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 .
Response to Arguments
Applicant’s amendment and arguments filed 3/16/2026 regarding the 35 USC 102 rejection of the claims with respect to Hershey have been fully considered and are persuasive. The 35 USC 102 rejection with respect to Hershey has been withdrawn.
Applicant's amendment and arguments filed 3/16/2026 regarding the 35 USC 102 rejections with respect to Ollivier have been fully considered but they are not persuasive. Applicant amended the claim to require the first and second conductor to be “configured to contact the pharyngeal wall”. This is intended use language that requires the first and second conductors to have external surfaces that can contact tissue. One example of this can be seen in Applicant’s Fig. 4 in which a pin 416 from the second elongate member electrically contact a surface electrode 418 from the first elongate member to form a conductor that has a surface on the exterior surface of the first elongate member. Ollivier likewise discloses this feature. Ollivier discloses a pin 24, 31 from a second elongate member 200 that electrically contacts a surface electrode 28 of a first elongate member 21, forming a conductor that has a surface on the exterior surface of the first elongate member. The rejection with respect to Ollivier is maintained.
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.
(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 27-31 and 34-41 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ollivier et al. (2019/0083795).
First, the Examiner notes the claims are device claims and the functional language “is configured to be inserted into the pharynx…” and “configured to provide bipolar stimulation to nerves proximate the treatment site” are intended use recitations. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding Claims 27, 34, 35 and 41, Ollivier discloses a device having a first elongate member 21 with a lumen therein for receiving a second elongate member 200. The first elongate member 21 has first and second conductive elements 28, 29 carried thereon and the second elongate member 200 has first and second conductive members (206a that can be replicated for multiple conductive wires in lumens 202a, b, c, etc. (par. [0093]; Fig. 7). The conductive elements 28, 29 of the first elongate member 21 have respective holes (female connectors) that receive male connectors (i.e. pins) from the second elongate member 200 (through hole and pin 31, 24 in Fig. 7). Lastly, the outer surface of elements 28, 29 are on an exterior surface of the assembly (Fig. 7) that is capable of contacting tissue and therefor meets the capability provided by the language “configure to contact the pharyngeal wall”.
In regards to Claims 27, 30, 38, 39 and 41, Ollivier in a separate embodiment, discloses a first elongate member 21 with first and second conductive contacts 28, 29, wherein the first elongate member 21 has a lumen therein for receiving a second elongate member 301 with multiple conductive members 306a, b, c, etc. carried thereon (Fig. 8,9). Olliveir discloses the first and second conductive members of the second elongate member 301 are wires extending along a longitudinal dimension of the second conductive member that have a distal portion connected to the first conductive element and a second end connected to a power supply (not shown but located within a pulse generator that provides energy to the electrodes), see Fig. 8, 9. The designation of the power supply as “extracorporeal” is intended use and such a device disclosed by Olliveir is capable, during implantation to have the lead on the inside of the body while the pulse generator is on the outside of the body. Lastly, the outer surface of elements 28, 29 are on an exterior surface of the assembly (Fig. 8, 9) that is capable of contacting tissue and therefor meets the capability provided by the language “configure to contact the pharyngeal wall”.
In regard to Claim 28, Applicant is claiming an intended use of a device claim. Applicant fails to further define any other structural elements. Therefore, it is asserted that the structure as claimed in Claim 27 and as disclosed by Ollivier is capable of the claimed function.
Regarding Claim 29, Ollivier discloses the distal end of the first elongate member is closed (see Fig. 4A as an example of the closed end). Fig. 7 is just a cross-section of a closed end (see par. [0055]).
In regard to Claim 31, Applicant is claiming the intended use of disposing and reusing components and not defining any new structural details to the claim. The second elongate member of Ollivier can be inserted and removed from the frist elongate member. Each component is capable of being thrown away (disposed) and is also capable of being reused (i.e. removed and re-inserted).
Regarding Claims 36 and 37, Ollivier discloses the exterior surface of elements 28, 29 of Fig. 7 or Fig. 9 extend around a circumference of the first elongate member.
In regard to Claim 40, Ollivier discloses a retaining structure 53 that can releasably fix the first and second elongate members relative to each other. Structure 53 can press fit into a corresponding groove in the second elongate member (par. [0073]).
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 32 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Ollivier et al. (2019/0083795) in view of Donofrio et al. (8,200,335). Ollivier discloses all of the claimed invention except for the elongate members and/or conductors thereof having opposing magnetic polarities. However, Donofrio, in the same field of endeavor of electrical connectors discloses magnetizing respective leads and/or portions of the leads to that they can be "compatible" (e.g. opposite polarity) when they are intended to connect and "incompatible" (same polarity) when they are not intended to connect (col. 24, lines 11-41). This would ensure correct operation of the device as well as providing extra connection security to the device. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Ollivier reference to include magnetic portions/conductors of opposite polarity on two elongated members that are configured to connect, as taught and suggested by Donofrio, for the purpose of ensuring correct operation of the device as well as providing extra connection security to the device.
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.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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