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 .
Response to Amendment
The Office Action is responsive to the Amendment filed 01 June 2026. Claims 58-77 are now pending. The Examiner acknowledges the amendments to claims 58-77.
Claim Rejections - 35 USC § 102/35 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 58-77 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Dissing et al. (US 20120101327 A1).
Regarding claims 58 and 77, Dissing et al. teaches a repetitive transcranial magnetic stimulation (rTMS) method for slowing or preventing a conversion of mild cognitive impairment (MCI) to Alzheimer’s disease (“preventing, treating, or relieving a disorder”, paragraph [0027]), treating or preventing Alzheimer’s disease (“pulsed electromagnetic field applied trans-cranially at the bi-temporal area of a subject for the treatment...Alzheimer’s disease”, paragraph [0026]),
comprising repetitively applying a magnetic pulse to the scalp of a patient in need thereof thereby stimulating neurons in the brain of the patient (“electrical field induced by supplying pulses to said at least one coil will stimulate serotonergic neurons”, paragraph [0021]; shown in Fig. 7), and
at a frequency of about 100 Hz to about 150 Hz (“current pulses are supplied with a frequency of preferably 20-300”, paragraph [0069])
Dissing does not teach the magnetic pulses being applied repetitively over the patient’s brain at an intensity of 5,000 milligauss to about 15,000 milligauss.
However, Dissing does teach an intensity of about 1,000 to about 9,000 milligauss (Fig. 4 shows a magnetic field range of 1 to 9 Gauss, which is 1,000 to 9,000 milligauss).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that the range of frequencies and intensities of the magnetic pulses would be subject to optimization within the claimed range by routine experimentation with a reasonable expectation of success, in order to provide transcranial magnetic stimulation to a patient with Alzheimer’s. Moreover, it would have been obvious to one of ordinary skill in the art at the time of the invention to choose the instantly claimed ranges through process optimization, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 II and in re Boesch, 205 USPQ 215 (1980).
Regarding claim 59, Dissing et al. teaches all the limitations of claim 58, but does not teach the magnetic pulse being applied at a frequency of about 125 to about 145 Hz, or at a frequency of about 135 Hz;
Wherein the magnetic pulse is applied at an intensity of about 10,000 milligauss; and/or
Wherein the magnetic pulse generates an electric field of about 0.1 to about 10 V/m^7. About 0.5 to about 1.5 V/m^7, or about 1 V/m^7.
However, Dissing et al. does teach the magnetic pulse being applied at a frequency of 10-400 Hz (paragraph [0108]), and the magnetic pulse being applied at an electric field intensity of about 1x10^-6-0.1 V/m (paragraph [0063]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the frequency and intensity of the magnetic pulse to be within the claimed ranges in order to increase the therapeutic effects of rTMS. A higher frequency and intensity would enhance neural excitability, improving cognitive function and memory in patients with Alzheimer’s disease. Since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, the Applicant appears to have placed no criticality on the claimed range (see paragraph [026]).
Regarding claim 60, Dissing et al. teaches the method being undertaken once, or twice, or thrice, or four times daily (“pulsed electromagnetic field applied…several times a day, such as 2, 3, 4 or 5 times a day, on a daily basis”, paragraph [0110]);
and/or wherein the method is undertaken for greater than about 15 minutes (“the pulsed electromagnetic field applied…for a period of…preferably 15-60, more preferred 20-40, preferably about 30 minutes”, paragraph [0131]).
Regarding claim 61, Dissing et al. teaches all the limitations of claim 58, including pulses (paragraph [0057]), but does not teach repetitively applying the magnetic pulse about 300 to about 400 times.
However, it would have been obvious to one of ordinary skill in the art to routinely experiment the number of pulses that are effective during the treatment as an optimal range. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Dissing et al. by making the number of the pulses to the claimed amount as a matter of routine optimization since it has been held that “where general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation,” in re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 62, Dissing et al. teaches repetitively applying the magnetic pulse and applying the pulses discontinuously. This is interpreted that pulses are a discontinuous moment of an action. Unless applicant intends to claim at a certain time interval, there is a number of pulses and then silent for another time interval before another set of magnetic pulses is generated.
Regarding claim 63, Dissing et al. teaches all the limitations of claim 58, but does not teach repetitively applying the magnetic pulse and applying the pulses for about four seconds, or wherein the pulses last for about four seconds followed by one second without pulsing.
However, Dissing et al. does teach the time between each new current pulse being “5-100, preferably 10-50, more preferred 15-20, preferably 18 ms”, in paragraph [0074], and the delay between pulse pairs being “1-50, preferably 5-25, more preferred 10-15, preferably 12 ms”, in paragraph [0075].
It would have been obvious to one of ordinary skill in the art to modify the duration of each pulse of Dissing et al. to the claimed range, as it involves only adjusting the timing to be a little bit longer. Adjusting the time of each pulse and in between pulse would vary the strength of the treatment depending on the level of severity in a patient with Alzheimer’s disease. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Dissing et al. by making the time of the pulses about four seconds and one second in between pulses as a matter of routine optimization since it has been held that “where general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation,” in re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 64, Dissing et al. teaches the method being applied chronically, and/or (“patients…receive daily PEMF treatments for a 5-week period”, paragraph [0180]) wherein the treatment is applied for greater than about 2 months, greater than about 6 months, or greater than about one year.
Regarding claim 65, Dissing et al. teaches the treatment being self-applied by a device that is suitable for home use, and/or wherein the device is portable (“subject comes to the clinic and places the PEMF device on his or her own head…subject may subsequently use the device at home”, paragraph [0180]).
Regarding claim 66, Dissing et al. teaches the magnetic pulse being applied using a device, the device being suitable for conducting electric current through a coil, and wherein the device generates a magnetic field (“a pulse generator and seven coils, in which pulsed currents cause fluctuating magnetic fields in a predetermined region”, paragraph [0009]; Fig. 7).
Regarding claims 67, 73 and 74, Dissing et al. teaches all the limitations of claim 72, and further teaches using the Hamilton Depression scale (HAM-D17) (see paragraph [0103]) to measure the degree of the disease, but fails to teach any of the claimed treatment scales.
However, it would have been obvious to one of ordinary skill in the art to selectively choose any of the scale to measure the degree of the disease and to provide treatment using rTMS, since each one of these scales would be functionally equivalent to allow healthcare workers to make an assessment.
Regarding claim 68, Dissing et al. teaches the patient is afflicted with dementia with using the Hamilton Depression scale (HAM-D17) to indicate the presence of cognitive impairment (see paragraph [0103]).
Regarding claim 69, Dissing et al. teaches using a biomarker indicative of Alzheimer’s disease instead of high A6, high Tau in cerebrospinal fluid, and the presence of the ApoE4 allele.
However, because Dissing et al. teaches using one of the biomarkers, it would have been obvious to one of ordinary skill in the art to have any of the equivalent biomarkers to yield an indicator whether the patient needs treatment or not.
Regarding claim 70, Dissing et al. teaches all the limitations of claim 58, but does not teach the method stimulating neurons around about 2 cm to about 3 cm from the skull, and/or wherein the magnetic pulse is applied repetitively over the patient’s left prefrontal dorsolateral cortex.
However, Dissing et al. does teach the seven coils being arranged such that every area of the brain can be treated (paragraphs [0022], [0023], [0024]), which would include the left prefrontal dorsolateral cortex.
Regarding claim 71, Dissing et al. teaches the method stimulating neurons throughout the patient’s brain, stimulates neurons in a left hemisphere of the patient’s brain, stimulates neurons in a frontal lobe of the patient’s brain, stimulates neurons in a cerebral cortex of the patient’s brain, and/or stimulates neurons outside of the patient’s left prefrontal dorsolateral cortex. The seven coils are placed around the scalp of the patient to treat various points of the brain (see paragraphs [0022], [0023], [0024]).
Regarding claim 72, Dissing et al. teaches the method preventing or delaying the progression of MCI to Alzheimer’s disease, improving cognitive traits of the patient, preventing diminution of cognitive traits of the patient, and/or slows the patient’s memory loss or retains or increases memory capacity (“a method and an apparatus for stimulating cellular activities in brain tissue causing improved neural function for patient suffering from mental disorders”, paragraph [0001], paragraph [0026]).
Regarding claim 75, Dissing et al. teaches the method being used in tandem with ne or more additional agents, and/or wherein the method obviates the need for treatment with one or more additional agents (paragraph [0060]).
Regarding claim 76, Dissing et al. teaches treating of Alzheimer’s disease as the same to Applicant’s invention with the claimed frequency and electric field. Therefore, making the method substantially free of adverse effects selected from epileptic seizures, nausea, and headache.
Response to Arguments
Applicant’s arguments, see page 6, filed 01 June 2026, with respect to the specification objections have been fully considered and are persuasive in light of the amendments. The claim objections have been withdrawn.
Applicant’s arguments, see page 6, filed 01 June 2026, with respect to the 35 U.S.C. 112 rejections have been fully considered and are persuasive in light of the amendments. The 35 U.S.C. 112 rejections have been withdrawn.
Applicant’s arguments with respect to claims 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 rejection of all pending claims 58-77 under 35 U.S.C. 103 have been updated accordingly.
Applicant declares that the ranges have criticality. It is noted that the disclosure, and even the declaration appears to suggest otherwise, showing that there are various levels of testing of magnetic pulses and frequencies without a specific range that appears to be critical. Generally, criticality is when a specific range is shown to be better. It is also noted that the prior art appears to teach the ranges of “a frequency of about 100 Hz to about 150 Hz” (“current pulses are supplied with a frequency of preferably 20-300”, paragraph [0069]) and it is overlapping with “an intensity of about 5,000 milligauss to about 15,000 milligauss” (Fig. 4 shows a magnetic field range of 1 to 9 Gauss, which is 1,000 to 9,000 milligauss). Therefore, it is also obvious to one of ordinary skill in the art to modify the overlapping ranges to be within the claimed range.
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 LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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, Alexander Valvis can be reached at 5712724233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights