DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Objections
Claim 1 is objected to because of the following informalities: line 1 should be amended to -A medical instrumentcomprising: a porous metal layer -. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 7 is 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.
Regarding claim 7:
The claim is unclear because of the limitation “the metal layer comprises glass” in lines 1-3. This limitation is unclear because it does not establish the glass as part of the non-metallic particles established in claim 1 (on which this claim is dependent) raising a question of if the glass is within the scope of the non-metallic particles or is a separate structure. For the sake of examination, the office has interpreted the glass as part of the non-metallic particles based on the previous claims and the specification. however, the applicant should amend the claim to clarify.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20070224116 A1 to Chandrasekaran et al. (Chandrasekaran) in view of US 20050070989 A1 to Lye et al. (Lye).
Regarding claim 1:
Chandrasekaran discloses:
A medical instrument (10; ¶0068 “catheters”; figure 1), wherein it comprises a porous metal layer (35; ¶0053 indicates 35 is metal and further that it includes pores 40).
Chandrasekaran fails to disclose:
Wherein the porous metal layer is a sintered metal layer comprising non-metallic particles of a ceramic material permanently embedded within the sintered metal layer to enhance the ultrasound echogenicity thereof.
Lye teaches:
A medical instrument (10; stent as indicated in ¶0049) that includes multiple layers (12 and 14). Layer 12 can be porous and layer 14 can be non-porous (¶0049). Further, the reference teaches the porous layer can be made from sintered metal powders (¶0006 and 0038) that can include a sacrificial material made of glass (¶0015). Further, the reference teaches a portion of the sacrificial material/glass is removed for a therapeutic agent (¶0007 and 0016).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chandrasekaran to further include the porous metal layer made of sintered metal that includes particles of ceramic/glass and a therapeutic agent as taught by Lye for the purpose of adding a therapeutic agent to the medical device since the therapeutic agents enhance the efficacy of the medical device (¶0005). In regards to the function of “enhance the ultrasound echogenicity thereof”, this is a byproduct of the ceramic material/glass added to the porous metal layer incorporated from Lye.
Regarding claim 2:
Chandrasekaran discloses:
The medical instrument according to claim 1, wherein the metal layer comprises or consists of gold (¶0060 indicates that the metal oxide or metal material of 35 can be gold).
Regarding claim 3:
Chandrasekaran discloses:
The medical instrument according to claim 1, wherein the metal layer is applied to a region (30) of the medical instrument, wherein the region comprises a metal or an alloy selected from the group consisting of Pt, Ir, Ta, Pd, Ti, Fe, Au, Mo, Nb, W, Ni, Ti, MP35N, 316L, 301, 304 and Nitinol (the reference indicates in ¶0061 that the metal layer 30 (metal or metal oxide layer) can be made from titanium/ti).
Regarding claim 4:
Chandrasekaran discloses:
The medical instrument according to claim 3, wherein the region (30) is a metal carrier foil applied to the medical instrument (layer 30 can be a foil since ¶0065 indicates the outer region of the medical device can be any thickness which would include foil thickness).
Regarding claim 5:
Chandrasekaran discloses:
The medical instrument according to claim 1, wherein the metal layer has radiopaque and/or ultrasound-echogenic properties (¶0061 indicates that several of the materials outlined for the outer layer 30 can be radiopaque and the metal layer 35 is made from the same material as outlined in ¶0060 indicating that it is also radiopaque).
Regarding claim 6:
Chandrasekaran discloses:
The medical instrument according to claim 1, comprising a catheter, a guiding sheath, a needle or a medical electrode (¶0068 indicates the instrument can be a catheter).
Regarding claim 7:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Chandrasekaran and Lye:
The medical instrument according to claim 1, wherein the metal layer comprises glass (see the glass particles of Lye incorporated into Chandrasekaran).
Regarding claim 8:
Chandrasekaran discloses:
The medical instrument according to claim 1, wherein the metal layer has a layer thickness of 5 pm to 250 pm, preferably 50 pm to 150 pm (¶0065 indicates the metal oxide or metal material having pores 35 can have an average thickness of 1 to 50 micros (1-50 µm) which overlaps with the range of the claim).
Response to Arguments
Applicant’s arguments, see remarks, filed 12/08/25, with respect to the rejection(s) of claim(s) 1-8 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chandrasekaran and Lye.
Regarding the 35 USC 112(b) claim rejections:
The applicant’s amendments to the claims have addressed the previous claim rejections and for this reason they are withdrawn. However, a new set of rejections have been made above based on the applicant’s amendments to the claims.
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 WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783