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 Arguments
Applicant’s arguments concerning the previous § 103 rejections have been fully considered. Applicant’s arguments rely entirely on the remarks made in the accompanying affidavit by one of the inventors, Dr. Donald Vaughn. Many of those remarks are ultimately moot in view of the claim amendments and/or in view of the new/updated grounds of rejection. As an example, paragraph (13) on page 8 of the affidavit refers to the previously claimed “values from the treatment history as performed” which is a limitation that is no longer claimed. As another example, paragraph (28) on page 14 of the affidavit refers to limitations which were previously found in now-cancelled claim 28 and are no longer present in any of the claims. There are numerous other remarks in the affidavit that refer to limitations or other aspects of the invention which are not claimed; for example, in paragraph (14) on page 8 of the affidavit, it is stated that “my claimed invention requires a fixed protocol without modification …”; this limitation is not claimed. Nevertheless, several of the remarks in the affidavit are still potentially relevant to the updated rejections, and thus they will be addressed below.
Concerning the affidavit as a whole, as an initial matter, the Examiner notes that as explained in MPEP 716.01(c)(III), “in assessing the probative value of an expert opinion, the examiner must consider … the interest of the expert in the outcome of the case …” and “an affidavit of an applicant as to the advantages of their claimed invention, while less persuasive than that of a disinterested person, cannot be disregarded for this reason alone.” As such, it must be noted that the affidavit is generally less persuasive as a whole compared to an affidavit of a disinterested person.
Applicant argues that Ravindranathan is non-analogous art. The Examiner respectfully disagrees. Ravindranathan is, at a minimum, reasonably pertinent to the problem of how to transmit and deliver initial and updated dosages to a remote stimulation device, and/or how to update an ongoing or future stimulation protocol in view of the effectiveness of an ongoing or past stimulation. Many of Ravindranathan’s teachings on this matter are relevant regardless of the type of stimulation being performed. For example, the various possible configurations shown in FIGS. 1A-1C of Ravindranathan as to how to arrange the various components within the devices of the system are clearly applicable regardless of the stimulation type.
Applicant’s arguments on page 4 of the affidavit concerning Ravindranathan’s teaching of other embodiments which may include drug delivery or electrical stimulation are not persuasive because they are irrelevant to the rejections (both past and updated). Ravindranathan’s teaching of alternative embodiments using other stimulation modalities does not discount its explicit teaching of TMS, and does not discount the combination with Etkin which clearly addresses TMS in more detail, specifically to treat depression. In short, the rejection does not rely on Ravindranathan’s alternative embodiments which use other treatment modalities such as drug delivery.
Applicant also argues that Ravindranathan lacks enablement due to lacking an explicit teaching of various TMS parameters. The Examiner respectfully disagrees. Applicant’s own argument refers to “standard TMS protocols” from cleared FDA submissions and points to FDA guidance from 2011 on these parameters. It is well established that “a patent need not teach, and preferably omits, what is well known in the art” (see MPEP § 2164.01). The test for enablement is not whether one skilled in the art would be enabled to practice Ravindranathan’s invention given only the knowledge found in Ravindranathan’s own disclosure in a vacuum. Rather, the question of enablement looks at many factors including what was already well known in the art.
Claim Objections
Claim 26 is objected to because of the following informalities:
the claim refers twice to “the medical device” which lacks proper antecedent basis. Both recitations should be corrected to “the TNM device.”
the claim refers twice to “an initial TNM treatment protocol” (see the “receive …” and then the “supply …” steps). The second recitation should be corrected to either “the initial TNM treatment protocol” or “said initial TNM treatment protocol.”
Claim 48 is objected to because of the following informalities: “the central server” lacks proper antecedent basis since it had not been previously recited in this claim’s chain of dependency. Appropriate correction is required.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 41, 44, 47 and 49 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 41, 44, 47 and 49 recite the broad recitation “by a human”, and the claim also recites “which may include a health care provider” which is the narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Similarly, in those same claims, the limitation “by a human - which may include a health care provider” renders the claims indefinite because it is unclear whether the phrase “may include” is an indication of an optional limitation.
Claim Rejections - 35 USC § 102
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 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.
Claims 26-27, 30, 45, 48 and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0126055 A1 to Etkin et al. (hereinafter “Etkin”).
Regarding Claim 26, Etkin teaches a method for administering treatment of transcranial neuromodulation (TNM) to the brain of a human patient suffering from depression to treat depression in said human patient (see e.g. the abstract: “Provided herein are, for example, systems and methods of diagnosing and treating depression, in which a transcranial magnetic stimulation (TMS) therapy is administered to a subject in need thereof …”), comprising the following steps:
providing the patient with a TNM device configured to deliver TNM to one or more stimulation locations associated with depression on a head of the patient (see e.g. Para. 73: “TMS stimulation can be administered to a subject via a coil positioned on the head of the subject, e.g. a patient”; also see e.g. Paras. 43, 50, 109), wherein the device is configured to:
receive an initial TNM treatment protocol (see e.g. “a treatment used prior to the modification, e.g. from an originally planned treatment protocol” in Para. 74; “initial course of treatment” in Para. 75; also see e.g. Para. 77, 79-81, 96; also see e.g. claim 1: there is a first administration of therapy before measuring the response and making subsequent changes to the protocol, e.g. in claim 4);
supply an initial TNM treatment protocol to the medical/TNM device (see e.g. “a treatment used prior to the modification, e.g. from an originally planned treatment protocol” in Para. 74; “initial course of treatment” in Para. 75; also see e.g. Para. 77, 79-81, 96; also see e.g. claim 1: there is a first administration of therapy before measuring the response and making subsequent changes to the protocol, e.g. in claim 4); and
activate the medical/TNM device to perform the initial TNM protocol on the human patient (see e.g. “a treatment used prior to the modification, e.g. from an originally planned treatment protocol” in Para. 74; “initial course of treatment” in Para. 75; also see e.g. Para. 77, 79-81, 96; also see e.g. claim 1: there is a first administration of therapy before measuring the response and making subsequent changes to the protocol, e.g. in claim 4).
Concerning the limitation that the TNM device is in communication with an electronic control unit (ECU) having a processor and computer-readable memory, with the ECU performing the above steps, these limitations are implicitly taught by Etkin in at least Paras. 80, 96 and 109-110. Specifically, Para. 80 states “for instance, the TMS-EEG system can perform, based on the clean TMS-EEG data, real-time adjustments to one or more treatment protocols such as treatment duration, stimulation frequency, stimulation magnitude, stimulation area, time interval between stimuli, and/or the like” and Para. 96 states “a machine learning algorithm can use EEG analysis of the rTMS evoked response to modulate an rTMS treatment protocol in real-time,” which are limitations that would inherently necessitate a processor and memory. Furthermore, Paras. 109-110 clarify that the stimulator can be one of the known FDA-cleared conventional TMS stimulators from MagVenture, such as the MagVenture MagPro X100, which are devices that communicate with a processor and memory and which perform steps as instructed by the processor.
Regarding Claims 27, 30, see e.g. Paras. 45-50, 52, 77, 145, and 150-157 (the treatment protocols are characterized by a wide variety of parameters such as the ones listed in these paragraphs).
Regarding Claim 45, see e.g. Paras. 47, 52, 72, 108, 138, 154 (duration refers not only to duration in a single session but also to overall length of course of treatment in terms of number of sessions, and the course of treatment can be extended).
Regarding Claim 48, see e.g. Paras. 75, 96 (machine learning can be used for closed-loop modulation of the treatment protocol based on past treatments).
Regarding Claim 50, Etkin teaches a method for administering treatment of transcranial neuromodulation (TNM) to the brain of a human patient suffering from depression to treat depression in said human patient (see e.g. the abstract: “Provided herein are, for example, systems and methods of diagnosing and treating depression, in which a transcranial magnetic stimulation (TMS) therapy is administered to a subject in need thereof …”), comprising the following steps:
providing the patient with a TNM device configured to deliver TNM to one or more stimulation locations associated with depression on a head of the patient (see e.g. Para. 73: “TMS stimulation can be administered to a subject via a coil positioned on the head of the subject, e.g. a patient”; also see e.g. Paras. 43, 50, 109), wherein the device is configured to:
perform an initial TNM treatment protocol on the human patient at one or more stimulation locations on the head of the patient (see e.g. “a treatment used prior to the modification, e.g. from an originally planned treatment protocol” in Para. 74; “initial course of treatment” in Para. 75; also see e.g. Para. 77, 79-81, 96; also see e.g. claim 1: there is a first administration of therapy before measuring the response and making subsequent changes to the protocol, e.g. in claim 4);
wherein an amplitude of one or more pulses from the TNM device is a function of the delivered amplitude of prior calibration and treatment pulses of that patient (see e.g. Para. 153).
Concerning the limitation that the TNM device is in communication with an electronic control unit (ECU) having a processor and computer-readable memory, with the ECU performing the above steps, these limitations are implicitly taught by Etkin in at least Paras. 80, 96 and 109-110. Specifically, Para. 80 states “for instance, the TMS-EEG system can perform, based on the clean TMS-EEG data, real-time adjustments to one or more treatment protocols such as treatment duration, stimulation frequency, stimulation magnitude, stimulation area, time interval between stimuli, and/or the like” and Para. 96 states “a machine learning algorithm can use EEG analysis of the rTMS evoked response to modulate an rTMS treatment protocol in real-time,” which are limitations that would inherently necessitate a processor and memory. Furthermore, Paras. 109-110 clarify that the stimulator can be one of the known FDA-cleared conventional TMS stimulators from MagVenture, such as the MagVenture MagPro X100, which are devices that communicate with a processor and memory and which perform steps as instructed by the processor.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 26-27, 30, 40-41 and 43-50 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0126055 A1 to Etkin et al. (hereinafter “Etkin”) in view of 2021/0280286 A1 to Ravindranathan et al. (hereinafter “Ravindranathan”).
Regarding Claim 26, Etkin teaches a method for administering treatment of transcranial neuromodulation (TNM) to the brain of a human patient suffering from depression to treat depression in said human patient (see e.g. the abstract: “Provided herein are, for example, systems and methods of diagnosing and treating depression, in which a transcranial magnetic stimulation (TMS) therapy is administered to a subject in need thereof …”), comprising the following steps:
providing the patient with a TNM device configured to deliver TNM to one or more stimulation locations associated with depression on a head of the patient (see e.g. Para. 73: “TMS stimulation can be administered to a subject via a coil positioned on the head of the subject, e.g. a patient”; also see e.g. Paras. 43, 50, 109), wherein the device is configured to:
receive an initial TNM treatment protocol (see e.g. “a treatment used prior to the modification, e.g. from an originally planned treatment protocol” in Para. 74; “initial course of treatment” in Para. 75; also see e.g. Para. 77, 79-81, 96; also see e.g. claim 1: there is a first administration of therapy before measuring the response and making subsequent changes to the protocol, e.g. in claim 4);
supply an initial TNM treatment protocol to the medical/TNM device (see e.g. “a treatment used prior to the modification, e.g. from an originally planned treatment protocol” in Para. 74; “initial course of treatment” in Para. 75; also see e.g. Para. 77, 79-81, 96; also see e.g. claim 1: there is a first administration of therapy before measuring the response and making subsequent changes to the protocol, e.g. in claim 4); and
activate the medical/TNM device to perform the initial TNM protocol on the human patient (see e.g. “a treatment used prior to the modification, e.g. from an originally planned treatment protocol” in Para. 74; “initial course of treatment” in Para. 75; also see e.g. Para. 77, 79-81, 96; also see e.g. claim 1: there is a first administration of therapy before measuring the response and making subsequent changes to the protocol, e.g. in claim 4).
Concerning the limitation that the TNM device is in communication with an electronic control unit (ECU) having a processor and computer-readable memory, with the ECU performing the above steps, these limitations are implicitly taught by Etkin in at least Paras. 80, 96 and 109-110. Specifically, Para. 80 states “for instance, the TMS-EEG system can perform, based on the clean TMS-EEG data, real-time adjustments to one or more treatment protocols such as treatment duration, stimulation frequency, stimulation magnitude, stimulation area, time interval between stimuli, and/or the like” and Para. 96 states “a machine learning algorithm can use EEG analysis of the rTMS evoked response to modulate an rTMS treatment protocol in real-time,” which are limitations that would inherently necessitate a processor and memory. Furthermore, Paras. 109-110 clarify that the stimulator can be one of the known FDA-cleared conventional TMS stimulators from MagVenture, such as the MagVenture MagPro X100, which are devices that communicate with a processor and memory and which perform steps as instructed by the processor.
Nevertheless, in addition to the explanation above, this is an incredibly common, well-known and industry standard setup for virtually all modern medical stimulation devices. As one example, Ravindranathan teaches a variety of stimulation devices, including repetitive transcranial magnetic stimulation (see e.g. Paras. 3, 7, 93) utilizing this setup (see e.g. FIGS. 1A-1C and 4; see e.g. Paras. 100-101 which describe that computing entity 401 includes a processor 405 and memory 410). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Etkin to have the TNM device in communication with an electronic control unit (ECU) having a processor and computer-readable memory (assuming, purely for the sake of argument, that Etkin doesn’t already implicitly teach these limitations) because this was a well-known and standard setup for modern stimulation devices to provide the well-understood and predictable benefits of a modern computerized system.
Regarding Claims 27, 30, see e.g. Paras. 45-50, 52, 77, 145, and 150-157 (the treatment protocols are characterized by a wide variety of parameters such as the ones listed in these paragraphs).
Regarding Claims 40 and 46, Etkin teaches the method of claim 26 above but fails to specifically teach that the initial TNM protocol originates from a central server with which the ECU is in contact. However, Ravindranathan teaches that an initial treatment protocol may be created/provided by a provider device which may be any from a variety of standard computing devices, including a server (see e.g. Paras. 58-59, 98 and 100; also see Paras. 107-114 describing a further embodiment of an external computing device). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Etkin to receive the initial protocol from a provider server, as seen in Ravindranathan, because this is a typical and standard arrangement in modern medical computing systems, and doing so would advantageously and predictably allow a patient device to conveniently and quickly receive the protocol from the appropriate provider.
Regarding Claim 41, 44, 47 and 49, Ravindranathan further teaches that the initial prescription can be created by the provider (see e.g. Para. 74: “the PROVIDER being an entity that provided or authorized the initial prescription 112”) and that ongoing changes can be manually provided/authorized by the provider (see e.g. Para. 56: “the provider manually authorizes the updated prescription”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Etkin have a human provider be the creator of the initial prescription and to have at least some control of the ongoing treatment, since this would advantageously and predictably help ensure patient safety by requiring a trained provider (e.g. a doctor) to set the parameters, and since generally speaking in the medical field a prescription for medical treatment (both initial and ongoing) is almost always provided at least in part by a human provider who is specially educated, trained, and authorized to do so.
Regarding Claim 43, as noted previously, Ravindranathan teaches that the provider device can include a variety of conventional computing devices including any of a variety of conventional user interface elements (see e.g. Para. 111 describing such user interface elements). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Etkin to provide a user interface for the provider to set the initial protocol, since this would merely be an extremely conventional arrangement for conveniently providing inputs to a modern computerized medical system.
Regarding Claim 45, see e.g. Paras. 47, 52, 72, 108, 138, 154 (duration refers not only to duration in a single session but also to overall length of course of treatment in terms of number of sessions, and the course of treatment can be extended).
Regarding Claim 48, see e.g. Paras. 75, 96 (machine learning can be used for closed-loop modulation of the treatment protocol based on past treatments).
Regarding Claim 50, Etkin teaches a method for administering treatment of transcranial neuromodulation (TNM) to the brain of a human patient suffering from depression to treat depression in said human patient (see e.g. the abstract: “Provided herein are, for example, systems and methods of diagnosing and treating depression, in which a transcranial magnetic stimulation (TMS) therapy is administered to a subject in need thereof …”), comprising the following steps:
providing the patient with a TNM device configured to deliver TNM to one or more stimulation locations associated with depression on a head of the patient (see e.g. Para. 73: “TMS stimulation can be administered to a subject via a coil positioned on the head of the subject, e.g. a patient”; also see e.g. Paras. 43, 50, 109), wherein the device is configured to:
perform an initial TNM treatment protocol on the human patient at one or more stimulation locations on the head of the patient (see e.g. “a treatment used prior to the modification, e.g. from an originally planned treatment protocol” in Para. 74; “initial course of treatment” in Para. 75; also see e.g. Para. 77, 79-81, 96; also see e.g. claim 1: there is a first administration of therapy before measuring the response and making subsequent changes to the protocol, e.g. in claim 4);
wherein an amplitude of one or more pulses from the TNM device is a function of the delivered amplitude of prior calibration and treatment pulses of that patient (see e.g. Paras. 153).
Concerning the limitation that the TNM device is in communication with an electronic control unit (ECU) having a processor and computer-readable memory, with the ECU performing the above steps, these limitations are implicitly taught by Etkin in at least Paras. 80, 96 and 109-110. Specifically, Para. 80 states “for instance, the TMS-EEG system can perform, based on the clean TMS-EEG data, real-time adjustments to one or more treatment protocols such as treatment duration, stimulation frequency, stimulation magnitude, stimulation area, time interval between stimuli, and/or the like” and Para. 96 states “a machine learning algorithm can use EEG analysis of the rTMS evoked response to modulate an rTMS treatment protocol in real-time,” which are limitations that would inherently necessitate a processor and memory. Furthermore, Paras. 109-110 clarify that the stimulator can be one of the known FDA-cleared conventional TMS stimulators from MagVenture, such as the MagVenture MagPro X100, which are devices that communicate with a processor and memory and which perform steps as instructed by the processor.
Nevertheless, in addition to the explanation above, this is an incredibly common, well-known and industry standard setup for virtually all modern medical stimulation devices. As one example, Ravindranathan teaches a variety of stimulation devices, including repetitive transcranial magnetic stimulation (see e.g. Paras. 3, 7, 93) utilizing this setup (see e.g. FIGS. 1A-1C and 4; see e.g. Paras. 100-101 which describe that computing entity 401 includes a processor 405 and memory 410). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Etkin to have the TNM device in communication with an electronic control unit (ECU) having a processor and computer-readable memory (assuming, purely for the sake of argument, that Etkin doesn’t already implicitly teach these limitations) because this was a well-known and standard setup for modern stimulation devices to provide the well-understood and predictable benefits of a modern computerized system.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Etkin in view of Ravindranathan as applied to claim 40 above, and further in view of US 2021/0196971 A1 to Lowin (hereinafter “Lowin”).
Regarding Claim 42, Etkin as modified above teaches an initial TNM protocol as discussed above, but fails to specify that the parameters of the initial TNM protocol are selected from a finite list of preset protocols. However, this is a well-known and commonly used practice in stimulation arts generally. As one example, Lowin teaches a magnetic stimulation device in which a preset protocol can be chosen (see e.g. Para. 38: “Through the user interface, the user can define a set of TPUs that the processor applies to the subject as a set treatment protocol or can select a preset protocol comprising a set of TPUs defined locally or otherwise provided to the controller 232 from a remote site. As one example, in a neurological medical facility, a doctor or other medical professional can treat a patient with Parkinson's disease by selecting a treatment protocol from the TPU library 240 tailored for this condition.”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Etkin to allow the provider to initially select from among a list of predetermined protocols since this would advantageously and predictably provide a useful starting point which is likely to be at least somewhat effective and safe based on past experiences, and/or it would enhance the convenience of using the system from the provider’s perspective by not requiring the provider to manually input all of the initial parameters.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Epstein et al. (US 6,425,852): see the title and abstract.
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 JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792