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 and 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lombardi et al. (WO97/37616).
Regarding claims 1, 3-4 and 7, 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).
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”.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lombardi et al. (WO97/37616) as applied to claims 1 and 6-8 above and further in view of Gan et al. (USPGPub 2011/0008407).
Regarding claim 2, the teachings of Lombardi are as shown above. Lombardi fails to teach wherein the marker body comprises a coating as claimed. However, Gan teaches that it is known to coat medical devices with an oxide coating comprising silver for the purpose of providing active agents to the body via the coating [0024-0029] where the coating thickness reads on that claimed. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to apply the coating of Gan to the medical devices of Lombardi so that they may provide the same active agents to the human body as those provided in the invention of Gan.
Response to Arguments
As relates to the applicant’s arguments, the examiner acknowledges the general differences in shape between the claimed product and the shape of the product of Lombardi. However, as previously stated, 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).
As relates to new and unexpected results, the applicant argues that because of the shape of the product is as provided, the likelihood of the formation of corrosion products is eliminated. However, this is due to the manner in which the applicant chooses to break away the product prior to coating the edge of the product with an oxide as the rest of the surface is coated. As such, if formed in the manner claimed, the product of the current claims results in a product with an uncoated portion that may be subject to corrosion more so than the remainder of the implant. However, the current claims are not manufacturing claims. They are instead product claims. The product itself is not claimed to have an uncoated portion devoid of oxide and it is not a requirement of the product claims that they be manufactured by any particular process so long as they are structurally provided as claimed. As such, the product of the current claims does not have coated and uncoated portions that vary from the current invention. In fact, claim 2 requires that the prior art product be coated, seemingly entirely, which would not leave a product that would seemingly achieve benefit from the shape provided because the surface in question would already be oxidized. As such, the product of claim 2 and that of Lombard in view of Gan would be the same with the exception of the shape which would provide no new or unexpected result from the provided shape due to the presence of an oxide coating.
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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/ANDREW J BOWMAN/Examiner, Art Unit 1717