DETAILED ACTION
Response to Amendment
This Office Action is in response to the amendment filed 08/14/2026. Claims 1-3, 9, 11, 14, 16-17, 19-20, 23-24, 28, 32-35, 39, 42, and 44 are acknowledged as pending with claims 1-3, 11, 14, 16-17, 19-20, 23, 28, 33, 35, 39, and 42 being currently amended and claim 44 being new.
The claim objections, rejections under 35 U.S.C. 112(b), and rejections under 35 U.S.C. 102(a)(1) are withdrawn as having been overcome by the amendment. The amendment of claim 1 introduces new claim limitations that change the scope of the claim. The rejections under 35 U.S.C. 103 mailed in the Non-Final Rejection on 05/19/2026 are maintained but have been adjusted as necessitated by the amendment.
Response to Arguments
Applicant’s arguments filed 08/14/2026 have been fully considered but they are not persuasive.
With respect to Dissing et al. (US 2012/0101327) (see Applicant’s response, pages 8-9, “Claim Rejection – 35 U.S.C. § 102), applicant argues that the examiner has failed to make a prima facie case of anticipation for claims 1 and 2. The requirements for anticipation are discussed in MPEP § 2131. MPEP § 2131 notes that
“To reject a claim as anticipated by a reference, the disclosure must teach every element required by
the claim under its broadest reasonable interpretation.” In the most recent office action, multiple
rejections under 35 U.S.C. 102 with specific mappings addressing every element of the claimed invention
for the pertinent claims were provided.
On page 8, para. 5 of Applicant’s response, applicant argues that the examiner has failed to establish a proper prima facie case of anticipation because Dissing et al. does not teach a method for treating major depressive disorder (MDD) and persistent depressive disorder (PDD). It is noted that rejected claim 1’s preamble states, “a repetitive transcranial magnetic stimulation (rTMS) method for treating or preventing major depressive disorder (MDD) or persistent depressive disorder (PDD)”. Furthermore, rejected claim 2’s preamble states, “A rTMS method for slowing or preventing a conversion of MDD to PDD”. As stated in the previous office action, Dissing et al. teaches providing pulsed electromagnetic field trans-cranially at the bitemporal area of a subject for the treatment of depression, major depressive disorder, bipolar disorder/manic depressive, etc., and/or alleviating one or more symptoms associated with said condition (see paras. 0026, 0029, and 0140). One of common knowledge in the art would understand that if Dissing et al.’s PMEF application is designed to treat MDD, and PDD or dysthymia is treated with the same stimulation parameters (i.e., a frequency of 100–1000 Hz and an intensity of 1,000-15,000 milligauss) as claimed by applicant, then the PMEF stimulation of Dissing et al. may concurrently treat MDD and PDD and their associated symptoms. MPEP § 2111 discusses proper claim interpretation, including giving claims their broadest reasonable interpretation in light of the specification during examination. Under broadest reasonable interpretation, the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim. Since Dissing et al. stimulation parameters overlap the claimed stimulation parameters (the stimulation parameters of Dissing et al. will be further elaborated on below) for the treatment of MDD and PDD, it reasonable to ascertain that Dissing et al. does in fact teach a method of treatment or prevent MDD and PDD. Therefore, the rejection of these limitations is maintained.
On page 8, para. 8 and page 9, paras. 1-2 of Applicant’s response, applicant argues that the examiner has failed to establish a proper prima facie case of anticipation because Dissing et al. does not “clearly and unequivocally disclose the claimed frequency parameter as arranged in amend claim 1”. MPEP § 2111 discusses proper claim interpretation, including giving claims their broadest reasonable interpretation in light of the specification during examination. Under broadest reasonable interpretation, the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim. Dissing et al. explicitly discloses that the frequency of the PEMF stimulation is preferably above 20 Hz and below 1000 Hz (para. 0070). Dissing et al.’s stimulation frequency range encompasses the previously claimed frequency range of 100-1000 Hz and the amended frequency range of 500-600 Hz. While the examiner acknowledges that Dissing et al. discloses various combinations of frequency ranges; the BRI of claim 1 does not preclude the specific frequency teaching of Dissing et al. (i.e., a frequency above 20 Hz and below 1000 Hz – para 0070) from being relied upon to teach the applicant’s claimed frequency parameter. Thus, the rejection of this limitation has been adjusted as necessitated by the amendment. Likewise, the rejection of dependent claims 3, 9, 11, 19, 23-24, 28, 32, 35, and 39, though not specifically addressed, is maintained but has been adjusted as necessitated by the amendment herein.
On page 9, paras. 3-5 of Applicant’s response, applicant argues that the examiner has failed to establish a proper prima facie case of anticipation because Figure 4 of Dissing et al.’s disclosure “does not teach selection of a magnetic intensity for treating MDD or PDD”. Instead, applicant argues that Figure 4 describes a relationship between a coil distance and magnetic field strength for magnetic field decay calculation purposes rather than field strength parameters for treatment. MPEP § 2111 discusses proper claim interpretation, including giving claims their broadest reasonable interpretation in light of the specification during examination. Under broadest reasonable interpretation, the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim. In the previous office action, examiner explicitly cited to Figure 4 of Dissing et al., Figure 4 depicts a magnetic field strength of 1-9 gauss (1,000-9,000 milligauss). With BRI in mind, Figure 4 of Dissing et al. discloses an intensity/magnetic field strength that encompasses the applicant’s claimed intensity range. Therefore, the magnetic field strength of Dissing et al. is considered to meet the claimed “an intensity of about 1,000 to above 15,000 milligauss.” The rejection of this limitation is maintained.
With respect to Dissing et al. and Eriksson et al. (see Applicant’s response, page 12, “Claim Rejection – 35 U.S.C. § 103 – 1”), applicant argues that the references are non-analogous because Eriksson et al. “fails to supply any clear magnetic intensities paired with any particular frequencies”. Therefore, there is no suggestion to combine Eriksson et al. with Dissing et al. MPEP § 2141.01(a) states that in order for a reference to be used in an obviousness rejection, it must be analogous art to the claimed invention. A reference is analogous art to the claimed invention when it is either from the same field of endeavor as the claimed invention or is reasonably pertinent to the problem faced by the inventor. In response to applicant’s argument that Eriksson et al. is nonanalogous art, it has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Eriksson et al. is considered to be analogous art because it is reasonably pertinent to the particular problem with which the applicant was concerned. Eriksson et al. is reasonably related to the particular problem of repetitively stimulating a patient trans-cranially using a coil configured to emit magnetic fields in specific regions of the brain (Eriksson et al., Abstract; para. 0036; Claims 1-3 and 5). With respect to the obviousness rejection of claim 14, Eriksson et al. was relied upon to teach the number of magnetic pulses– not the frequency and intensity stimulation parameters, which are addressed above in connection with the applicant’s response on pages 8-9. One of ordinary skill would have been motivated to incorporate the methodology of Eriksson et al. The specific number of applied magnetic pulses may effectively “modulate the proliferation, differentiation, and/or migration of neural stem cells in an adult’s central nervous system.” Therefore, Dissing et al. and Eriksson et al. are considered to be analogous art to the claimed invention and the rationale to combine provided in the most recent office action is considered to be proper. The rejection of claim 14 as obvious over Dissing et al. in view of Eriksson et al. is maintained.
With respect to Dissing et al. and Etkin et al. (see Applicant’s response, page 12, “Claim Rejection – 35 U.S.C. § 103 – 2”), applicant argues that the references are non-analogous because Etkin et al. “fails to supply any clear magnetic intensities paired with any particular frequencies”. Therefore, there is no suggestion to combine Etkin et al. with Dissing et al. MPEP § 2141.01(a) states that in order for a reference to be used in an obviousness rejection, it must be analogous art to the claimed invention. A reference is analogous art to the claimed invention when it is either from the same field of endeavor as the claimed invention or is reasonably pertinent to the problem faced by the inventor. In response to applicant’s argument that Etkin et al. is nonanalogous art, it has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Etkin et al. is considered to be analogous art because it is reasonably pertinent to the particular problem with which the applicant was concerned. Etkin et al. is reasonably related to the particular problem of repetitively stimulating a patient trans-cranially using a coil configured to emit magnetic fields in specific regions of the brain for the treatment of depression (Etkin et al., Abstract; paras. 0043-0044). With respect to the obviousness rejection of claims 16-17, 20, and 34, Etkin et al. was relied upon to teach, respectively, the discontinuous application of magnetic pulses, the duration of the magnetic pulses, the treatment duration, and the location of the stimulation in the left prefrontal dorsolateral cortex – not the frequency and intensity stimulation parameters, which are addressed above in connection with the applicant’s response on pages 8-9. One of ordinary skill would have been motivated to incorporate the methodology of Etkin et al. Doing so would create a protocol with stimulation parameters comparable to scientifically validated rTMS treatment protocols designed to treat depression, such that stimulating the left prefrontal dorsolateral cortex with “on” and “off” intervals would create a highly effective yet tolerable stimulation pattern for reducing depressive symptoms, and wherein a treatment duration of two months may be effective for treating a patient with severe depression. Therefore, Dissing et al. and Etkin et al. are considered to be analogous art to the claimed invention and the rationale to combine provided in the most recent office action is considered to be proper. The rejection of claims 16-17, 20, and 34 as obvious over Dissing et al. in view of Etkin et al. is maintained.
With respect to Dissing et al. and Zangen et al. (see Applicant’s response, page 12, “Claim Rejection – 35 U.S.C. § 103 – 3”), applicant argues that the references are non-analogous because Zangen et al. “fails to supply any clear magnetic intensities paired with any particular frequencies”. Therefore, there is no suggestion to combine Zangen et al. with Dissing et al. MPEP § 2141.01(a) states that in order for a reference to be used in an obviousness rejection, it must be analogous art to the claimed invention. A reference is analogous art to the claimed invention when it is either from the same field of endeavor as the claimed invention or is reasonably pertinent to the problem faced by the inventor. In response to applicant’s argument that Zangen et al. is nonanalogous art, it has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Zangen et al. is considered to be analogous art because it is reasonably pertinent to the particular problem with which the applicant was concerned. Zangen et al. is reasonably related to the particular problem of trans-cranially stimulating a patient using a coil configured to emit magnetic fields in specific regions of the brain (Zangen et al., Abstract; Col. 1, lines 6-10). With respect to the obviousness rejection of claims 33 and 44, Zangen et al. was relied upon to teach, respectively, a coil distance from the patient’s skull and treatment that is substantially free of adverse effects – not the frequency and intensity stimulation parameters, which are addressed above in connection with the applicant’s response on pages 8-9. One of ordinary skill would have been motivated to incorporate the methodology of Zangen et al. Doing so may induce cortical excitability in deep brain regions without eliciting large electrical fields at the brain’s surface, thereby minimizing epileptic seizures and increasing the focality of the magnetic field in the prefrontal cortex. Therefore, Dissing et al. and Zangen et al. are considered to be analogous art to the claimed invention and the rationale to combine provided in the most recent office action is considered to be proper. The rejection of claims 33 and 44 as obvious over Dissing et al. in view of Zangen et al. is maintained.
With respect to Dissing et al. and Fu et al. (see Applicant’s response, page 12, “Claim Rejection – 35 U.S.C. § 103 – 4”), applicant’s arguments have been considered but are motto 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.
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) 1-3, 9, 11, 19, 23-24, 28, 32, 35, and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dissing et al. (US 2012/0101327), hereinafter “Dissing et al. 327”.
Regarding claim 1, Dissing et al. 327 teaches a repetitive transcranial magnetic stimulation (rTMS) method for treating or preventing major depressive disorder (MDD) or persistent depressive disorder (PDD) (para. 0026, wherein pulsed electromagnetic fields are produced via rTMS), comprising repetitively applying a magnetic pulse to the scalp of a patient in need thereof thereby stimulating neurons in the brain of the patient (paras. 0021 and 0085; Fig. 7, wherein the magnetic field generating coils are placed on the patient’s skull), wherein the magnetic pulse is applied:
repetitively over the patient's brain (Fig. 7, para. 0026, “pulsed electromagnetic field applied trans-cranially”); and
at an intensity of 1,000 to 15,000 milligauss (Fig. 4, wherein the magnetic field strength is between 1-9 gauss).
Dissing et al. 327 further teaches a frequency of above 20 Hz and below 1000 Hz (para. 0070).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to methodically modify and condense the frequency range of Dissing et al. 327, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05 II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is an rTMS frequency range of 500-600 Hz which achieves the recognized result of treating neuropsychiatric conditions, including depression and cancerous tissue, as evidenced by Velasco Valcke (US 2021/0038892) – see paras. 0003, 0010, 0071, “magnetic field transducers”, 0079, 0161, 0199, 0201, 0208, 0212-0214, and 0219; therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980). The Examiner notes there appears to be no criticality for the claimed range(s).
Regarding claim 2, Dissing et al. 327 teaches a rTMS method for slowing or preventing a conversion of MDD to PDD (para. 0026, wherein pulsed electromagnetic fields are produced via rTMS), comprising repetitively applying a magnetic pulse to the scalp of a patient in need thereof thereby stimulating neurons in the brain of the patient (paras. 0021 and 0085; Fig. 7, wherein the magnetic field generating coils are placed on the patient’s skull), wherein the magnetic pulse is applied:
repetitively over the patient's brain (Fig. 7, para. 0026, “pulsed electromagnetic field applied trans-cranially”); and
at an intensity of 1,000 to 15,000 milligauss (Fig. 4, wherein the magnetic field strength is between 1-9 gauss).
Dissing et al. 327 further teaches a frequency of above 20 Hz and below 1000 Hz (para. 0070).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to methodically modify and condense the frequency range of Dissing et al. 327, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05 II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is an rTMS frequency range of 500-600 Hz which achieves the recognized result of treating neuropsychiatric conditions, including depression and cancerous tissue, as evidenced by Velasco Valcke (US 2021/0038892) – see paras. 0003, 0010, 0071, “magnetic field transducers”, 0079, 0161, 0199, 0201, 0208, 0212-0214, and 0219; therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980). The Examiner notes there appears to be no criticality for the claimed range(s).
Regarding claim 3, Dissing et al. 327 teaches the method according to claim 1 as stated above wherein the magnetic pulse is applied at a frequency of 400 to 600 Hz (para. 0070; see MPEP 2144.05 II), or at a frequency of 575 Hz; and/or wherein the magnetic pulse is applied at an intensity of 10,000 milligauss; and/or wherein the magnetic pulse generates an electric field of 0.1 to 10
V
/
m
2
, or 0.5 to 1.5
V
/
m
2
, or 1
V
/
m
7
.
Regarding claim 9, Dissing et al. 327 teaches the method according to claim 1 as stated above wherein the method is undertaken once, or twice, or thrice, or four times daily (paras. 0110 and 0131).
Regarding claim 11, Dissing et al. 327 teaches the method according to claim 1 as stated above wherein the method is undertaken for greater than 15 minutes, or for 15 to 60 minutes, or for 30 minutes (para. 0171, “Each treatment session lasted 30 min”).
Regarding claim 19, Dissing et al. 327 teaches the method according to claim 1 as stated above wherein the magnetic pulse is applied chronically (para. 0171, “the planned 5 weeks PEMF administration over 25 consecutive workdays. (Monday-Friday)”).
Regarding claim 23, Dissing et al. 327 teaches the method according to claim 1 as stated above wherein the magnetic pulse is self-applied (para. 0180, “the subject may subsequently use the device at home”).
Regarding claim 24, Dissing et al. 327 teaches the method according to claim 1 as stated above wherein the magnetic pulse is applied using a device, the device being suitable for conducting electric current through a coil, wherein the device generates a magnetic field (Abstract; paras. 0040-0044); and/or wherein the device is suitable for home use (para. 0180) and/or is portable (para. 0060).
Regarding claim 28, Dissing et al. 327 teaches the method according to claim 1 as stated above wherein the patient is afflicted with MDD or PDD (paras. 0026 and 0171); and/or wherein the patient presents as having a diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); and/or wherein the patient presents as having a test score of one or more identified instruments for assessment of MDD or PDD symptoms that is considered to indicate the presence of MDD or PDD, selected from Table 1 (para. 0150).
Regarding claim 32, Dissing et al. 327 teaches the method according to claim 1 as stated above wherein the method provides an improvement in a test score of one or more identified instruments for assessment of MDD or PDD symptoms that is considered to indicate the presence of MDD or PDD (Table 3, wherein the mean Hamilton depression scale score decreased after each visit; para. 0171), optionally wherein the one or more identified instruments for assessment are selected from Table 1.
Regarding claim 35, Dissing et al. 327 teaches the method according to claim 1 as stated above wherein the method stimulates neurons throughout the patient's brain (Fig. 7, wherein the coils are oriented around the patient’s brain; paras. 0021 and 0024); and/or stimulates neurons in the left hemisphere of the patient's brain and/or frontal lobe of the patient's brain; and/or stimulates neurons in the cerebral cortex of the patient; and/or stimulates neurons outside of the patient's left prefrontal dorsolateral cortex.
Regarding claim 39, Dissing et al. 327 teaches the method according to claim 1 as stated above wherein the method prevents or delays a progression of MDD to PDD; and/or improves depressive symptoms of the patient (paras. 0171 and 0173; Table 3, wherein the mean Hamilton depression scale score decreased after each visit); and/or prevents diminution of depressive traits of the patient.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dissing et al. 327 in view of Eriksson et al. (US 2007/0135859).
Regarding claim 14, Dissing et al. 327 teaches the method according to claim 1 as stated above. Dissing et al. 327 fails to teach wherein repetitively applying the magnetic pulse comprises allying the magnetic pulse 300 to 400 times, or 360 times.
Eriksson et al. teaches an analogous method wherein repetitively applying the magnetic pulse comprises allying the magnetic pulse 300 to 400 times (para. 0036), or 360 times.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the method of Dissing et al. 327 with the number of applied pulses of Eriksson et al. Doing so may modulate the proliferation, differentiation, and/or migration of neural stems cells in an adult’s central nervous system (Eriksson et al., paras. 0036 and 0038).
Claim(s) 16-17, 20, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dissing et al. 327 in view of Etkin et al. (US 2019/0126055).
Regarding claim 16, Dissing et al. 327 teaches the method according to claim 1 as stated above. Dissing et al. 327 fails to specifically teach wherein the magnetic pulses are applied discontinuously.
Etkin et al. teaches an analogous method wherein the magnetic pulses are applied discontinuously (paras. 0008 and 0085; Fig. 1B).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the method of Dissing et al. 327 with the discontinuous magnetic pulses of Etkin et al. Implementing a stimulation block, consisting of “on” and “off” intervals, is not only tolerable for patients but is also highly effective (Etkin et al., para. 0085).
Regarding claim 17, Dissing et al. 327 teaches the method according to claim 1 as stated above. Dissing et al. 327 fails to specifically teach wherein repetitively applying the magnetic pulse comprises applying the magnetic pulse for four seconds, or wherein the magnetic pulse lasts for four seconds followed by one second without the magnetic pulse, or wherein the magnetic pulse lasts for 3 seconds followed by one second without the magnetic pulse.
Etkin et al. teaches an analogous method repetitively applying the magnetic pulse comprises applying the magnetic pulse for four seconds (Fig. 1B; paras. 0008 and 0085), or wherein the magnetic pulse lasts for four seconds followed by one second without the magnetic pulse, or wherein the magnetic pulse lasts for 3 seconds followed by one second without the magnetic pulse.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the method of Dissing et al. 327 with the four second pulse train of Etkin et al. Doing so creates a protocol with stimulation parameters comparable to scientifically validated rTMS treatment protocols designed to treat depression (Etkin et al., 0084-0085).
Regarding claim 20, Dissing et al. 327 teaches the method according to claim 1 as stated above. Dissing et al. 327 fails to specifically teach wherein the magnetic pulse is applied for greater than 2 months, or greater than 6 months, or greater than one year.
Etkin et al. teaches an analogous method wherein the magnetic pulse is applied for greater than 2 months (paras. 0047 and 0069), or greater than 6 months, or greater than one year (para. 0163).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the method of Dissing et al. 327 with the treatment duration of Etkin et al. A treatment duration of two months may be required if the patient is still experiencing severe depressive symptoms after their initial session (Etkin et al., paras. 0066-0069, 0075, 0083, and 0085).
Regarding claim 34, Dissing et al. 327 teaches the method according to claim 1 as stated above. Dissing et al. 327 fails to teach wherein the magnetic pulse is applied repetitively over the patient's left prefrontal dorsolateral cortex.
Etkin et al. teaches an analogous method wherein the magnetic pulse is applied repetitively over the patient's left prefrontal dorsolateral cortex (paras. 0069 and 0084-0085).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Dissing et al. 327 with the targeted brain location of Etkin et al. Focusing stimulation to the patient’s left prefrontal dorsolateral cortex may reduce depressive symptoms (Etkin et al., paras. 0083-0088).
Claim(s) 33 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dissing et al. 327 in view of Zangen et al. (US 7976451).
Regarding claim 33, Dissing et al. 327 teaches the method according to claim 1 as stated above. Dissing et al. 327 fails to teach wherein the method stimulates neurons around 2 to 3 cm from the skull.
Zangen et al. teaches an analogous method wherein the method stimulates neurons around 2 to 3 cm from the skull (Col. 2, lines 27-31).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the method of Dissing et al. 327 with the stimulation depth of Zangen et al. Doing so induces effective excitability in deep brain areas like the prefrontal cortex (Zangen et al., Col. 1, lines 25-35; Col. 2, lines 24-31).
Regarding claim 44, Dissing et al. 327 teaches the method according to claim 1 as stated above. Dissing et al. 327 fails to teach wherein the magnetic pulse is free of adverse effects, optionally selected from epileptic seizures, nausea, and headaches.
Zangen et al. teaches an analogous method wherein the magnetic pulse is free of adverse effects, optionally selected from epileptic seizures, nausea, and headaches (Col. 5, lines 6-18 and 50-61).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the method of Dissing et al. 327 with the substantially free adverse effects of Zangen et al. Doing so creates a treatment designed to penetrate deep regions without eliciting large electrical fields at the surface areas of the brain, thereby minimizing adverse side effects, such as epileptic seizures (Zangen et al., Col. 5, lines 6-61).
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dissing et al. 327 in view of Dissing et al. (WO 2010/149164), hereinafter “Dissing et al. 164”.
Regarding claim 42, Dissing et al. 327 teaches the method according to claim 1 as stated above. Dissing et al. 327 fails to teach wherein the magnetic pulse is used in tandem with one or more additional agents.
Dissing et al. 164 teaches an analogous method wherein the magnetic pulse is used in tandem with one or more additional agents (page 5, lines 17-33; Claims 5-9).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the method of Dissing et al. 327 with the additional agents of Dissing et al. 164. An antidepressant substance may treat, prevent or relieve diseases/conditions/disorders, including major depressive disorder, bipolar disorder, and epilepsy (Dissing et al. 164, page 5, lines 17-33).
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 BROGAN R LANDEEN whose telephone number is (571)272-1390. The examiner can normally be reached Monday - Friday 8:30am - 6:00pm.
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/B.R.L./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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