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).
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.
Regarding claims 3-4 and 12, 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.
Regarding claim 6, the teachings of Lombardi are as shown above. Lombardi 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 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 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 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.
Regarding claim 10, 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.
Response to Arguments
The applicants argues that Lombardi fails to teach the formation of a passivation layer of an oxide of the marker body material. However, it is noted that it is a material property of tantalum that it readily oxidizes in air or environments comprising oxygen. As such, even prior to implantation in the body the tantalum markers would be expected to have a natural oxide layer present on them and even if it were prevented somehow prior to implantation, which is not taught by Lombardi, it would be expected to be present after implantation. As such, the prior art stills read upon the currently claimed invention.
Further the applicant Gan would not lead one to provide a passivation layer on a medical implant. However, Gan is no longer applied herein and as such arguments related to Gan are moot.
Further the applicant argues general advantages to the shape and scale modifications of the markers but none of the listed advantages would reasonably be considered unexpected results and are not argued as such by the applicant. It is specifically the burden of the applicant to show that the results of their modifications to the prior art product provide unexpected results. Otherwise, the Court has held that in general changes to shape and size of a prior art product are not capable of overcoming a prima facie case of obviousness. Further still, the primary shape related argument pointed to by the applicant states that the unexpected result arises from cutting the marker from a tube in order to provide a particular shape. However, the claims do not require this tube cutting step. Instead, the claims require that the product have a “curved form”, which the prior art product already comprises with its curved edges. As such, even the result argued is not truly claimed in the manner argued.
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 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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/ANDREW J BOWMAN/Examiner, Art Unit 1717
/Dah-Wei D. Yuan/Supervisory Patent Examiner, Art Unit 1717
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