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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 6/25/25 has/have been acknowledged and is/are being considered by the Examiner.
Claim Rejections - 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 14 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The recites a computer program to execute the steps of claim 5. However, a computer alone cannot complete the steps holding, fixing and connecting physical objects. The specification is silent as to how a computer program can perform the operations alone.
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) 1-14, 16-18 and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nunez et al. (U.S. Pub. 2018/0064860 A1 hereinafter “Nunez”).
Regarding claims 1 and 13-14, Nunez discloses a system, computer program and method for manufacturing a cardiac support system (e.g. see Figs. 1-5), the method comprising the steps of: providing a sensor device (e.g. 60), an inlet tube (e.g. 40) with a first end and a second end opposite the first end (e.g. Fig. 1B), the inlet tube (e.g. 40) configured to aspirate a body fluid of a patient, and a drive unit (e.g. 30) for operating the cardiac support system (e.g. Abstract); and connecting the sensor device with the first end of the inlet tube and connecting the drive unit with the second end of the inlet tube (e.g. ¶¶42, 46).
Regarding claim 2, Nunez further discloses wherein connecting the sensor device with the first end of the inlet tube forms a connecting device (e.g. Fig. 1B).
Regarding claim 3, Nunez further discloses wherein connecting the connecting device and the drive unit forms at least a portion of the cardiac support system (e.g. ¶50).
Regarding claim 4, Nunez further discloses providing a housing element (e.g. 36); and connecting the drive unit to the housing element (e.g. ¶50).
Regarding claims 5, Nunez further discloses pre-positioning and fixing the sensor device (e.g. 60), the inlet tube (e.g. 40) and the drive unit (e.g. 30), wherein the sensor device, the inlet tube and the drive unit are connected to one another (e.g. Figs. 1B-F).
Regarding claims 6, Nunez further discloses providing a sensor (e.g. 60); providing at least one electrically conductive element (e.g. 64); and electrically contacting the sensor and the at least one electrically conductive element (e.g. ¶48).
Regarding claims 7, Nunez further discloses manufacturing the sensor device by: providing a carrier element (e.g. 40); bonding the carrier element to the electrically contacted sensor and the at least one electrically conductive element (e.g. ¶49); providing an ultrasonic transducer (e.g. 60); and conductively bonding the ultrasonic transducer to a result component from the bonding step (e.g. ¶49).
Regarding claims 8, Nunez further discloses manufacturing the connecting device by: providing the inlet tube (e.g. 40); and connecting the inlet tube to the manufactured sensor device (e.g. ¶49).
Regarding claims 9, Nunez further discloses assembling corresponding sensor cables and/or joining the sensor cables to the connecting device (e.g. ¶48); and siliconizing assembled components (e.g. ¶49).
Regarding claims 10, Nunez further discloses assembling the drive unit by: providing the drive unit (e.g. 30); joining the drive unit to the connecting device (e.g. ¶¶48-49); and laying and fixing the joined drive unit and connecting device (e.g. ¶49).
Regarding claims 11, Nunez further discloses electrically contacting a sensor cable of the cardiac support system with a connection point in a connection interface (e.g. ¶48); and protecting a sensor positioned on or near the connection interface by a biocompatible cover (e.g. ¶49).
Regarding claims 12, Nunez further discloses assembling a sleeve over the sensor cable to obtain a hybrid cable (e.g. ¶49); electrically connecting the hybrid cable to the connection interface (e.g. ¶48); providing the housing element (e.g. 36); and attaching the housing element to a result component from the electrically connecting step (e.g. Figs. 1-5).
Regarding claims 16, Nunez discloses a sensor device (e.g. 60); an inlet tube (e.g. 40) with a first end and a second end opposite the first end coupled to the sensor device (e.g. Fig. 1B), the inlet tube (e.g. 40) configured to aspirate a body fluid of a patient; and a drive unit (e.g. 30) for operating the cardiac support system, wherein the drive unit is connected to the second end of the inlet tube (e.g. ¶¶42, 46).
Regarding claims 17, Nunez further discloses wherein the inlet tube comprises at least one inlet opening at the first end (e.g. 31), wherein the at least one inlet opening is configured: to allow the body fluid to flow into the inlet tube (e.g. see Fig. 1B; ¶9), and as an interface between the sensor device (e.g. 60) and the inlet tube (e.g. 40).
Regarding claims 18, Nunez further discloses wherein the inlet tube further comprises at least one outlet (e.g. 41) opening at the second end, wherein the at least one outlet opening is configured to enable the body fluid to be discharged from the inlet tube (e.g. ¶63).
Regarding claims 20, Nunez further discloses wherein the sensor device comprises a plurality of sensor components, the plurality of sensor components (e.g. Abstract) comprising at least one sensor (e.g. 60), a layer substrate (e.g. ¶49), a carrier element (e.g. ¶49) and/or an ultrasonic transducer (e.g. ¶49).
Regarding claims 21, Nunez further discloses wherein at least two of the plurality of sensor components are electrically connected to each other (e.g. ¶64).
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) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nunez as applied to claims 1-14, 16-18 and 20-21 above, and further in view of Kang et al. (U.S. Pub. 2010/0191035 hereinafter “Kang”).
Regarding claims 19, Nunez discloses the claimed invention except for the drive unit comprises a deployable anchoring structure. However, Kang teaches that it is known to use deployable anchors as set forth in Paragraph 10 to provide an anchor for the pump to prevent movement while in use. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Nunez, with a deployable anchor as taught by Kang, since such a modification would provide the predictable results of providing an anchor for the pump to prevent movement while in use to improve function and reduce injury.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/ Primary Examiner, Art Unit 3796