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
This Office Action is responsive to the amendment filed on 11/22/2024. As directed by the amendment: claims 1-2, and 4-12 have been amended, and claim 14 have been added. Thus, claims 1-14 are presently under consideration in this application.
Claim Objections
Claim 1 is objected to because of the following informalities: the listing of bullet points a-f should be removed. Appropriate correction is required. Regarding claims 2 and 4-11, Examiner suggests removing the bullet point step recitation and replacing the letter with the recitation of what is further comprised from claim 1.
Claim 8 is objected to because of the following informalities: the phrase “µ seconds” should be combined to recite “µseconds”. Appropriate correction is required.
Claims 10-11 are objected to because of the following informalities: the Markush phrase is missing a semicolon following the terms “consisting of” and should recite “consisting of:”. Appropriate correction is required.
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 1-14 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.
The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated that the inventor was in possession of the claimed invention. Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art. For some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement. Information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. See MPEP 2163 (II)(2).
A "representative number of species" means that the species which are adequately described are representative of the entire genus. See MPEP 2163(III)(a)(ii).
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand inventor to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. Id.; see also Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833 (Fed. Cir. 1998)(holding that the disclosure of a species in a parent application did not provide adequate written description support for claims to a genus in a child application where the specification taught against other species). See MPEP 2163(III)(a)(ii).
Claims 1 and 12 fails to sufficiently describe the treatment of cognitive disorder or enhancing normal cognition by delivering stimulation to the lateral lobe of the brain in enough detail for one skilled in the art to have possession of the broadly claimed genus. A described in the instant specification in [0020], the lateral temporal lobe contains the following subregions: superior temporal gyrus, middle temporal gyrus, inferior temporal gyrus, temporopolar cortex and fusiform cortex. Although [0018] of the instant specification discloses the treatment of the lateral temporal lobe, the instant specification only discloses the MTG, and the lateral temporal cortex ([0043]-[0045]). Further, the instant specification fails to detail the treating of any disease, as ([0043]-[0045]) only describe the observed enhancement of memory, while failing to detail the stimulation parameters administered, the disease that the population had for administrating the stimulation to, and the treatment effects of the diseases. Similar to Lizardtech, there is no evidence that the specification contemplated a more generic method of treatment of cognitive disorder or enhancing normal cognition by delivering stimulation to the lateral lobe of the brain. The instant specification fails to disclose any other embodiment/species, and therefore does not have a representative number of species to claim the genus, as instantly claimed. Therefore, claims 1-14 do not provide sufficient detail for a person skilled in the art to have been in possession of the invention as broadly claimed.
Claims 1-14 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.
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
Merely recite a description of the problem to be solved while claiming all solutions to it, leaving the industry to “complete an unfinished invention.” See Ariad, 598 F.3d at 1353
Disclosure of function alone is little more than a wish possession. See MPEP 2163(II)(A)(3)(a).
The written description requirement is not satisfied by merely outlining the goals or results one hopes to achieve with the invention. See MPEP 2163(II)(A)(3)(a).
Claim 1 fails to sufficiently disclose the treatment of any and all cognitive disorders or enhancing normal cognition using any and all appropriate levels of stimulation in enough detail for one skilled in the art to have sufficient written description. The mere statement and recitation of “treating the cognitive disorder or enhancing normal cognition by operating the signal generator to deliver stimulation at the appropriate level to the lateral temporal lobe of the brain” in claim 1 and the instant specification in PG PUB 20250073469 discloses in [0030]-[0032] the different parameters that can be used and their values, but is insufficient to the disclosure of the particular parameters used for particular treatments. Specifically, the instant specification provides insufficient detail to the stimulation parameters required for a single cognitive disorder or enhancing normal cognition. Applicant fails to discuss what cognitive disorders or enhancing normal cognition require what stimulation parameter for treatment. It is simply unknown what is being treated and how the treatment is provided. Furthermore, the instant specification fails to detail the treatment of cognitive disorders, specifically for populations with a specific cognitive disorder. Even though claim 13 lists different cognitive disorders, Applicant fails to disclose the application of the treatment of the listed cognitive disorders with specific electric stimulation parameters. The instant specification also fails to disclose if the population of people in [0043]-[0045] are directed to normal control population or to a specific cognitive disorder. Therefore, claims 1-14 do not provide sufficient detail to have sufficient written description.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification does not reasonably provide enablement for the treatment of cognitive disorder or enhancing normal cognition by delivering stimulation to the lateral temporal lobe of the brain and the lack of working examples of the treatment to the treatment of all cognitive disorders. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, for “treating the cognitive disorder or enhancing normal cognition by operating the signal generator to deliver stimulation at the appropriate level to the lateral temporal lobe of the brain via the electrode” as the invention commensurate in scope with these claims.
In making a determination as to whether an application has met the requirements for enablement under 35 U.S.C. 112(a), the following factors enumerated In re Wands, 8 USPQ2d 1400, at 1404 (CAFC 1988) are considered:
(1) the breadth of the claims,
(2) the amount of direction or guidance presented, (3) the presence or absence of working examples,
(4) the nature of the invention,
(5) the state of the prior art,
(6) the relative skill of those in the art,
(7) the predictability or unpredictability of the art, &
(8) the quantity of experimentation necessary.
While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered.
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Taking into account the factors discussed in MPEP 2164.01 (a), there is insufficient guidance and direction for one of ordinary skill in the art to make and use a processor where the electrical stimulation of the lateral temporal lobe for treatment of cognitive disorder or enhancing normal cognition. The nature of the invention is highly technical, and the level of predictability in the art is low, as the treatment of cognitive disorder or enhancing normal cognition by delivering stimulation to the lateral lobe of the brain lacks sufficient working examples in the instant specification.
Absence of Working Examples/The Amount of Direction
In view of the absence of a specific and detailed description in Applicant’s specification of how to effectively use the method as claimed, and absence of working examples providing evidence which is reasonably predictive that the claims 1-14 would work, and the lack of predictability in the art at the time the invention was made, an undue amount of experimentation would be required to practice the claimed methods with a reasonable expectation of success. Although the instant specification merely states that “The invention discloses techniques for delivering treatment therapy to the lateral temporal lobe of a human brain to improve cognitive function” ([0018]), when looking at the study conducted in [0043]-[0045], the instant specification discloses that stimulation of the MTG and lateral temporal cortex appear to have statistical significance for better memory recall. The applicant has provided no direction whatsoever with regards to how to treatment of cognitive disorder or enhancing normal cognition by delivering stimulation to the lateral lobe of the brain, as claimed. Furthermore, the instant specification fails to disclose working examples of the treatment of cognitive disorders other than the list of cognitive disorders recited in claim 13. [0043]-[0045] fails to disclose the state of being of the subjects, and no study was provided to show that the stimulation of the lateral temporal lobe is capable of treating all the cognitive disorders. For example, it is unknown how the treatment of “autoimmune” or “toxic”, of claim 13, can be achieved as it is unknown what is being treated and the stimulation parameters required to treat these disorders. As such, the Examiner believes the quantity of experimentation needed to make and use the invention based on the lack of content in the disclosure would be high.
The State of the Prior Art
Applicant admits in the instant specification [0044] where it is disclosed that “it was observed that there was a significant decrease in memory performance due to Left PRC stimulation (50.6% vs. 58.9%, P<0.05)” indicating that the genus of treating all lateral temporal lobe cognitive disorder or enhancing normal cognition is not possible. Additionally, other pieces of art, fail to show treating the cognitive disorder or enhancing normal cognition by operating the signal generator to deliver stimulation at the appropriate level to the lateral temporal lobe of the brain. For example, Merkow et al. (“Stimulation of the human medial temporal lobe between learning and recall selectively enhances forgetting” Brain Stimulation, Volume 10, Issue 3, May–June 2017, Pages 645-650) shows that the medial temporal lobe stimulation is time-dependent and disrupted memory performance (Abstract). Thus, the state of the art contradicts the instantly claimed method.
It is noted that Kosnoff et al. (“Transcranial Focused Ultrasound to V5 Enhances Human Visual Motion Brain-Computer Interface by Modulating Feature-Based Attention” bioRXIV, September, 05, 2023, doi: 10.1038/s41467-024-48576-8) shows that the MTG/V5 portion of the lateral temporal lobe raises brain feature attention to visual motion, albeit from transcranial focused ultrasound (Abstract).
Taking all of the factors into consideration leads to a conclusion that there is no enablement for the limitations discussed above. The dependent claims also lack enablement based on their association with claims 1-14.
Claims 1-14 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 has been amended to include the limitation, " positioning a sensor in or on a lateral temporal lobe of a brain ". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for sensor. However, the specification does not provide support for where the sensor is located. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, " positioning a sensor in or on a lateral temporal lobe of a brain”. Therefore, the new claim limitations introduce new matter.
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 1-14 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 1 recites the limitation "the electrode" in 16. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending to recite “the at least one electrode”.
Regarding claim 4, it is unclear if the “at least two electrodes” of line 2 are the same or different than the “at least one electrode” of claim 1 line 3.
Regarding claim 5, it is unclear how an electrode can select the amplitude, pulse, and frequency, when a “selecting” step can be done by a processor or human, but not the electrode itself.
Claim 5 recites the limitation "the electrode" in 2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending to recite “the at least one electrode”.
Regarding claim 10, it is unclear if the “electrophysiological characteristic” of line 2 the same or different than the “electrophysiological characteristic” of claim 1 line 9.
Regarding claim 11, the Markush recitation of the parameters in the group “amplitude, pulse width, frequency” is missing an “and”, and should recite “amplitude, pulse width, and frequency”.
Claim 11 recites the limitation "the parameter" in 2. There is insufficient antecedent basis for this limitation in the claim. Line 2 of claim 11 recites “at least one parameter”.
Regarding claim 12, it is unclear how the sensor can determine the appropriate level when the step of “determin[ing]” can be done by a processor or human, but not the sensor itself.
Regarding claim 13, the Markush recitation “is selected from the group:” is improper and should be amended to recite “is selected from the group consisting of:”.
Claim 14 recites the limitation "the appropriate electrical stimulation" in 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Reymers et al. (WO 2015/149170)(Hereinafter Reymers)(IDS)(citations from US20170143966).
Regarding claim 1, Reymers teaches A method for treating a human cognitive disorder or enhancing normal cognition using a neurostimulator device including signal generator and a lead having a proximal end coupled to the signal generator and a distal portion having at least one electrode (Abstract “treating a cognitive disease or disorder are provided… a stimulator with one or more stimulation leads” [0043] “an electrode such as one or more electrodes configured to deliver electrical stimulation energy”), the method comprising:
(a) positioning a sensor in or on a lateral temporal lobe of a brain ([0109] “Sensors 130, 230 and/or 430 can comprise a sensor selected from the group consisting of: neuronal activity sensor; EEG sensor… Sensor 130, 230 and/or 430 can each comprise an implanted or external sensor.”);
(b) positioning a stimulation portion of the at least one electrode in or on the lateral temporal lobe of a brain (Fig. 1 [0085] “stimulator 100 and one or more stimulation leads 110 are configured to deliver electrical energy to one or more target volumes TV (e.g. via pathway 40).” [0086] “In some embodiments, target volume TV comprises tissue selected from the group consisting of:…temporal neocortex” The temporal neocortex is known to be the lateral temporal cortex, which is part of the lateral temporal lobe.);
(c) coupling the at least one electrode to the signal generator using the lead (Fig. 1 where lead 110 is couple to stimulation element/electrode 115 ([0084]) of the stimulator.); and
(d) sensing an electrophysiological characteristic indicative of normal, enhanced, or impaired cognition at the lateral temporal lobe of the brain with the sensor and generating a sensor signal for the electrophysiological characteristic ([0110] “system 10 can be configured to provide closed loop stimulation to brain B, such as closed loop stimulation based on diagnostic data 405 provided by diagnostic tool 400 and/or a signal provided by one or more of sensors 130, 230, 330 and/or a separate implanted or external sensor.” [0142] “a closed-loop system discussed below which incorporates a sensor 130 to provide feedback can be used to provide enhanced results. Sensor 130 (e.g. an implanted or external sensor) can be used with a closed loop feedback system in order to automatically determine the level of electrical stimulation [appropriate level] necessary to achieve the desired level of improved cognitive function.”);
(e) determining an appropriate level of electrical stimulation based on the generated sensor signal for the electrophysiological characteristic ([0110] “system 10 can be configured to provide closed loop stimulation to brain B, such as closed loop stimulation based on diagnostic data 405 provided by diagnostic tool 400 and/or a signal provided by one or more of sensors 130, 230, 330 and/or a separate implanted or external sensor.” [0142] “a closed-loop system discussed below which incorporates a sensor 130 to provide feedback can be used to provide enhanced results. Sensor 130 (e.g. an implanted or external sensor) can be used with a closed loop feedback system in order to automatically determine the level of electrical stimulation [appropriate level] necessary to achieve the desired level of improved cognitive function.” Examiner notes that closed loop stimulation extracts sensor data to determine the adjustment for stimulation. Examiner further notes that a processor for determining this “appropriate level” is not actively recited.); and
(f) treating the cognitive disorder or enhancing normal cognition by operating the signal generator to deliver stimulation at the appropriate level to the lateral temporal lobe of the brain via the electrode ([0085] “stimulator 100 and one or more stimulation leads 110 are configured to deliver electrical energy to one or more target volumes TV (e.g. via pathway 40).” [0086] “In some embodiments, target volume TV comprises tissue selected from the group consisting of:…temporal neocortex” [0097] “System 10 can be configured to achieve at least one of: treats memory impairment; improves memory function; treats cognitive function loss; reverses synaptic loss; improves cognitive function; reduces degradation of cognitive function” [0142] “a closed-loop system discussed below which incorporates a sensor 130 to provide feedback can be used to provide enhanced results. Sensor 130 (e.g. an implanted or external sensor) can be used with a closed loop feedback system in order to automatically determine the level of electrical stimulation necessary to achieve the desired level of improved cognitive function.”).
Regarding claim 2, Reymers teaches wherein (d) is performed in relation to a learning task ([0145] “the stimulation can be applied before, after and/or during the performance of a memory, cognitive or motor task learning task to facilitate the acquisition of learning or consolidation of the task”).
Regarding claim 3, Reymers teaches wherein the learning task is selected from the group consisting of a memory task, a cognitive task, and a motor task ([0145] “the stimulation can be applied before, after and/or during the performance of a memory, cognitive or motor task learning task to facilitate the acquisition of learning or consolidation of the task”).
Regarding claim 4, Reymers teaches (b) comprises bilaterally implanting at least two electrodes (Fig. 1 and [0088] “stimulation elements 115a can be placed on one side of a target volume TV and stimulation elements 115b can be placed on another (e.g. opposite) side of a target volume TV, such as to allow bilateral stimulation of the target volume TV (e.g. bilateral stimulation of the…brain B structure)”).
Regarding claim 5, Reymers teaches wherein (d) comprises selecting amplitude, pulse width and frequency of stimulation by the electrode ([0148] “In the case of electrical stimulation, a parameter of the stimulation can be adjusted such as amplitude, pulse width and/or frequency”).
Regarding claim 6, Reymers teaches wherein (d) comprises operating the signal generator to pulse at a frequency of up to 300 Hertz ([0141] “Energy is typically applied at a frequency of 2 to 1000 Hz, such as at a frequency of approximately 130 Hz.” 130 Hz is included in the range between 0-300 Hz. The device is also capable of generating to 300 Hz.).
Regarding claim 7, Reymers teaches wherein (d) comprises operating the signal generator to pulse at an amplitude of up to 5 milliamps ([0141] “Energy is typically delivered at a pulse amplitude, such as at a pulse amplitude of approximately 500 μA.” 0.5 mA is included in the range between 0-5 mA.).
Regarding claim 8, Reymers teaches wherein (d) comprises operating the signal generator to pulse at a pulse width of up to 500 microseconds ([0141] “Energy delivery can be given in a series of on and off times, such as with an on-time of approximately 30 μseconds to 200 μseconds, such as with an on time of approximately 90 μseconds.” 90 microseconds in included in the range on 0-500 microseconds.).
Regarding claim 9, Reymers teaches wherein (e) further comprises regulating operation of the signal generator in response to the sensor signal ([0149] “The information contained within the neuronal firing spike train…can be used to deliver therapies on a contingency basis in a closed loop system.”).
Regarding claim 10, Reymers teaches wherein (d) comprises detecting an electrophysiological characteristic selected from the group consisting of activity of single neurons, local field potentials, event related potentials, an electroencephalogram, and an electrocorticogram ([0149] “Parameters which can be sensed include the activity of single neurons as detected with microelectrode recording techniques, local field potentials, and event related potentials”).
Regarding claim 11, Reymers teaches wherein (f) comprises adjusting at least one parameter of the stimulation, the parameter being selected from the group consisting of amplitude, pulse width, frequency (par. [0148]: In the case of electrical stimulation, a parameter of the stimulation can be adjusted such as amplitude, pulse width and/or frequency).
Regarding claim 12, Reymers teaches wherein the sensor automatically determines the appropriate level of electrical stimulation automatically as part of a closed- loop system ([0142] “a closed-loop system discussed below which incorporates a sensor 130 to provide feedback can be used to provide enhanced results. Sensor 130 (e.g. an implanted or external sensor) can be used with a closed loop feedback system in order to automatically determine the level of electrical stimulation necessary to achieve the desired level of improved cognitive function.”).
Regarding claim 13, Reymers teaches wherein said cognitive disorder is selected from the group: Alzheimer's disease, MCI, dementia, amnesia and memory disorders as can occur after injury, trauma, stroke, cranial irradiation, and in the context of genetic, congenital, infectious, autoimmune, toxic (drugs and alcohol), nutritional (vitamin deficiencies) metabolic, inflammatory, neurodegenerative neoplastic or idiopathic processes involving the brain, amnestic syndromes, Wernicke-Korsakoff and Korsakoff syndromes, Herpes encephalitis, severe hypoxia, vascular disorders, head injury, transient global amnesia, global amnesia, epileptic amnesia, cerebral palsy, autism, mental retardation and attention deficit and hyperactivity disorders ([0077] “The cognitive diseases and/or disorders include but are not limited to: Alzheimer's Disease (AD) such as Mild or Moderate Alzheimer's Disease; probable Alzheimer's Disease; a genetic form of Alzheimer's Disease; Mild Cognitive Impairment (MCI); hippocampal damage such as hippocampal damage due to Alzheimer's disease, anoxia, epilepsy or depression; neuronal loss; neuronal damage; … epilepsy; a seizure disorder; dementia; amnesia; a memory disorder such a spatial memory disorder; traumatic brain injury; cognitive impairment associated with Schizophrenia; Parkinson's Disease related cognitive impairment or dementia; and combinations of these. Additionally or alternatively, the patient can be selected to treat negative symptoms of a disease or disorder selected from the group consisting of: schizophrenia; depression; other conditions of reversible impaired memory or cognition; and combinations of these”).
Regarding claim 14, Reymers teaches wherein a microprocessor processes the sensor signal and automatically determines the appropriate electrical stimulation via a control algorithm (Fig. 3(153 microprocessor) and [0142] “a closed-loop system discussed below which incorporates a sensor 130 to provide feedback can be used to provide enhanced results. Sensor 130 (e.g. an implanted or external sensor) can be used with a closed loop feedback system in order to automatically determine the level of electrical stimulation necessary to achieve the desired level of improved cognitive function. In a closed-loop embodiment, microprocessor 153 executes an algorithm in order to provide stimulation with closed loop feedback control. Such an algorithm can analyze a sensed signal and deliver stimulation therapy (e.g. delivery or electrical, magnetic, light, sound and/or chemical treatment therapy) based on the sensed signal.”).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5, 8, 10-11, and 13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12029907 (Hereinafter Kahana). Although the claims at issue are not identical, they are not patentably distinct from each other because the method of Kahana is a species of the method of the instant claims.
Regarding claim 1, Kahana teaches A method for treating a human cognitive disorder or enhancing normal cognition using a neurostimulator device including signal generator and a lead having a proximal end coupled to the signal generator and a distal portion having at least one electrode (Claim 1 “A method for treating a human cognitive disorder or enhancing normal cognition using a neurostimulator device including a signal generator and a lead having a proximal end coupled to the signal generator and a distal portion having at least one electrode”), the method comprising:
(a) positioning a sensor in or on a lateral temporal lobe of a brain (Claim 1 “implanting a sensor only within a left middle temporal gyrus of a brain”);
(b) positioning a stimulation portion of the at least one electrode in or on the lateral temporal lobe of a brain (Claim 1 “implanting a stimulation portion of the at least one electrode within only the left middle temporal gyrus of a brain”);
(c) coupling the at least one electrode to the signal generator using the lead (Claim 1 “coupling the at least one electrode to the signal generator using the lead”); and
(d) sensing an electrophysiological characteristic indicative of normal, enhanced, or impaired cognition at the lateral temporal lobe of the brain with the sensor and generating a sensor signal for the electrophysiological characteristic (Claim 1 “sensing an electrophysiological characteristic indicative of normal, enhanced, or impaired cognition only at the left middle temporal gyrus with the sensor”);
(e) determining an appropriate level of electrical stimulation based on the generated sensor signal for the electrophysiological characteristic (Claim 1 “determining an appropriate level of electrical stimulation based on the sensed electrophysiological characteristic”); and
(f) treating the cognitive disorder or enhancing normal cognition by operating the signal generator to deliver stimulation at the appropriate level to the lateral temporal lobe of the brain via the electrode (Claim 1 “treating the cognitive disorder or enhancing normal cognition by operating the signal generator to deliver stimulation at the appropriate level only to the left middle temporal gyrus of the brain via the electrode”).
The instant claims 2-3, 5, 8, 10-11, and 13 are taught in Kahana’s claims 2-8.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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, Jennifer McDonald can be reached at (571) 270-3061. 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.
/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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