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
Applicant is advised that should claim 1 be found allowable, claim 65 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 1, 2, 4, 8, 10, 12, 17, 22, 27, 29, 44, 46, 48, 50, 52, 56, and 63-65 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.
In claim 1, the single clip configured to be attached “to the tragus of only the left ear of the subject” is vague as it is unclear what structural limitation makes the clip/claim configured to be attached to “the tragus of only the left ear of the subject”. Does this mean that it cannot be used on the right ear also? In the last paragraph, “an outer arm” is vague as it is unclear what is meant by an “outer arm”—is this one of the “opposing arms” used in line 5 or a different arm. In addition, what makes an arm an “outer arm”?
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, 2, 4, 8, 10, 12, 17, 22, 27, 29, 44, 46, 48, 50, 52, 56, and 63-65 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 subject matter which was not described in the original disclosure is the “single clip configured to be attached to the tragus of only the left ear of the subject”, in combination with the other elements and/or functions of the claim(s).
While the figures may show the use of the clip on the left ear, the examiner could find no specific negative limitation or exclusionary proviso (mpep 2173.05i) of having a single clip configured to be attached to the tragus of only the left ear of the subject—completely discounting the use of the clip on the right ear. The specification specifically states that the clip or the lead to the clip is “malleable” (e.g. paras. 123, 174, etc.) so that it can be shaped to be used on the patient, and it is unclear how the clip is configured to be attached to the tragus of “only the left ear”. Does this mean the clip cannot be used on the right ear? What prevents the clip from being used on the right ear?
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 63-65 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 claim limitation of “consisting of a single lead and no other leads extending from an outer 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 figure 37, the system 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 claim limitation of “consisting of a single lead and no other leads extending from one arm and no other arms of the clip”.
As to the new claim limitations of “a single clip configured to be attached to the tragus of only the left ear of the subject” and “an outer arm”, it is noted that the claim is an open-ended “comprising” claim and does not preclude the use of a clip on the right ear or anywhere else. In addition, Cartledge specifically states the use of a clip on the left ear (e.g. para. 24 states the electrodes are used on both sides, but each respective pair is “only” on one side, figures 12, 17, 37, etc.). The claimed use of the clip on the tragus and extending from an “outer arm” is met by Cartledge, as he describes the use of any of the clips 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 and having the arm with the lead being the “outer arm” due to the clip’s/clamp’s biased armed structure with electrodes that can be placed so the lead comes from the outer arm.
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 63-65 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 “a single clip configured to be attached to the tragus of only the left ear of the subject”, it is noted that the claim is an open-ended “comprising” claim and does not preclude the use of a clip on the right ear or anywhere else. In addition, Cartledge specifically states the use of a clip on the left ear (e.g. para. 24 states the electrodes are used on both sides, but each respective pair is “only” on one side, figures 12, 17, 37, etc.).
As to the new claim limitation of “consisting of a single lead and no other leads extending from an outer 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. As the clip is a flexible clip structure, the clip can be placed/flipped to have the lead extending from an outer arm. 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 an outer 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, or so the single lead is not placed in a tight squeeze between the patient and skin, but used on an outer arm
.
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 (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 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 6/26/26 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 limitations of “a single clip configured to be attached to the tragus of only the left ear of the subject” and on an “outer arm” is not persuasive as discussed above in the prior art rejection. Cartledge states that the clip can be used only on the left side, and/or in addition, the claim is an open ended “comprising” claim and does not preclude the use of a clip on the right ear.
The argument that the examiner must provide evidentiary support for this 103 assertion that it is known to provide a hook extending from the clip to loop over and behind the ear is not persuasive. As stated in MPEP 2144.03, to adequately traverse a finding based on official notice, an applicant must specifically point out the supposed errors in the examiner’s action, which would include stating why the noticed fact is not considered to be common knowledge or well-known in the art. A mere request by the applicant that the examiner provide documentary evidence in support of an officially-noticed fact is not a proper traversal. See 37 CFR 1.111(b). See also Chevenard, 139 F.2d at 713, 60 USPQ at 241. In addition, evidence already exists in the application to Honeycutt (see figures 3, 4, 6, para. 21, claim 3, etc.).
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.
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 George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached on 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 9/8/26
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