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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/20/26 has been entered.
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 1, 4, 8, 10, 12, 17, 22, 27, 29, 44, 46, 48, 50, 52, 56, and 63-64 are rejected under 35 U.S.C. 102a1 as being anticipated by Cartledge et al (2017/0087364).
Cartledge discloses a transcutaneous vagus stimulation system and method (e.g. paras. 26, 30, 31, etc.) with a signal generator housing containing a controller/processor/software (e.g. figures 1, 2, 136-142, paras. 350-363, etc.) with control mode buttons to increase/decrease the therapy (e.g. paras. 257-259, 363, 376, etc.), where the housing is coupled to the electrodes through a lead/wires (e.g. figures 1, 2, 136-142, paras. 375, 463-467, etc.) to deliver electrical pulses to both electrodes (e.g. figures 144-151, paras. 370-374, etc.; asymmetrical, symmetrical, monophasic or biphasic, changing parameters, etc.), and also deliver non-electrical stimulus such as an auditory stimulus (e.g. abstract, paras. 284, 357, 361, 402, etc.), where the system is used for pain, mood elevation, concentration, etc. (e.g. para. 25, etc.).
The housing is connected to a clip, with biased arms (and hence must necessarily have a biasing mechanism), and electrodes. The system and method of Cartledge is used in a method for the tragus (e.g. figures 52-57, 175-177, paras. 287, 462-464, etc., where one arm is configured to be position within a concha) and the numerous clips/clamps disclosed by Cartledge also are capable of being placed on the tragus due to the clip’s/clamp’s biased armed structure with electrodes. Such as in figures 10-14, which also provides another system that is capable of meeting the functional use recitations of the claims of being urged into engagement with opposing faces of the tragus as the clip in figures 10-14 can be moved onto the tragus and the vagus stimulation can be applied. The system and method has electrodes that can be spherical and textured (i.e. roughened) to have serrations or barbs (e.g. para. 274, etc.) to have better contact and conductivity. Note that for the claims that use the term optionally, the limitations after optionally are left to personal choice and/or not required for the claims or to be found in the prior art.
As to the new claim limitation of “consisting of a single lead and no other leads extending from one arm and no other arms of the clip”, and without interruptions from the housing (claim 64), and being capable of looping over and behind the ear (e.g. claim 4, etc.). As seen in figures 1 and 2, there is one lead 5, that bifurcates and provides a separate lead wire to each arm/electrode (e.g. paras. 247-249, etc.). For figures 10-14, Cartledge states the clip can be wired like figure 1 (e.g. para. 259, etc.) therefore having one lead to each arm. Figure 37 shows one wire to one arm of the clip and states “a wire” is used (e.g. para. 263, etc.). As shown in the figures using a lead or leads, the leads are capable of being looped behind the ear based on where the stimulation generator is placed. In the alternative, see the 103 rejection below for the new claim limitation of “consisting of a single lead and no other leads extending from one arm and no other arms of the clip.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
In the alternative, claims 1, 4, 8, 10, 12, 17, 22, 27, 29, 44, 46, 48, 50, 52, 56, and 63-64 are rejected under 35 U.S.C. 103 as obvious over Cartledge in view of Honeycutt et al (2020/0338348) or over Cartledge in view of Batzer (2018/0132717).
Cartledge discloses a transcutaneous vagus stimulation system and method (e.g. paras. 26, 30, 31, etc.) with a signal generator housing containing a controller/processor/software (e.g. figures 1, 2, 136-142, paras. 350-363, etc.) with control mode buttons to increase/decrease the therapy (e.g. paras. 257-259, 363, 376, etc.), where the housing is coupled to the electrodes through a lead/wires (e.g. figures 1, 2, 136-142, paras. 375, 463-467, etc.) to deliver electrical pulses to both electrodes (e.g. figures 144-151, paras. 370-374, etc.; asymmetrical, symmetrical, monophasic or biphasic, changing parameters, etc.), and also deliver non-electrical stimulus such as an auditory stimulus (e.g. abstract, paras. 284, 357, 361, 402, etc.), where the system is used for pain, mood elevation, concentration, etc. (e.g. para. 25, etc.).
The housing is connected to a clip, with biased arms (and hence must necessarily have a biasing mechanism), and electrodes. The system and method of Cartledge is used in a method for the tragus (e.g. figures 52-57, 175-177, paras. 287, 462-464, etc., where one arm is configured to be position within a concha) and the numerous clips/clamps disclosed by Cartledge also are capable of being placed on the tragus due to the clip’s/clamp’s biased armed structure with electrodes. Such as in figures 10-14, which also provides another system that is capable of meeting the functional use recitations of the claims of being urged into engagement with opposing faces of the tragus as the clip in figures 10-14 can be moved onto the tragus and the vagus stimulation can be applied. The system and method has electrodes that can be spherical and textured (i.e. roughened) to have serrations or barbs (e.g. para. 274, etc.) to have better contact and conductivity. Note that for the claims that use the term optionally, the limitations after optionally are left to personal choice and/or not required for the claims or to be found in the prior art.
As to the new claim limitation of “consisting of a single lead and no other leads extending from one arm and no other arms of the clip”, Honeycutt or Batzer discloses the use of a single lead, and no other leads, extending from one arm of a clip, and without interruptions to the housing in order to provide a simple electrical connection to the different parts of the system so that multiple wires are not needed and won’t get tangled between themselves or on the patient. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Cartledge, with the use of a single lead, and no other leads, extending from one arm of a clip, and without interruptions to the housing, as taught by Honeycutt or Batzer, in order to provide the predictable results of providing a simple electrical connection to the different parts of the system so that multiple wires are not needed and won’t get tangled between themselves or on the patient.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Cartledge et al in view of Honeycutt or over Cartledge in view of Batzer (i.e. “modified Cartledge”). Modified Cartledge discloses the claimed invention except for a hook extending laterally from the clip so that the lead can loop over and behind the ear. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by modified Cartledge, with a hook extending laterally from the clip so that the lead can loop over and behind the ear, as is well known and common knowledge in the art (mpep 2144), since it would provide the predictable results of allowing the ear device/clip to be securely attached to the patients ear and held in place during physical activity and allowing the lead to be located out of the way of the patient’s face, such as behind the ear, to be connected unobtrusively to the stimulator.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Cartledge et al. Cartledge discloses the claimed invention except for a hook extending laterally from the clip so that the lead can loop over and behind the ear. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed (and is admitted prior art as the applicant has not specifically pointed out the errors in the examiner’s findings and/or provided evidence of non-obviousness) to have modified the system and method as taught by Cartledge, with a hook extending laterally from the clip so that the lead can loop over and behind the ear, as is well known and common knowledge in the art (mpep 2144), since it would provide the predictable results of allowing the ear device/clip to be securely attached to the patients ear and held in place during physical activity and allowing the lead to be located out of the way of the patient’s face, such as behind the ear, to be connected unobtrusively to the stimulator.
Response to Arguments
Applicant's arguments filed 1/20/26 have been fully considered but they are not persuasive in view of the new grounds of rejection necessitated by amendment. The argument that Cartledge does not provide the new claim limitation of “consisting of a single lead and no other leads extending from one arm and no other arms of the clip” is not persuasive as the clips of Cartledge show the use of two arms for the clip, with one lead and no other leads extending from one arm, and without interruption to the housing. This can be seen in figure 37 specifically. Figure 37 shows one wire to one arm of the clip and states “a wire” is used (e.g. para. 263, etc.). Figure 1 shows the use of one lead to each ear device, where figures 10-14 are stated to be able to be wired like figure 1 (e.g. para. 259, etc.), therefore having one lead to each arm. As an alternative/backup, a 103 rejection was provided with two different teachings showing the use of a single lead to one arm of the clip to provide electrical communication to the entire clip so that multiple wires are not needed. While it is argued that Honeycutt or Batzer, or the common knowledge in the art for claim 2, has no basis to be combined with Cartledge, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). For the arguments to be persuasive and not amount to a general allegation of patentability, the applicant must specifically point out the errors in the examiner’s findings or provide evidence of non-obviousness, and not merely traverse the rejections or state that the rejections are not valid.
Conclusion
The prior art made of record is considered pertinent to applicant's disclosure and shows some of the well-known in the art elements.
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/George R Evanisko/Primary Examiner, Art Unit 3792 2/14/26