DETAILED ACTION
The amendment submitted on April 20, 2026 has been entered. Claims 1-20 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
Notice of Pre-AIA or AIA Status
This application, filed on or after March 16, 2013, is being examined under the first-to-file provisions of the Leahy-Smith America Invents Act (AIA ), Pub. L. No. 112-29, 125 Stat. 284 (2011). In the event that 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 statu-tory basis 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.
Withdrawn Rejections
The rejection of claims 1, 3-18, and 20 under 35 U.S.C. 103 as being unpatentable over Fisher, PLoS One 2017;12(7):e0181654 in view of Ohmura, Anticancer Res. 2011 Jul.;31(7):2527-33 and Wang, J. Neurosurg. 2004;100(2):272-77 is withdrawn because the independent claims have been limited to “defocused or planar” ultrasound.
Response to Arguments
Applicant has not substantively responded to the rejections for double patenting, so they are maintained.
New Grounds for Rejection 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.
Claims 2 and 19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The word “broad” is a matter of opinion, which would necessarily vary from person to person, and is therefore indefinite.
Maintained Rejections 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 possi-ble 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 provi-sions 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 accompa-nied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejec-tion 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 1-20 remain rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,318,332 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘332 Patent is directed to a non-invasive method of treating tumors with an oral pro drug, comprising: instructing oral admin-istration of a pro drug to a patient with tumor cells, wherein the pro drug comprises 5-aminolevulinic acid (5-ALA), wherein said 5-ALA results in increased production of protopor-phyrin IX, wherein said protoporphyrin IX is preferentially accumulated in said tumor cells, activating said protoporphyrin IX via defocused or planar ultrasound to produce a reactive oxygen species (ROS) thereby causing apoptosis of said tumor cells, wherein the activating of said proto-porphyrin IX comprises sonoluminescence; and cooling the patient by circulating a cooling fluid to a membrane configured for conforming to a skin surface of the patient.
Claims 1-20 remain rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,617,904 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘904 Patent, of which the present application is a continuation, is directed to a non-invasive method of treating a tumor with a pro drug, comprising: administering a pro drug to a patient with tumor cells, wherein said pro drug comprises 5-aminolevulinic acid (5-ALA), wherein said 5-ALA results in increased production of protoporphyrin IX via a heme biosynthesis pathway, wherein said protoporphyrin IX is selectively accumulated in said tumor cells, activating said protoporphyrin IX via ultrasound, wherein said ultrasound is defocused or planar, wherein said activating said protoporphyrin IX results in said protoporphyrin IX becoming cytotoxic thereby causing apoptosis of said tumor cells; and cooling said patient by circulating a cooling fluid around said patient.
Claims 1-20 remain rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,724,132 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 (in part) of the ‘132 Patent is directed to a method of producing zero vergence ultrasound waves for sonodynamic therapy to treat tumor cells harboring a sonosensitizer, comprising: coupling a sonodynamic therapy device to a skin surface over a treatment region with the tumor cells of a patient, the sonodynamic therapy device comprising a controller, a flexible membrane coupled to a shell and a cooling system, wherein each of the piezoelectric ultrasound transducer elements is configured to emit a zero vergence ultrasound wave that delivers a planar ultrasound wave to the tumor cells, driving the array of piezoelectric ultrasound transducer elements with a signal to activate the sonosensitizer in the tumor cells of the patient, wherein the sonosensitizer comprises protoporphyrin IX, wherein the flexible membrane is configured for conforming to the patient at the skin surface; wherein the cooling system is configured to absorb heat through the skin surface over a treat-ment region. Dependent claim 12 further requires administering a pro drug to the patient, wherein the pro drug comprises 5-aminolevulinic acid (5-ALA), wherein the 5-ALA results in increased production of the protoporphyrin IX.
Claims 1-20 remain rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,865,372 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘372 Patent is directed to a non-invasive method of treating cancer with a drug, comprising: administering a drug to a patient with cancerous cells, wherein said drug results in increased production of protoporphyrin IX, wherein said protoporphyrin IX is selectively accumulated in said cancerous cells, activating said protoporphyrin IX via ultrasound, wherein said ultrasound is defocused or planar, wherein said activating said protoporphyrin IX results in said protoporphyrin IX becoming cytotoxic thereby causing apoptosis of said cancer cells; and cooling said patient by circulating a cooling fluid.
Claims 1-20 remain rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,872,414 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 (in part) of the ‘414 Patent is drawn to a method of producing ultrasound waves for sonodynamic therapy to treat tumor cells harboring a sonosensitizer, comprising: coupling a sonodynamic therapy device to a skin surface over a treatment region with the tumor cells of a patient, the sonodynamic therapy device, comprising: a controller, a patient interface, and a cooling system, wherein the patient interface comprises an array of piezoelectric ultrasound transducer elements and at least one of a cap, a rigid shell and a flexible shell, wherein each of the piezoelectric ultrasound transducer elements comprises an emitting surface configured to emit ultrasound waves, wherein the ultrasound waves are planar or defocused, driving the array of piezoelectric ultrasound transducer elements with a signal to activate the sonosensitizer in the tumor cells of the patient, wherein the sonosensitizer comprises a porphyrin compound, wherein the sonodynamic therapy device is configured to acoustically couple the array of piezoelectric ultrasound transducer elements to the skin surface, circulating a fluid in the cooling system, wherein the cooling system is configured to absorb heat through the skin surface over the treatment region. Dependent claim 11 further requires “administering a pro drug to the patient, wherein the pro drug comprises aminolevulinic acid (ALA), wherein the ALA results in increased production of the porphyrin compound.”
Claims 1-20 remain rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,980,777 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 10 (in part) of the ‘777 Patent is directed to a method of producing randomized ultrasound waves for sonodynamic therapy to treat tumor cells harboring a sonosensitizer, comprising: administering aminolevulinic acid (ALA) to a patient, wherein the ALA results in increased production of a sonosensitizer, coupling a sonodynamic therapy device to a skin surface over a treatment region with the tumor cells of the patient, wherein the sonodynamic therapy device comprises: an array of piezoelectric ultrasound trans-ducer elements, wherein each of the piezoelectric ultrasound transducer elements comprises an emitting surface configured to emit randomized ultrasound waves, wherein the randomized ultrasound waves are planar or defocused, wherein the sonodynamic therapy device is config-ured to acoustically couple the array of piezoelectric ultrasound transducer elements to the skin surface, wherein the patient interface is configured for non-invasively conforming to the patient at the skin surface. Dependent claim 11 further requires circulating a fluid in a cooling system to absorb heat through the skin surface over the treatment region.
Claims 1-20 remain rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 12,097,392 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 (in part) of the ‘392 Patent is directed to a 1. An ultrasound transducer system that generates an incoherent acoustic pressure field for activating a sonosensitizer in conjunction with providing sonodynamic therapy, the ultrasound transducer system comprising: an ultrasound transducer array comprising a plurality of ultrasonic piezoelectric transducer elements, wherein the plurality of ultrasonic piezoelectric transducer elements is configured to generate the incoherent acoustic pressure field via an aperture sized and configured with an energy profile to saturate a treatment volume to ensure treatment of a targeted lesion of cancer cells and extraneous cancer cells located within a tissue of a patient by activating the sonosensitizer located within the tissue of the patient, wherein each ultrasonic piezoelectric transducer element in the plurality of ultrasonic piezoelectric transducer elements comprises an emitting surface configured to emit planar acoustic waves or defocused acoustic waves, wherein the signal is configured to minimize a spatial variation of an acoustic wave inten-sity to activate the sonosensitizer at the targeted lesion of cancer cells with the planar acoustic waves or the defocused acoustic waves, and wherein the signal is configured with a duty cycle to drive each ultrasonic piezoelectric transducer element in the plurality of ultrasonic piezoelectric transducer elements to generate (i) a high temporal peak acoustic intensity sufficient to activate the sonosensitizer at the targeted lesion of cancer cells with the planar acoustic waves or the defocused acoustic waves and (ii) a low temporal average acoustic intensity to preserve tissue. Dependent claim 4 further requires a cooling system configured to remove excess heat from the patient, wherein the cooling system comprises a flexible cavity configured for circulation of a cooling fluid. Dependent claim 6 requires that the sonosensitizer is aminolevulinic acid (ALA), among other things.
Claims 1-20 remain rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 12,138,488 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘488 Patent is drawn to a non-invasive method of treating cancer with a drug, comprising: administering a drug to a patient with cancer cells, wherein said drug results in increased production of a porphyrin compound, wherein said porphyrin compound is accumulated in said cancer cells, activating said porphyrin compound via ultrasound, wherein said ultrasound is defocused or planar, wherein said activat-ing said porphyrin compound results in said porphyrin compound causing apoptosis of said cancer cells; and cooling said patient by circulating a cooling fluid. Dependent claim 8 further comprises oral administration of aminolevulinic acid (ALA).
Claims 1-20 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/919,841 (reference application) in view of Ohmura and Wang as applied above. Although the claims at issue are not identical, they are not patentably distinct from each other. See the claims submitted on January 8, 2025 in the ‘841 Application. Briefly, these claims are directed to a method of treating cancer comprising administering ALA (see claim 8) together with defocused or planar ultrasound (claim 4). Although the claims of the ‘841 Application do not specifically require cooling the patient, it nevertheless would have been prima facie obvious for substantially the same reasons discussed above. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (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, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
April 29, 2026
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