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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out
and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1: It is unclear to recite an implantable device that comprises an external controller. Examiner suggests perhaps reciting an implantable “system” instead of device in the preamble instead, or other equivalent correction.
In addition, there are various errors which make the claims grammatically unclear, many of which can be resolved by amendments shown in the amended claims of 10/30/2020 in the parent application:
Claim 1, line 1: Should be blood from “a” left atrium.
Claim 1, line 4: Should be inlet “cannula” and outlet cannula “are” in fluid communication.
Claim 1, line 6: Should be “a” housing.
Claim 1, line 12: Should delete the comma after “signals”.
Claim 1, line 13: Should be “the analysed” ECG signals.
Claim 1, line 14: Should be “the” left atrium to “a” left ventricle.
Claim 2, line 2: Should delete “the” so as to read data “based on movement”.
Claim 4, line 2: Should delete “the” so as to read data “based on movement”.
Claim 5, line 2: Should replace “for detecting” with “in order to detect”.
Claim 7, lines 2-3: Should be “a” determined patient activity.
Claim 8, lines 2-3: Should be “a” determined patient activity.
Claim 9: “second” electrical lead is indefinite, since this claim depends from claim 1, where no electrical lead has been yet recited.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,980,750 in view of O’Brien (US 2010/0179611). The Patent claims substantially the same invention as claimed, except the Patent claims an implanted controller for processing the detected signal data, whereas the instant claims recite an external controller for processing the detected signal data. However, O’Brien teaches it is a common alternative to offload processing to an external controller (Paragraph 37), in order to reduce power consumption in the implanted device. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the Patent as taught by O’Brien to include an external controller as recited, in order to reduce power consumption in the implanted device.
Allowable Subject Matter
Claims 1-9 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and a terminal disclaimer is filed.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art are Garrigue (US 2019/0160214), Arabia (US 2002/0019577), McConnell (US 2008/0097226), and Ayre (US 2008/0183287). Garrigue shows a blood pump including an accelerometer for detecting mitral valve closure (Paragraphs 45-47) and ECG electrodes (Paragraphs 45, 104). Garrigue does not show a configuration for connecting from the left atrium to a descending aorta, but Arabia shows that this configuration is generally known (Paragraph 3). However, Garrigue also notes that the accelerometer is placed inside the ventricle and does not disclose the accelerometer on the housing of the blood pump. Ayre also shows an accelerometer, but it is mounted on a controller rather than the pump housing (Paragraph 104). Garrigue also shows the ECG electrodes on separate ventricular leads (Figure 2), and does not show ECG sensors positioned on a device between the pump and controller. McConnell likewise shows ECG sensors may be generally positioned inside the body (Paragraph 74), but does not show the sensors in the same arrangement on a device. Thus, the prior art does not sufficiently disclose or suggest the particular combination of elements as recited in the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eugene T Wu whose telephone number is (571)270-5053. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached on 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eugene T Wu/Primary Examiner, Art Unit 3792