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 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.
Claim 37 is 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 37, lines 2-3 are not understandable. In line 2, “that extends…” is vague as it is unclear what element “that” is directed to. In line 2, “that extends a first lateral end to a second lateral end” is vague. Is the word “from” supposed to be inserted after “extends”? In line 3, “when in the unfurled state” is vague as it is unclear what part of the claim this is directed to.
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 16 and 36 are rejected under 35 U.S.C. 102a1 as being anticipated by Meadows et al (9849288). Meadows discloses stimulation of the HGN branch (e.g. col. 1, lines 44-48, etc.) and the HGN trunk (e.g. col. 15, lines 45-50, etc.) with a self-curling helical cuff electrode (e.g. figures 6E, col. 15, etc.) where the electrode structure has multiple transverse electrodes (e.g. col. 14, lines 15-25, col. 16, lines 51-55, etc.) and the self-curling helical cuff electrode is made of a biological, insulative, material (e.g. col. 16, lines 51-60, etc.), allowing for the cuff to be furled, partially unfurled, and unfurled when a force is applied to the cuff. Meadows also discloses that the trunk is of diameter 4-5 mm (e.g. col. 6, line 59, etc.) and that in the expandable cuff embodiments, the cuff is expandable from 2 mm to 12 mm to increase or decrease in accordance with the HGN and since there may be some swelling when initially placed on the HGN (e.g. col.15, lines 13-15; col. 14, lines 49-55, etc.), and therefore is configured to, and/or meets the intended/functional use recitations of, being for both the HGN branch and trunk. Meadows cuff electrodes will stimulate the nerve fascicles around the branch or trunk since the self-curling cuff with electrodes is meant to stimulate the HGN over the different expandable cuff diameters.
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.
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 16-17 and 37 are rejected under 35 U.S.C. 102(a1) as anticipated by Christopherson et al (9486628) or, in the alternative, under 35 U.S.C. 103 as obvious over Christopherson in view of Meadows.
Christopherson discloses in col. 6, lines 40-55 that he uses a sensor to sense data from the patient which represents “activity of a nerve to be stimulated, such as the hypoglossal nerve, including specification of the trunk and/or one or more branches”. Christopherson discloses placing an electrode on, and stimulating, the HGN (e.g. col. 4, lines 31-50, trunk and/or branches, col. 6, line 50, etc.) where he uses a self-sizing helical cuff electrode (e.g. figures 18-19, col. 24, line 49-col. 25, line 46, etc.). As the electrode cuff is flexible and self-sizing and moves to fit the diameter of the nerve (i.e. elastic), it is configured to furl, partially unfurl, and unfurl due to force applied to the cuff and is configured for one and/or both the trunk and GM branch due to any one of: the material used (biocompatible, non-metallic/insulative, elastic/flexible, etc.); electrode used; self-sizing; stated use to stimulate the trunk and/or branches, etc. The self-sizing cuff will stimulate the nerve fascicles around the branch or trunk since the self-sizing cuff with electrodes is meant to stimulate the HGN over the expandable cuff diameter. For claim 37, Christopherson shows in figures 18 and 19 the cuff body with first and second ends, where the length in the unfurled state will be greater than in the furled state.
In addition, the diameter used of the claimed cuff is relative and not set forth in the claims. The HGN has different sizes in different people and different animals, and the HGN branch may be swollen or the trunk may be smaller. As Christopherson has a self-sizing helical cuff electrode, that goes between different diameters for the HGN, he is capable of, and does meet, the functional and relative size use recitations as set forth in the claims for being for both the trunk and branch.
In the alternative, Meadows (e.g. col 14, line 42 to col. 15, line 54, etc.) teaches that it is well-known to provide a wide range of diameters for the nerve cuff electrode leads for stimulation of the HGN, such self-curling diameter being from 2mm to 12mm which necessarily would allow for use on both the HGN branch and HGN trunk, so that they can be placed on different sized areas of the nerve in the body and allow for adjustment or swelling of the nerves. 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 Christopherson, with the use of the nerve cuff electrode lead having an adjustable internal diameter, such as from 2mm to 12mm which necessarily would allow for use on both the HGN branch and HGN trunk, as taught by Meadows, since it would provide the predictable results of allowing the nerve cuff electrode lead to be used on different sized nerves and places on the same nerve due to different patient physiology and/or allow for swelling of the nerve.
Claims 36 is rejected under 35 U.S.C. 103 as obvious over Christopherson in view of Meadows.
Christopherson discloses in col. 6, lines 40-55 that he uses a sensor to sense data from the patient which represents “activity of a nerve to be stimulated, such as the hypoglossal nerve, including specification of the trunk and/or one or more branches”. Christopherson discloses placing an electrode on, and stimulating, the HGN (e.g. col. 4, lines 31-50, trunk and/or branches, col. 6, line 50, etc.) where he uses a self-sizing helical cuff electrode (e.g. figures 18-19, col. 24, line 49-col. 25, line 46, etc.). As the electrode cuff is flexible and self-sizing and moves to fit the diameter of the nerve (i.e. elastic), it is configured to furl, partially unfurl, and unfurl due to force applied to the cuff and is configured for one and/or both the trunk and GM branch due to any one of: the material used (biocompatible, non-metallic/insulative, elastic/flexible, etc.); electrode used; self-sizing; stated use to stimulate the trunk and/or branches, etc. The self-sizing cuff will stimulate the nerve fascicles around the branch or trunk since the self-sizing cuff with electrodes is meant to stimulate the HGN over the expandable cuff diameter.
In addition, the diameter used of the claimed cuff is relative and not set forth in the claims. The HGN has different sizes in different people and different animals, and the HGN branch may be swollen or the trunk may be smaller. As Christopherson has a self-sizing helical cuff electrode, that goes between different diameters for the HGN, he is capable of, and does meet, the functional and relative size use recitations as set forth in the claims for being for both the trunk and branch. Christopherson does not disclose the HGN branch of about 2.5mm and a trunk of about 4 mm.
Meadows (e.g. col 14, line 42 to col. 15, line 54, etc.) teaches that it is well-known to provide a wide range of diameters for the nerve cuff electrode leads for stimulation of the HGN, such self-curling diameter being from 2mm to 12mm which necessarily would allow for use on both the HGN branch and HGN trunk, and use on an HGN trunk and of typical diameter of 4-5 mm (e.g. col. 6, lines 56-60, etc.), so that the cuff electrodes can be placed on different sized areas of the nerve in the body and allow for adjustment or swelling of the nerves. 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 Christopherson, with the use of the nerve cuff electrode lead having an adjustable internal diameter, such as from 2mm to 12mm which necessarily would allow for use on both the HGN branch and HGN trunk, such as on an HGN trunk and of typical diameter of 4-5 mm, as taught by Meadows, since it would provide the predictable results of allowing the nerve cuff electrode lead to be used on different sized nerves and places on the same nerve, such as the HGN trunk or branch due to different patient physiology and/or allow for swelling of the nerve.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Christopherson et al or Christopherson in view of Meadows. Christopherson or Christopherson in view of Meadows discloses the claimed invention and using the electrodes to apply stimulation to the trunk and/or branch, but does not disclose one of the other electrodes is used to return the stimulation, and in the alternative if it is considered that Christopherson or Christopherson in view of Meadows does not have the cuff and electrodes on the HGN GM branch, that the cuff and electrodes are on the HGN GM branch. 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 as taught by Christopherson or Christopherson in view of Meadows, with using one of the electrodes as the return for the stimulation, and in the alternative, that the cuff and electrodes are on the HGN GM, as is well known and common knowledge in the art (mpep 2144I, 2144.03) since it would provide the predictable results of: providing bipolar stimulation to the nerve so that the stimulation does not pass through other nerves or tissue and cause side effects; and applying the stimulation directly to the HGN GM branch so as to not stimulate other tissue and activate other muscles or cause side effects.
Allowable Subject Matter
Claims 34-35 are allowed.
Claims 19-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 12/9/25 have been fully considered but they are not persuasive.
The argument that Meadow’s teaching of his expandable cuff’s use on 2-12mm diameter nerves is meant to apply to the perforated cuff electrodes and not the helical cuff electrodes is not persuasive. In instances where Meadows discusses perforated cuff electrodes, he specifically calls out the “perforated” cuff electrodes. However, when Meadows discusses the use of the expandable cuff electrodes being usable from 2-12 mm diameters (e.g. col. 15, lines 1-15, etc.), Meadows states this is for “expandable cuff embodiments”, which the helical cuff electrode is an expandable cuff embodiment.
The argument that Meadows does not contain a step to selectively activating nerve fascicles of the HGN trunk is not persuasive. Meadows specifically calls out stimulating the hypoglossal (HGN) nerve with electrodes where the cuff is placed on the HGN trunk and therefore does selectively stimulate/activate the nerve fascicles (e.g. col. 16, lines 51-67, etc.).
The applicant’s argument that Christopherson’s cuff electrode cannot be placed on both the HGN trunk and HGN branch is not persuasive.
Christopherson states that activity from the nerve is sensed so that data is received of the “activity of a nerve to be stimulated, such as the hypoglossal nerve, including specification of the trunk and/or one or more branches”. This specifically states that the “nerve to be stimulated” includes the “trunk and/or one or more branches” and therefore recognizes that the HGN trunk and/or branches will be stimulated with his system and method that uses a “self-sizing” helical cuff electrode.
While the applicant states that the same helical coil member cannot be placed on both the trunk and branch, it is noted that no specific sizes/diameters have been set forth in the claims, the trunk and branch sizes are relative, that different people/animals have different sized trunks and branches, and that Christopherson uses a self-sizing cuff that changes diameter and will be able to meet the relative sizes of the trunk and branch. The argument that Christopherson does not teach a cuff that has a larger diameter/less furled shape for the trunk and a smaller, furled diameter for the branch is not persuasive as Christopherson teaches “a self-sizing cuff” that is furled and moves between diameters. The argument that Christopherson has electrodes that are linearly aligned along one side and therefore does not furl/unfurl is not persuasive as nerve sizes in patients are relative and not all the same size, which may or may not result in linear arrangement of electrodes. Also Christopherson specifically states the helical coil member is not strictly limited to this arrangement. In the alternative for the nerve diameters and the use of the cuff electrodes over a range of diameters, such as an HGN trunk and branch, Meadows discloses that self-sizing cuff electrodes can have a diameter of 2-12mm. Note that both electrode structures of Christopherson and Meadows are meant to stimulate the nerve over the different cuff diameters and necessarily will activate nerve fascicles around the trunk and branch since they both recognize that their cuffs change diameters and their electrodes are meant to stimulate the HGN to provide therapy. In addition, for the 103 rejection of Christopherson in view of Meadows, the above arguments directed to Meadows address the applicant’s arguments regarding the 103 combination of Christopherson in view of Meadows.
Conclusion
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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/George R Evanisko/Primary Examiner, Art Unit 3792 1/3/26
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