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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 22, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on April 22, 2024 are accepted.
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 1-3 and 5-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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 1, Lo Shao-Hsiang discloses A medical device having at least one multilayer structure comprising (Abstract and entire document and FIG. 1 and page 2231, right- hand column, lines 30-41) “parylene C substrate with a galvanic copper induction coil and a capacitor, and a multi-layer MXcne film located between two electrodes of the capacitor”):
at least one metal layer; and 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).
Regarding claim 2, Lo Shao-Hsiang 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 (FIG. 1-3 and page 2232, left-hand column, line 17 - right-hand column, line 17; PDMS layer, copper layer, Cr/Au layer).
Regarding claim 3, Lo Shao-Hsiang 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 (FIG. 1-3 and page 2232, left-hand column, line 17 - right-hand column, line 17; PDMS layer, copper layer, Cr/Au layer).
Regarding claim 5, Lo Shao-Hsiang 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. 1-3 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 6, Lo Shao-Hsiang discloses The medical device according to claim 1, 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).
Regarding claim 7, Lo Shao-Hsiang discloses The medical device according to claim 6, 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 (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, Lo Shao-Hsiang discloses The medical device according to claim 6, 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 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 9, Lo Shao-Hsiang 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. 1-3 and page 2232, left-hand column, line 17 - right-hand column, line 17; PDMS layer, copper layer, Cr/Au layer, FIG. 3 showing additional elastomer materials).
Regarding claim 10, Lo Shao-Hsiang 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. 1-4 and page 2232, left-hand column, line 17 - right-hand column, line 17; PDMS layer, copper layer, Cr/Au layer, FIG. 3 showing additional elastomer materials and deposition processes all resulting in varying surface morphology as shown in FIG. 4).
Regarding claim 11, Lo Shao-Hsiang 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 (Abstract, “implantable wireless sensors for monitoring blood pressure”).
Regarding claim 12, Lo Shao-Hsiang discloses The medical device according to claim 1, wherein the medical device is curved (FIG. 2 And 5 showing curvature and integration into a catheter based system).
Regarding claim 13, Lo Shao-Hsiang discloses The medical device according to claim 1, wherein the medical device comprises a balloon catheter having a balloon that includes the at least one multilayer structure (FIG. 2 And 5 showing curvature and integration into a catheter based system).
Regarding claim 14, Lo Shao-Hsiang discloses The medical device according to claim 1, 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”).
Regarding claim 15, Lo Shao-Hsiang 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 (Fabrication section and see at least rejection of claim 1, above).
Regarding claim 16, Lo Shao-Hsiang discloses A multilayer structure comprising (Abstract and entire document and see at least FIG. 1 and page 2231, right- hand column, lines 30-41) “parylene C substrate with a galvanic copper induction coil and a capacitor, and a multi-layer MXcne film located between two electrodes of the capacitor”):
at least one metal layer; and 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).
Regarding claim 17, Lo Shao-Hsiang discloses The multilayer structure according to claim 16, wherein the multilayer structure comprises a sensor unit (FIG. 2 And 5 showing curvature and integration into a catheter based system; Abstract, “implantable wireless sensors for monitoring blood pressure”).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lo Shao-Hsiang.
Regarding claim 4, Lo Shao-Hsiang discloses The medical device according to claim 1, Lo Shao-Hsiang fails to explicitly disclose 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.
However, Lo Shao-Hsiang discloses (FIG. 1-3 and page 2231-2332, “An exemplary sensor comprises a PDMS layer 30 µm thick, a copper layer 10 µm thick and a chromium/gold (Cr/Au) layer with a thickness of 20 nm/200 nm”)
It would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal thicknesses, including 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. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the thickness is such, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
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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