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 .
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-4 and 6-12 and is/are rejected under 35 U.S.C. 103 as being unpatentable over Lombardi et al. (WO97/37616) in view of Schlun (WO2009/030748).
Regarding claims 1, 7 and 11, Lombardi teaches xray markers that are shaped similarly to those claimed (see Fig. 8A). Lombardi fails to teach the exact shape claimed. However, the Court has long held that changes in shape of a prior art product, in the absence of a new and unexpected result arising from said change in shape are unpatentable over the provided prior art shape for the same product. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Further, Lombardi teaches wherein the markers may be made of tantalum (claim 17) wherein it is noted that tantalum readily oxidizes in air alone. Therefore, in the absence of a teaching in Lombardi (which does not seem to be present), it would be expected that the tantalum markers of Lombardi would also comprise a tantalum oxide layer on the surface formed through natural passivation. Further it is noted that as shown in Figs. 8A-B, the marker of Lombardi is thinner than it is wide. Lombardi fails to teach wherein the marker excludes the presence of holes or cutouts, which is pertinent because the method of attachment of Lombardi uses the holes of Lombardi to tie the markers to the implants. However, Schlun teaches that markers may be bonded to medical devices by welding. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to weld the markers of Lombardi as described by Schlun as a simple substitution of one attachment method of markers to medical devices wherein the results of the substitution would have been expected to be successful based upon the teachings of Schlun attaching similar markers to similar devices in the same way.
Regarding claims 3-4 and 12, Lombardi teaches xray markers that are shaped similarly to those claimed (see Fig. 8A). Lombardi in view of Schlun fails to teach the exact shape claimed. However, the Court has long held that changes in shape of a prior art product, in the absence of a new and unexpected result arising from said change in shape are unpatentable over the provided prior art shape for the same product. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Further, Lombardi teaches wherein the markers may be made of tantalum (claim 17) wherein it is noted that tantalum readily oxidizes in air alone. Therefore, in the absence of a teaching in Lombardi in view of Schlun (which does not seem to be present), it would be expected that the tantalum markers of Lombardi would also comprise a tantalum oxide layer on the surface formed through natural passivation. Further it is noted that as shown in Figs. 8A-B, the marker of Lombardi in view of Schlun is thinner than it is wide.
Regarding claim 6, the teachings of Lombardi in view of Schlun are as shown above. Lombardi in view of Schlun fails to teach wherein the web portion is of the thickness claimed. However, those of ordinary skill in the art would readily recognize that the thickness of the web would directly relate to the amount of material employed in the manufacture of the xray markers of Lombardi in view of Schlun and changing the amount metal in the web portion connecting the xray markers to be separated would be done in a way that balances both the durability of the part before it is separated and the ability to break it as well as just a general control over the amount of material employed. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to control the width of the web of Lombardi in view of Schlun in order to control the mechanical properties of the part to be separated and the amount of material to be used in the overall manufacture of the xray markers.
Regarding claim 8, the medical devices shown in the figures of Lombardi would be considered as those to comprise a “framework”.
Regarding claims 9, Lombardi in view of Schlun teaches xray markers that are shaped similarly to those claimed (see Fig. 8A). Lombardi in view of Schlun fails to teach the exact shape claimed. However, the Court has long held that changes in shape of a prior art product, in the absence of a new and unexpected result arising from said change in shape are unpatentable over the provided prior art shape for the same product. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Further, Lombardi teaches wherein the markers may be made of tantalum (claim 17) wherein it is noted that tantalum readily oxidizes in air alone. Therefore, in the absence of a teaching in Lombardi in view of Schlun (which does not seem to be present), it would be expected that the tantalum markers of Lombardi would also comprise a tantalum oxide layer on the surface formed through natural passivation. Further it is noted that as shown in Figs. 8A-B, the marker of Lombardi in view of Schlun is thinner than it is wide.
Regarding claim 10, Lombardi in view of Schlun teaches xray markers that are shaped similarly to those claimed (see Fig. 8A). Lombardi in view of Schlun fails to teach the exact shape claimed. However, the Court has long held that changes in shape of a prior art product, in the absence of a new and unexpected result arising from said change in shape are unpatentable over the provided prior art shape for the same product. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Further, Lombardi teaches wherein the markers may be made of tantalum (claim 17) wherein it is noted that tantalum readily oxidizes in air alone. Therefore, in the absence of a teaching in Lombardi in view of Schlun (which does not seem to be present), it would be expected that the tantalum markers of Lombardi would also comprise a tantalum oxide layer on the surface formed through natural passivation. Further it is noted that as shown in Figs. 8A-B, the marker of Lombardi is thinner than it is wide.
Response to Arguments
The applicants’ arguments are generally moot as they are drawn to newly provided claim amendments wherein the examiner has provided new art herein to address those arguments.
However, it is noted that the applicant further argues against Lombardi in general wherein the applicant argues the significance of their shape. The examiner agrees that the shape is different from that of the prior art, but the applicant does not show that the shape provides a new and unexpected result over the previously provided shape. The applicant argues that inwardly recessed breaking points avoids potentially irregular breaking surface. However, as previously described by the examiner and acknowledged by the applicants in the current arguments, Lombardi teaches rounding the edges and as such the potential for irregular edges is alleviated. The technical advantage provided by the particular shape in preventing exposure to irregular edges is not an advantage over Lombardi.
As relates to the reduction in galvanic corrosion explained, the applicant argues that the current invention because of the moving of potentially irregular surfaces away from the edge of the marker allows the marker to be placed in a manner so as to reduce galvanic corrosion. However, again, because Lombardi does away with irregular edges before use, this is not a technical advantage over Lombardi.
As relates to the preservation of radiopaque material, the added teachings of Schlun show that Lombardi may still preserve all of the radiopaque material of his invention while also being capable of being able to perform its intended function.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J BOWMAN whose telephone number is (571)270-5342. The examiner can normally be reached Mon-Sat 5:00AM-11:00AM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dah-Wei Yuan can be reached at 571-272-1295. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J BOWMAN/Examiner, Art Unit 1717
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