I. ACKNOWLEDGEMENTS
This Office Action addresses U.S. Application No. 18/857239 (“’239 Application” or “instant application”). Based upon a review of the instant application, the actual filing date of the instant application is October 16, 2024.
II. STATUS OF CLAIMS
Claims 1-16 were filed with the application
a. Claim 1-16 (“Pending Claims”).
b. Claim 1-160are examined (“Examined Claims”)
III. PRIORITY AND CONTINUING DATA
The ‘239 application is a national stage entry of PCT/EP2023/059602, filed 4/13/2023, which claims the benefit of provisional application 63/332763, filed 4/20/2023. Because the earliest possible effective filing date is after March 16, 2013, the first to file provision of the AIA , apply to this proceeding.
IV. REJECTIONS UNDER 35 USC 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
As to claim 6, the background section states that the flexible circuit is wrapped in a spiral pattern around the distal core member. However, the disclosure shows that the distal conductive members are spirally wound. It s unclear whether this is meant to the support for claim 6 or not or just the reference in the background section. Clarification is required.
V. ART REJECTION
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.
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.
Claims 1, 2, 4, 6-13 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuisma US PG PUB 20190133527.
As to claim 1, Kuisma shows a flexible elongate catheter 120 (see paragraph [0049]) having a distal portion (to the left in figure 1a). The distal portion has a core member, i.e. the catheter body, and a sensor 150 (see paragraph [0070], [0072], and [0073]. The catheter also has a proximal portion (to the right in figure 1a) that has electrical conductors 130, and a flex circuit 100 positioned around a majority of the length of distal portion of the catheter, where the circuit has a distal portion coupled to the sensor and a proximal portion coupled to the conductors 130 such that the sensor and conductors are electrically connected by the circuit (see figure 1c and 5c).
As to claim 2, the circuit board is made of a polymer base with conductive traces 110 (see paragraph [0051]).
As to claim 4, the circuit includes a distal conductive pad 155 formed on the polymer base at the distal portion of the circuit (see figures 1c), a proximal conductive pad 1154 at a proximal portion of the circuit, where the conductive traces 110 are connected to both pads 155 and pads 115, where the proximal conductor 130 is connected the pads 115 and where the sensor is connected to pads 155.
As to claim 6, this claim amounts to a product by process claim, which is met if the end result is the same. See MPEP 2113. At present, the method of wrapping the circuit of Kuisma results in the same end resulting structure as a spirally wound circuit. Hence, the claim is anticipated.
As to claim 7, the circuit is rolled in a cylindrical configuration around the catheter.
As to claim 8, the circuit extends parallel to the longitudinal axis of the catheter (see figures 1 and 5).
As to claim 9, the flex circuit is formed prior to being positioned around the distal core member.
As to claim 10, the circuit is a sheet, having a trace across the sheet, which is then wrapped on the distal core member.
As to claim 11, the flex circuit can be considered to be positioned at the intersection of the proximal and distal portions and therefore is positioned around both.
As to figure 12, the flex circuit has a polymer coating, i.e. the heat shrink tubing in paragraph [0083]).
As to claim 13, the coating directly contacts the circuit 100.
As to claim 16, the Examiner notes that the catheter Kuisma has all of the recited structure. In addition, it is capable of acting like a guidewire. Hence, it meets the claim.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kuisma in view of Pagliuso et al US PG PUB 2023/0363660.
As to claim 3, Kuisma does not show the coating. However, Pagliuso teaches in paragraph [0054] that flexible circuit used on pressure sensing catheters are typical coated with a polymer to protect the circuit. As such, it would have been obvious to modify Kuisma combination to use such a coating, to protect the circuits in Kuisma
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kuisma in view of Salahieh at al US PG PUB 2017/0042614.
As to claim 5, the circuit of Kuisma is attached by an external adhesive tube. The adhesive is not between the circuit and the catheter. However, Salahieh teaches in paragraph [0104] using an adhesive to connect a wrapped flex circuit to its substrate. Hence, it would have been obvious to modify Kuisma to use an adhesive between the circuit and catheter, as it is merely the substitution of one known connection means for another.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kuisma in view of Raval US PG PUB 2021/0290908.
As to claims 14 and 15, Kuisma does not have a hydrophilic coating. However, Raval teaches that in intravascular catheters, it is known to provide such a coating, the reduce friction between he catheter and the tissue. As such, it would have been obvious to modify Kuisma to use the hydrophilic coating, to reduce friction and prevent injury.
VIII. CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT L NASSER whose telephone number is (571)272-4731. The examiner can normally be reached M-F 8-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Kosowski can be reached at (571) 272-3744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT L NASSER/Primary Examiner, Art Unit 3992
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