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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/14/25 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In claim 1, there is no support for the probe module that “conforms to the contour” of the patient’s abdomen. Rather, it is only said that the module is fixed to the abdomen.
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, and 11 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.
In claim 1, line 19, it appears ‘at least one probe modules’ should be ‘the probe module’. In line 20, ‘at least one probe modules’ should be ‘probe module’. In line 23, ‘the irradiation process’ lacks antecedence. In line 24, ‘a’ should be ‘the’.
In claim 8, line 4, it appears ‘plurality of second probe’ should be ‘second probe’ to coincide with subsequent usage of the term.
In claim 11, line 8, it appears ‘control unit’ should be ‘first probe’. In line 27, it is unclear what is meant by “or/and without”.
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 8 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guha et al (US Pub 2020/0398084 -previously cited).
Re claims 8, 9: Guha discloses an ultrasound generator system for inhibiting intestinal inflammatory factor and/or improving neuroinflammation through the gut brain axis [0101, 0315; see the application to the colon, stomach, and intestine and see the application to tumors which are inflammatory which includes alignment on the abdomen], the system comprises at least a transducer probe module (figure 27 see the transducer probes), a processor module and an image module (Figure 25, 0268; see the display and processor); wherein a first probe of the probes sends a first ultrasound to a target area, and then the reflected wave of the first ultrasound is received by the first probe, and converted into an image signal and sent to a control unit that regulates the probe (Figure 27 see the imaging probe and the computer controller); a display screen is electrically communicated with the control unit (Figures 25, 27; see the processor and controller as part of the laptop computer), the display screen receives the image signal and displays the target area on the display screen (Figure 25; see the display of the ultrasound image); a second probe of the probes includes piezo-patches, the control unit controls the piezo-patches to send a second ultrasound and a third ultrasound with a plurality of frequency differences to the target area to generate a beating wave; and the second ultrasound and the third ultrasound focus in the target area; the control unit regulates the frequency difference between the ultrasounds allowing them to generate the beating wave, the system modulates intestinal flora/gut microbiota by generating a beating wave field in the abdomen, and indirectly improves neurodegenerative diseases caused by brain inflammation though the gut-brain axis by inhibiting microglial activation and increases BDNF (Figure 27, 0204; see the treatment probes for focused ultrasound wherein the probe is a TIPS probe that is known to use piezo elements; also see the LOFU which produces beating waves; 0064, 0216, 0272, 0291; see that the LOFU can be pulsed and known as LIPUS, wherein the controller can adjust the frequency of the pulses whereby a frequency difference generates a beating wave comprising a wave field due to the interference of the pulses in the target area, wherein the system is capable of modulating intestinal flora when applied to the intestine/stomach region which indirectly improves neurodegenerative diseases through the gut-brain axis). Further, the first probe and the second probe of the probe module are an integrated single probe, each electrically communicated with the transducer at one end while the other end sends ultrasound to the target, the first probe is in the center of the integrated single probe, the second probe is in the peripheral region of the integrated single probe and has an annular sector shape forming a ring that surrounds the first probe (Figures 23, 25, 27; see the cross section of the image probe in the center and the treatment probes at the periphery with the peripheral second probe has an annular sector shape at its distal end).
Furthermore, the sound field frequency of the ultrasounds generated by the second probe is 20 kHz ~ 20 MHz, the sound power is 1 mW/cm2 ~ 10 W/cm2, the frequency difference of the ultrasounds generated is less than or equal to 100 kHz [0069; see the disclosed frequency ranges, acoustic output intensity (power), and differences when the ultrasounds are between 300 kHz and 3 MHz]. The system also includes a wearable device, the wearable device can be equipped with the probe modules that may be worn on (i.e. fixed to) and conformable to the abdomen to align with the target area, such that the probe module moves with the patient through the wearable device and during the irradiation process (Figures 27, 30; see that the device is placed on the subject and is capable of being placed on the abdomen, thereby being wearable and see the plural probes are placed on the subject to move with the subject).
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.
Claims 1, 3, 4, 6, 7, 11, and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Guha et al (US Pub 2020/0398084 -previously cited) in view of Sumner et al (US Pub 2008/0255049).
Re claims 1, 3, 4, 6, 7, 11: Guha discloses an ultrasound generator system and method for inhibiting intestinal inflammatory factor and/or improving neuroinflammation through the gut brain axis [0101, 0315; see the application to the colon, stomach, and intestine and see the application to tumors which are inflammatory which includes alignment on the abdomen], the system comprises at least a transducer probe module (figure 27 see the transducer probes), a processor module and an image module (Figure 25, 0268; see the display and processor); wherein a first probe of the probes sends a first ultrasound to a target area, and then the reflected wave of the first ultrasound is received by the first probe, and converted into an image signal and sent to a control unit that regulates the probe (Figure 27 see the imaging probe and the computer controller); a display screen is electrically communicated with the control unit (Figures 25, 27; see the processor and controller as part of the laptop computer), the display screen receives the image signal and displays the target area on the display screen (Figure 25; see the display of the ultrasound image); a second probe of the probes includes piezo-patches, the control unit controls the piezo-patches to send a second ultrasound and a third ultrasound with a plurality of frequency differences to the target area to generate a beating wave; and the second ultrasound and the third ultrasound focus in the target area; the control unit regulates the frequency difference between the ultrasounds allowing them to generate the beating wave, the system modulates intestinal flora/gut microbiota by generating a beating wave field in the abdomen, and indirectly improves neurodegenerative diseases caused by brain inflammation though the gut-brain axis by inhibiting microglial activation and increases BDNF (Figure 27, 0204; see the treatment probes for focused ultrasound wherein the probe is a TIPS probe that is known to use piezo elements; also see the LOFU which produces beating waves; 0064, 0216, 0272, 0291; see that the LOFU can be pulsed and known as LIPUS, wherein the controller can adjust the frequency of the pulses whereby a frequency difference generates a beating wave comprising a wave field due to the interference of the pulses in the target area, wherein the system is capable of modulating intestinal flora when applied to the intestine/stomach region which indirectly improves neurodegenerative diseases through the gut-brain axis). Further, the first probe and the second probe of the probe module are an integrated single probe, each electrically communicated with the transducer at one end while the other end sends ultrasound to the target, the first probe is in the center of the integrated single probe, the second probe is in the peripheral region of the integrated single probe and has an annular sector shape forming a ring that surrounds the first probe (Figures, 23, 25, 27; see the cross section of the image probe in the center and the treatment probes at the periphery with the peripheral second probe has an annular sector shape at its distal end).
Furthermore, the sound field frequency of the ultrasounds generated by the second probe is 20 kHz ~ 20 MHz, the sound power is 1 mW/cm2 ~ 10 W/cm2, the frequency difference of the ultrasounds generated is less than or equal to 100 kHz [0069; see the disclosed frequency ranges, acoustic output intensity (power), and differences when the ultrasounds are between 300 kHz and 3 MHz]. The system also includes a wearable device, the wearable device can be equipped with the probe modules that may be worn on (i.e. fixed to) and conformable to the abdomen to align with the target area, such that the probe module moves with the patient through the wearable device and during the irradiation process (Figures 27, 30; see that the device is placed on the subject and is capable of being placed on the abdomen, thereby being wearable and see the plural probes are placed on the subject to move with the subject).
Further still, Guha discloses image analysis algorithms including image segmentation for intra-treatment motion tracking and dose delivery verification which is a tracking of motion or shifting of a target area, wherein the hardware/software that moves the probe is in response to the target area moving. The movement of the probe is a warning to the operator that the target area has shifted based on the image analysis [0274; see the positional scanning based on motion tracking].
Guha discloses all features including that the probe module may be manipulated manually [0259], but does not disclose that it is secured by a girdle and/or Velcro. However, Sumner teaches of a LIPUS device wherein the probe modules are fixed to the subject using Velcro straps [0044; see the Velcro straps use to anchor the transducers]. It would have been obvious to the skilled artisan to modify Guha, to use the straps as taught by Sumner, in order to improve fixation of the modules to the subject thereby resulting in more accurate irradiation of a target without damaging healthy tissue.
Re claims 13, 14: Guha discloses the beating waves can modulate the expression level of colonic inflammatory factor and apoptosis factor by inhibiting the mitigation mediated the pro-inflammatory pathway by TLR4/NF-κB or in the tight junction protein of the cerebral cortex [0014, 0101, 0204; see the LOFU that generates beating waves and see the modulation of expression level in the cells of the intestine].
Re claims 15-18: Guha discloses the gut microbial homeostasis can be regulated by the beating waves, which can elevate Proteobacteria population, Verrucomicrobacteria population, Cyanobacteria population, or Tenericutes population in the colon of a subject by 548.61% and can decrease Firmicutes-Bacteroidetes (F/B) ratio of 9.44% or Bacteroidetes-Proteobacteria (B/P) Ratio 83.25% [0101, 0204; see the application to the colon or intestine with LOFU which generates beating waves and which can increase bacteria populations and can decrease F/B or B/P ratios to 9.44% and 83.25%, respectively, depending on the intensity and duration of ultrasound treatment].
Response to Arguments
Applicant’s arguments with respect to claims 1, 3, 4, 6, 7, 11, and 13-18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The new rejection incorporates the Sumner reference to teach Velcro means as obvious, as such would be useful to provide further fixation to a subject, especially when Guha’s manual positioning is utilized.
Regarding claim 8, Applicant argues that Guha does not disclose an annular structure forming a ring. However, Examiner finds that Guha’s figures 27 and 30 both show a distal face of the probes as having an annular shape, thereby meeting the limitation. The figures show a cross section but the second probe actually forms a ring (see also figures 23 and 25).
The prior claim objections, 112a rejections, and 112b rejections are withdrawn due to amendments.
Conclusion
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.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797