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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-8, 11, and 31-38 in the reply filed on 1/26/26 is acknowledged. The traversal is on the ground(s) that the USPTO, acting as the International Searching Authority ("ISA") for the corresponding PCT application (PCT/US2022/074376) from which national stage was entered in the US, indicated in the Written Opinion that claims 62-64 were not subject to a lack of unity under PCT Rule 13.1 and instead the USPTO included claims 62-64 in the same group as claims 1-8, 11 and 31-38 (among other claims). This is not found persuasive because MPEP 1845.01 states:
all written opinions are nonbinding and a patent does not issue; what does issue is an international preliminary report on patentability (IPRP), which is nonbinding on the elected States.
However, after further consideration of the scope of the claims, the restriction requirement has been withdrawn and all claims will be examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/1/24, 1/6/25, and 1/28/26 are being considered by the examiner.
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 1-8 and 11 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 limitation of “a removeable neurostimulator device” in line 16 is indefinite. It remains unclear whether this is the same or different than “a removeable neurostimulator device” in line 1. For the purposes of examination, they are being interpreted as the same removeable neurostimulator device.
In claim 1, the limitation of “one or more peripheral nerves of a user” on the last line is indefinite. It remains unclear whether this is the same or different than “one or more peripheral nerves of a user” in line 3. For the purposes of examination, the one or more peripheral nerves of the user are being interpreted as the same.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 62-64 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Campean (WO 2021055716 filed on 9/18/20).
Regarding claim 62, Campean teaches a wrist wearable system (¶16-the system also can be applied to the wrist area) configured to removably secure a controller (¶125-the control unit 70 is detachably connected to the remainder of the neurostimulator 10), the system having an inside and an outside (Figs. 2A-2B-the inside touches the skin and the outside does not), the inside being configured to be in contact with a wrist of a user (¶16- the system also can be applied to the wrist area; ¶7-engage the subject’s skin at desired locations when the wearable is worn), the wrist wearable system comprising: a frame comprising an engagement structure configured to receive the controller from the inside of the system to engage and secure the controller (¶125-the control unit 70 is detachably connected to the remainder of the neurostimulator 10 via a plug-in or snap-in connector 72 (see Fig. 2B where 56 surrounds 70)); and a strap extending from a first portion of the frame (Figs. 2A-2B-strap 20 extending from housing 56), wherein an end of the strap is not secured to the frame (Figs. 2A-2B-the end of strap 20 is not secured to housing 56).
Regarding claim 63, Campean teaches the wrist wearable system of claim 62, wherein the engagement structure is an abutment surface (¶125-the control unit 70 is detachably connected to the remainder of the neurostimulator 10 via a plug-in or snap-in connector 72; Fig. 2B), and wherein the controller comprises a contact surface shaped and sized to contact the abutment surface when the controller is secured to the frame (see Fig. 2B where 56 surrounds 70)).
Regarding claim 64, Campean teaches the wrist wearable system of Claim 62, wherein the engagement structure is an opening (¶127-the connector 72 can, for example, extend through a hole in the strap 20; ¶125-the control unit 70 is detachably connected to the remainder of the neurostimulator 10 via a plug-in or snap-in connector 72 (see Fig. 2B)).
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Regarding claim 1, the scope of the removable neurostimulation device being configured to modulate one or more peripheral nerves of a user, a band, an electrode system, a frame, a removable neurostimulation device having an upper surface, a lower surface, and an outer wall disposed therebetween, the outer wall comprising one or more electrical contacts, the outer wall being sized and shaped to be mechanically secured within the engagement structure of the frame; wherein the one or more electrical contacts of the neurostimulation device are configured to electrically interface with the one or more electrical contacts of the frame when the outer wall is mechanically secured within the engagement structure of the frame; and when the removable neurostimulation device is inserted into the frame from the inside of the band the engagement structure prevents the removable neurostimulation device from passing entirely through the frame were not found in the prior art alone or in combination with one another to be obvious over the prior art of record. The closest prior art of record is US 9802041; however it fails to recite the outer wall comprising one or more electrical contacts, the outer wall being sized and shaped to be mechanically secured within the engagement structure of the frame; wherein the one or more electrical contacts of the neurostimulation device are configured to electrically interface with the one or more electrical contacts of the frame when the outer wall is mechanically secured within the engagement structure of the frame; and when the removable neurostimulation device is inserted into the frame from the inside of the band the engagement structure prevents the removable neurostimulation device from passing entirely through the frame.
Regarding claim 31, the scope of a wearable system for modulating one or more peripheral nerves of a user, the system comprising: a band having a frame with an engagement structure, the band having an outside and an inside, the outside being viewable by the user and the inside facing skin of the user when the band is worn by the user; and a neurostimulation device having an upper surface, a lower surface, and an outer wall disposed therebetween, the outer wall being sized and shaped to be secured against the engagement structure when the neurostimulation device is inserted into the frame from the inside of the band while preventing the neurostimulation device from passing entirely through the frame were not found in the prior art alone or in combination with one another to be obvious over the prior art of record. The closest prior art of record is US 9802041; however it fails to recite the outer wall being sized and shaped to be secured against the engagement structure when the neurostimulation device is inserted into the frame from the inside of the band while preventing the neurostimulation device from passing entirely through the frame.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA HODGE whose telephone number is (571) 272-7101. The examiner can normally be reached M-F: 8:00 am-5:00 pm.
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/L.N.H./Examiner, Art Unit 3792 /AMANDA L STEINBERG/Examiner, Art Unit 3792