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 .
Claim Objections
Claim 31 objected to because of the following informalities: “an ultrasound senor” in line 2 should read “an ultrasound sensor”. Appropriate correction is required.
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(s) 21, 23-25, 27, 29-30, 32, 36 and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pomeranz et al. (US 5345936).
As to claim 21 Pomeranz et al. discloses a medical device (apparatus for mapping the wall of a chamber of the heart; see abstract) comprising; a first polymer substrate (67 elongate arms) having a first surface coupled to a conductive layer comprising a conductive trace electrically coupled to an electrode pad (72) that is exposed through a second surface of the first polymer substrate via an opening in the first polymer substrate (see 82 of Fig. 5, col. 4,lines 43-65).
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As to claim 23, fluid is provided to expand the lumens of the arms (see col. 7, lines 28-27).
As to claims 24 and 25, the substrate forms a soft-electronic beam of a plurality of beams forming a 3-D structure (See Fig. 1 and 3).
As to claim 27, the device is configured to detect signals at a biological tissue when the electrode pad is in direct contact.
As to claim 29, the device provides signals detected at the electrode pad to a catheter which transmits to an external device (See col. 6, lines 1-16).
As to claim 30, the conductive trace is coupled to a flexible printed circuit board coupled to the first polymer substrate (see col. 4,lines 54-60).
As to claim 32, the component is coupled to the substrate (see col. 6, lines 38-55).
As to claim 36, Pomeranz et al. disclose a method of positioning a medical device within the body of a patient where the device comprises a first polymer substrate (67 elongate arms) having a first surface coupled to a conductive layer comprising a conductive trace electrically coupled to an electrode pad (72) that is exposed through a second surface of the first polymer substrate via an opening in the first polymer substrate (see 82 of Fig. 5, col. 4,lines 43-65). The device passes a signal between the electrode pad and tissue.
As to claim 40, the structure is the atrium of a heart of the patient through septal puncture (see col. 3,lines 30-45).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 22, 26, 28, 31, 33-35, 37 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pomeranz et al. (US 5345936) as applied to claims 22 and 36 above in view of Klinker et al. “Balloon catheters with integrated stretchable electronics for electrical stimulation, ablation, and blood flow monitoring”.
The teachings of Pomeranz et al. as applied to claim 22 are as stated above.
Pomeranz et al. fail to teach a second polymer substrate and forming a first cavity between the first polymer substrate and the second substrate as required by claim 22.
Klinker et al. teaches a balloon catheter formed of two polymer films sealed at their edges defining an internal cavity for inflation (see fig. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the medical device of Pomeranz et al. to include the second polymer substrate to form the laminated film in order to improve flexibility and provide protection and support. One would have been motivated to do so since both are directed to balloon catheters carrying electronics for electrical stimulation.
As to claim 26, Klinker discloses the use of polyurethane.
As to claim 28 and 31, Klinker disclose the use of flow and thermal sensors.
As to claim 33, kKlinker teaches multiple sensors being used.
As to claims 34 and 35, the conductive pattern has a zig-zag pattern (see Fig. 2 of Klinker).
As to claim 37, Klinker teaches the second polymer substrate forming a cavity for expanding (see Fig 3 – inflated balloon) and adjusting fluid based on signal.
As to claim 39, Klinker teaches monitoring using force and temperature sensors ( see Fig. 4).
Conclusion
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/CACHET I. PROCTOR/
Examiner
Art Unit 1715
/CACHET I PROCTOR/ Primary Examiner, Art Unit 1715