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 .
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 2-8, 10-18, and 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 12, 14-16, and 19 of U.S. Patent No. 11,006,924. Although the claims at issue are not identical, they are not patentably distinct from each other because patent ‘924 anticipates subject matter in the instant claims. Claim 2 recites a system for detecting abnormal blood flow conditions, comprising: a processor (encompassed by processor in claim 1 of ‘924); a first ultrasound transmitter located on a patient’s head in communication with the processor (encompassed by first ultrasound transmitter in claim 1 of ‘924); a first ultrasound receiver located on a patient’s head in communication with the processor (encompassed by first ultrasound receiver in claim 1 of ‘924); a memory in communication with the processor (encompassed by memory in claim 1 of ‘924), comprising a diagnostic application, wherein the diagnostics application directs the processor to: transmit a first ultrasound signal from the first ultrasound transmitter across a patient’s brain (encompassed by transmit step in claim 1 of ‘924); receive the first ultrasound signal using the first ultrasound receiver, where the ultrasound signal is affected during transit by a signal tracer (encompassed by microbubble in claim 1 of ‘924) in the blood of the patient stimulated by the first ultrasound signal (encompassed by receive step in claim 1 of ‘924); analyze the first received ultrasound signal to detect a profile of the signal tracer (encompassed by detect and time-box steps in claim 1 of ‘924); and identify an abnormal blood flow condition based on the detected profile of the signal tracer (encompassed by locate step in claim 1 of ‘924). Claim 3 is encompassed by claim 3 of ‘924. Claim 4 is encompassed by claim 1 of ‘924. Claim 5 is encompassed by claim 2 of ‘924. Claim 6 is encompassed by claim 2 of ‘924. Claim 7 is encompassed by claim 1 of ‘924. Claim 8 is encompassed by claim 1 of ‘924. Claim 10 is encompassed by claim 1 of ‘924. Claim 11 is encompassed by claim 12 of ‘924. Claim 12 recites a method for detecting abnormal blood flow conditions, comprising transmitting a first ultrasound signal from a first ultrasound transmitter located on a patient’s head across the patient’s brain (encompassed by transmitting in claim 14 of ‘924); receiving the first ultrasound signal using a first ultrasound receiver located on the patient’s head, wherein the ultrasound signal is affected during transmit by a signal tracer in the blood of the patient stimulated by the first ultrasound signal (encompassed by receiving in claim 14 of ‘924); analyzing the first received ultrasound signal to detect a profile of the signal tracer (encompassed by detecting, time-boxing, and determining steps in claim 14 of ‘924); and identifying an abnormal blood flow condition based on the detected profile of the signal tracer (encompassed by locating in claim 14 of ‘924). Claim 13 is encompassed by 16 of ‘924. Claim 14 is encompassed by claim 14 of ‘924. Claim 15 is encompassed by claim 15 of ‘924. Claim 16 is encompassed by claim 15 of ‘924. Claim 17 is encompassed by claim 14 of ‘924. Claim 18 is encompassed by claim 14 of ‘924. Claim 20 is encompassed by claim 14 of ‘924. Claim 21 is encompassed by claim 19 of ‘924.
Claims 9 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,006,924 in view of Arditi et al. (US 2008/0228080). Patent’ 924 anticipates the subject matter substantially as claimed (see above) except for monitoring a wash-in and wash-out of the signal tracer. However, Arditi et al. teaches in the same field of endeavor monitoring wash-in and wash-out of a bolus administration ([0055]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided ‘924 with monitoring wash-in and wash-out as taught by Arditi et al. in order to determine when the bolus passes and when microbubbles recirculate ([0057]).
Claims 2-8 and 11-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 14, 16-18, and 19 of U.S. Patent No. 12,376,827. Although the claims at issue are not identical, they are not patentably distinct from each other because patent ‘827 anticipates subject matter in the instant claims. Claim 2 recites a system for detecting abnormal blood flow conditions, comprising: a processor (encompassed by processor in claim 1 of ‘827); a first ultrasound transmitter located on a patient’s head in communication with the processor (encompassed by first ultrasound transmitter in claim 1 of ‘827); a first ultrasound receiver located on a patient’s head in communication with the processor (encompassed by first ultrasound receiver in claim 1 of ‘827); a memory in communication with the processor (encompassed by memory in claim 1 of ‘827), comprising a diagnostic application, wherein the diagnostics application directs the processor to: transmit a first ultrasound signal from the first ultrasound transmitter across a patient’s brain (encompassed by transmit step in claim 1 of ‘827); receive the first ultrasound signal using the first ultrasound receiver, where the ultrasound signal is affected during transit by a signal tracer (encompassed by microbubble in claim 1 of ‘827) in the blood of the patient stimulated by the first ultrasound signal (encompassed by receive step in claim 1 of ‘827); analyze the first received ultrasound signal to detect a profile of the signal tracer (encompassed by identify and time-box steps in claim 1 of ‘827); and identify an abnormal blood flow condition based on the detected profile of the signal tracer (encompassed by detect step in claim 1 of ‘827). Claim 3 is encompassed by claim 3 of ‘827. Claim 4 is encompassed by claim 1 of ‘827. Claim 5 is encompassed by claim 2 of ‘827. Claim 6 is encompassed by claim 2 of ‘827. Claim 7 is encompassed by claim 1 of ‘827. Claim 8 is encompassed by claim 1 of ‘827. Claim 11 is encompassed by claim 14 of ‘827. Claim 12 recites a method for detecting abnormal blood flow conditions, comprising transmitting a first ultrasound signal from a first ultrasound transmitter located on a patient’s head across the patient’s brain (encompassed by transmitting in claim 16 of ‘827); receiving the first ultrasound signal using a first ultrasound receiver located on the patient’s head, wherein the ultrasound signal is affected during transmit by a signal tracer in the blood of the patient stimulated by the first ultrasound signal (encompassed by receiving in claim 16 of ‘827); analyzing the first received ultrasound signal to detect a profile of the signal tracer (encompassed by identifying and time-boxing steps in claim 16 of ‘827); and identifying an abnormal blood flow condition based on the detected profile of the signal tracer (encompassed by detecting in claim 16 of ‘827). Claim 13 is encompassed by 18 of ‘827. Claim 14 is encompassed by claim 16 of ‘827. Claim 15 is encompassed by claim 17 of ‘827. Claim 16 is encompassed by claim 17 of ‘827. Claim 17 is encompassed by claim 16 of ‘827. Claim 18 is encompassed by claim 16 of ‘827.
Claims 9 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,376,827 in view of Arditi et al. (US 2008/0228080). Patent’ 924 anticipates the subject matter substantially as claimed (see above) except for monitoring a wash-in and wash-out of the signal tracer. However, Arditi et al. teaches in the same field of endeavor monitoring wash-in and wash-out of a bolus administration ([0055]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided ‘827 with monitoring wash-in and wash-out as taught by Arditi et al. in order to determine when the bolus passes and when microbubbles recirculate ([0057]).
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) 2-6, 10-16, and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoelscher et al. (US 2016/0030009).
Hoelscher et al. discloses a system for detecting abnormal blood flow conditions, comprising: a processor (210; 310); a first ultrasound transmitter located on a patient’s head in communication with the processor (220); a first ultrasound receiver located on a patient’s head in communication with the processor (220); a memory (315) in communication with the processor, comprising a diagnostics application (345; [0025]), where the diagnostics application directs the processor to: transmit a first ultrasound signal from the first ultrasound transmitter across a patient’s brain ([0020]); receive the first ultrasound signal using the first ultrasound receiver ([0020]; [0024]), where the ultrasound signal is affected during transit by a signal tracer in the blood of the patient stimulated by the first ultrasound signal ([0019]; [0035]); analyze the first received ultrasound signal to detect a profile of the signal tracer ([0045]; [0047]; [0049]; [0051]); and identify an abnormal blood flow condition based on the detected profile of the signal tracer ([0025]; [0035]; [0045]; [0047]; [0050-0052]; [0056]).
With respect to claims 3 and 13, Hoelscher et al. discloses wherein the first ultrasound receiver is located on the patient’s head ipsilaterally with respect to the first ultrasound transmitter ([0020]).
With respect to claims 4 and 14, Hoelscher et al. discloses wherein the signal tracer is a microbubble tracer ([0019]).
With respect to claims 5-6 and 15-16, Hoelscher et al. discloses comparing two hemispheres ([0047]; [0053]; [0056]).
With respect to claims 10 and 20, Hoelscher et al. discloses wherein the abnormal flow condition is a stroke ([0019]).
With respect to claims 11 and 21, Hoelscher et al. discloses wherein a first transducer assembly comprises the first ultrasound transmitter and the first ultrasound receiver ([0020]; [0038]).
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 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoelscher et al. (US 2016/0030009) in view of Arditi et al. (US 2008/0228080).
Hoelscher et al. discloses the subject matter substantially as claimed except for monitoring a wash-in and wash-out of the signal tracer. However, Arditi et al. teaches in the same field of endeavor monitoring wash-in and wash-out of a bolus administration ([0055]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Hoelscher et al. with monitoring wash-in and wash-out as taught by Arditi et al. in order to determine when the bolus passes and when microbubbles recirculate ([0057]).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to disclose or render obvious the claimed combination of subject matter particularly time-boxing the received ultrasound signals to reflect spatial segments of the brain which contains the abnormal blood flow condition.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER LUONG whose telephone number is (571)270-1609. The examiner can normally be reached M-F 9-6.
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, Anhtuan T Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PETER LUONG/Primary Examiner, Art Unit 3797
Prosecution Insights