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 .
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 03/31/2023, has been considered by the examiner.
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 1-8 are 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] The claim recites the limitation of “calculating a cumulative therapeutic ultrasound dose received at each sub-region” in the 6th line of the claim. There is a lack of antecedent basis for the recitation of “each sub-region.” Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear how “each sub-region” relates to the “therapy ROI.” For purposes of examination, it is interpreted that the therapy ROI includes a plurality of sub-regions.
[Claims 2-8] The claims are rejected based upon their dependency from independent claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Konofagou et al. (PGPub 2020/0147415).
[Claim 1] Konofagou teaches a method (abstract), comprising:
for one or more therapeutic ultrasound beams of a plurality of therapeutic ultrasound beams delivered to a therapy region of interest (ROI) of a patient via an ultrasound probe (figure 1; paragraphs [0068],[0069], [0120], [0149]-[0151]), identifying a respective location of the one or more therapeutic ultrasound beams relative to the therapy ROI of the patient based on one or more images of the therapy ROI acquired via the ultrasound probe (paragraphs [0149], [0150]);
calculating a cumulative therapeutic ultrasound dose received at each sub-region of the therapy ROI based on the respective location of the one or more therapeutic ultrasound beams (figure 15a; paragraphs [0151], [0193], [0227]); and
displaying a representation of the cumulative therapeutic ultrasound dose received at each sub-region of the therapy ROI on a display device (paragraph [0145]).
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,514,557. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the recited instant application claims are found in the recited patent claims. For example, all of the elements of claim 1 of the instant application can be found in claim 1 of the patent. The difference between claim 1 of the instant application and claim 1 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus, the invention of claim 1 of the patent is in effect a “species” of the "generic” invention of claim 1 of the instant application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the instant application is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
Allowable Subject Matter
Claims 9-20 are allowed.
Claims 2-8 would be allowable if rewritten 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 to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
The prior art of record fails to disclose or render obvious the system or method recited in independent claims 9 and 16, as well as dependent claim 2.
The closest prior art of record is Konofagou et al. (PGPub 2020/0147415).
The prior art of record fails to teach among all the limitations or render obvious a system or method comprising
an ultrasound probe;
a display; and
a computing device operably coupled to the ultrasound probe and the display and including one or more processors configured to execute instructions stored in memory to:
control the ultrasound probe to deliver a therapeutic ultrasound beam to a therapy region of interest (ROI) of a patient, the therapy ROI including a plurality of sub-regions;
control the ultrasound probe to acquire one or more images of the therapy ROI;
identify a location of the therapeutic ultrasound beam relative to the therapy ROI of the patient based on the one or more images;
calculate a respective cumulative therapeutic ultrasound dose received at each sub-region of the therapy ROI based on the location of the therapeutic ultrasound beam; and
display a representation of the 3D dose model on the display.
Specifically, regarding independent claims 9 and 16 and dependent claim 2, the prior art to Konofagou, either alone or in combination, fails to disclose or render obvious the specific method, structural, and/or functional features as claimed;
wherein the system is further configured to update a 3D dose model of the therapy ROI based on each respective cumulative therapeutic ultrasound dose; or
wherein the method further comprises updating a 3D model of the therapy ROI based on the cumulative therapeutic ultrasound dose received at each sub-region of the therapy ROI, and wherein displaying the representation of the cumulative therapeutic ultrasound dose received at each sub-region of the therapy ROI on the display device comprises displaying the 3D model on the display device.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 03/26/2026
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