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 21-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 12-13, 16-18, and 20 of U.S. Patent No. 12,220,282. Although the claims at issue are not identical, they are not patentably distinct from each other because patent ‘282 anticipates the subject matter in the instant claims. Claim 21 recites a method comprising capturing, using an ultrasound image sensor, an image sequence of a blood flow in a target region of a blood vessel (encompassed by capturing in claim 1 of ‘282); measuring, based on the image sequence, a central frequency corresponding to a first Doppler frequency shift of the blood flow viewed with the ultrasound image sensor in the target region of the blood vessel, and a second Doppler frequency shift corresponding to one or more objects suspended within the blood flow viewed with the ultrasound image sensor (encompassed by measuring in claim 1 of ‘282); determining, based on the central frequency and the second Doppler frequency shift, a differential in speed between the one or more objects suspended within the blood flow and the blood flow (encompassed by determining in claim 1 of ‘282); and detecting, based at least on the differential speed, that the one or more objects correspond to one or more anomalies present in the blood flow (encompassed by detecting in claim 1 of ‘282). Claim 22 is encompassed by claim 13 of ‘282. Claim 23 is encompassed by claim 1 of ‘282. Claim 24 is encompassed by claim 1 of ‘282. Claim 25 is encompassed by claim 13 of ‘282. Claim 26 is encompassed by claim 18 of ‘282. Claim 27 is encompassed by claim 1 of ‘282. Claim 28 is encompassed by claim 2 of ‘282. Claim 29 is encompassed by claim 16 of ‘282. Claim 30 is encompassed by claim 17 of ‘282. Claim 31 is encompassed by claim 15 of ‘282. Claim 32 is encompassed by claim 19 of ‘282. Claim 33 is encompassed by claim 19 of ‘282. Claim 34 is encompassed by claim 5 of ‘282. Claim 35 is encompassed by claim 12 of ‘282. Claim 36 is encompassed by claim 20 of ‘282. Claim 37 is encompassed by claim 20 of ‘282.
Claims 38-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13 of U.S. Patent No. 12,220,282 in view of Heldt et al. (US 2022/0181008). Patent ‘282 in view of Heldt et al. renders the subject matter in the instant claims obviuos. Patent ‘282 encompasses the steps of measuring, determining, and detecting (see above). Patent ‘282 does not claim a non-transitory computer-readable medium. However, Heldt et al. teaches in the same field of endeavor non-transitory computer-readable medium stores executable instructions for ultrasound systems ([0005]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided patent ‘282 with a non-transitory computer-readable medium as it is well known to one of ordinary skill in the art for non-transitory computer-readable medium comprising executable instructions to cause a processor to perform a method.
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) 21 and 35-36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moehring et al. (US 5,348,015).
Moehring et al. discloses a method comprising capturing, using an ultrasound image sensor, an image sequence of a blood flow in a target region of a blood vessel (col. 7, lines 28-31); measuring, based on the image sequence, a central frequency corresponding to a first Doppler frequency shift of the blood flow viewed with the ultrasound image sensor in the target region of the blood vessel (col. 7, lines 28-31), and a second Doppler frequency shift corresponding to one or more objects suspended within the blood flow viewed with the ultrasound image sensor (col. 1, lines 31-37, col. 5, lines 25-42); determining, based on the central frequency and the second Doppler frequency shift, a differential in speed between the one or more objects suspended within the blood flow and the blood flow (col. 1, lines 31-37, col. 5, lines 25-42; col. 5, line 53 to col. 6, line 32); and detecting, based at least on the differential speed, that the one or more objects correspond to one or more anomalies present in the blood flow (col. 5, line 53 to col. 6, line 32).
With respect to claim 35, Moehring et al. discloses treating a medical condition corresponding to the one or more anomalies detected in the blood flow (col. 4, 45-54).
With respect to claim 36, Moehring et al. discloses wherein the one or more anomalies are one or more blood clots (col. 1, lines 18-24).
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) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moehring et al. (US 5,348,015) in view Jumbe et al. (US 2021/0345939).
Moehring et al. discloses the subject matter substantially as claimed except for a trained machine learning model. However, Jumbe et al. teaches in the same field of endeavor incorporating artificial intelligence through a trained machine learning model to analyze sensor data and increase accuracy of predictive models across patient populations ([0092]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Moehring et al. with machine learning as taught by Jumbe et al. in order to incorporate artificial intelligence to analyz the sensor data.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moehring et al. (US 5,348,015) in view Moehring (US 6,196,972).
Moehring et al. discloses the subject matter substantially as claimed except wherein the ultrasound image sensor uses Color Doppler to construct the image sequence. However, Moehring teaches in the same field of endeavor using Color Doppler to indicate the direction of blood flow and varying intensity is well known (abstract; col. 3, lines 40-52). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Moehring et al. with Color Doppler as taught by Moehring in order to indicate direction of blood flow and varying intensity.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moehring et al. (US 5,348,015) in view Heldt et al. (US 2022/0181008.
Moehring et al. discloses an ultrasound image sensor (100) and a method comprising capturing, using an ultrasound image sensor, an image sequence of a blood flow in a target region of a blood vessel (col. 7, lines 28-31); measuring, based on the image sequence, a central frequency corresponding to a first Doppler frequency shift of the blood flow viewed with the ultrasound image sensor in the target region of the blood vessel (col. 7, lines 28-31), and a second Doppler frequency shift corresponding to one or more objects suspended within the blood flow viewed with the ultrasound image sensor (col. 1, lines 31-37, col. 5, lines 25-42); determining, based on the central frequency and the second Doppler frequency shift, a differential in speed between the one or more objects suspended within the blood flow and the blood flow (col. 1, lines 31-37, col. 5, lines 25-42; col. 5, line 53 to col. 6, line 32); and detecting, based at least on the differential speed, that the one or more objects correspond to one or more anomalies present in the blood flow (col. 5, line 53 to col. 6, line 32). Moehring et al. does not teach a non-transitory computer-readable medium. However, Heldt et al. teaches in the same field of endeavor non-transitory computer-readable medium stores executable instructions for ultrasound systems ([0005]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Moehring et al. with a non-transitory computer-readable medium as it is well known to one of ordinary skill in the art for non-transitory computer-readable medium comprising executable instructions to cause a processor to perform a method.
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moehring et al. (US 5,348,015) in view Heldt et al. (US 2022/0181008 as applied to claim 38, further in view of Jumbe et al. (US 2021/0345939).
Moehring et al. discloses the subject matter substantially as claimed except for a trained machine learning model. However, Jumbe et al. teaches in the same field of endeavor incorporating artificial intelligence through a trained machine learning model to analyze sensor data and increase accuracy of predictive models across patient populations ([0092]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Moehring et al. with machine learning as taught by Jumbe et al. in order to incorporate artificial intelligence to analyze the sensor data.
Allowable Subject Matter
Claims 23-33 and 37 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 further comprising measuring relative position of the one or more object within a cross section of the blood vessel; detecting based at least on the differential in speed and one or more risk thresholds for the one or more anomalies associated with a threshold differential in speed, that the one or more objects correspond to the one or more anomalies present in the blood flow; and locations of the blood clots suspended with the sample blood flows relative to blood vessels, and distances between the blood clots suspended with the sample blood flows and one or more other blood clots suspended within the sample blood flows.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hileman et al. (US 5,441,051) discloses using amplitude in Doppler signal to count emboli in the blood stream.
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