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 Arguments
Applicant’s arguments, see Remarks, filed 6/29/26, with respect to the rejection(s) of claim(s) 1-5, 8-14, 16-19 and 21 under Nunez 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 Therefore, the rejection has been withdrawn.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 Casas et al. (U.S. Pub. 2018/0333059 A1 hereinafter “Casas”).
Applicant’s arguments, see Remarks, filed 6/29/26, with respect to the 112 rejections have been fully considered and are persuasive. The 112 rejections of 3/27/26 have been withdrawn.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 6/29/26 has/have been acknowledged and is/are being considered by the Examiner.
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) 1-5, 8, 10-11, 13-14, 16-18 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Casas et al. (U.S. Pub. 2018/0333059 A1 hereinafter “Casas”).
Regarding claims 1 and 13-14, Casas discloses a system, computer program and method for manufacturing a cardiac support system (e.g. see Figs. 1-3), the method comprising the steps of: providing a sensor device (e.g. see Fig. 2, elements 44, 46 and 48), an inlet tube (e.g. 18) with a first end and a second end opposite the first end (e.g. see Figs. 1-2), the inlet tube (e.g. 18) configured to aspirate a body fluid of a patient, and a drive unit (e.g. combination of 32, 36 and 38) 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. ¶¶7 and 19), wherein the method further comprises manufacturing the sensor device by: providing a sensor (e.g. 44); providing at least one electrically conductive element (e.g. ¶25; conductors); electrically contacting the sensor and the at least one electrically conductive element (e.g. ¶25; sensor connected to conductor); providing a carrier element (e.g. 46; flange); bonding the carrier element to the electrically contacted sensor and the at least one electrically conductive element to form a result component (e.g. ¶¶7, 19); providing an ultrasonic transducer (e.g. 48); and conductively bonding the ultrasonic transducer to the result component (e.g. ¶40).
Regarding claim 2, Casas 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, Casas 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, Casas further discloses providing a housing element (e.g. 36); and connecting the drive unit to the housing element (e.g. ¶50).
Regarding claims 5, Casas 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 8, Casas 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 10, Casas 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, Casas 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 16, Casas 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, Casas 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, Casas 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 21, Casas 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) 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Casas as applied to claims 1-5, 8, 10-11, 13-14, 16-18 and 21 above, and further in view of Nunez et al. (U.S. Pub. 2018/0065860 hereinafter “Nunez”).
Regarding claims 9 and 12, Casas discloses the claimed invention except for the system being siliconized and having a sleeve over the sensor cable. However, Nunez teaches that it is known to use encapsulation techniques as set forth in Paragraph 48-49 to provide siliconized components and sleeved cables to provide biocompatibility and to further enhanced sealing to ensure patient safety and device longevity. 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 Casas, with silicon encapsulation and sleeved cables as taught by Nunez, since such a modification would provide the predictable results of providing biocompatibility and to further enhanced sealing to ensure patient safety and device longevity.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Casas as applied to claims 1-5, 8, 10-11, 13-14, 16-18 and 21 above, and further in view of Kang et al. (U.S. Pub. 2010/0191035 hereinafter “Kang”).
Regarding claims 19, Casas 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 Casas, 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kardio (DE 102018212153 A1) – teaches a similar device with a sensor and encapsulation.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REX R HOLMES/ Primary Examiner, Art Unit 3796
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