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 .
DETAILED ACTION
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).
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,491,353. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application is claiming a similar method for treating the brain administer with drug using ultrasound.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,724,132. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application is claiming a similar method for treating the brain administer with drug using ultrasound.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,097,392. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application is claiming a similar method for treating the brain administer with drug using ultrasound.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,427,345. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application is claiming a similar method for treating the brain administer with drug using ultrasound.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 16, 21-22, 28,32-33,35-41,43,45,47 and 50-52 of copending Application No. 18/215515. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application is claiming a method perform by the device in the application 18/215515.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claims 1, 3 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hynynen et al. (US 2018/0177491 (provided in the IDS)).
3. Addressing claim 1, Hynynen discloses a transducer system, comprising:
a transducer array comprising a plurality of ultrasonic piezoelectric transducer elements configured for driving at a frequency in a range of 20 kHz to 12 MHz (see abstract, Fig. 1A, 1C, 2A and [0044]),
a patient interface comprising a detachable flexible membrane configured to couple to a skin surface of a patient (see [0065-0066] and Fig. 2A; elastic membrane is detachable),
wherein the plurality of ultrasonic piezoelectric transducer elements is configured to generate an acoustic pressure field, wherein the plurality of ultrasonic piezoelectric transducer elements are configured for acoustic coupling to the patient interface (see [0029], [0063-0066] and Fig. 4),
wherein the plurality of ultrasonic piezoelectric transducer elements is configured to be driven by a signal to generate the acoustic pressure field, wherein the signal comprises one or more of the group consisting of: a modulated phase across the plurality of ultrasonic piezoelectric transducer elements, wherein the modulated phase comprises a randomized phase difference, a modulated frequency across the plurality of ultrasonic piezoelectric transducer elements, and a modulated amplitude across the plurality of ultrasonic piezoelectric transducer elements (see [0081] and [0083]; modulate or using different frequencies);
wherein each ultrasonic piezoelectric transducer element in the plurality of ultrasonic piezoelectric transducer elements comprises an emitting surface configured to emit acoustic waves (see Fig. 1A),
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 an acoustic wave intensity of 1 - 20 W/cm² (see [0004], [0047] and [0141]; Hynynen’s device is capable of output temporal average intensity between 1 and 20 W/cm2).
4. Addressing claims 3 and 6-9, Hynynen discloses:
addressing claim 3, wherein the signal is configured to minimize a spatial variation of the acoustic wave intensity (see claims 9, 13 and 38; planar wave also minimizes a spatial variation of an acoustic intensity in the treatment region).
addressing claim 6, wherein the plurality of piezoelectric transducer elements is driven at one or more frequencies in a range of 650 kHz to 2 MHz (see [0042] and [0044]).
addressing claim 7, wherein the transducer system is configured for treating cancerous tissue in a brain, lung, breast, liver, stomach, prostate, vagina, testes, ovary, pancreas, or intestines (see [0004]; brain cancer/tumor).
addressing claim 8, wherein the transducer system is configured for treating cancerous tissue in a brain of the patient (see [0004] and [0060]).
addressing claim 9, wherein the detachable flexible membrane is configured to couple to a head of the patient (see [0065-0066] and Fig. 2A).
Claim Rejections - 35 USC § 103
5. 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.
6. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (US 2018/0177491 (provided in the IDS)) and in view of Sanghvi et al. (US 2010/0092424).
7. Addressing claim 4, Hynynen discloses vary the duty cycle; the duty cycle that is not too high and not too low would lead to a balance between high temporal peak acoustic intensity and low temporal average acoustic intensity; decrease the duty cycle led to lower temporal average intensity. Hynynen discloses low duty cycle which result in a low temporal average acoustic intensity (see [0004] and [0047]). Sanghvi explicitly disclose wherein the signal is configured to generate (i) a high temporal peak acoustic intensity (see [0041]; spatial peak temporal peak intensities is a subset of high temporal peak). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have a high temporal peak acoustic intensity as taught by Sanghvi because this enhance energy delivery and improve penetration and focusing.
8. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (US 2018/0177491 (provided in the IDS)) and in view of Lacoste et al. (US 2005/0085726 (provided in the IDS)).
9. Addressing claim 5, Hynynen does not disclose a cooling system comprising a cavity configured for circulation of a fluid for acoustic coupling with the transducer array. Lacoste discloses a cooling system comprising a cavity configured for circulation of a fluid for acoustic coupling with the transducer array (see Fig. 21, [0041], [0056], [0128] and [0136]; Lacoste explicitly discloses circulation of a cooling fluid in balloon (flexible cavity)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have a cooling system comprising a cavity configured for circulation of a fluid for acoustic coupling with the transducer array as taught by Lacoste because circulate fluid to keep the liquid cool, the device and tissue cool.
10. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (US 2018/0177491 (provided in the IDS)) and in view of Liu et al. (US 2018/0207447 (provided in the IDS)).
11. Addressing claim 10, Hynynen does not disclose wherein the transducer system is configured for activating a sonosensitizer, wherein the sonosensitizer is selected from the group consisting of: aminolevulinic acid (ALA), hematoporphyrin, Rose Bengal, curcumin, titanium nanoparticles, and chlorine e6. Liu discloses wherein the transducer system is configured for activating a sonosensitizer, wherein the sonosensitizer is selected from the group consisting of: aminolevulinic acid (ALA), hematoporphyrin, Rose Bengal, curcumin, titanium nanoparticles, and chlorine e6 (see [0006], [0033], [0044] and [0059]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to use sonosensitizer as taught by Liu because this provides effective treatment against cancer cells (see [0044] and [0059]).
12. Claims 2 and 11-12, 14-15, 17-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (US 2018/0177491 (provided in the IDS)) and in view of Kajitani et al. (US 2010/0228523 (provided in the IDS)).
13. Addressing claims 2, 11 and 18, Hynynen discloses an transducer system, comprising:
an transducer array comprising a plurality of piezoelectric transducer elements, and a patient interface comprising a flexible membrane configured to couple to a skin surface of a patient (see abstract, Fig. 1A, 1C, 2A, [0044] and [0065-0066]),
wherein the plurality of piezoelectric transducer elements is configured to generate an acoustic pressure field (see [0029], [0063-0066] and Fig. 4),
wherein each piezoelectric transducer element in the plurality of piezoelectric transducer elements comprises an emitting surface configured to emit acoustic waves (see Fig. 1A),
wherein the signal is configured to minimize a spatial variation of an acoustic wave intensity (see claims 9, 13 and 38; planar wave also minimizes a spatial variation of an acoustic intensity in the treatment region).
Hynynen does not disclose wherein the signal comprises a modulated phase across the plurality of piezoelectric transducer elements. Kajitani discloses modulated phase comprises a randomized phase difference (see [0018]; Hynynen discloses plurality of piezoelectric transducer elements; Hynynen in views of Kajitani disclose a modulated phase across the plurality of piezoelectric transducer elements). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have modulated phase comprises a randomized phase difference as taught by Kajitani because this eliminates an effect of residual vibration of piezoelectric and increase correlativity (see abstract and [0036]).
Addressing claims 12, 14-15, 17 and 20, Hynynen discloses:
addressing claim 12, wherein the plurality of piezoelectric transducer elements are arranged to acoustically couple to a head of the patient (see [0064-0066], Figs. 1C and 3).
addressing claim 14, wherein the plurality of piezoelectric transducer elements is acoustically coupled to the patient interface via a fluid (see [0065]).
addressing claim 15, wherein the transducer system is configured for treating cancerous tissue in a brain, lung, breast, liver, stomach, prostate, vagina, testes, ovary, pancreas, or intestines (see [0004]; brain cancer/tumor).
addressing claim 17. The transducer system of claim 11, wherein the plurality of piezoelectric transducer elements comprises between 128 to 1024 piezoelectric transducer elements (see [0042]).
addressing claim 20, wherein the acoustic pressure field is driven at one or more frequencies in a range of 20 kHz to 12 MHz (see abstract, Fig. 1A, 1C, 2A and [0044]).
14. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (US 2018/0177491 (provided in the IDS)), in view of Kajitani et al. (US 2010/0228523 (provided in the IDS)) and further in view of Sanghvi et al. (US 2010/0092424).
15. Addressing claim 13, Hynynen discloses vary the duty cycle; the duty cycle that is not too high and not too low would lead to a balance between high temporal peak acoustic intensity and low temporal average acoustic intensity; decrease the duty cycle led to lower temporal average intensity. Hynynen discloses low duty cycle which result in a low temporal average acoustic intensity (see [0004] and [0047]). Sanghvi explicitly disclose wherein the signal is configured to generate (i) a high temporal peak acoustic intensity (see [0041]; spatial peak temporal peak intensities is a subset of high temporal peak). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have a high temporal peak acoustic intensity as taught by Sanghvi because this enhance energy delivery and improve penetration and focusing.
16. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (US 2018/0177491 (provided in the IDS)), in view of Lacoste et al. (US 2005/0085726 (provided in the IDS)) and further in view of Liu et al. (US 2018/0207447 (provided in the IDS)).
17. Addressing claim 16, Hynynen does not disclose wherein the transducer system is configured for treating cancerous tissue via activation of a sonosensitizer, wherein the sonosensitizer is selected from the group consisting of: aminolevulinic acid (ALA), hematoporphyrin, Rose Bengal, curcumin, titanium nanoparticles, and chlorine e6. Liu discloses wherein the transducer system is configured for treating cancerous tissue via activation of a sonosensitizer, wherein the sonosensitizer is selected from the group consisting of: aminolevulinic acid (ALA), hematoporphyrin, Rose Bengal, curcumin, titanium nanoparticles, and chlorine e6 (see [0006], [0033], [0044] and [0059]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to use sonosensitizer as taught by Liu because this provides effective treatment against cancer cells (see [0044] and [0059]).
18. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (US 2018/0177491 (provided in the IDS)), in view of Lacoste et al. (US 2005/0085726 (provided in the IDS)) and further in view of Lacoste et al. (US 2005/0085726 (provided in the IDS)).
19. Addressing claim 19, Hynynen does not disclose a cooling system configured to remove excess heat from the patient, wherein the cooling system comprises a cavity configured for circulation of a fluid. Lacoste discloses a cooling system configured to remove excess heat from the patient, wherein the cooling system comprises a cavity configured for circulation of a fluid (see Fig. 21, [0041], [0056], [0128] and [0136]; Lacoste explicitly discloses circulation of a cooling fluid in balloon (flexible cavity)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have a cooling system configured to remove excess heat from the patient, wherein the cooling system comprises a cavity configured for circulation of a fluid as taught by Lacoste because circulate fluid to keep the liquid cool, the device and tissue cool.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HIEN NGOC NGUYEN whose telephone number is (571)270-7031. The examiner can normally be reached Monday-Thursday 8:30am-6:30pm.
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
Prosecution Insights