DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not). For the purpose of examination, newly numbered claims are used.
Misnumbered claims have been renumbered as follows:
Original Claim
Renumbered Claim
Claim 17 and references to Claim 17 in Claims 18 and 19
Claim 16
First occurrence of Claim 18
Claim 17
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 1-20 rejected on the ground of nonstatutory double patenting as they anticipate claims 1-18 of U.S. Patent No. US 12,053,631, claims 1-21 of US 11,027,127, claims 1-27 of US 10,350,411, and claims 1-13 US 9,427,581. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of the current application are directed towards similar subject matter and are broader than the parent applications and thus anticipate the parent applications. This requires a terminal disclaimer to remedy.
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.
Claim(s) 1-3, 5-8, 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maschino et al. (Pub. No.: US 2007/0179557 A1); hereinafter referred to as “Maschino”.
Regarding claim 1, Maschino discloses applying a stimulus to a patient having a medical condition (e.g. see [0046], [0113], “external evoking signal”); measuring a baseline physiological response from the patient (e.g. see [0046], [0113], “The latencies or other indications resulting from the response to the external evoking signal may provide indications of neuro-pathway efficiency in a particular patient”); applying an electrical impulse to a nerve within the patient (e.g. see [0048]); measuring a response of the patient to the electrical impulse (e.g. see [0048]), wherein the response comprises a second physiological response evoked by the electrical impulse (e.g. see [0048]), wherein the second physiological response comprises a symptom of a medical disorder or condition (e.g. see [0040]-[0044]); and comparing the second physiological response to the first baseline physiological response (e.g. see [0048] discloses “The physiological factors relating to the internal evoking signal may be compared with baseline values, reference values, and/or expected values of various physiological responses”. And “expected values of various physiological responses” are determined in [0046]-[0047] and [0113]).
Regarding claim 2, Maschino discloses the stimulus comprises at least one of a visual (e.g. see [0046], [0049]), auditory (e.g. see [0046], [0049]), somatosensory (e.g. see [0049]), or olfactory (e.g. see [0074]).
Regarding claim 3, Maschino discloses the nerve is a vagus nerve (e.g. see [0042], [0047]).
Regarding claim 5, Maschino discloses the medical disorder or condition comprises a primary headache (e.g. see [0041]).
Regarding claim 6, Maschino discloses the symptom comprises a reduction in pain of the patient (e.g. see [0041]).
Regarding claim 7, Maschino discloses varying a plurality of different parameters of the electrical impulse based on comparing the response to the electrical impulse with the baseline physiological response (e.g. see [0046]-[0048], [0067], [0091], [0092], [0115]).
Regarding claim 8, Maschino discloses the different parameters comprise at least one of an amplitude or a frequency of the electrical impulse (e.g. see [0046]-[0048], [0067], [0091], [0092], [0115]).
Regarding claim 11, Maschino discloses determining whether the nerve has fired an action potential based on the electrical impulse (e.g. see figure 6A, [0087]-[0090]).
Regarding claim 12, Maschino discloses determining whether the patient is a responder to the electrical impulse based on the first and second physiological responses (e.g. see figure 10 element 1060, [0046]-[0048], [0113]).
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.
Claims 13-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino in view of Gliner et al. (Pub. No.: US 2006/0015153 A1); hereinafter referred to as “Gliner”.
Regarding claim 13, Maschino discloses the claimed invention (see the rejection for claim 1 above) but is silent as to multiple doses per day for a period of time greater than 1 day and less than 3 months, wherein each of the multiple doses comprising applying the electrical impulses for a period of time. Gliner teaches that it is known to use such a modification as set forth in [0042] to provide a treatment program that may be applied over one or more limited time intervals that correspond to an extent of the patient's recovery or functional gain(s) (e.g. see [0042]. Note: The applicant only references the treatment durations in [0029]. This paragraph does not seem to provide criticality as to why this claimed duration must be used or provides certain advantages). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the stimulation duration and timing as taught in [0042] in a headache treatment device (e.g. see [0041]) as taught by Gliner in the method of Maschino, since said modification would provide the predictable results of a treatment program that may be applied over one or more limited time intervals that correspond to an extent of the patient's recovery or functional gain(s).
Regarding claim 14, Maschino discloses the stimulus comprises at least one of a visual (e.g. see [0046], [0049]), auditory (e.g. see [0046], [0049]), somatosensory (e.g. see [0049]), or olfactory (e.g. see [0074]).
Regarding claim 15, Maschino discloses the medical condition comprises a primary headache (e.g. see [0041]).
Regarding claim 16, Maschino discloses the symptom comprises a reduction in pain of the patient (e.g. see [0041]).
Regarding claim 17, Maschino discloses the response comprises a symptom of a medical disorder or condition (e.g. see [0040]-[0044]).
Regarding claim 18, Maschino discloses the symptom comprises a number of headache days of the patient (e.g. see [0041]).
Regarding claim 19, Maschino discloses the claimed invention but is silent as to the electrical impulse increases a habituation of the response. Gliner teaches that it is known to use such a modification as set forth in [0038] to provide neuroplastic, neuroregenerative, neuroprotective, and/or neurogenic effects (e.g. see [0038]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use an electrical impulse increases a habituation as taught by Gliner in the method of Maschino, since said modification would provide the predictable results of neuroplastic, neuroregenerative, neuroprotective, and/or neurogenic effects.
Claims 4, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino in view of Lesser et al. (Pub. No.: US 2008/0208266 A1); hereinafter referred to as Lesser.
Regarding claims 4, Maschino discloses the claimed invention except but is silent as to applying an electrical impulse transcutaneously through an outer skin surface of a neck of the patient to a vagus nerve of the patient. Lesser teaches that it is known to use such a modification as set forth in figure 2, elements 40 and 42, [0046]-[0047] to locate a current source for such methods and systems outside the body, for patients who do not need or desire an implanted power supply or battery-operated device (e.g. see [0010]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Maschino, with such a modification as taught by Lesser, since such a modification would provide the predictable results of locating a current source for such methods and systems outside the body, for patients who do not need or desire an implanted power supply or battery-operated device.
Regarding claims 9 and 10, Maschino discloses the claimed invention but is silent as to the different parameters comprise applying the electrical impulse to a different location on the neck of the patient and the different parameters comprise applying the electrical impulse via a different orientation on the neck of the patient. Lesser teaches that it is known to use such a modification as set forth in figure 2, elements 40 and 42, [0046]-[0047] to locate a current source for such methods and systems outside the body, for patients who do not need or desire an implanted power supply or battery-operated device (e.g. see [0010]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Armstrong, with such a modification as taught by Lesser, since such a modification would provide the predictable results of locating a current source for such methods and systems outside the body, for patients who do not need or desire an implanted power supply or battery-operated device.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Maschino in view of Gliner as applied to claim 13 above, and further in view of Lesser.
Regarding claim 20, Maschino in view of Gliner discloses the claimed invention except but is silent as to applying an electrical impulse transcutaneously through an outer skin surface of a neck of the patient to a vagus nerve of the patient. Lesser teaches that it is known to use such a modification as set forth in figure 2, elements 40 and 42, [0046]-[0047] to locate a current source for such methods and systems outside the body, for patients who do not need or desire an implanted power supply or battery-operated device (e.g. see [0010]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Maschino in view of Gliner, with such a modification as taught by Lesser, since such a modification would provide the predictable results of locating a current source for such methods and systems outside the body, for patients who do not need or desire an implanted power supply or battery-operated device.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792