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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 30, 2025 has been entered.
Claim Objections
Claims 12, 13 and 15 are objected to because of the following informalities:
In claim 12, in line 2, --- is --- should be inserted after “energy”.
In claim 13, in line 2, --- is --- should be inserted after “energy”.
In claim 15, in line 1, the word “of” should be replaced with –is applied by generating ---.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1, 10-11, 15, 17, 20-22 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alford et al. (US Pub No. 2014/0058292), alone, or, alternatively, in view of Mishelevich et al. (US Pub No. 2007/0260107) and Zaaroor (“Magnetic resonance–guided focused ultrasound thalamotomy for tremor: a report of 30 Parkinson’s disease and essential tremor cases”, January 2018; Published online February 24, 2017), as evidenced by NursingHero (online: The Somatosensory System | Boundless Anatomy and Physiology | Study Guides).
With regards to claims 1 and 24, Alford et al. disclose method of inducing weight loss in a subject, the method comprising:
selecting a subject that does not suffer from essential tremor (ET) (paragraphs [0006], [0100], referring to the system for planning and delivering a neuromodulation therapy using external focused ultrasound to deliver neuromodulation to a patient, wherein the condition of the patient to be evaluated and treated can comprise of “obesity”, wherein such a patient who has obesity is not indicated as having ET),
applying high intensity focused ultrasound (HIFU) energy to a tissue of a portion of targeted tissue of the selected subject (paragraphs [0043]-[0044], [0047]-[0049], referring to the multi-transducer array (112) which can be controlled to emit and focus ultrasound energy for therapeutic benefit at one or more target sites; paragraphs [0057]-[0058], referring to the transducer array (174) which is controlled to focus emitted ultrasound energy at one or more target sites, wherein the ultrasound waveforms emitted by the array may be controlled for neuromodulation; paragraph [0050], referring emitted waveforms having a frequency ranging between 0.1 MHz and 20 MHz, which encompasses a HIFU frequency range; paragraph [0094], referring to, in some applications, non-destructive, high-intensity ultrasound is focused at a target site; Figures 1-2),
thereby creating at least one of an ablative lesion and tissue stimulation (i.e. stimulating volume of tissue and/or activating neuronal activity at target site), of the portion of the targeted tissue (paragraphs [0038], [0071], [0074]-[0075], referring to the volume of tissue stimulated by the focused ultrasonic waveforms at a target site; paragraph [0094], referring to applying high-intensity ultrasound to temporarily disrupt neuronal activity and/or activating or up regulating neuronal activity at that target site), and
wherein applying the HIFU energy is by generating between 1 to 3000 sonications per treatment (paragraphs [0080], [0093]-[0094], referring to repeating blocks 210 through 224 of Figure 4, which includes applying the ultrasonic stimulation at the same target site, and therefore the HIFU energy will be generated for at least 1 sonication per treatment; Figure 4),
thereby inducing a weight loss in a subject that does not suffer from ET and is in need of weight loss (paragraph [0100], referring to a condition being treated is obesity, wherein it is implicit that a patient suffering from obesity would be considered as a subject in need of weight loss and that effective treatment for obesity would be a loss of at least some amount of weight; paragraph [0112], referring to providing “therapeutically effective neuromodulation” at the target site). Additionally/alternatively, the limitation directed to the creation of the at least one of an ablative lesion and tissue stimulation “thereby inducing a weight loss in the subject” is viewed as being directed to a result that naturally/inherently flows from performing the recited active steps of applying the HIFU energy as claimed to the specific portion of the one thalamic nucleus. Since Applicant has set forth in their disclosure that by performing the steps as claimed, then weight loss could be induced in a subject, it would then appear that an inherent result of performing the steps as claimed is inducing weight loss in a subject. See MPEP 2112, IV. and MPEP 2112.02.
However, Alford et al. do not specifically disclose that the HIFU energy applied is between 100 to 35000 joules of HIFU energy.
Further, though Alford et al. do disclose that the HIFU energy could be applied to the thalamus (paragraph [0100]) of the subject, Alford et al. do not specifically disclose that the portion of the targeted tissue for treatment of obesity is a portion of one thalamic nucleus, wherein the portion of the one thalamic nucleus is within a radius of less than 10 mm of the thalamic Ventral Intermediate Nucleus.
However, Alford et al. disclose that waveform control parameters of the transducer, including amplitude/intensity of the ultrasonic waveform emitted by each selected transducer, can be adjusted and increased to achieve a desired neuromodulation response (paragraphs [0079]-[0083], [0093]). Alford et al. additionally disclose that the location of energy focus with a target site may be altered and the efficacy of stimulating different targets in reducing symptoms may be compared (paragraphs [0097]-[0098]). Multiple combinations of transducers and/or waveform control parameter settings may be tested for a target site to collect data for identifying optimal neuromodulation therapy delivery parameters for that site (paragraph [0097]).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art, through routine optimization, to modify the applied HIFU energy applied in Alford et al. to comprise between 100 to 35,000 joules of HIFU energy and to further modify the treatment target site to include a portion of one thalamic nucleus, wherein the portion of the one thalamic nucleus is within a radius of less than 10 mm of the thalamic Ventral Intermediate Nucleus, in order to determine the optimal neuromodulation therapy delivery parameters to treat obesity (paragraphs [0097]-0098]).
Alternatively, if applying 100-35000 joules of HIFU and/or having the portion of tissue treated comprise the one thalamic nucleus as claimed is not viewed as being a matter of routine optimization:
Mishelevich et al. disclose modulate neural activity at arbitrary deep and superficial brain locations, wherein (Abstract; paragraph [0001]). Examples of conditions that may be treated, as well as brain structures that may be targeted for treating those conditions, include: Obesity: Ventromedial nucleus of thalamus, Ventrolateral nucleus of thalamus (paragraph [0072], [0076]). Note that the “Ventrolateral” nucleus of thalamus is immediately adjacent the ventral intermediate nucleus, and therefore would inherently be within a radius of less than 10 mm of the thalamic Ventral Intermediate Nucleus. This is evidenced by the below annotated Figure of NursingHero (see the below image which depicts the Ventrolateral (VL) nucleus as being immediately adjacent the ventral intermediate nucleus (VI)).
Annotated Figure of Nursing Home:
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Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the portion of the targeted tissue for treatment of obesity of Alford et al. correspond to a portion of one thalamic nucleus, wherein the portion of the one thalamic nucleus is within a radius of less than 10 mm of the thalamic Ventral Intermediate Nucleus, as taught by Mishelevich et al, in order to effectively treat obesity using a known brain target for treatment of obesity (paragraph [0076]). Additionally/alternatively, it would have been obvious to one of ordinary skill in the art to substitute the portion of the targeted tissue for treatment of obesity of Alford et al with a portion of one thalamic nucleus, wherein the portion of the one thalamic nucleus is within a radius of less than 10 mm of the thalamic Ventral Intermediate Nucleus, as taught by Mishelevich et al., as the substitution of one known targeted tissue portion for obesity for another yields predictable results (i.e. provide effective treatment for obesity) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
However, the above combined references do not specifically disclose that the HIFU energy applied is between 100 to 35000 joules of HIFU energy.
Zaaroor et al. disclose a maximal energy of reaching 5,850-23,040 Joules for applying ultrasound penetrating the skull for providing treatment to the thalamus (Abstract; pg. 205, Section “Results-Patient Characteristics”).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the HIFU energy of the above combined references comprise between 100 to 35,000 joules of HIFU energy, as taught by Zaaroor et al., in order to effectively penetrate the skull for providing treatment to the thalamus (Abstract; pg. 205, Section “Results-Patient Characteristics”).
With regards to claims 10-11, as discussed above, the above combined references meet the limitations of claim 1. However, though the above combined references do not specifically disclose that the HIFU energy is continued for a period of time between 5 and 40 seconds, wherein applying the HIFU energy is continued for a period of time between 0.5 second and 60 minutes, Alford et al. do disclose that waveform control parameters of the transducer can be adjusted, such as duty cycle, etc., to achieve a desired neuromodulation response (paragraphs [0079]-[0083], [0093]). Therefore, it would have been obvious to one of ordinary skill in the art to have the HIFU energy be continued for a period of time between 5 and 40 seconds, wherein applying the HIFU energy is continued for a period of time between 0.5 second and 60 minutes, through routine optimization, in order to determine the optimal duration of time to achieve a desired neuromodulation response (paragraphs [0079]-[0083]).
With regards to claim 15, Alford et al. disclose that the HIFU energy is between 1 and 28 sonications per treatment (paragraphs [0080], [0093]-[0094], referring to repeating blocks 210 through 224 of Figure 4, which includes applying the ultrasonic stimulation at the same target site, and therefore the HIFU energy will be generated for at least 1 sonication per treatment; Figure 4).
With regards to claim 17, Alford et al. disclose that applying the HIFU energy is under guidance of Magnetic Resonance Imaging (MRI) (paragraphs [0037]-[0038], [0084], [0117], referring to MRI being used to provide input to identify a target site and monitor a neuromodulation response).
With regards to claims 20 and 21, though Alford et al. do not specifically disclose that inducing the weight loss in the subject comprises reducing at least 3% of a weight of the subject or that inducing the weight loss in the subject comprises inducing the weight loss in the subject over a period of at least three months from application of the treatment, the limitations are considered to be a direct result that naturally/inherently flows from performing the recited active steps of claim 1, and therefore it would follow that the above steps carried out by the above combined references would result in the claimed weight loss. Note that since Applicant has set forth in their disclosure that by performing the steps as claimed, then weight loss in the claimed period of time could be induced in a subject, it would then appear that an inherent result of performing the steps as claimed is inducing weight loss in a subject. See MPEP 2112, IV. and MPEP 2112.02. Further note that an alternative rejection for claim 20 is provided below.
With regards to claim 22, Alford et al. disclose that creating the tissue stimulation of the at least the portion of the thalamic nucleus comprises applying the HIFU energy to the radius of less than 10 mm of the thalamic Ventral Intermediate Nucleus by ultrasound without creating a lesion (paragraph [0094], referring to, in some applications, non-destructive [and therefore “without creating a lesion”], high-intensity ultrasound is focused at a target site; Figures 1-2).
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alford et al., alone, or, alternatively, in view of Mishelevich et al. and Zaaroor, as evidenced by NursingHero as applied to claim 1 above, and further in view of Asirvatham et al. (US Pub No. 2014/0296680).
With regards to claims 12 and 13, as discussed above, the above combined references meet the limitations of claim 1. However, they do not specifically disclose that applying the HIFU energy to achieve a temperature at the portion of the thalamic nucleus of between 55-60 degrees Celsius or of between 40-50 degrees Celsius.
Asirvatham et al. disclose providing ablation energy, such as ultrasound energy, or other treatments to targeted brain tissue, wherein the targeted portions of the brain includes portions in the thalamus, etc. (Abstract; paragraphs [0007], [0012]). Some of the devices may be capable of targeting and ablating or stimulating neurons in the arcuate nucleus of the hypothalamus so as to treat obesity or other conditions (paragraphs [0012], [0077]). Ablation energy is applied to heat the targeted tissue (paragraphs [0013], [0065]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the HIFU energy of the above combined references be applied to achieve a temperature at the portion of the thalamic nucleus that results in heating of the portion of the thalamic nucleus, as taught by Asivatham et al, as ablation of targeted tissue is a known alternative treatment to stimulating neurons in brain tissue that is a target site for the treatment of obesity (paragraph [0077]). Though Asirvatham et al. do not specifically disclose that the ablation/heating of tissue is used to achieve a temperature at the portion of the thalamic nucleus of between 55-60 degrees Celsius or of between 40-50 degrees Celsius, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to modify the parameters for ablation/heating of tissue to achieve a temperature of between 55-60 degrees Celsius or of between 40-50 degrees Celsius in order to determine the optimal temperature that provides a desired effective treatment of the targeted tissue.
Claim(s) 20 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Alford et al., alone, or, alternatively, in view of Mishelevich et al. and Zaaroor, as evidenced by NursingHero, as applied to claim 1 above, and further in view of Rousseaux (Rousseaux et al., “Disorders of Smell, Taste, and Food Intake in a Patient With a Dorsomedial Thalamic Infarct”, Stroke, Volume 27, Issue 12, December 1996; Pages 2328-2330, https://doi.org/10.1161/01.STR.27.12.2328).
Regarding Claim 20, the above combined references are silent as to wherein inducing the weight loss in the subject comprises reducing at least 3% of a weight of the subject.
Rousseaux teaches wherein inducing the weight loss in the subject comprises reducing at least 3% of a weight of the subject (see Rousseaux, Page 1, “after bilateral dorsomedial thalamic nuclei injury; this disappearance can be associated with reduction of food intake and severe weight loss, suggesting a yet unrecognized role of the thalamus in food intake and body weight regulation” … “A 68-year-old woman, whose weight had been stable at 65 kg”; See also Rousseaux, Abstract, “bilateral dorsomedial and intralaminar thalamic lesions. … A 68-year-old patient … . A severe drop in appetite for foods and a weight loss of 10 kg were observed,” wherein 10 Kg weight loss for a person whose weight had been stable at 65 kg will result in at least 3% of a weight of the subject).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the brain stimulation method, as taught by the above combined references, to reduce subject’s weight by at least %3, as taught by Rousseaux, in order to provide an effective method for modifying/controlling biological activities of the subject that will result in biological changes such as inducing weight loss.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 10-13, 15, 17, 20-22 and 24 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. Alford and Mishelevich et al. have been introduced to teach the limitations of claims 1 and 24, etc..
Conclusion
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798