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 .
Status of Claims
The present Office action is responsive to the Remarks and Amendments filed on 04-17-2026. As directed, claims 1, 4-5, and 13-21 have been amended, claim 6 has been canceled, and no new claims have been added. Thus, claims 1-5 and 7-21 are currently pending examination.
Response to Amendment
Applicant has amended each of claims 4, 13-16, 18, and 20-21 to address minor informalities therein. The previously held claim objections are hereby withdrawn.
Applicant has amended claim 5 to eliminate recitation of a trademark/trade name in the claim. The previously held rejection under 35 USC 112b is hereby withdrawn.
Response to Arguments
Applicant requests, see Remarks at the bottom of page 7 as filed, that the double patenting rejections of record be held in abeyance until the claims are otherwise allowable. The double patenting rejections will be updated hereinbelow to better match the amendments made to the claims, but will not be held in abeyance. The rejections may be overcome with the filing of a terminal disclaimer.
Applicant’s arguments with respect to use of Ben-Tsur (US 2020/0315541) to reject claim 1, see Remarks as filed pages 8-9, have been considered, but are moot because the new ground of rejection does not principally rely on Ben-Tsur ‘541 in the prior rejection of record for any teaching or matter specifically challenged in the argument. Rather, Ben-Tsur (US 2020/0214592), as supplied in the IDS of 04-17-2026, will be relied on as the primary reference of record hereinbelow.
For the same reasons, each of Applicant’s arguments with respect to claims 5 and 10-20, see Remarks as filed pages 10-12, are moot.
Claim Objections
Claim 20 is objected to because of the following informalities:
At claim 20, line 6, it is suggested that “a longitudinal axis” be replaced with “the longitudinal axis” as the limitation was introduced in claim 19, line 5 from which claim 20 depends.
Appropriate correction is required.
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.
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 non-obviousness.
Claims 1-4 and 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592) in view of Trovato (US 2009/0306632) and Gross (US 2005/0058701).
Regarding claim 1, Ben-Tsur discloses an ingestible capsule (110) (paragraph 233, lines 1-8; Fig. 1) comprising:
a housing (112) forming a cavity (space within 112 and 122) (paragraph 233, lines 1-8; paragraph 234, lines 1-4; Fig. 1);
a vibrator (114) disposed in the cavity (space within 112 and 122) (paragraph 233, lines 1-4; Fig. 1);
a power supply (118) disposed in the cavity (space within 112 and 122) (paragraph 233, lines 4-8; Fig. 1).
Ben-Tsur fails to disclose a biodegradable insulating membrane disposed in electrical series with the vibrator and the power supply and in fluid communication with an exterior of the housing, the biodegradable insulating membrane configured to dissolve in a fluid having a pH of 1.5 to 3, thereby closing a circuit connecting the power supply and the vibrator.
However, Trovato teaches a capsule (100) (paragraph 25, lines 1-7; Fig. 1), which includes a biodegradable insulating membrane disposed in electrical series between two electrical contacts, in fluid communication with an exterior of the capsule housing, and configured to dissolve in a fluid with a pH of about 7, thereby closing a circuit connecting the two electrical contacts, so that the medicament in the capsule is properly timed for release at a desired location (paragraph 61, lines 6-9, Examiner notes that the coating is “water soluble”, and water is known to have a pH of 7, further the coating is understood to be in fluid communication with the exterior of the capsule in order to be dissolved; see paragraph 61, lines 1-3 for the release at a desired time).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ben-Tsur to include a biodegradable insulating membrane disposed in electrical series between the power supply and the vibrator (note that Ben-Tsur discloses circuitry associated with the control element at paragraph 184, lines 1-7 and paragraph 233, lines 1-8) and in fluid communication with an exterior of the housing and configured to dissolve in a fluid having a pH of 7, thereby closing a circuit connecting the power supply to the vibrator, as taught by Trovato, in order to properly time release of the therapeutic agent in the capsule at a desired location within the GI tract.
While Trovato indicates that the biodegradable insulating membrane is configured to dissolve in a fluid with a pH of about 7 (paragraph 61, lines 6-9), Ben-Tsur does indicate that at least one targeted release location for its medicament is within the stomach (paragraph 299, lines 1-3).
Although, as presently modified Ben-Tsur fails to disclose wherein the biodegradable insulating membrane is configured to dissolve in a fluid having a pH of 1.5-3.
However, Gross teaches an ingestible capsule (30) for delivery of a therapeutic agent into a desired portion of the GI tract (paragraph 272, lines 1-15, note the different places in the GI tract, e.g. the stomach and the small intestine and the pH for dissolution of the film at these places; Fig. 15), wherein an ingestible capsule (30) includes a biodegradable coating (46A) disposed on the housing (see Fig. 15, where 46A is disposed on the exterior of capsule 30) of the ingestible capsule (30), and is configured to dissolve in a fluid having a pH of 1.5 to 3, thereby exposing the therapeutic agent (36) in the stomach as desired (paragraph 272, lines 1-15, note that Gross contemplates dissolution in acidic stomach environments with pH 1.2-3.5, and thus the claimed range is anticipated by the disclosed range per MPEP 2131.03 II, as the range is overlapped with sufficient specificity).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the biodegradable insulating membrane of Ben-Tsur as a material capable of dissolving in a solution between 1.5 and 3 pH, as taught by Gross, in order to allow for treatment by the capsule at a desired portion of the GI tract, i.e., the stomach, particularly because Ben-Tsur indicates that its medicament is targeted to release in the stomach (paragraph 299, lines 1-4).
Regarding claim 2, Ben-Tsur in view of Trovato and Gross disclose the ingestible capsule of claim 1, as discussed above.
Ben-Tsur further discloses wherein the vibrator (114) comprises:
a motor (“motor” of the “motor driven rotor”) having a shaft (“rotor”/”shaft”) (paragraph 233, lines 1-4; paragraph 182, lines 1-6; see also paragraph 255, lines 1-6 for the shaft of the motor in the radial agitation means);
a weight (“eccentric weight”/”unbalanced weight”) mechanically coupled to the shaft (“rotor”/”shaft”) and radially offset from a longitudinal axis of the shaft (“rotor”/”shaft”) (paragraph 233, lines 1-4; paragraph 182, lines 1-6; see also paragraph 255, lines 1-6 for the shaft of the motor in the radial agitation means; note the art-recognized terms “eccentric” and “unbalanced” where at least eccentric means to be offset from a geometric center).
Regarding claim 3, Ben-Tsur in view of Travato and Gross disclose the ingestible capsule of claim 2, as discussed above.
Ben-Tsur further discloses wherein the shaft is configured to rotate about the longitudinal axis of the shaft at a frequency between 10 Hz and 650 Hz (paragraph 233, lines 1-4; paragraph 182, lines 1-6; see also paragraph 255, lines 1-6 for the shaft of the motor in the radial agitation means; paragraph 275, lines 1-6).
Ben-Tsur does not specifically limit the range of frequency to about 20-300 Hz as claimed.
However, given that Ben-Tsur discloses the frequency range of 10-650 Hz (paragraph 78, lines 1-2), and that the claimed range of about 20 Hz to about 300 Hz lies within this disclosed range, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the portion of the Ben-Tsur range coinciding with 20-300 Hz since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, per MPEP 2144.05 I (note In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); note In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Regarding claim 4, Ben-Tsur in view of Travato and Gross disclose the ingestible capsule of claim 2, as discussed above.
Ben-Tsur further discloses wherein when the ingestible capsule (110) is in a subject’s stomach, the vibrator (114) is configured to rotate the weight (“eccentric weight”/”unbalanced weight”) about the longitudinal axis of the shaft (“rotor”/”shaft”) to generate a centrifugal force, thereby stroking a portion of mucosa in the subject’s stomach with the ingestible capsule (110) (paragraph 233, lines 1-4; paragraph 182, lines 1-6; see also paragraph 255, lines 1-6 for the shaft of the motor in the radial agitation means; see paragraph 262, lines 1-6 for interface with GI tract wall and paragraph 299, lines 1-3 for positioning of capsule 110 within the stomach and paragraph 394, lines 1-7 for vibration mode within the stomach).
Regarding claim 10, Ben-Tsur in view of Travato and Gross disclose the ingestible capsule of claim 1, as discussed above.
Modified Ben-Tsur fails to disclose wherein the housing comprises a protruding member disposed on an outer surface of the housing.
However, Gross teaches an ingestible capsule (30) which includes a protruding member (16) in the form of an electrode disposed on its outer surface (see Figs. 5 and 6A; paragraph 260, lines 1-8; paragraph 261, lines 1-12), wherein the electrodes aid in determining what portion of the GI tract the capsule has traversed (abstract, lines 1-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided protruding members in the form of electrodes on the surface of the housing of the modified Ben-Tsur device, as taught by gross, in order to determine what portion of the GI tract the capsule has traversed.
Regarding claim 11, Ben-Tsur in view of Travato and Gross disclose the ingestible capsule of claim 10, as discussed above.
Modified Ben-Tsur disclose wherein the protruding member has a grooved shape (see electrode 16 in Fig. 6A of Gross, where the hills and valleys create a groove shape).
Regarding claim 12, Ben-Tsur in view of Travato and Gross disclose the ingestible capsule of claim 10, as discussed above.
Modified Ben-Tsur disclose wherein the protruding member is a plurality of studs protruding from an outer surface of the housing (see electrode 16 in Fig. 5 of Gross, where the electrodes are shown protruding from the outer surface of capsule 30).
Regarding claim 13, Ben-Tsur in view of Travato disclose the ingestible capsule of claim 1, as discussed above.
Modified Ben-Tsur discloses wherein when the ingestible capsule (Ben-Tsur: 110) is in a stomach of a subject who has ingested the ingestible capsule (Ben-Tsur: 110) (paragraph 233, lines 1-4; see paragraph 262, lines 1-6 for interface with GI tract wall and paragraph 299, lines 1-3 for positioning of capsule 110 within the stomach and paragraph 394, lines 1-7 for vibration mode within the stomach), closing the circuit connecting the power supply (Ben-Tsur: 118) and the vibrator (Ben-Tsur: 114) causes the vibrator (Ben-Tsur: 114) to vibrate the ingestible capsule (Ben-Tsur: 110) at a frequency (Trovato, for dissolution of membrane for closing he circuit: paragraph 61, lines 6-9, Examiner notes that the coating is “water soluble”, and water is known to have a pH of 7, further the coating is understood to be in fluid communication with the exterior of the capsule in order to be dissolved; see paragraph 61, lines 1-3 for the release at a desired time; Gross, for dissolution of membrane in the stomach: paragraph 272, lines 1-15, note that Gross contemplates dissolution in acidic stomach environments with pH 1.2-3.5; see Ben-Tsur at paragraph 275, lines 1-6 for frequencies).
Given that Ben-Tsur discloses the frequency range of 10-650 Hz (paragraph 275, lines 1-6), and that the instant specification notes that frequencies in the range of 60-120 Hz induce the feeling of satiety (see paragraph 15), the ordinarily skilled artisan would recognize that, because the Ben-Tsur device is capable of operating between 60 and 120 Hz, that the device of modified Ben-Tsur is capable of inducing a feeling of satiety in the subject when operated in the range of 60-120 Hz (see also MPEP 2112.01, where when the claimed apparatus and the reference apparatus are substantially identical, as they are based on modification of Ben-Tsur with Trovato and Gross, claimed properties and functions are presumed to be present).
Regarding claim 14, Ben-Tsur in view of Travato and Gross disclose the ingestible capsule of claim 1, as discussed above.
Modified Ben-Tsur discloses wherein when the ingestible capsule (Ben-Tsur: 110) is in a stomach of a subject who has ingested the ingestible capsule (Ben-Tsur: 110) (paragraph 233, lines 1-4; see paragraph 262, lines 1-6 for interface with GI tract wall and paragraph 299, lines 1-3 for positioning of capsule 110 within the stomach and paragraph 394, lines 1-7 for vibration mode within the stomach), closing the circuit connecting the power supply (Ben-Tsur: 118) and the vibrator (Ben-Tsur: 114) causes the vibrator (Ben-Tsur: 114) to vibrate the ingestible capsule (Ben-Tsur: 110) at a frequency (Trovato, for dissolution of membrane for closing he circuit: paragraph 61, lines 6-9, Examiner notes that the coating is “water soluble”, and water is known to have a pH of 7, further the coating is understood to be in fluid communication with the exterior of the capsule in order to be dissolved; see paragraph 61, lines 1-3 for the release at a desired time; Gross, for dissolution of membrane in the stomach: paragraph 272, lines 1-15, note that Gross contemplates dissolution in acidic stomach environments with pH 1.2-3.5; see Ben-Tsur at paragraph 275, lines 1-6 for frequencies).
Given that Ben-Tsur discloses the frequency range of 10-650 Hz (paragraph 78, lines 1-2), and that the instant specification notes that frequencies in the range of 60-120 Hz induce the illusory insufflation (see paragraph 15), the ordinarily skilled artisan would recognize that, because the Ben-Tsur device is capable of operating between 60 and 120 Hz, that the device of Ben-Tsur is capable of inducing an illusory insufflation in the subject when operated in the range of 60-120 Hz (see also MPEP 2112.01, where when the claimed apparatus and the reference apparatus are substantially identical, as they are based on modification of Ben-Tsur with Trovato and Gross, claimed properties and functions are presumed to be present).
Regarding claim 15, Ben-Tsur in view of Travato and Gross disclose the ingestible capsule of claim 1, as discussed above.
Modified Ben-Tsur discloses wherein when the ingestible capsule (Ben-Tsur: 110) is in a stomach of a subject who has ingested the ingestible capsule (Ben-Tsur: 110) (paragraph 233, lines 1-4; see paragraph 262, lines 1-6 for interface with GI tract wall and paragraph 299, lines 1-3 for positioning of capsule 110 within the stomach and paragraph 394, lines 1-7 for vibration mode within the stomach), closing the circuit connecting the power supply (Ben-Tsur: 118) and the vibrator (Ben-Tsur: 114) causes the vibrator (Ben-Tsur: 114) to vibrate the ingestible capsule (Ben-Tsur: 110) at a frequency (Trovato, for dissolution of membrane for closing he circuit: paragraph 61, lines 6-9, Examiner notes that the coating is “water soluble”, and water is known to have a pH of 7, further the coating is understood to be in fluid communication with the exterior of the capsule in order to be dissolved; see paragraph 61, lines 1-3 for the release at a desired time; Gross, for dissolution of membrane in the stomach: paragraph 272, lines 1-15, note that Gross contemplates dissolution in acidic stomach environments with pH 1.2-3.5; see Ben-Tsur at paragraph 275, lines 1-6 for frequencies).
Given that Ben-Tsur discloses the frequency range of 10-650 Hz (paragraph 78, lines 1-2), and that the instant specification notes that fa frequency of 80 Hz induces the release of serotonin (see paragraph 128), the ordinarily skilled artisan would recognize that, because the Ben-Tsur device is capable of operating between 60 and 120 Hz, that the device of Ben-Tsur is capable of inducing a release of serotonin in the subject when operated at 80 Hz (see also MPEP 2112.01, where when the claimed apparatus and the reference apparatus are substantially identical, as they are based on modification of Ben-Tsur with Trovato and Gross, claimed properties and functions are presumed to be present).
Regarding claim 16, Ben-Tsur in view of Travato and Gross disclose the ingestible capsule of claim 1, as discussed above.
Modified Ben-Tsur discloses wherein when the ingestible capsule (Ben-Tsur: 110) is in a stomach of a subject who has ingested the ingestible capsule (Ben-Tsur: 110) (paragraph 233, lines 1-4; see paragraph 262, lines 1-6 for interface with GI tract wall and paragraph 299, lines 1-3 for positioning of capsule 110 within the stomach and paragraph 394, lines 1-7 for vibration mode within the stomach), closing the circuit connecting the power supply (Ben-Tsur: 118) and the vibrator (Ben-Tsur: 114) causes the vibrator (Ben-Tsur: 114) to vibrate the ingestible capsule (Ben-Tsur: 110) at a frequency (Trovato, for dissolution of membrane for closing he circuit: paragraph 61, lines 6-9, Examiner notes that the coating is “water soluble”, and water is known to have a pH of 7, further the coating is understood to be in fluid communication with the exterior of the capsule in order to be dissolved; see paragraph 61, lines 1-3 for the release at a desired time; Gross, for dissolution of membrane in the stomach: paragraph 272, lines 1-15, note that Gross contemplates dissolution in acidic stomach environments with pH 1.2-3.5; see Ben-Tsur at paragraph 275, lines 1-6 for frequencies).
Given that Ben-Tsur discloses the frequency range of 10-650 Hz (paragraph 78, lines 1-2), and that the instant specification notes that frequencies of 80 Hz induces the stimulation of mucosal receptors in the stomach (see paragraph 128), the ordinarily skilled artisan would recognize that, because the Ben-Tsur device is capable of operating at 80 Hz, that the device of Ben-Tsur is capable of inducing stimulation of mucosal receptors in the stomach when operated at 80 Hz (see also MPEP 2112.01, where when the claimed apparatus and the reference apparatus are substantially identical, as they are based on modification of Ben-Tsur with Trovato and Gross, claimed properties and functions are presumed to be present).
Regarding claim 17, Ben-Tsur discloses an ingestible capsule (110) (paragraph 233, lines 1-8; Fig. 1) comprising:
a housing (112) forming a cavity (space within 112 and 122) (paragraph 233, lines 1-8; paragraph 234, lines 1-4; Fig. 1);
an actuator (114) disposed in the cavity (space within 112 and 122) (paragraph 233, lines 1-4; Fig. 1) and configured to oscillate about a longitudinal axis of the ingestible capsule (110) at a frequency of about 10-650 Hz, thereby causing the ingestible capsule (110) to rotate (paragraph 233, lines 1-4; paragraph 182, lines 1-6; see also paragraph 255, lines 1-6 for the shaft of the motor in the radial agitation means; paragraph 275, lines 1-6);
a power supply (118) disposed in the cavity (space within 112 and 122) and configured to provide power to the actuator (114) (paragraph 233, lines 4-8; Fig. 1).
Ben-Tsur does not specifically limit the range of frequency to about 5-120 Hz as claimed.
However, given that Ben-Tsur discloses the frequency range of 10-650 Hz (paragraph 78, lines 1-2), and that the claimed range of about 20 Hz to about 300 Hz lies within this disclosed range, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the portion of the Ben-Tsur range coinciding with 20-300 Hz since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, per MPEP 2144.05 I (note In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); note In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Ben-Tsur fails to disclose a biodegradable insulating membrane disposed in electrical communication with the actuator and the power supply and in fluid communication with an exterior of the housing, the biodegradable insulating membrane configured to dissolve in stomach acid; and a conductor electrically connecting the actuator and the power supply, wherein the conductor is configured to close a circuit between the actuator and the power supply when the biodegradable membrane dissolves.
However, Trovato teaches a capsule (100) (paragraph 25, lines 1-7; Fig. 1), which includes a biodegradable insulating membrane disposed in electrical series between two electrical contacts, in fluid communication with an exterior of the capsule housing, and configured to dissolve in a fluid with a pH of about 7, thereby closing a circuit connecting the two electrical contacts, so that the medicament in the capsule is properly timed for release at a desired location (paragraph 61, lines 6-9, Examiner notes that the coating is “water soluble”, and water is known to have a pH of 7, further the coating is understood to be in fluid communication with the exterior of the capsule in order to be dissolved; see paragraph 61, lines 1-3 for the release at a desired time); and
a conductor (“switch”) electrically connecting two electrical contacts, wherein the conductor (“switch”) is configured to close a circuit between the two electrical contacts when the biodegradable membrane dissolves (paragraph 61, lines 5-9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ben-Tsur to include a biodegradable insulating membrane disposed in electrical series between the power supply and the vibrator (note that Ben-Tsur discloses circuitry associated with the control element at paragraph 184, lines 1-7 and paragraph 233, lines 1-8) and in fluid communication with an exterior of the housing and configured to dissolve in a fluid having a pH of 7, wherein electrical contact between the actuator and the power supply is facilitated by a conductor, such that the conductor is configured to close a circuit between the two electrical contacts when the biodegradable membrane dissolves, as taught by Trovato, in order to properly time release of the therapeutic agent in the capsule at a desired location within the GI tract.
While Trovato indicates that the biodegradable insulating membrane is configured to dissolve in a fluid with a pH of about 7 (paragraph 61, lines 6-9), Ben-Tsur does indicate that at least one targeted release location for its medicament is within the stomach (paragraph 299, lines 1-3).
Although, as presently modified Ben-Tsur fails to disclose wherein the biodegradable insulating membrane is configured to dissolve in a fluid having a pH of 1.5-3.
However, Gross teaches an ingestible capsule (30) for delivery of a therapeutic agent into a desired portion of the GI tract (paragraph 272, lines 1-15, note the different places in the GI tract, e.g. the stomach and the small intestine and the pH for dissolution of the film at these places; Fig. 15), wherein an ingestible capsule (30) includes a biodegradable coating (46A) disposed on the housing (see Fig. 15, where 46A is disposed on the exterior of capsule 30) of the ingestible capsule (30), and is configured to dissolve in a fluid having a pH of 1.5 to 3, thereby exposing the therapeutic agent (36) in the stomach as desired (paragraph 272, lines 1-15, note that Gross contemplates dissolution in acidic stomach environments with pH 1.2-3.5, and thus the claimed range is anticipated by the disclosed range per MPEP 2131.03 II, as the range is overlapped with sufficient specificity).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the biodegradable insulating membrane of Ben-Tsur as a material capable of dissolving in a solution between 1.5 and 3 pH, as taught by Gross, in order to allow for treatment by the capsule at a desired portion of the GI tract, i.e., the stomach, particularly because Ben-Tsur indicates that its medicament is targeted to release in the stomach (paragraph 299, lines 1-4).
Regarding claim 18, Ben-Tsur in view of Trovato and Gross disclose the ingestible capsule of claim 17, as discussed above.
Ben-Tsur further discloses wherein when the ingestible capsule (110) is in a subject’s stomach, rotation of the ingestible capsule (110) causes the ingestible capsule (110) to stroke a portion of mucosa in the subject’s stomach (paragraph 233, lines 1-4; paragraph 255, lines 1-6 for radial rotation; see paragraph 262, lines 1-6 for interface with GI tract wall and paragraph 299, lines 1-3 for positioning of capsule 110 within the stomach and paragraph 394, lines 1-7 for vibration mode within the stomach, where the stomach walls are understood to include mucosa).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592) in view of Trovato (US 2009/0306632) and Gross (US 2005/0058701), as applied to claim 1 above, in further view of Langer (US 2019/0209090).
Regarding claim 5, Ben-Tsur in view of Travato and Gross disclose the ingestible capsule of claim 1, as discussed above.
Modified Ben-Tsur fails to disclose wherein the biodegradable insulating membrane comprises gelatin.
However, Langer teaches an ingestible capsule which includes a biodegradable coating (22) comprising gelatin for dissolution within the stomach (paragraph 164, lines 1-6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biodegradable insulating membrane of the modified Ben-Tsur device to be a gelatin dissolvable in the stomach, as taught by Langer, as a known material for constructing a biodegradable coating of an ingestible capsule that allows for the predictable dissolution of the membrane in the stomach to enact therapy in the stomach as desired.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592).
Regarding claim 19, Ben-Tsur discloses a method of stimulating the stomach in a subject (paragraph 233, lines 1-4; paragraph 255, lines 1-6 for radial rotation; see paragraph 262, lines 1-6 for interface with GI tract wall and paragraph 299, lines 1-3 for positioning of capsule 110 within the stomach and paragraph 394, lines 1-7 for vibration mode within the stomach, where the stomach walls are understood to include mucosa), the method comprising:
with an ingestible capsule (110), stroking a portion of mucosa in a stomach of a subject at a frequency of about 10-650 Hz with the ingestible capsule (110) (paragraph 233, lines 1-4; paragraph 255, lines 1-6 for radial rotation; see paragraph 262, lines 1-6 for interface with GI tract wall and paragraph 299, lines 1-3 for positioning of capsule 110 within the stomach and paragraph 394, lines 1-7 for vibration mode within the stomach, where the stomach walls are understood to include mucosa; see paragraph 275, lines 1-6 for frequency range) by radially oscillating the ingestible capsule (110) about a longitudinal axis of the ingestible capsule (110) with a vibrator (114) (paragraph 233, lines 1-4; paragraph 255, lines 1-6 for radial rotation).
Ben-Tsur does not specifically limit the range of frequency to about 50-120 Hz as claimed.
However, given that Ben-Tsur discloses the frequency range of 10-650 Hz (paragraph 78, lines 1-2), and that the claimed range of about 50 Hz to about 120 Hz lies within this disclosed range, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the portion of the Ben-Tsur range coinciding with 50-120 Hz since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, per MPEP 2144.05 I (note In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); note In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Thus, as modified, given that the method and device of Ben-Tsur is capable of outputting a vibration frequency of 50-120 Hz to the stomach mucosa, it is would be understood by the ordinarily skilled artisan that the method reasonably stimulates a feeling of satiety by inducing an illusory distention in the stomach (note MPEP 2112.02 I, where cases of prima facie anticipation and/or obviousness may be made in the case where the prior art device carries out the claimed method during normal operation).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592), as applied to claim 19 above, in view of Trovato (US 2009/0306632) and Gross (US 2005/0058701).
Regarding claim 20, Ben-Tsur discloses the method of claim 19, as discussed above.
Ben-Tsur further discloses a circuit connecting a power supply (118) and a vibrator (114) in the ingestible capsule (110) (paragraph 233, lines 1-8; paragraph 184, lines 1-8), wherein the stroking the portion of mucosa comprises radially oscillating the ingestible capsule (110) about a longitudinal axis of the ingestible capsule (110) with the vibrator (114) (paragraph 233, lines 1-8; paragraph 255, lines 1-6).
Ben-Tsur fails to explicitly disclose closing a circuit connecting the power supply and the vibrator to induce the moving by dissolving, with stomach fluid, a biodegradable insulating membrane disposed in electrical series between the power supply and the vibrator.
However, Trovato teaches a capsule (100) (paragraph 25, lines 1-7; Fig. 1), which includes the step of closing a circuit by dissolving a biodegradable insulating membrane disposed in electrical series between two electrical contacts, so that the medicament in the capsule is properly timed for release at a desired location (paragraph 61, lines 6-9, Examiner notes that the coating is “water soluble”; see paragraph 61, lines 1-3 for the release at a desired time).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device and method of Ben-Tsur to include closing a circuit to induce the moving by dissolving a biodegradable insulating membrane disposed in electrical series between two electrical contacts of the power supply and the vibrator, as taught by Trovato, in order to properly time release of the therapeutic agent in the capsule at a desired GI tract location.
Modified Ben-Tsur fails to explicitly disclose wherein the biodegradable insulating membrane is configured to dissolve in a stomach fluid.
However, Gross teaches an ingestible capsule (30) for delivery of a therapeutic agent into a desired portion of the GI tract (paragraph 272, lines 1-15, note the different places in the GI tract, e.g. the stomach and the small intestine and the pH for dissolution of the film at these places; Fig. 15), wherein ingestible capsule (30) includes a biodegradable coating (46A) disposed on the housing (see Fig. 15, where 46A is disposed on the exterior of capsule 30) ingestible capsule (30), and configured to dissolve in stomach a fluid having a pH of 1.5 to 3, thereby exposing the therapeutic agent (36) in the stomach as desired (paragraph 272, lines 1-15, note that Gross contemplates dissolution in acidic stomach environments with pH 1.2-3.5, and thus the claimed range is anticipated by the disclosed range per MPEP 2131.03 II, as the range is overlapped with sufficient specificity).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the biodegradable insulating membrane of Ben-Tsur as a material capable of dissolving in a stomach fluid between 1.5 and 3 pH, as taught by Gross, in order to allow for treatment by the capsule at a desired portion of the GI tract, i.e., the stomach.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-18 of copending Application No. 18/182,854 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner notes that all citation given with respect to Srinivasan are relative to the claim set as submitted on 04-15-2026.
Regarding claim 1, Srinivasan discloses an ingestible capsule (claim 17, line 1) comprising:
a housing forming a cavity (claim 17, lines 2-3);
a vibrator disposed in the cavity (claim 17, line 4);
a power supply disposed in the cavity (claim 17, line 5); and
a biodegradable insulating membrane disposed in electrical series with the vibrator and the power supply and in fluid communication with an exterior of the housing, the biodegradable insulating membrane configured to dissolve in a fluid having a pH of 2 to 9, thereby closing a circuit connecting the power supply and the vibrator (claim 18, lines 1-9, note that the claimed range of 1.5 to 3 is overlapped with by the disclosed range of 2-9).
In the case where the range disclosed by the prior art overlaps the claimed range, a prima facie case of obviousness exists. In the instant case, the claimed range of 1.5-3 is overlapped by the disclosed range of 2-9 (see MPEP 2144.05 I). Thus, a prima facie case of obviousness exists for the claimed range.
Claims 2-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-18 of copending Application No. 18/182,854 in view of Ben-Tsur (US 2020/0315541).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 2, Srinivasan disclose the ingestible capsule of claim 1, as discussed above.
Srinivasan fails to disclose wherein the vibrator comprises:
a motor having a shaft; and
a weight mechanically coupled to the shaft and radially offset from a longitudinal axis of the shaft.
Ben-Tsur teaches an ingestible capsule (110) (paragraph 233, lines 1-8; Fig. 1) comprising a vibrator (114) disposed in the cavity (see space within 112 and 122) (paragraph 233, lines 1-8; paragraph 234, lines 1-6) a motor (“motor”) having a shaft (“rotor”/”shaft”) (paragraph 182, lines 1-7; paragraph 233, lines 1-8; paragraph 255, lines 1-6 for the shaft of the motor in the radial agitation means), wherein the vibrator (114) includes a weight (“eccentric weight”/”unbalanced weight”) mechanically coupled to the shaft (“rotor”/”shaft”) and radially offset from a longitudinal axis of the shaft (“rotor”/”shaft”) (paragraph 182, lines 1-7; paragraph 255, lines 1-6).
Therefore, given that each of Srinivasan and Ben-Tsur are directed to vibrating ingestible capsules, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the vibrator of Srinivasan with a motor having a shaft, and a weight mechanically coupled to the shaft and radially offset from a longitudinal axis of the shaft, and taught by Ben-Tsur, as a known device for enacting vibratory motion in an ingestible capsule.
Regarding claim 3, Srinivasan in view of Ben-Tsur disclose the ingestible capsule of claim 2, as discussed above.
Srinivasan does not specifically limit the range of frequency to about 20-300 Hz as claimed.
Ben-Tsur further teaches wherein the shaft is configured to rotate about the longitudinal axis of the shaft at a frequency between 10 Hz and 650 Hz (paragraph 275, lines 1-6).
Ben-Tsur does not specifically limit the range of frequency to about 20-300 Hz as claimed.
However, given that Ben-Tsur discloses the frequency range of 10-650 Hz (paragraph 275, lines 1-2), and that the claimed range of about 20 Hz to about 300 Hz lies within this disclosed range, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the portion of the Ben-Tsur range coinciding with 20-300 Hz since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, per MPEP 2144.05 I (note In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); note In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Regarding claim 4, Srinivasan in view of Ben-Tsur disclose the ingestible capsule of claim 2, as discussed above.
Srinivasan fails to disclose wherein, when the ingestible capsule is in a subject's stomach, the vibrator is configured to rotate the weight about the longitudinal axis of the shaft to generate a centrifugal force, thereby stroking a portion of mucosa in the subject's stomach with the ingestible capsule.
However, Ben-Tsur further teaches wherein when the ingestible capsule (110) is in a subject’s stomach, the vibrator (114) is configured to rotate the weight (“eccentric weight”/”unbalanced weight”) about the longitudinal axis of the shaft (“rotor”/”shaft”) to generate a centrifugal force, thereby stroking a portion of mucosa in the subject’s stomach with the ingestible capsule (110) (paragraph 233, lines 1-4; paragraph 182, lines 1-6; see also paragraph 255, lines 1-6 for the shaft of the motor in the radial agitation means; see paragraph 262, lines 1-6 for interface with GI tract wall and paragraph 299, lines 1-3 for positioning of capsule 110 within the stomach and paragraph 394, lines 1-7 for vibration mode within the stomach).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device and method of modified Srinivasan to include when the ingestible capsule is in a subject’s stomach, the vibrator being configured to rotate the weight about the longitudinal axis of the shaft to generate a centrifugal force, thereby stroking a portion of mucosa in the subject’s stomach with the ingestible capsule, and producing the vibration to treat the subject.
Claim 5 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-18 of copending Application No. 18/182,854 in view of Langer (US 2019/0209090).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 5, Srinivasan discloses the ingestible capsule of claim 1, as discussed above.
Srinivasan fails to disclose wherein the biodegradable insulating membrane comprises gelatin.
However, Langer teaches an ingestible capsule which includes a biodegradable coating (22) comprising gelatin for dissolution within the stomach (paragraph 164, lines 1-6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biodegradable insulating membrane of the modified Ben-Tsur device to be a gelatin dissolvable in the stomach, as taught by Langer, as a known material for constructing a biodegradable coating of an ingestible capsule that allows for the predictable dissolution of the membrane in the stomach to enact therapy in the stomach as desired.
Claims 10-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-18 of copending Application No. 18/182,854 in view of Gross (US 2005/0058701).
Regarding claim 10, Srinivasan discloses the ingestible capsule of claim 1, as discussed above.
Srinivasan fails to disclose wherein the housing comprises a protruding member disposed on an outer surface of the housing.
However, Gross teaches an ingestible capsule (30) which includes a protruding member (16) in the form of an electrode disposed on its outer surface (see Figs. 5 and 6A; paragraph 260, lines 1-8; paragraph 261, lines 1-12), wherein the electrodes aid in determining what portion of the GI tract the capsule has traversed (abstract, lines 1-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided protruding members in the form of electrodes on the surface of the housing of the Srinivasan device, as taught by gross, in order to determine what portion of the GI tract the capsule has traversed.
Regarding claim 11, Srinivasan in view of Gross disclose the ingestible capsule of claim 10, as discussed above.
Modified Srinivasan discloses wherein the protruding member has a grooved shape (see electrode 16 in Fig. 6A of Gross, where the hills and valleys create a groove shape).
Regarding claim 12, Srinivasan in view of Gross discloses the ingestible capsule of claim 10, as discussed above.
Modified Srinivasan discloses wherein the protruding member is a plurality of studs protruding from an outer surface of the housing (see electrode 16 in Fig. 5 of Gross, where the electrodes are shown protruding from the outer surface of capsule 30).
Claims 13-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-18 of copending Application No. 18/182,854 in view of Ben-Tsur (US 2020/0214592) and Gross (US 2005/0058701).
Regarding claim 13, Srinivasan discloses the ingestible capsule of claim 1, as discussed above.
Srinivasan fails to explicitly disclose wherein when the ingestible capsule is in a stomach of a subject who has ingested the ingestible capsule, closing the circuit connecting the power supply and the vibrator causes the vibrator to vibrate the ingestible capsule at a frequency that induces a feeling of satiety in the subject, because Srinivasan fails to disclose the closing of the circuit in the stomach and placement of the capsule in the stomach.
However, Gross teaches an ingestible capsule (30) for delivery of a therapeutic agent into a desired portion of the GI tract (paragraph 272, lines 1-15, note the different places in the GI tract, e.g. the stomach and the small intestine and the pH for dissolution of the film at these places; Fig. 15), wherein ingestible capsule (30) includes a biodegradable coating (46A) disposed on the housing (see Fig. 15, where 46A is disposed on the exterior of capsule 30) ingestible capsule (30), and configured to dissolve in a fluid having a pH of 1.5 to 3, thereby exposing the therapeutic agent (36) in the stomach as desired (paragraph 272, lines 1-15, note that Gross contemplates dissolution in acidic stomach environments with pH 1.2-3.5, and thus the claimed range is anticipated by the disclosed range per MPEP 2131.03 II, as the range is overlapped with sufficient specificity).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the biodegradable insulating membrane of Srinivasan as a material capable of dissolving in a solution between 1.5 and 3 pH, and thus creating closing of the circuit in the stomach, as taught by Gross, in order to allow for treatment by the capsule at a desired portion of the GI tract, i.e., the stomach.
Presently modified Srinivasan fails to disclose use of placement of the ingestible capsule in the stomach, and operating the capsule at a frequency which induces a feeling of satiety in the subject.
However, Ben-Tsur teaches an ingestible capsule (110) configured for placement and treatment in a subject’s stomach (paragraph 233, lines 1-8; paragraph 182, lines 1-8; paragraph 255, lines 1-6; see paragraph 262, lines 1-6 for interface with GI tract wall and paragraph 299, lines 1-3 for positioning of capsule 110 within the stomach and paragraph 394, lines 1-7 for vibration mode within the stomach), at a frequency of between 10 and 650 Hz (paragraph 275, lines 1-5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have operated the device of modified Srinivasan at a frequency of between 10 and 650 Hz, and localized the capsule to the stomach, as taught by Ben-Tsur, in order to treat various conditions of the stomach by the capsule.
Thus, the modified Srinivasan device now discloses wherein when the ingestible capsule is in a stomach of a subject who has ingested the ingestible capsule (Srinivasan: claims 17-18 for the capsule; Ben-Tsur: note paragraph 262, lines 1-6, which describe the interfacing of the capsule with walls of the tract), closing the circuit connecting the power supply and the vibrator causes the vibrator to vibrate the ingestible capsule at a frequency (Srinivasan: claims 17-18 for the capsule and biodegradable insulating membrane, modified to be dissolvable in the stomach per Gross; Ben-Tsur: paragraph 255, lines 1-6 for the vibration of the capsule via motor assembly, and the frequency outlined at paragraph 275, lines 1-6; and note the modification of the biodegradable insulating membrane to dissolve in the stomach as discussed above).
Given that Ben-Tsur discloses the frequency range of 10-650 Hz (paragraph 78, lines 1-2), and that the instant specification notes that frequencies in the range of 60-120 Hz induce the feeling of satiety (see paragraph 15), the ordinarily skilled artisan would recognize that, because the modified Srinivasan device is capable of operating between 60 and 120 Hz, that the device of modified Srinivasan is capable of inducing a feeling of satiety in the subject when operated in the range of 60-120 Hz (see also MPEP 2112.01, where when the claimed apparatus and the reference apparatus are substantially identical, as they are based on modification of Srinivasa with Ben-Tsur and Gross, claimed properties and functions are presumed to be present).
Regarding claim 14, Srinivasan discloses the ingestible capsule of claim 1, as discussed above.
Srinivasan fails to explicitly disclose wherein when the ingestible capsule is in a stomach of a subject who has ingested the ingestible capsule, closing the circuit connecting the power supply and the vibrator causes the vibrator to vibrate the ingestible capsule at a frequency that induces an illusory insufflation in the subject, because Srinivasan fails to disclose the closing of the circuit in the stomach and placement of the capsule in the stomach.
However, Gross teaches an ingestible capsule (30) for delivery of a therapeutic agent into a desired portion of the GI tract (paragraph 272, lines 1-15, note the different places in the GI tract, e.g. the stomach and the small intestine and the pH for dissolution of the film at these places; Fig. 15), wherein ingestible capsule (30) includes a biodegradable coating (46A) disposed on the housing (see Fig. 15, where 46A is disposed on the exterior of capsule 30) ingestible capsule (30), and configured to dissolve in a fluid having a pH of 1.5 to 3, thereby exposing the therapeutic agent (36) in the stomach as desired (paragraph 272, lines 1-15, note that Gross contemplates dissolution in acidic stomach environments with pH 1.2-3.5, and thus the claimed range is anticipated by the disclosed range per MPEP 2131.03 II, as the range is overlapped with sufficient specificity).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the biodegradable insulating membrane of Srinivasan as a material capable of dissolving in a solution between 1.5 and 3 pH, and thus creating closing of the circuit in the stomach, as taught by Gross, in order to allow for treatment by the capsule at a desired portion of the GI tract, i.e., the stomach.
Presently modified Srinivasan fails to disclose use of placement of the ingestible capsule in the stomach, and operating the capsule at a frequency which induces a feeling of satiety in the subject.
However, Ben-Tsur teaches an ingestible capsule (110) configured for placement and treatment in a subject’s stomach (paragraph 233, lines 1-8; paragraph 182, lines 1-8; paragraph 255, lines 1-6; see paragraph 262, lines 1-6 for interface with GI tract wall and paragraph 299, lines 1-3 for positioning of capsule 110 within the stomach and paragraph 394, lines 1-7 for vibration mode within the stomach), at a frequency of between 10 and 650 Hz (paragraph 275, lines 1-5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have operated the device of modified Srinivasan at a frequency of between 10 and 650 Hz, and localized the capsule to the stomach, as taught by Ben-Tsur, in order to treat various conditions of the stomach by the capsule.
Thus, the modified Srinivasan device now discloses wherein when the ingestible capsule is in a stomach of a subject who has ingested the ingestible capsule (Srinivasan: claims 17-18 for the capsule; Ben-Tsur: note paragraph 262, lines 1-6, which describe the interfacing of the capsule with walls of the tract), closing the circuit connecting the power supply and the vibrator causes the vibrator to vibrate the ingestible capsule at a frequency (Srinivasan: claims 17-18 for the capsule and biodegradable insulating membrane, modified to be dissolvable in the stomach per Gross; Ben-Tsur: paragraph 255, lines 1-6 for the vibration of the capsule via motor assembly, and the frequency outlined at paragraph 275, lines 1-6; and note the modification of the biodegradable insulating membrane to dissolve in the stomach as discussed above).
Given that Ben-Tsur discloses the frequency range of 10-650 Hz (paragraph 78, lines 1-2), and that the instant specification notes that frequencies in the range of 60-120 Hz induce the feeling of satiety (see paragraph 15), the ordinarily skilled artisan would recognize that, because the modified Srinivasan device is capable of operating between 60 and 120 Hz, that the device of modified Srinivasan is capable of inducing illusory insufflation in the subject when operated in the range of 60-120 Hz (see also MPEP 2112.01, where when the claimed apparatus and the reference apparatus are substantially identical, as they are based on modification of Srinivasa with Ben-Tsur and Gross, claimed properties and functions are presumed to be present).
Regarding claim 15, Srinivasan discloses the ingestible capsule of claim 1, as discussed above.
Srinivasan fails to explicitly disclose wherein when the ingestible capsule is in a stomach of a subject who has ingested the ingestible capsule, closing the circuit connecting the power supply and the vibrator causes the vibrator to vibrate the ingestible capsule at a frequency that induces serotonin release in the subject, because Srinivasan fails to disclose the closing of the circuit in the stomach and placement of the capsule in the stomach.
However, Gross teaches an ingestible capsule (30) for delivery of a therapeutic agent into a desired portion of the GI tract (paragraph 272, lines 1-15, note the different places in the GI tract, e.g. the stomach and the small intestine and the pH for dissolution of the film at these places; Fig. 15), wherein ingestible capsule (30) includes a biodegradable coating (46A) disposed on the housing (see Fig. 15, where 46A is disposed on the exterior of capsule 30) ingestible capsule (30), and configured to dissolve in a fluid having a pH of 1.5 to 3, thereby exposing the therapeutic agent (36) in the stomach as desired (paragraph 272, lines 1-15, note that Gross contemplates dissolution in acidic stomach environments with pH 1.2-3.5, and thus the claimed range is anticipated by the disclosed range per MPEP 2131.03 II, as the range is overlapped with sufficient specificity).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the biodegradable insulating membrane of Srinivasan as a material capable of dissolving in a solution between 1.5 and 3 pH, and thus creating closing of the circuit in the stomach, as taught by Gross, in order to allow for treatment by the capsule at a desired portion of the GI tract, i.e., the stomach.
Presently modified Srinivasan fails to disclose use of placement of the ingestible capsule in the stomach, and operating the capsule at a frequency which induces a feeling of satiety in the subject.
However, Ben-Tsur teaches an ingestible capsule (110) configured for placement and treatment in a subject’s stomach (paragraph 233, lines 1-8; paragraph 182, lines 1-8; paragraph 255, lines 1-6; see paragraph 262, lines 1-6 for interface with GI tract wall and paragraph 299, lines 1-3 for positioning of capsule 110 within the stomach and paragraph 394, lines 1-7 for vibration mode within the stomach), at a frequency of between 10 and 650 Hz (paragraph 275, lines 1-5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have operated the device of modified Srinivasan at a frequency of between 10 and 650 Hz, and localized the capsule to the stomach, as taught by Ben-Tsur, in order to treat various conditions of the stomach by the capsule.
Thus, the modified Srinivasan device now discloses wherein when the ingestible capsule is in a stomach of a subject who has ingested the ingestible capsule (Srinivasan: claims 17-18 for the capsule; Ben-Tsur: note paragraph 262, lines 1-6, which describe the interfacing of the capsule with walls of the tract), closing the circuit connecting the power supply and the vibrator causes the vibrator to vibrate the ingestible capsule at a frequency (Srinivasan: claims 17-18 for the capsule and biodegradable insulating membrane, modified to be dissolvable in the stomach per Gross; Ben-Tsur: paragraph 255, lines 1-6 for the vibration of the capsule via motor assembly, and the frequency outlined at paragraph 275, lines 1-6; and note the modification of the biodegradable insulating membrane to dissolve in the stomach as discussed above).
Given that Ben-Tsur discloses the frequency range of 10-650 Hz (paragraph 78, lines 1-2), and that the instant specification notes that frequencies in the range of 60-120 Hz induce the feeling of satiety (see paragraph 15), the ordinarily skilled artisan would recognize that, because the modified Srinivasan device is capable of operating between 60 and 120 Hz, that the device of modified Srinivasan is capable of inducing serotonin release in the subject when operated in the range of 60-120 Hz (see also MPEP 2112.01, where when the claimed apparatus and the reference apparatus are substantially identical, as they are based on modification of Srinivasa with Ben-Tsur and Gross, claimed properties and functions are presumed to be present).
Regarding claim 16, Srinivasan discloses the ingestible capsule of claim 1, as discussed above.
Srinivasan fails to explicitly disclose wherein when the ingestible capsule is in a stomach of a subject who has ingested the ingestible capsule, closing the circuit connecting the power supply and the vibrator causes the vibrator to vibrate the ingestible capsule at a frequency that stimulates mucosal receptors in the stomach, because Srinivasan fails to disclose the closing of the circuit in the stomach and placement of the capsule in the stomach.
However, Gross teaches an ingestible capsule (30) for delivery of a therapeutic agent into a desired portion of the GI tract (paragraph 272, lines 1-15, note the different places in the GI tract, e.g. the stomach and the small intestine and the pH for dissolution of the film at these places; Fig. 15), wherein ingestible capsule (30) includes a biodegradable coating (46A) disposed on the housing (see Fig. 15, where 46A is disposed on the exterior of capsule 30) ingestible capsule (30), and configured to dissolve in a fluid having a pH of 1.5 to 3, thereby exposing the therapeutic agent (36) in the stomach as desired (paragraph 272, lines 1-15, note that Gross contemplates dissolution in acidic stomach environments with pH 1.2-3.5, and thus the claimed range is anticipated by the disclosed range per MPEP 2131.03 II, as the range is overlapped with sufficient specificity).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the biodegradable insulating membrane of Srinivasan as a material capable of dissolving in a solution between 1.5 and 3 pH, and thus creating closing of the circuit in the stomach, as taught by Gross, in order to allow for treatment by the capsule at a desired portion of the GI tract, i.e., the stomach.
Presently modified Srinivasan fails to disclose use of placement of the ingestible capsule in the stomach, and operating the capsule at a frequency which induces a feeling of satiety in the subject.
However, Ben-Tsur teaches an ingestible capsule (110) configured for placement and treatment in a subject’s stomach (paragraph 233, lines 1-8; paragraph 182, lines 1-8; paragraph 255, lines 1-6; see paragraph 262, lines 1-6 for interface with GI tract wall and paragraph 299, lines 1-3 for positioning of capsule 110 within the stomach and paragraph 394, lines 1-7 for vibration mode within the stomach), at a frequency of between 10 and 650 Hz (paragraph 275, lines 1-5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have operated the device of modified Srinivasan at a frequency of between 10 and 650 Hz, and localized the capsule to the stomach, as taught by Ben-Tsur, in order to treat various conditions of the stomach by the capsule.
Thus, the modified Srinivasan device now discloses wherein when the ingestible capsule is in a stomach of a subject who has ingested the ingestible capsule (Srinivasan: claims 17-18 for the capsule; Ben-Tsur: note paragraph 262, lines 1-6, which describe the interfacing of the capsule with walls of the tract), closing the circuit connecting the power supply and the vibrator causes the vibrator to vibrate the ingestible capsule at a frequency (Srinivasan: claims 17-18 for the capsule and biodegradable insulating membrane, modified to be dissolvable in the stomach per Gross; Ben-Tsur: paragraph 255, lines 1-6 for the vibration of the capsule via motor assembly, and the frequency outlined at paragraph 275, lines 1-6; and note the modification of the biodegradable insulating membrane to dissolve in the stomach as discussed above).
Given that Ben-Tsur discloses the frequency range of 10-650 Hz (paragraph 78, lines 1-2), and that the instant specification notes that frequencies in the range of 60-120 Hz induce the feeling of satiety (see paragraph 15), the ordinarily skilled artisan would recognize that, because the modified Srinivasan device is capable of operating between 60 and 120 Hz, that the device of modified Srinivasan is capable of stimulating mucosal receptors in the stomach when operated in the range of 60-120 Hz (see also MPEP 2112.01, where when the claimed apparatus and the reference apparatus are substantially identical, as they are based on modification of Srinivasa with Ben-Tsur and Gross, claimed properties and functions are presumed to be present).
Claim 17 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17 and 22-23 of copending Application No. 18/182,854 in view of Trovato (US 2009/0306632) and Gross (US 2005/0058701).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 17, Srinivasan discloses an ingestible capsule (claim 17, line 1) comprising:
a housing forming a cavity (claim 17, lines 2-3);
an actuator disposed in the cavity and configured to oscillate about a longitudinal axis of the ingestible capsule at a frequency of about 5 Hz to about 120 Hz, thereby causing the ingestible capsule to rotate (claim 17, line 4; claim 22, lines 1-5; claim 23, lines 1-3; it is noted that the offset weight is understood to create rotation of the capsule, and rotation of the shaft occurs along at least one axis of the capsule); and
a power supply disposed in the cavity and configured to provide power to the actuator (claim 17, line 5); and
a biodegradable insulating membrane in fluid communication with an exterior of the housing configured to dissolve in a fluid with a pH between 1.5 to 9 (claim 17, lines 7-9).
Srinivasan fails to disclose that the biodegradable insulating membrane is disposed in electrical communication with the actuator and the power supply, the biodegradable insulating membrane configured to dissolve in stomach acid; and a conductor electrically connecting the actuator and the power supply, wherein the conductor is configured to close a circuit between the actuator and the power supply when the biodegradable membrane dissolves.
However, Trovato teaches a capsule (100) (paragraph 25, lines 1-7; Fig. 1), which includes a biodegradable insulating membrane disposed in electrical series between two electrical contacts, in fluid communication with an exterior of the capsule housing, and configured to dissolve in a fluid with a pH of about 7, thereby closing a circuit connecting the two electrical contacts, so that the medicament in the capsule is properly timed for release at a desired location (paragraph 61, lines 6-9, Examiner notes that the coating is “water soluble”, and water is known to have a pH of 7, further the coating is understood to be in fluid communication with the exterior of the capsule in order to be dissolved; see paragraph 61, lines 1-3 for the release at a desired time); and
a conductor (“switch”) electrically connecting two electrical contacts, wherein the conductor (“switch”) is configured to close a circuit between the two electrical contacts when the biodegradable membrane dissolves (paragraph 61, lines 5-9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Srinivasan to include a biodegradable insulating membrane disposed in electrical series between the power supply and the vibrator and in fluid communication with an exterior of the housing and configured to dissolve in a fluid having a pH of 7, wherein electrical contact between the actuator and the power supply is facilitated by a conductor, such that the conductor is configured to close a circuit between the two electrical contacts when the biodegradable membrane dissolves, as taught by Trovato, in order to properly time release of the therapeutic agent in the capsule at a desired location within the GI tract.
As presently modified, Srinivasan fails to disclose wherein the biodegradable insulating membrane is configured to dissolve in a fluid having a pH of 1.5-3.
However, Gross teaches an ingestible capsule (30) for delivery of a therapeutic agent into a desired portion of the GI tract (paragraph 272, lines 1-15, note the different places in the GI tract, e.g. the stomach and the small intestine and the pH for dissolution of the film at these places; Fig. 15), wherein an ingestible capsule (30) includes a biodegradable coating (46A) disposed on the housing (see Fig. 15, where 46A is disposed on the exterior of capsule 30) of the ingestible capsule (30), and is configured to dissolve in a fluid having a pH of 1.5 to 3, thereby exposing the therapeutic agent (36) in the stomach as desired (paragraph 272, lines 1-15, note that Gross contemplates dissolution in acidic stomach environments with pH 1.2-3.5, and thus the claimed range is anticipated by the disclosed range per MPEP 2131.03 II, as the range is overlapped with sufficient specificity).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the biodegradable insulating membrane of Srinivasan as a material capable of dissolving in a solution between 1.5 and 3 pH, as taught by Gross, in order to allow for treatment by the capsule at a desired portion of the GI tract, i.e., the stomach.
Claim 18 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17 and 22-23 of copending Application No. 18/182,854 in view of Trovato (US 2009/0306632) and Gross (US 2005/0058701), as applied to claim 17 above, in further view of Ben-Tsur (US 2020/0214592).
Regarding claim 18, Srinivasan in view of Trovato and Gross disclose the ingestible capsule of claim 17, as discussed above.
Srinivasan fails to disclose wherein, when the ingestible capsule is in a subject's stomach, rotation of the ingestible capsule causes the ingestible capsule to stroke a portion of mucosa in the subject’s stomach
Ben-Tsur teaches wherein when an ingestible capsule (110) is in a subject’s stomach, rotation of the ingestible capsule (110) causes the ingestible capsule (110) to stroke a portion of mucosa in the subject’s stomach (paragraph 233, lines 1-4; paragraph 255, lines 1-6 for radial rotation; see paragraph 262, lines 1-6 for interface with GI tract wall and paragraph 299, lines 1-3 for positioning of capsule 110 within the stomach and paragraph 394, lines 1-7 for vibration mode within the stomach, where the stomach walls are understood to include mucosa).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device and method of modified Srinivasan to include when the ingestible capsule is in a subject’s stomach, the vibrator being configured to rotate the weight about the longitudinal axis of the shaft to generate a centrifugal force and rotate the capsule, thereby stroking a portion of mucosa in the subject’s stomach with the ingestible capsule, as taught by Ben-Tsur, and thereby producing vibration to treat the subject’s stomach.
Allowable Subject Matter
Claim 21 is allowed.
Claims 7-9 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding the subject matter of each of claims 7-8 and 21, while Trovato teaches a capsule (100) (paragraph 25, lines 1-7; Fig. 1), which includes the step of closing a circuit by dissolving a biodegradable insulating membrane disposed in electrical series between two electrical contacts, so that the medicament in the capsule is properly timed for release at a desired location (paragraph 61, lines 6-9, Examiner notes that the coating is “water soluble”; see paragraph 61, lines 1-3 for the release at a desired time), Trovato does not contemplate the interfacing of the biodegradable insulating membrane with a spring that is in a compressed or extended position based on the state of dissolution of the membrane.
Further, while Langer (US 2020/0009371) discusses utilization of “a compressed spring held in place by a dissolvable, timed actuation barrier to propel the needles into the tissue” at paragraph 538, there is no accompanying disclosure that ties use of this spring to an ingestible, vibrating capsule, rather the spring is used to propel needles into the GI tract for medicament delivery.
The closest prior art relative to claim 9 is Shohat (US 9,078,799), which shows multiple press-fit portions of a capsule in Figure 2. However, this arrangement does not include three separate portions to be press-fit, and further does not provide a conduit for fluid communication with a biodegradable insulating membrane.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 04-17-2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 PAIGE BUGG whose telephone number is (571)272-8053. The examiner can normally be reached Monday-Friday 9-5.
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, Kendra Carter can be reached at (571) 272-9034. 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.
/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
Prosecution Insights