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.
This second non-final rejection has been submitted since the previous final rejection filed on 3/24/26 failed to reject the claims 16 and 17.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim 17 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20070224116 A1 to Chandrasekaran et al. (Chandrasekaran).
Chandrasekaran discloses:
Regarding claim 17:
A medical instrument, comprising means for simultaneously providing a radiopaque and an ultrasound-echogenic marking, said means comprising a porous metal layer (35; ¶0053 indicates 35 is metal and further that it includes pores 40) wherein the metal of the layer provides the radiopacity (¶0061) and the porosity of the layer provides the ultrasound-echogenicity (inherent function of the porosity of the layer 35 due to its porosity; the applicants disclosure references US 6106473 to Violante when discussing the echogenicity and this reference indicates pores or bubbles provides the echogenic feature in column 3, lines 1-10).
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 and 16 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), wherein the medical instrument/particles have the shape of hollow spheres (¶0113).
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 non-metallic particles comprise 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).
Regarding claim 16:
Chandrasekaran discloses:
The medical instrument according to claim 3, wherein the region comprises Nitinol (¶0072).
Response to Arguments
Applicant's arguments filed 5/26/26 have been fully considered but they are not persuasive.
Regarding the 35 USC 103 rejection of claim 1:
The applicant argues that the references Chandrasekaran and Lye fail to disclose that the non-metallic particles have a hollow sphere shape (pages 6-7). However, as indicated above the Chandrasekaran does indicate the particles can be hollow spheres (¶0113) and for this reason the above rejection reads on the claims.
Regarding the 35 USC 112b claim rejection:
The applicant’s amendments to the claims have addressed the previous claim rejections and for this reason it is withdrawn.
Conclusion
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
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