendment filed 11/25/2025. Claims 1-8, 10, 11 and 13-21 are pending. Claims 15 and 16 remain withdrawn.
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(s) 1-8, 10, 11, 13-14 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bao et al. (U.S. 2008/0109081 A1) in view of Lumauig et al. (U.S. 10,610,387 B2) and Hockett et al. (U.S. 8,753,396 B1).
Concerning claims 1, 2 and 21, Bao et al. disclose a surgical implant comprising: an implant body (see Fig. 28, element 605) comprising a polyaryletherketone polymer material (see par. 0200); and a radio-opaque marker (see par. 0063); wherein the surgical implant is a knee implant (see Fig. 28); and wherein the implant body has an internal or bone-facing surface.
Concerning claim 3, wherein the marker is formed of a metal (see par. 0055).
However, Bao et al. do not explicitly disclose the details of the connection of the marker to the implant such as by seating the marker with an interference fit in a bore formed in the body.
Lumauig et al. disclose the concept of securing radiopaque markers to a medical implant utilizing an interference fit for retaining the marker within an opening or recess of the implant (see Figs. 2A-2B; and col. 12, lines 9-47).
Hockett et al. teach an orthopedic implant having a bore formed in a bone facing interface to receive a radio-opaque marker in an interference fit within the bore (see col. 5, lines 30-42; and Fig. 3, elements 500 and 172) in the same field of endeavor for the purpose of making the implant visible and trackable during imaging procedures.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize an interference fit method of connecting the marker on a bone facing interface, the concepts of which are disclosed by Lumauig et al. and Hockett et al., because doing so is a well known and simple connection mechanism between two components. The positioning of radiopaque markers within knee implants or other orthopedic implants at the bone interface to help track positioning and micromotion using X-rays is well known in the art. Markers have been found to be crucial for precise surgical placement, post-operative monitoring of implant position, and detecting potential issues like implant migration, loosening, or fracture. Positioning at the bone interface would help doctors determine if/how much the implant has loosened and moved away from the bone.
Concerning claim 4, wherein the marker is seated at the base of the bore (see Fig. 2B of Lumauig et al.). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to position the marker at a base of the receiving bore, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Concerning claim 5, wherein the bore has a first diameter and the marker has second diameter which is greater than or equal to the first diameter (see col. 12 – col. 13, line 10 of Lumauig et al.). Table 1 lists the bore diameter and the marker diameter. It is noted that an interference fit would require the marker diameter to be greater than or equal to the bore diameter.
Concerning claim 6, wherein the second diameter is at least 5% bigger than the first diameter – see table 1 of Lumauig et al. in col. 13. It would have been an obvious matter of design choice to form the second diameter at least 5% bigger than the first diameter, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 7, it would have been an obvious matter of design choice to form the first diameter between 0.1 mm and 2 mm, and the second diameter is between 0.1 mm and 2 mm, since such a modification would have involved a mere change in the size of a component.
Concerning claim 8, it would have been an obvious matter of design choice to form the bore with a depth between 1 mm and 2 mm such that the distance from any part of the bore to an exterior surface of the implant body is at least 1 mm, and to form a countersunk bore opening, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Furthermore, Applicant’s attention is directed to Fig. 19 of Lumauig et al. which discloses a countersunk bore opening. The countersunk bore opening would be an obvious modification since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of receiving a marker within a PEEK implant. In re Dailey and Eilers, 149 USPQ 47 (1966). Applicant’s attention is also directed to par. 0055 of Bao et al. which specifically discloses “markers are preferably displaced from the primary articulation and wear surfaces so as to avoid the generation of potentially harmful metallic wear particulate.”
Concerning claims 10 and 11, Bao does not explicitly disclose that there are at least three spaced apart bores formed in the implant body - located proximal to a peripheral part of the implant body, with a marker seated in each bore. However, in par. 0063 Bao notes that multiple markers may be included on the peripheral surface of an implant.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include three spaced apart bores housing a marker, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Concerning claim 13, Bao discloses a femoral knee implant but does not explicitly disclose the location of each marker. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the first bore in a tip of a pillar (see Fig. 29, element 617 of Bao) extending in use away from an articulating portion of the implant body towards the femur, to form a second bore proximal to a tip of a condyle (see Fig. 29, element 616 of Bao) of the implant body; and to form a third bore proximal to a tip of an anterior flange (see Fig. 29, near element 618) of the implant body, since it has been held that rearranging parts of an invention and duplication parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Concerning claim 14, wherein the implant body has two condyles (see Fig. 29, element 616 of Bao). However, Bao does not explicitly disclose that the bores are formed proximal to the tip of each.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the bores proximal to the tip of each condyle, since it has been held that rearranging parts of an invention and duplication parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Concerning claim 17, wherein the second diameter is less than or equal to 11% bigger than the first diameter – see table 1 of Lumauig et al. in col. 13. It would have been an obvious matter of design choice to form the second diameter less than or equal to 11% bigger than the first diameter, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Concerning claim 18, wherein the second diameter is in a range from 7.6% to 10.7% bigger than the first diameter – see table 1 of Lumauig et al. in col. 13. It would have been an obvious matter of design choice to form the second diameter in a range from 7.6% to 10.7% bigger than the first diameter, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 19, it would have been an obvious matter of design choice to form the first diameter between 0.3 mm and 0.6 mm, and the second diameter between 0.3 mm and 0.7 mm, since such a modification would have involved a mere change in the size of a component.
Concerning claim 20, it would have been an obvious matter of design choice to form the bore with a depth of approximately 1.5 mm such that the distance from any part of the bore to an exterior surface of the implant body is at least 2 mm, and to form a countersunk bore opening, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Furthermore, Applicant’s attention is directed to Fig. 19 of Lumauig et al. which discloses a countersunk bore opening. The countersunk bore opening would be an obvious modification since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of receiving a marker within a PEEK implant. In re Dailey and Eilers, 149 USPQ 47 (1966). Applicant’s attention is also directed to par. 0055 of Bao et al. which specifically discloses “markers are preferably displaced from the primary articulation and wear surfaces so as to avoid the generation of potentially harmful metallic wear particulate.”
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bao et al. (U.S. 2008/0109081 A1) in view of Lumauig et al. (U.S. 10,610,387 B2) and Hockett et al. (U.S. 8,753,396 B1) as applied to claims 1 and 3 above, further in view of Sack (U.S. 2020/0188128 A1) as noted on the IDS filed 02/21/2024.
Bao et al. in view of Lumauig and Hockett disclose the invention substantially as described above except for explicitly stating that the metal material to form the radiopaque marker is tantalum.
Sack teaches an orthopedic implant having a tantalum marker (see par. 0167 and see pars. 0178-0183) in the same field of endeavor for the purpose of making PEEK components visible via imaging techniques.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the metallic markers of tantalum, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Response to Arguments
Applicant's arguments filed 11/25/2025 have been fully considered but they are not persuasive. In response to Applicant’s argument that Lumauig is nonanalogous art, it has been held that the determination that a reference is from a nonanalogous art is twofold. First, we decide if the reference is within the field of the inventor's endeavor. If it is not, we proceed to determine whether the reference is reasonably pertinent to the particular problem with which the inventor was involved. In re Wood, 202 USPQ 171, 174. In this case, Lumauig is within the field of using radiopaque markers to determine implant positioning. The concept of incorporating radiopaque markers within an implant – bioresorbable or PEEK, to allow medical professionals to see and track the implant during surgery and after, ensuring precision placement, monitoring for migration/malposition Ing, checking for wear/biodegradation, and verifying proper fit using x-ryas, CT scans, or fluoroscopy, is known to improve surgical success, reduce risk, and enhance patient outcomes.
Additionally, Lumauig teaches the use of radiopaque markers in stents to make them highly visible under x-ray or fluoroscopy, allowing doctors to precisely guide, position, and confirm the stent’s placement thereby improving patient safety and outcomes. This is similar to the problem to be solved regarding the use of radiopaque markers in femoral knee implants. The use of markers in knee implant also serve to help surgeons precisely position components during surgery, confirm correct placement with x-rays, track implant migration and wear over time, and evaluate long-term fixation and stability. In both cases the markers act as visible landmarks, enabling accurate measurement, alignment, and detection of loosening or failure.
In response to Applicant’s argument that there is no suggestion to combine the references, the Examiner recognizes that references cannot be arbitrarily combined and that there must be some reason why one skilled in the art would be motivated to make the proposed combination of primary and secondary references. In re Nomiya, 184 USPQ 607 (CCPA 1975). However, there is no requirement that a motivation to make the modification be expressly articulated. The test for combining references is what the combination of disclosures taken as a whole would suggest to one of ordinary skill in the art. In re McLaughlin, 170 USPQ 209 (CCPA 1971). References are evaluated by what they suggest to one versed in the art, rather than by their specific disclosures. In re Bozek, 163 USPQ 545 (CCPA) 1969. In this case, both Lumauig and Bao address the addition of radiopaque markers to medical devices thereby allowing doctors to precisely see their location, orientation, and contour on X-rays/CT scans for accurate placement and follow-up, ensuring proper function and patient safety. It is known that the markers can be permanent or temporary, and integrate into the device using different techniques for seamless performance. Using the teaching of Lumauig et al. and Hockett et al. to find the best position and technique for radiopaque integration would be desirable to one of ordinary skill in the art. All references are directed to the concept of incorporating radiopaque markers within an implant.
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 ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773