Prosecution Insights
Last updated: October 02, 2026
Application No. 18/826,930

Cuff For Providing Vagus Nerve Stimulation

Final Rejection §102§103
Filed
Sep 06, 2024
Priority
Sep 06, 2023 — provisional 63/580,881
Examiner
HOLTZCLAW, MICHAEL T.
Art Unit
3796
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
United States Department of Veterans Affairs
OA Round
2 (Final)
78%
Grant Probability
Favorable
3-4
OA Rounds
8m
Est. Remaining
94%
With Interview

Examiner Intelligence

Grants 78% — above average
78%
Career Allowance Rate
190 granted / 245 resolved
+7.6% vs TC avg
Strong +16% interview lift
Without
With
+16.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
41 currently pending
Career history
277
Total Applications
across all art units

Statute-Specific Performance

§101
7.1%
-32.9% vs TC avg
§103
36.3%
-3.7% vs TC avg
§102
19.9%
-20.1% vs TC avg
§112
27.9%
-12.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 245 resolved cases

Office Action

§102 §103
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 arguments, see page 5, filed 07/15/2026, with respect to claim objections have been fully considered and are persuasive. The claim objection has been obviated by an amendment to claim 3. The claim objections of claim 3 has been withdrawn. Applicant’s arguments, see pages 5-8, filed 07/15/2026, with respect to 35 U.S.C. 102 rejections of claims 1 and 14 have been fully considered but they are not persuasive. The Applicant argues that as best understood, the Office Action takes the position that the plurality of bands "must be" a single helical band based on the disclosure of Boveja noting that multiple electrodes are on a single band. The Applicant argues that this conclusion is unsupported for multiple reasons. The Applicant first argues that as shown in Fig. 18, a respective conductor extends to each electrode, requiring four conductors for the illustrated embodiment. The Applicant argues that if these four electrodes were attached to a helical body, the helical body could not be wrapped around the esophagus. The Applicant further argues that the conductors themselves, by way of attachment, would effectively traverse the gap necessary to wrap the helical body around the esophagus, and thus Fig. 18 cannot be showing a helical body wrapped around an esophagus. This is not found persuasive. The Applicant appears to be taking the position that Fig. 18 shows a plurality of bands instead of a single helical band. The Examiner does not find this position that there are a plurality of bands to be supported by Boveja’s disclosure at Fig. 18 and Par. [0093]. For instance, Boveja teaches (Fig. 18) that in one preferred embodiment, without limitation, multiple electrodes comprising both blocking and stimulation electrodes are placed in a band (Par. [0093]). Boveja further teaches that as shown in conjunction with FIG. 18, the band comprising multiple electrodes is wrapped around the esophagus, close to the junction of esophagus and the stomach 5 (just below the diaphragm) (Par. [0093]). Every mention of “band” is in the singular form and there isn’t any support that there are a plurality of bands. The Examiner does not find Applicant’s argument that a respective conductor extends to each electrode precludes Boveja’s Fig. 18 embodiment from teaching a helical body wrapped around the esophagus. Again, Boveja teaches “In one preferred embodiment, without limitation, multiple electrodes comprising both blocking and stimulation electrodes are placed in a band” (emphasis added). Therefore, the stimulating electrodes and blocking electrodes (shown in Fig. 18) are found to be in a singular band wrapped around the esophagus in a helical fashion. The Applicant further argues that the stimulating electrodes and blocking electrodes are the structure illustrated in FIG. 18. The Applicant argues that Par. [0093] states that multiple electrodes can be on a single band, but that single band is not shown. The Applicant argues that at most Par. [0093] and FIG. 18 indicate that a single band (not shown) surrounding the esophagus can include a plurality of the illustrated electrodes. The Applicant further argues that because the electrodes themselves are not helical, and because, as noted above, a helical band could not be installed with the four illustrated conductors attached along its length, Boveja fails to disclose a helical body as recited in claim 1 and claim 14. The Applicant argues that to the contrary, Boveja merely discloses conventionally known circumferential band electrodes that Applicant's present application (U.S. App. No. 18/826,930) describes in paragraph [0025] as undesirably causing stenosis. This is not found persuasive. The Examiner does not agree with the Applicant’s assertion that the single band is not shown, and does not find Boveja’s disclosure to support this assertion. Boveja teaches “In one preferred embodiment, without limitation, multiple electrodes comprising both blocking and stimulation electrodes are placed in a band. As shown in conjunction with FIG. 18, the band comprising multiple electrodes is wrapped around the esophagus, close to the junction of esophagus and the stomach 5 (just below the diaphragm).” (emphasis added). The Examiner maintains that Fig. 18 is showing a single band surrounding the esophagus, and does not agree with the Applicant that this teaching in Par. [0093] discusses a separate embodiment not shown in Fig. 18 along with the embodiment shown in Fig. 18. As explained above, the Examiner does not find in disclosure in Boveja teaching that Fig. 18 is showing a plurality of bands. Therefore, the 35 U.S.C. 102 rejections of claims 1 and 14 over Boveja are maintained. Please see 35 U.S.C. 102 rejections below. Applicant’s arguments, see page 8, filed 07/15/2026, with respect to dependent claims have been fully considered but they are not persuasive. The Applicant argues that with regards to claim 5, the embodiment that the Office Action is citing to modify FIG. 18 is directed to separate spiral wire leads and associated structure that is inapplicable to the series of axially spaced band electrodes shown in FIG. 18. The Applicant further argues that within the context of the band electrodes of FIG. 18, it is unclear how the electrodes could be bifurcated, and why it would have been desirable to bifurcate the band electrodes. This is not found persuasive. The Examiner disagrees with Applicant’s assertion that Fig. 32C is inapplicable to Fig. 18. As explained above, the Examiner also disagrees with Applicant’s characterization that Fig. 18 shows a series of axially spaced band electrodes. The Examiner notes that Figs. 32A-C show schematic diagrams implantable lead configurations (Pars. [0085-0087] and Par. [0118]). These implantable lead configurations are seen as lead configurations for the implantable lead in the single helical band of Fig. 18. This position is supported by Boveja’s teaching that the electrodes 61, 62 are for stimulating/blocking the vagus nerve 54 and may either wrap around the nerve or may be adapted to be in contact with tissue to be blocked/stimulated (Par. [0118]). As shown in Fig. 18, the electrodes wrapped around the esophagus (i.e., tissue to be blocked/stimulated) are blocking and stimulating electrodes. Therefore, since the implantable lead configurations of Figs. 32A-C are applicable to Fig. 18, the Examiner finds Boveja’s teaching of the electrodes in the implantable lead configuration in Fig. 32C, which can be bifurcated (Par. [0118]), to be applicable and sufficient to teach the limitation of claim 5. Therefore, the 35 U.S.C. 102 rejection of claim 5 over Boveja is maintained. The Examiner notes that the 35 U.S.C. 102 and 103 rejections of the remaining dependent claims are also maintained. Please see 35 U.S.C. 102 and 103 rejections below. Specification The disclosure is objected to because of the following informalities: Par. [0065], lines 4-5: It is believed “high-field MR environment” should be “high-field MRI environment”. Appropriate correction is required. 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 1-5, 7, 9-12, and 14-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Boveja, et al. (U.S. PGPub No. 2005/0131486). Regarding claim 1, Boveja teaches (Fig. 18) a cuff for providing vagus nerve stimulation to a subject having an esophagus (Abstract – Method and system to provide therapy for obesity … comprises vagal blocking and/or vagal stimulation; Par. [0066]; Par. [0093] – the band (i.e., cuff) providing multiple electrodes is wrapped around the esophagus), the cuff comprising: (Fig. 18) a helical body that is configured to wrap around at least a portion of the esophagus of the subject, the helical body having an inner surface, the inner surface having a length and a width, the length extending along a helical path of the inner surface, wherein the inner surface defines an interior space that is configured to receive the esophagus (Par. [0093] – As shown in conjunction with FIG. 18, the band comprising multiple electrodes is wrapped around the esophagus; The Examiner notes that Bojeva discloses that multiple electrodes are said to be on a single band wrapped around the esophagus. Therefore, the band must be helical because of the spaces shown between the band in Fig. 18); (Fig. 18) a first electrode coupled to the helical body (Par. [0093] – the band comprising multiple electrodes); and (Fig. 18; Fig. 32C, # 61/62 – bipolar electrodes) at least one additional electrode coupled to the helical body that is configured to provide a polarity opposite of the first electrode (Par. [0093] – the band comprising multiple electrodes; Par. [0118] – bipolar electrodes 61 and 62; Table 4 – bipolar wrap-around electrodes). Therefore, claim 1 is unpatentable over Boveja, et al. Regarding claim 2, Boveja teaches the cuff of claim 1, wherein (Fig. 18) the least one additional electrode comprises a plurality of electrodes (Par. [0093] – multiple electrodes comprising both blocking and stimulation electrodes are placed in the band). Therefore, claim 2 is unpatentable over Boveja, et al. Regarding claim 3, Boveja teaches the cuff of claim 1, wherein (Fig. 18; Fig. 32C, # 61/62) the first electrode is a cathode, and wherein the at least one additional electrode is an anode (Par. [0093]; Par. [0118] – bipolar electrodes 61 and 62; The Examiner notes that it would be understood that bipolar electrodes would consist of one anode (negative electrode) and one cathode (positive electrode)). Therefore, claim 3 is unpatentable over Boveja, et al. Regarding claim 4, Boveja teaches the cuff of claim 2, wherein (Fig. 32C, # 61/62) the first electrode and the plurality of electrodes are helical (Par. [0118]; The Examiner notes that the bipolar electrodes 61/62 are shown to be helical in Fig. 32C). Therefore, claim 4 is unpatentable over Boveja, et al. Regarding claim 5, Boveja teaches the cuff of claim 1, further comprising (Fig. 18; Fig. 32C, # 61/62) a second electrode that is configured to provide a polarity that is the same as the first electrode, wherein the first and second electrodes are spaced along the width of the inner surface of the helical body (Par. [0093] – multiple electrodes comprising both blocking and stimulation electrodes are placed in a band (i.e., spaced along the width of the inner surface of the helical body); Par. [0118] – a pair of electrodes 61, 62 is shown in FIG. 32C. The lead terminal preferably is linear bipolar, even though it can be bifurcated; The Examiner notes that since Boveja teaches that there can be multiple electrodes and that the lead terminal can be bifurcated (i.e., divided into two branches or forks), there could be two electrodes (i.e., first and second electrode) with the same polarity). Therefore, claim 5 is unpatentable over Boveja, et al. Regarding claim 7, Boveja teaches the cuff of claim 5, wherein (Fig. 18; Fig. 32C, # 61/62) the at least one additional electrode comprises a plurality of electrodes spaced along the length of the inner surface of the helical body (Par. [0093] – multiple electrodes comprising both blocking and stimulation electrodes are placed in a band (i.e., spaced along the length of the inner surface of the helical body)). Therefore, claim 7 is unpatentable over Boveja, et al. Regarding claim 9, Boveja teaches the cuff of claim 5, wherein (Fig. 18; Fig. 32C, # 61/62) the second electrode extends a majority of the length of the inner surface of the helical body (Par. [0093]; Par. [0118]; Examiner notes that electrodes (i.e., including second electrode) extend a majority of the length of the inner surface of the helical body). Therefore, claim 9 is unpatentable over Boveja, et al. Regarding claim 10, Boveja teaches the cuff of claim 1, wherein (Fig. 18; Fig. 32C, # 61/62) the first electrode extends a majority of the length of the inner surface of the helical body (Par. [0093]; Par. [0118]; Examiner notes that electrodes (i.e., including first electrode) extend a majority of the length of the inner surface of the helical body). Therefore, claim 10 is unpatentable over Boveja, et al. Regarding claim 11, Boveja teaches the cuff of claim 1, wherein (Fig. 18) the helical body has a consistent pitch (Par. [0093]; The Examiner notes that Boveja’s Fig. 18 shows the band to have a consistent pitch). Therefore, claim 11 is unpatentable over Boveja, et al. Regarding claim 12, Boveja teaches the cuff of claim 1, wherein (Fig. 18) the helical body has a consistent radius (Par. [0093]; The Examiner notes that Boveja’s Fig. 18 shows the band to have a consistent radius). Therefore, claim 12 is unpatentable over Boveja, et al. Regarding claim 14, Boveja teaches (Fig. 19) a method of providing vagus nerve stimulation to a subject having an esophagus and a vagus nerve (Abstract – Method and system to provide therapy for obesity … comprises vagal blocking and/or vagal stimulation; Par. [0066]; Par. [0093] – the band (i.e., cuff) providing multiple electrodes is wrapped around the esophagus), the method comprising: (Fig. 18) positioning a cuff around the esophagus of the subject (Par. [0093] – the band (i.e., cuff) providing multiple electrodes is wrapped around the esophagus), the cuff comprising: (Fig. 18) a helical body that is wraps around at least a portion of the esophagus of the subject, the helical body having an inner surface, the inner surface having a length and a width, the length extending along a helical path of the inner surface, wherein the inner surface defines an interior space that is configured to receive the esophagus (Par. [0093] – As shown in conjunction with FIG. 18, the band comprising multiple electrodes is wrapped around the esophagus; The Examiner notes that Bojeva discloses that multiple electrodes are said to be on a single band wrapped around the esophagus. Therefore, the band must be helical because of the spaces shown between the band in Fig. 18); (Fig. 18) a first electrode coupled to the helical body (Par. [0093] – the band comprising multiple electrodes); and (Fig. 18; Fig. 32C, # 61/62 – bipolar electrodes) at least one additional electrode coupled to the helical body that is configured to provide a polarity opposite of the first electrode (Par. [0093] – the band comprising multiple electrodes; Par. [0118] – bipolar electrodes 61 and 62; Table 4 – bipolar wrap-around electrodes); and (Fig. 18) applying stimulation to the vagus nerve of the subject using the cuff (Abstract; Par. [0093] – To provide vagal blocking and/or vagal stimulation therapy to a patient, blocking and stimulation electrodes are implanted at the appropriate sites. In one preferred embodiment, without limitation, multiple electrodes comprising both blocking and stimulation electrodes are placed in a band. As shown in conjunction with FIG. 18, the band comprising multiple electrodes is wrapped around the esophagus, close to the junction of esophagus and the stomach 5 (just below the diaphragm).). Therefore, claim 14 is unpatentable over Boveja, et al. Regarding claim 15, Boveja teaches the method of claim 14, wherein (Fig. 20) the stimulation is unilateral stimulation (Par. [0100] – Shown in conjunction with FIG. 20, is an overall schematic of a general implantable pulse generator system to deliver electrical pulses for modulating the vagus nerve(s) (selective stimulation and/or blocking) and providing therapy. Once programmed via an external programmer 85, the implanted pulse generator 391 provides appropriate electrical blocking and/or stimulation pulses to the vagal nerve(s) 54 via the blocking/stimulating electrodes 61,62,63.; The Examiner notes that Boveja teaches that stimulation can be controlled to stimulate vagus nerve(s), meaning one or both. Humans have two vagal nerves, one on each side of the brain. Unilateral stimulation is when only one of the two vagus nerves are stimulated. Bilateral stimulation is when both vagus nerves are stimulated.). Therefore, claim 15 is unpatentable over Boveja, et al. Regarding claim 16, Boveja teaches the method of claim 14, wherein (Fig. 20) the stimulation is bilateral stimulation (Par. [0100] – Shown in conjunction with FIG. 20, is an overall schematic of a general implantable pulse generator system to deliver electrical pulses for modulating the vagus nerve(s) (selective stimulation and/or blocking) and providing therapy. Once programmed via an external programmer 85, the implanted pulse generator 391 provides appropriate electrical blocking and/or stimulation pulses to the vagal nerve(s) 54 via the blocking/stimulating electrodes 61,62,63.; The Examiner notes that Boveja teaches that stimulation can be controlled to stimulate vagus nerve(s), meaning one or both. Humans have two vagal nerves, one on each side of the brain. Unilateral stimulation is when only one of the two vagus nerves are stimulated. Bilateral stimulation is when both vagus nerves are stimulated.). Therefore, claim 16 is unpatentable over Boveja, et al. Regarding claim 17, Boveja teaches the method of claim 14, wherein (Fig. 1) the subject is a human subject (Par. [0003]; Par. [0015]; Par. [0049]). Therefore, claim 17 is unpatentable over Boveja, et al. Regarding claim 18, Boveja teaches the method of claim 14, wherein (Fig. 1) the subject is an animal subject (Par. [0003]; Par. [0015]; Par. [0049]; Examiner notes that humans are considered animals). Therefore, claim 18 is unpatentable over Boveja, et al. Regarding claim 19, Boveja teaches the method of claim 14, wherein (Fig. 18) applying stimulation to the vagus nerve of the subject using the cuff comprises applying stimulation to a ventral subdiaphragmatic vagus nerve of the subject (Par. [0093] – As shown in conjunction with FIG. 18, the band comprising multiple electrodes is wrapped around the esophagus, close to the junction of esophagus and the stomach 5 (just below the diaphragm).; Par. [0100]; Examiner notes that Boveja’s indication of stimulating the esophagus just below the diaphragm necessitates that the ventral subdiaphragmatic vagus nerve and the dorsal subdiaphragmatic vagus nerve are being stimulated. The Examiner notes that Boveja teaches that both vagus nerves can be stimulated in Par. [0100]). Therefore, claim 19 is unpatentable over Boveja, et al. Regarding claim 20, Boveja teaches the method of claim 14, wherein (Fig. 18) applying stimulation to the vagus nerve of the subject using the cuff comprises applying stimulation to a dorsal subdiaphragmatic vagus nerve of the subject (Par. [0093] – As shown in conjunction with FIG. 18, the band comprising multiple electrodes is wrapped around the esophagus, close to the junction of esophagus and the stomach 5 (just below the diaphragm).; Par. [0100]; Examiner notes that Boveja’s indication of stimulating the esophagus just below the diaphragm necessitates that the ventral subdiaphragmatic vagus nerve and the dorsal subdiaphragmatic vagus nerve are being stimulated. The Examiner notes that Boveja teaches that both vagus nerves can be stimulated in Par. [0100]). Therefore, claim 20 is unpatentable over Boveja, et al. 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims 8 and 21 is rejected under 35 U.S.C. 103 as being unpatentable over Boveja, et al. (U.S. PGPub No. 2005/0131486) in view of Bashirullah, et al. (U.S. PGPub No. 2020/0316372). Regarding claim 8, Boveja teaches the cuff of claim 7, as indicated hereinabove. Boveja does not explicitly teach the limitation of instant claim 8, that is wherein the plurality of electrodes spaced along the length of the inner surface of the helical body comprise a first row of electrodes and a second row of electrodes, wherein the first row is spaced from the second row along the width of the inner surface of the helical body. It is noted that Boveja does teach electrodes on the inner surface of the helical body (as indicated above), but does not teach the electrode arrangement into first and second rows. Bashirullah, directed to analogous art, teaches a nerve stimulation device for unidirectional stimulation and current steering (Title, Abstract). Bashirullah also teaches the limitation of instant claim 8, that is wherein (Fig. 1A, # 15A, 15b, 25, 27) the plurality of electrodes spaced along the length [of the inner surface of the helical body] comprise a first row of electrodes and a second row of electrodes, wherein the first row is spaced from the second row along the width [of the inner surface of the helical body] (Par. [0071] – Referring to FIG. 1a, there is an array 1 with a first ring of electrodes 25 comprising a first electrode 15a, and with a second ring of electrodes 27 comprising a second electrode 15b. The first electrode 15a and the second electrode 15b are in a first pair mounted on opposing sides of the central axis 67. In this example, the first electrode 15a is different to the second electrode 15b. This helps to provide stimulation in a specific direction along the nerve. Specifically, the first electrode 15a is configured to have a first surface area in contact with the nerve in the assembled position, and the second electrode 15b is configured to have a second surface area in contact with the nerve in the assembled position.). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Bashirullah’s electrode arrangement into Boveja’s cuff, because doing so would help conduct stimulation in a specific direction along the nerve (see Par. [0071] of Bashirullah). One of ordinary skill in the art would desire implementing such an electrode arrangement in Boveja’s cuff because of Boveja’s capability of only stimulating one of the vagus nerves (i.e., unilateral stimulation) (see Par. [0100] of Boveja). Therefore, claim 8 is unpatentable over Boveja, et al. and Bashirrulah, et al. Regarding claim 21, Boveja, in view of Bashirrulah, renders obvious the cuff of claim 8, as indicated hereinabove. Bashirrulah also teaches the limitation of instant claim 21, that is wherein (Fig. 1a, # 15a, 15b) electrodes of the first row of electrodes are staggered and offset relative to electrodes of the second row of electrodes along the length of the helical body (Par. [0096] – there is a first radial offset between the longitudinal cuff axis 19 and a first electrode 15a of the first pair, and a second radial offset between the cuff axis 19 and a second electrode 15b of the second pair. The asymmetrical configuration may be provided by the first radial offset being different to the second radial offset [i.e., staggered]). Therefore, claim 21 is unpatentable over Boveja, et al. and Bashirrulah, et al. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Boveja, et al. (U.S. PGPub No. 2005/0131486) in view of Forsell (U.S. PGPub No. 2023/0062862). Regarding claim 13, Boveja teaches the cuff of claim 1, as indicated hereinabove. Boveja does not explicitly teach the limitation of instant claim 13, that is wherein the helical body is configured to resiliently expand to increase a diameter of the interior space defined by the inner surface of the helical body to permit swallowing of the subject. It is noted that Boveja does teach the helical body, as indicated above. Forsell, directed to analogous art, teaches a medical implant for treating gastroesophageal reflux disease (GERD) (Title, Abstract, Par. [0001]). Forsell also teaches the limitation of instant claim 13, that is wherein (Fig. 8, # 100; Figs. 13-21) [the helical body] is configured to resiliently expand to increase a diameter of the interior space defined by the inner surface [of the helical body] to permit swallowing of the subject (Par. [0159] – FIGS. 14-21 illustrate an apparatus 100 comprising an elongated core 210 having a length that allows the core 210 to be arranged to at least partly encircle the esophagus 20 of an adult human the patient. The length is variable to allow the core 210 to be arranged in a constricting state for hindering fluid from passing from the stomach 10 into the esophagus 20, and in an expanded state for allowing food to pass into the stomach 10 in response to the patient swallowing. The apparatus may hence by used for treating reflux disease by assisting contraction of the cardiac sphincter 26 and hindering stomach contents to rise up into the esophagus 20. The transition from the constricting state into the expanded state may be caused by the food passing through esophagus 20, wherein the core 210 may be configured to exert an encircling pressure on the esophagus 20 in at least the constricting state.). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Forsell’s elongated core placed around the esophagus into Boveja’s cuff, because doing so would be an example of using a known technique to improve similar devices in the same way. One of ordinary skill in the art would have desired Boveja’s cuff being configured to resiliently expand in order to permit swallowing by the patient, while also being able to constrict in order to prevent stomach contents from rising up into the esophagus (please see Par. [0159] of Forsell). Therefore, claim 13 is unpatentable over Boveja, et al. and Forsell. Conclusion THIS ACTION IS MADE FINAL. 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 MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
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Prosecution Timeline

Sep 06, 2024
Application Filed
Apr 15, 2026
Non-Final Rejection mailed — §102, §103
Jul 15, 2026
Response Filed
Sep 15, 2026
Final Rejection mailed — §102, §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
78%
Grant Probability
94%
With Interview (+16.0%)
2y 9m (~8m remaining)
Median Time to Grant
Moderate
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