DETAILED ACTION
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 .
Response to Amendment
The Amendment filed July 06, 2026 has been entered. Claims 1-12 and 14-17 remain pending in the application.
Response to Arguments
Applicant’s arguments, see Remarks pages 5-6, filed July 06, 2026, with respect to the rejection(s) of claims 1-3 and 5-17 under section 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 Therefore, the rejection has been withdrawn.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 Boyle et al. (US 2003/0028210 A1) (“Boyle”).
Claim Rejections - 35 USC § 102
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.
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.
Claims 1-5, 9-12 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boyle et al. (US 2003/0028210 A1) (“Boyle”).
Regarding claim 1, Boyle discloses A medical device having at least one multilayer structure comprising (Abstract and entire document):
at least one metal layer (FIG. 7 and [0031], metal layer 72); and
at least one elastomer material layer (FIG. 7 and [0031], elastomer layer 74);
wherein the medical device comprises a balloon catheter having a balloon that includes the at least one multilayer structure (FIG. 7 and [0031], balloon catheter).
Regarding claim 2, Boyle discloses The medical device according to claim 1, wherein the at least one elastomer material layer comprises an elastomer material selected from the group consisting of elastomers, thermoplastic elastomers, thermoplastic polyamide elastomers, thermoplastic copolyester elastomers, olefin-based thermoplastic elastomers, thermoplastic styrene block copolymers, urethane-based thermoplastic elastomers, olefin-based thermoplastic vulcanizates, olefin-based crosslinked thermoplastic elastomers, natural rubber vulcanizates, synthetic rubber vulcanizates, styrene-butadiene rubber, butadiene rubber, acrylonitrile-butadiene rubber, butyl rubber, ethylene- propylene-diene rubber, chloroprene rubber, polyisoprene rubber, polyalkylsiloxanes, polydimethylsiloxane, silicone rubbers, silicone elastomers, methyl silicone, vinyl methyl silicone, phenyl vinyl methyl silicone, phenyl-modified silicone, fluoroalkyl silicone, fluoro vinyl methyl silicone, and mixtures of at least two of the aforementioned elastomer materials ([0031]).
Regarding claim 3, Boyle discloses The medical device according to claim 1, wherein the at least one metal layer includes at least one metal selected from the group consisting of gold, platinum, indium, tin, copper, silver, gallium and alloys of at least two of the aforementioned metals ([0005]).
Regarding claim 4, Boyle discloses The medical device according to claim 1, wherein the at least one elastomer material layer has a layer thickness of 0.0001 mm to 0.2 mm, and the at least one metal layer has a layer thickness of < 150 nm ([0026]).
Regarding claim 5, Boyle discloses The medical device according to claim 1, wherein the at least one metal layer directly covers the at least one elastomer material layer (FIG. 1-6 and associated paragraphs, see at least FIG. 3, tube catheter then metal balloon).
Regarding claim 9, Boyle discloses The medical device according to claim 1, wherein the at least one multilayer structure further includes at least one additional elastomer material layer that directly covers the at least one metal layer (FIG. 7, elastomer directly covers the metal layer, FIG. 1-6, additional catheter body interpreted as the first layer and the outer elastomer coating is the additional layer).
Regarding claim 10, Boyle discloses The medical device according to claim 1, wherein the at least one multilayer structure or the at least one metal layer has a varying surface morphology (FIG. 7, [0008], deposition, [0030]).
Regarding claim 11, Boyle discloses The medical device according to claim 1, wherein the at least one multilayer structure forms part of a surface of the medical device or is integrated in a wall of the medical device (FIG. 7).
Regarding claim 12, Boyle discloses The medical device according to claim 1, wherein the medical device is curved (FIG. 7).
Regarding claim 15, Boyle discloses A process for producing the medical device according to claim 1, the process comprising the steps of: a) producing the at least one multilayer structure; and b) transferring the at least one multilayer structure to a substrate, with formation of the substrate provided with the at least one multilayer structure ([0032], [0036]).
Regarding claim 16, Boyle discloses A multilayer structure comprising (Abstract and entire document):
at least one metal layer; and at least one elastomer material layer (FIG. 7 and [0031], metal layer 72, elastomer layer 74).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 6-8, 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over 0Boyle in view of Lo Shao-Hsiang et al. “A Wireless Parylene-Based Cardiovasuclar Pressure Sensor with MXene Film”, 2019 20th International conference on solid-state sensors, actuators and microsystems & eurosensors XXXIII (Transducers & Eurosensors XXXIII), IEEE, 23 June 2019 (2019-06-023), pages 2231-2234, (“Lo Shao-Hsiang”).
Regarding claim 6, Boyle discloses The medical device according to claim 1, Boyle fails to disclose wherein at least one adhesion layer is formed between the at least one metal layer and the at least one elastomer material layer.
However, in the same field of endeavor, Lo Shao-Hsiang teaches wherein at least one adhesion layer is formed between the at least one metal layer and the at least one elastomer material layer (FIG. 1-3 and page 2232, left-hand column, line 17 - right-hand column, line 17; PDMS layer, copper layer, Cr/Au layer; the Cr/Au layer as the adhesion layer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Boyle to include wherein at least one adhesion layer is formed between the at least one metal layer and the at least one elastomer material layer as taught by Lo Shao-Hsiang to integrate a flexible sensor into medical devices (conclusion/introduction).
Regarding claim 7, Boyle as modified discloses The medical device according to claim 6, Boyle as modified further discloses wherein the at least one metal layer covers the at least one adhesion layer directly and completely and the at least one adhesion layer covers the at least one elastomer material layer directly and only in regions (Lo Shao-Hsiang FIG. 1-3 and page 2232, left-hand column, line 17 - right-hand column, line 17; PDMS layer, copper layer, Cr/Au layer; wherein the copper intermediate layer covers only parts of the PDMS layer and is in turn covered in full by the Cr/Au layer).
Regarding claim 8, Boyle discloses The medical device according to claim 6, Boyle as modified further discloses wherein the at least one adhesion layer includes at least one material selected from the group consisting of titanium, aluminum, chromium, and mixtures of at least two of the aforementioned materials (Lo Shao-Hsiang FIG. 1-3 and page 2232, left-hand column, line 17 - right-hand column, line 17; PDMS layer, copper layer, Cr/Au layer; the Cr/Au layer as the adhesion layer).
Regarding claim 14 and 17, Boyle discloses The medical device according to claim 1, wherein the at least one multilayer structure defines a sensor unit of the medical device.
However, in the same field of endeavor, Lo Shao-Hsiang teaches wherein the at least one multilayer structure defines a sensor unit of the medical device (FIG. 2 And 5 showing curvature and integration into a catheter based system; Abstract, “implantable wireless sensors for monitoring blood pressure”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Boyle to include wherein the at least one multilayer structure defines a sensor unit of the medical device as taught by Lo Shao-Hsiang to integrate a flexible sensor into medical devices (conclusion/introduction).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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/JOSEPH A TOMBERS/ Examiner, Art Unit 3791
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