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 .
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.
Claims 28-29 are 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.
With regards to claims 28-29, the claims recites that the method comprises “stopping said applying before producing a temperature above 60 degrees Celsius”. However, claims 28-29 are ultimately dependent upon claims 1 and 24, wherein claims 1 and 24 recite that the subject “does not suffer from essential tremor”. The only support in the specification for stopping said applying before producing a temperature above 60 degrees Celsius specifically sets forth that sonications are stopped “when adequate control of tremor was achieved, with the temperature reaching no more than 59 degrees Celsius” (see paragraphs [0038] and [0046] of Applicant’s PG-Pub 2020/0315829), and therefore the specification sets forth that stopping the application as claimed is associated with treatment of essential tremors (i.e. treatment of subjects that do suffer from essential tremor). Therefore, though the specification supports stopping said applying before producing a temperature above 60 degrees Celsius in subjects that are suffering from essential tremor, the specification does not provide support for stopping said applying as claimed in a subject that does not suffer from essential tremor.
The claims therefore fail to comply with the written description requirement.
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 22 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 22 recites the limitation "the tissue stimulation" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
With regards to claim 22, in lines 2-4, the claim recites “applying the HIFU energy…by ultrasound without creating a lesion…”, wherein claim 22 is dependent upon claim 1 which sets forth “applying..high intensity focused ultrasound (HIFU) energy to a tissue….to create an ablative lesion”. Claim 22 therefore appears to conflict with claim 1 in that claim 22 sets forth that the application of HIFU is done “without” creating a lesion and claim 1 sets forth that the application of HIFU is done “to create” an ablative lesion, thereby rendering the scope of the claim indefinite as it is unclear as to how the HIFU energy can be applied to both create a lesion and not create a lesion.
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, 12, 15, 17, 20-22, 24 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham et al. (US Pub No. 2014/0296680) 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, Asirvatham et al. disclose a method of inducing weight loss in a subject, the method comprising:
selecting a subject that does not suffer from essential tremor (ET) (paragraph [0007], referring to the ultrasound ablation energy being provided to targeted brain tissue of a patient, wherein the patient is not disclosed as suffering from essential tremor);
applying ultrasound ablation energy to a tissue of a portion of one nucleus of the brain of the selected subject for a time sufficient to create an ablative lesion of the portion of the one nucleus of the brain (paragraphs [0007], [0040], [0046]-[0047], [0071], referring to providing ablation energy, such as ultrasound energy, to targeted brain tissue; paragraphs [0012], [0077], referring to the devices, which include a device delivering ultrasound ablation energy, targeting and ablating (or stimulating) neurons in the arcuate nucleus of the hypothalamus “so as to treat obesity”), and
wherein applying the ultrasound ablation energy is by generating between 1 to 3000 sonications per treatment (paragraphs 0007], [0040], [0046]-[0047], [0071], referring to providing ablation energy, such as ultrasound energy, to targeted brain tissue, wherein to be effective to ablate tissue, at least 1 sonication would necessarily/inherently be required),
thereby inducing a weight loss in a subject that does not suffer from ET and is in need of weight loss (paragraphs [0012], [0077], referring to the devices, which include a device delivering ultrasound ablation energy, targeting and ablating neurons in the arcuate nucleus of the hypothalamus “so as to treat obesity”, wherein treatment of obesity (i.e. subject in need of weight loss) would inherently/necessarily be weight loss).
However, Asirvatham et al. do not specifically disclose that the ultrasound ablation energy is between 900 to 35000 joules of high intensity focused ultrasound (HIFU) energy.
Further, though Asirvatham et al. do disclose that the ablation treatment may be delivered to portions in the thalamus (paragraph [0078]), Asirvatham et al. do not specifically disclose that the portion of the one nucleus of the brain is specifically 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.
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/one nucleus of the brain for treatment of obesity of Asirvatham 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 Asirvatham 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.
With regards to the limitation concerning the “ultrasound ablation energy is between 900 to 35000 joules of high intensity focused ultrasound (HIFU) energy, 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 900 to 35,000 joules of HIFU energy, in order to determine the optimal treatment parameters to effectively ablate the portion of the one nucleus of the brain to treat obesity.
Alternatively, if applying 900-35000 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:
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 provide 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, it would have been obvious to one of ordinary skill in the art, through routine optimization, 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, in order to determine the optimal duration of time to provide an effective ablation of the targeted tissue for the treatment of obesity.
With regards to claims 12 and 27, though Asirvatham et al. do not specifically disclose that said creating the ablative lesion comprises producing a temperature at the portion of the thalamic nucleus of between 55-60 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 in order to determine the optimal temperature that provides a desired effective treatment of the targeted tissue.
With regard to claim 15, Asirvatham et al. disclose that the HIFU energy is applied by generating between 1 and 28 sonications per treatment (paragraphs 0007], [0040], [0046]-[0047], [0071], referring to providing ablation energy, such as ultrasound energy, to targeted brain tissue, wherein to be effective to ablate tissue, at least 1 sonication would necessarily/inherently be required).
With regards to claim 17, Asirvatham et al. disclose that applying the HIFU energy is under guidance of Magnetic Resonance Imaging (MRI) (paragraphs [0004], [0038], referring to the use of MRI images to permit identification of catheter positions with the nervous system).
With regards to claims 20 and 21, though Asirvatham 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, Asirvatham 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 thlamic Ventral Intermediate Nucleus by ultrasound without creating a lesion (paragraph [0077], referring to the treatment of obesity comprising of ablating or stimulating neurons in the arcuate nucleus of the hypothalamus, wherein stimulating the neurons comprises applying the energy “without creating a lesion”).
Claim(s) 20 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham et al. 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.
Claim(s) 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham et al. in view of Mishelevich et al. and Zaaroor, as evidenced by NursingHero, as applied to claims 12 and 27 above, alone, or alternatively, further in view of Gertner (US Pub No. 2012/0065493)
With regards to claims 28-29, as discussed above, the above combined references meet the limitations of claims 12 and 27.
However, the above combined references do not specifically disclose that the method comprises stopping said applying before producing a temperature above 60 degrees Celsius.
It would have been obvious to one of ordinary skill in the art, through routine experimentation/optimization, to stop said applying before producing a temperature above 60 degree Celsius, in order to determine the optimal temperature that would result in a desired lesion region.
Alternatively, Gertner provides a system for ablating nerves and using ultrasound to penetrate tissue and be focused to create ablation zones (paragraphs [0218], [0223]). Temperatures of regions of ablation may be increased to be between 40-60 degrees in order to temporarily inhibit or block the nerves in desired regions and these temperatures can be used to determine that a patient will respond to a specific treatment, wherein in some embodiments the temperature can be measured and held to be less than 60 degrees Celsius, or less, in which case the procedure may be stopped when a desired temperature is reached (paragraph [0364]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to stop said applying of the above combined references to be before producing a temperature above 60 degrees Celsius, as taught by Gertner, in order to temporarily inhibit or block the nerves in desired regions and these temperatures can be used to determine that a patient will respond to a specific treatment (paragraph [0364]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 10-12, 15, 17, 20-22, 24 and 27-29 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. Examiner notes that previously cited reference Asirvatham has been introduced to reject claims 1 and 24.
With regards to Asirvatham, Applicant argues that Asirvatham teaches ablation of the arcuate nucleus of the hypothalamus, not the VIM region of the thalamus as recited in claim 1.
However, Examiner respectfully refers Applicant to the above rejection which now introduces Asirvatham as the primary references in the rejection of claims 1 and 24 and wherein Asirvatham is further modified in view of previously relied upon Mishelevich and Zaaroor to meet the above limitation. Examiner emphasizes that it is the combination of the above references that meets claims 1 and 24, wherein the teaching of the VIM region of the thalamus as a target region of obesity treatment of Mishelevich is relied upon to modify Asirvatham to have the target for the obesity ablation treatment of Asirvatham to include the VIM region of the thalamus.
The claims therefore remain rejected.
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 KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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/KATHERINE L FERNANDEZ/ Primary Examiner, Art Unit 3798
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