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 Amendment
The amendment filed on 9/8/2025 has been entered. Claims 1-18 remain pending the application. Claims 1-8 and 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/15/2025.
Response to Arguments
Applicant's arguments filed on 9/8/2025 have been fully considered but they are not persuasive.
Applicant argues on page 5 that the claims have been amended to fix the 112b issues. However, one 112b issue still remains as outlined in the rejection below. Specifically, claim 15 sets forth the target regions but no plurality of target regions has previously been set forth. Accordingly, this argument is not persuasive.
Applicant argues on pages 5-6 that the double patenting rejection does not apply because US11766243 contains a limitation not found in this set of claims. However, the standard for nonstatutory double patenting does not require that the claims be identical, only that each of the limitations in the current set of claims is present in the claims of US11766243. Accordingly, this argument is not persuasive.
Election/Restrictions
Applicant’s election without traverse of invention II in the reply filed on 4/15/2025 is acknowledged. Claims 1-8 and 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/15/2025.
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.
Claim 15 is 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.
Regarding claim 15, claim 15 recites the limitation “the target regions”. It is unclear how these relate to the region of interest previously set forth since only region of interest is previously set forth. For examination purposes, this limitation will be interpreted as referring to the region of interest.
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 9-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-17 of U.S. Patent No. 11766243. Although the claims at issue are not identical, they are not patentably distinct from each other because each of the limitations in the claims is present in the claims of US11766243.
18144244
US11766243B2
9. A dynamic scaling, time-varying manner procedure used to determine the levels of the interested molecular marker in the target tissue comprises
14. A dynamic scaling, time-varying manner procedure used to determine the levels of an interested molecular marker configured to be bound to a contrast agent in a target tissue comprises
a. capturing a series of images of a target tissue over time,
a. capturing a series of images of the target tissue over time,
b. choosing a region of interest within the images that has targeted contrast agent signals,
b. choosing a region of interest within the images that has targeted contrast agent signals,
c. choosing a reference region of interest within the images that doesn't have targeted contrast agent signals but has circulating contrast agent signals,
c. choosing a reference region of interest within the images that doesn't have targeted contrast agent signals but has circulating contrast agent signals,
d. using the signal intensities of the reference region to scale the signal magnitudes from the targeted region at each time points;
d. using the signal intensities of the reference region to scale the signal magnitudes from the region of interest at each time points;
e. creating reference-scaled images or magnitudes of the target tissue in the different time points, and
e. creating reference-scaled images or magnitudes of the target tissue in the different time points, and
f. using the reference-scaled images or magnitudes to determine the levels of the interested molecular marker in the target tissue.
f. using the reference-scaled images or magnitudes to determine the levels of the interested molecular marker in the target tissue.
10. The procedure of claim 9, wherein the procedure is performed in units of linearized acoustic power.
15. The procedure of claim 14, wherein the procedure is performed in units of linearized acoustic power or amplitude.
11. The procedure of claim 9, wherein the procedure is performed in units of linearized acoustic amplitude.
15. The procedure of claim 14, wherein the procedure is performed in units of linearized acoustic power or amplitude.
12. The procedure of claim 9, further comprising color coding of the dynamically scaled images or the rate images derived from the rates of change of the dynamically scaled images.
16. The procedure of claim 14, further comprising (a) color coding of the dynamically scaled images including the images derived from the rates of change of the dynamically scaled images, (b) smoothing by low-pass filtering of the dynamically scaled images, or (c) nonlinear compression of the dynamically scaled images.
13. The procedure of claim 9, further comprising smoothing by low-pass filtering of the dynamically scaled images.
16. The procedure of claim 14, further comprising (a) color coding of the dynamically scaled images including the images derived from the rates of change of the dynamically scaled images, (b) smoothing by low-pass filtering of the dynamically scaled images, or (c) nonlinear compression of the dynamically scaled images.
14. The procedure of claim 9, further comprising nonlinear compression of the dynamically scaled images.
16. The procedure of claim 14, further comprising (a) color coding of the dynamically scaled images including the images derived from the rates of change of the dynamically scaled images, (b) smoothing by low-pass filtering of the dynamically scaled images, or (c) nonlinear compression of the dynamically scaled images.
15. The procedure of claim 9, wherein the reference scaled signal magnitude is computed within one or more target regions at several timepoints between peak signal and clearance of the reference region.
17. The procedure of claim 14, wherein the reference scaled signal magnitude is computed (a) within one or more targeted regions at several timepoints between peak signal and clearance of the reference region, or (b) at peak signal and at a subsequent time point of interest, and the average slope between the two points is computed.
16. The procedure of claim 9, wherein the reference scaled signal magnitude is computed at peak signal and at a subsequent time point of interest, and the average slope between the two points is computed.
17. The procedure of claim 14, wherein the reference scaled signal magnitude is computed (a) within one or more targeted regions at several timepoints between peak signal and clearance of the reference region, or (b) at peak signal and at a subsequent time point of interest, and the average slope between the two points is computed.
Allowable Subject Matter
Claims 9-16 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) and the double patenting rejections set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art does not disclose not reasonably suggest the limitations set forth in the independent claims. Specifically, the prior art does not disclose determining a level of a molecular marker in a subject configured to be bound to a contrast agent by capturing a series of images of a target tissue, choosing a region of interest in the target tissue, choosing a reference region in the target tissue, using signal intensities to scale signal magnitudes from the region of interest, creating scaled images over different time points, and using scaling to determine the levels of the molecular marker in the target tissue, particularly in view of US11766243.
Conclusion
THIS ACTION IS MADE FINAL. 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 John Li whose telephone number is (313)446-4916. The examiner can normally be reached Monday to Thursday; 5:30 AM to 3:30 PM Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN D LI/Primary Examiner, Art Unit 3798