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 application as filed on 03-13-2023. As directed, claims 1-21 are currently pending examination.
Claim Objections
Claims 4, 13-16, 18, and 20-21 are objected to because of the following informalities:
At claim 4, lines 1-2, it is suggested that “configured to be located” be added before “in a subject’s stomach” to more clearly avoid claiming the human organism.
At claim 4, line 3, it is suggested that “thereby stroking” be replaced with “thereby configured to produce stroking at” to more clearly avoid claiming the human organism.
At claim 13, lines 1-2, it is suggested that “configured to be located” be added before “in a subject’s stomach” to more clearly avoid claiming the human organism.
At claim 13, line 3, it is suggested that “causes” be replaced with “is configured to cause” to avoid positive recitation of method steps in an apparatus claim.
At claim 14, lines 1-2, it is suggested that “configured to be located” be added before “in a subject’s stomach” to more clearly avoid claiming the human organism.
At claim 14, line 3, it is suggested that “causes” be replaced with “is configured to cause” to avoid positive recitation of method steps in an apparatus claim.
At claim 15, lines 1-2, it is suggested that “configured to be located” be added before “in a subject’s stomach” to more clearly avoid claiming the human organism.
At claim 15, line 3, it is suggested that “causes” be replaced with “is configured to cause” to avoid positive recitation of method steps in an apparatus claim.
At claim 16, line 1, it is suggested that “configured to be located” be added before “in a stomach” to more clearly avoid claiming the human organism.
At claim 16, line 3, it is suggested that “causes” be replaced with “is configured to cause” to avoid positive recitation of method steps in an apparatus claim.
At claim 18, lines 1-2, it is suggested that “configured to be located” be added before “in a subject’s stomach” to more clearly avoid claiming the human organism.
At claim 18, line 2, it is suggested that “causes” be replaced with “is configured to cause” to avoid positive recitation of method steps in an apparatus claim.
At claim 20, line 5, it is suggested that “the” before “stroking” be eliminated for clarity.
At claim 21, line 12, it is suggested that “causes” be replaced with “is configured to cause” to avoid positive recitation of method steps in an apparatus claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 contains the trademark/trade name “Eudragit”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a membrane material and, accordingly, the identification/description is indefinite.
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 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0315541) in view of Trovato (US 2009/0306632).
Regarding claim 1, Ben-Tsur discloses an ingestible capsule (300) (paragraph 134, lines 1-7; Figs. 3A-D) comprising:
a housing (305) forming a cavity (see space within 305A and 305B in Figs. 3A-D) (paragraph 134, lines 1-12; Figs. 3A-D);
a vibrator (310+shaft+312) disposed in the cavity (see space within 305A and 305B in Figs. 3A-D) (paragraph 134, lines 1-7; paragraph 136, lines 1-6; see also paragraph 67, lines 1-9 for the shaft of the motor in the radial agitation means, and note in Figs. 3A-D, these components are housed in the cavity);
a power supply (340) disposed in the cavity (paragraph 134, lines 4-12; paragraph 135, lines 1-3; Fig. 3A).
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 9, 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, and 7 falls within the claimed range of about 2 to about 9, and is thus anticipated per MPEP 2131.03 I, 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 involving the motor 310 of the analogous vibrator and the power supply at paragraph 134, lines 1-9) 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.
Regarding claim 2, Ben-Tsur in view of Travato disclose the ingestible capsule of claim 1, as discussed above.
Ben-Tsur further discloses wherein the vibrator comprises:
a motor (310) having a shaft (paragraph 134, lines 1-7; paragraph 136, lines 1-6; see also paragraph 67, lines 1-9 for the shaft of the motor in the radial agitation means);
a weight (312) mechanically coupled to the shaft and radially offset from a longitudinal axis of the shaft (paragraph 134, lines 1-7; paragraph 136, lines 1-6; note Fig. 3A, where 312 has left and right portions which are radially offset from the longitudinal axis of motor 310).
Regarding claim 3, Ben-Tsur in view of Travato 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 136, lines 1-6; paragraph 78, lines 1-4).
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 disclose the ingestible capsule of claim 2, as discussed above.
Ben-Tsur further discloses wherein when the ingestible capsule (300) is in a subject’s stomach, the vibrator (310+shaft+312) is configured to rotate the weight (312) 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 (300) (paragraph 136, lines 1-6, note the radial movement of eccentric weight by the spin of the motor; paragraph 34, lines 1-5 describe the interfacing of the capsule with walls of the tract, where the walls are understood to include mucosa; paragraph 123, lines 7-13 describe the transit of the capsule in the stomach).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0315541) in view of Trovato (US 2009/0306632), as applied to claim 1 above, in further view of Gross (US 2010/0021536).
Regarding claim 5, Ben-Tsur in view of Travato disclose the ingestible capsule of claim 1, as discussed above.
Modified Ben-Tsur fails to disclose wherein the biodegradable insulating membrane comprises gelatin.
However, Gross teaches an ingestible capsule (20) which includes a biodegradable coating (22) comprising gelatin for dissolution in an environment with a pH between 2 and 9 (paragraph 135, lines 1-6, note that the pH of fluid in the small intestine is in the claimed range).
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 gelatin, as taught by Gross, as a known material for constructing a biodegradable coating of an ingestible capsule that allows for the predictable dissolution of the membrane in the small intestine to enact therapy in the small intestine as desired.
Claims 6 and 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0315541) in view of Trovato (US 2009/0306632), as applied to claim 1 above, in further view of Gross (US 2005/0058701).
Regarding claim 6, Ben-Tsur in view of Travato disclose the ingestible capsule of claim 1, as discussed above.
Modified Ben-Tsur fails to explicitly disclose wherein the biodegradable insulating membrane is configured to dissolve in a fluid having a pH of 1.5 to 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 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 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.
Regarding claim 10, Ben-Tsur in view of Travato 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 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 modified Ben-Tsur fails to disclose the closing of the circuit 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 Ben-Tsur 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.
Thus, the modified Ben-Tsur device now discloses wherein when the ingestible capsule (Ben-Tsur: 300) is in a stomach of a subject who has ingested the ingestible capsule (Ben-Tsur: 300, note paragraph 34, lines 1-5 which describe the interfacing of the capsule with walls of the tract, and paragraph 123, lines 7-13 which describe the transit of the capsule in the stomach), closing the circuit connecting the power supply (Ben-Tsur: 340) and the vibrator (Ben-Tsur: 310+shaft+312) causes the vibrator (Ben-Tsur: 310+shaft+312) to vibrate the ingestible capsule (Ben-Tsur: 300) at a frequency (Ben-Tsur: paragraph 136, lines 1-6 for the vibration of the capsule via motor assembly, and note the modification of the biodegradable insulating membrane to dissolve in the stomach as discussed above).
Presently modified Ben-Tsur fails to discloses wherein the frequency induces a feeling of satiety in the subject.
However, 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 Ben-Tsur device is capable of operating between 60 and 120 Hz, that the device of 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 disclose the ingestible capsule of claim 1, as discussed above.
Modified Ben-Tsur 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 modified Ben-Tsur fails to disclose the closing of the circuit 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 Ben-Tsur 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.
Thus, the modified Ben-Tsur device now discloses wherein when the ingestible capsule (Ben-Tsur: 300) is in a stomach of a subject who has ingested the ingestible capsule (Ben-Tsur: 300, note paragraph 34, lines 1-5 which describe the interfacing of the capsule with walls of the tract, and paragraph 123, lines 7-13 which describe the transit of the capsule in the stomach), closing the circuit connecting the power supply (Ben-Tsur: 340) and the vibrator (Ben-Tsur: 310+shaft+312) causes the vibrator (Ben-Tsur: 310+shaft+312) to vibrate the ingestible capsule (Ben-Tsur: 300) at a frequency (Ben-Tsur: paragraph 136, lines 1-6 for the vibration of the capsule via motor assembly, and note the modification of the biodegradable insulating membrane to dissolve in the stomach as discussed above).
Presently modified Ben-Tsur fails to discloses wherein the frequency induces an illusory insufflation in the subject.
However, 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 disclose the ingestible capsule of claim 1, as discussed above.
Modified Ben-Tsur 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 modified Ben-Tsur fails to disclose the closing of the circuit 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 Ben-Tsur 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.
Thus, the modified Ben-Tsur device now discloses wherein when the ingestible capsule (Ben-Tsur: 300) is in a stomach of a subject who has ingested the ingestible capsule (Ben-Tsur: 300, note paragraph 34, lines 1-5 which describe the interfacing of the capsule with walls of the tract, and paragraph 123, lines 7-13 which describe the transit of the capsule in the stomach), closing the circuit connecting the power supply (Ben-Tsur: 340) and the vibrator (Ben-Tsur: 310+shaft+312) causes the vibrator (Ben-Tsur: 310+shaft+312) to vibrate the ingestible capsule (Ben-Tsur: 300) at a frequency (Ben-Tsur: paragraph 136, lines 1-6 for the vibration of the capsule via motor assembly, and note the modification of the biodegradable insulating membrane to dissolve in the stomach as discussed above).
Presently modified Ben-Tsur fails to discloses wherein the frequency induces serotonin release in the subject.
However, 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 disclose the ingestible capsule of claim 1, as discussed above.
Modified Ben-Tsur 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 causes the ingestible capsule to stimulate mucosal receptors in the stomach, because modified Ben-Tsur fails to disclose the closing of the circuit 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 Ben-Tsur 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.
Thus, the modified Ben-Tsur device now discloses wherein when the ingestible capsule (Ben-Tsur: 300) is in a stomach of a subject who has ingested the ingestible capsule (Ben-Tsur: 300, note paragraph 34, lines 1-5 which describe the interfacing of the capsule with walls of the tract, and paragraph 123, lines 7-13 which describe the transit of the capsule in the stomach), closing the circuit connecting the power supply (Ben-Tsur: 340) and the vibrator (Ben-Tsur: 310+shaft+312) causes the vibrator (Ben-Tsur: 310+shaft+312) to vibrate the ingestible capsule (Ben-Tsur: 300) at a frequency (Ben-Tsur: paragraph 136, lines 1-6 for the vibration of the capsule via motor assembly, and note the modification of the biodegradable insulating membrane to dissolve in the stomach as discussed above).
Presently modified Ben-Tsur fails to discloses wherein the frequency causes the ingestible capsule to stimulate mucosal receptors in the stomach.
However, 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).
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0315541).
Regarding claim 17, Ben-Tsur discloses an ingestible capsule (300) (paragraph 134, lines 1-7; Figs. 3A-D) comprising:
a housing (305) forming a cavity (see space within 305A and 305B in Figs. 3A-D) (paragraph 134, lines 1-12; Figs. 3A-D);
an actuator (310+shaft+312) disposed in the cavity (see space within 305A and 305B in Figs. 3A-D) (paragraph 134, lines 1-7; paragraph 136, lines 1-6; see also paragraph 67, lines 1-9 for the shaft of the motor in the radial agitation means, and note in Figs. 3A-D, these components are housed in the cavity) configured to oscillate about a longitudinal axis of the ingestible capsule (300) at a frequency between 10 Hz and 650 Hz, thereby causing the ingestible capsule (300) to rotate (paragraph 136, lines 1-6, note the spin of the motor and the radial force; paragraph 78, lines 1-4);
a power supply (340) disposed in the cavity and configured to provide power to the actuator (310+shaft+312) (paragraph 134, lines 4-12; paragraph 135, lines 1-3; Fig. 3A).
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 5 Hz to about 120 Hz overlaps with 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 10-120 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)).
Regarding claim 18, Ben-Tsur discloses the ingestible capsule of claim 17, as discussed above.
Ben-Tsur further discloses wherein when the ingestible capsule (300) is in a subject’s stomach, rotation of the ingestible capsule (300) causes the ingestible capsule (300) to stroke a portion of mucosa in the subject’s stomach (paragraph 136, lines 1-6, note the radial movement of eccentric weight by the spin of the motor; paragraph 34, lines 1-5 describe the interfacing of the capsule with walls of the tract, where the walls are understood to include mucosa; paragraph 123, lines 7-13 describe the transit of the capsule in the stomach).
Regarding claim 19, Ben-Tsur discloses a method of stimulating the stomach in a subject (paragraph 34, lines 1-5 describe the interfacing of the capsule with walls of the tract, where the walls are understood to include mucosa; paragraph 123, lines 7-13 describe the transit of the capsule in the stomach; see paragraph 134, lines 1-7 for the capsule which employs the stimulation), the method comprising:
with an ingestible capsule (300), stroking a portion of mucosa in a stomach of a subject at a frequency of about 10-650 Hz thereby stroking a portion of mucosa in the subject’s stomach with the ingestible capsule (300) (paragraph 134, lines 1-7; paragraph 136, lines 1-6, note the radial movement of eccentric weight by the spin of the motor; paragraph 34, lines 1-5 describe the interfacing of the capsule with walls of the tract, where the walls are understood to include mucosa; paragraph 123, lines 7-13 describe the transit of the capsule in the stomach; see paragraph 78, lines 1-5 for frequency range).
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 2020/0315541), 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 (322) connecting a power supply (340) and a vibrator (310+shaft+312) in the ingestible capsule (30) (paragraph 134, lines 1-7; paragraph 136, lines 1-6; see also paragraph 67, lines 1-9 for the shaft of the motor in the radial agitation means, and note in Figs. 3A-D, these components are housed in the cavity), wherein the stroking the portion of mucosa comprises radially oscillating the ingestible capsule (300) about a longitudinal axis of the ingestible capsule (300) with the vibrator (310+shaft+312) (paragraph 136, lines 1-7; paragraph 34, lines1-5 describe the interfacing of the capsule with walls of the tract, where the walls are understood to include mucosa; paragraph 123, lines 7-13 describe the transit of the capsule in the stomach).
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.
Claims 1 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-18 of copending Application No. 18/182,832 (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 the citations with respect to application 18/182,854 are given relative to US Pre-Grant Publication 2023/0285227 to Srinivasan.
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, lines 5-6); 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 1.5 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 9 is overlapped with sufficient specificity by the disclosed range of 2-9, and is therefore anticipated per MPEP 2131.03 II).
Regarding claim 6, Srinivasan discloses the ingestible capsule of claim 1, as discussed above.
Srinivasan further discloses wherein the biodegradable insulating membrane is configured to dissolve in a fluid having a pH of 1.5 to 3 (claim 18, lines 1-9).
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 discloses 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 (300) (paragraph 134, lines 1-7; Figs. 3A-D) comprising a vibrator (310+shaft+312) disposed in the cavity (see space within 305A and 305B in Figs. 3A-D) (paragraph 134, lines 1-7; paragraph 136, lines 1-6; see also paragraph 67, lines 1-9 for the shaft of the motor in the radial agitation means, and note in Figs. 3A-D, these components are housed in the cavity)a motor (310) having a shaft (paragraph 134, lines 1-7; paragraph 136, lines 1-6; see also paragraph 67, lines 1-9 for the shaft of the motor in the radial agitation means), wherein the vibrator (310+shaft+312) includes a weight (312) mechanically coupled to the shaft and radially offset from a longitudinal axis of the shaft (paragraph 134, lines 1-7; paragraph 136, lines 1-6; note Fig. 3A, where 312 has left and right portions which are radially offset from the longitudinal axis of motor 310).
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 in view of Travato 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 136, lines 1-6; paragraph 78, lines 1-4).
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, 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 (300) is in a subject’s stomach, the vibrator (310+shaft+312) is configured to rotate the weight (312) 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 (300) (paragraph 136, lines 1-6, note the radial movement of eccentric weight by the spin of the motor; paragraph 34, lines 1-5 describe the interfacing of the capsule with walls of the tract, where the walls are understood to include mucosa; paragraph 123, lines 7-13 describe the transit of the capsule in 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 Gross (US 2010/0021536).
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, Gross teaches an ingestible capsule (20) which includes a biodegradable coating (22) comprising gelatin for dissolution in an environment with a pH between 2 and 9 (paragraph 135, lines 1-6, note that the pH of fluid in the small intestine is in the claimed range).
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 Srinivasan device to be gelatin, as taught by Gross, as a known material for constructing a biodegradable coating of an ingestible capsule that allows for the predictable dissolution of the membrane in the small intestine to enact therapy in the small intestine 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 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 the ingestible capsule (300) configured for placement and treatment in a subject’s stomach (paragraph 136, lines 1-6, note the radial movement of eccentric weight by the spin of the motor; paragraph 34, lines 1-5 describe the interfacing of the capsule with walls of the tract, where the walls are understood to include mucosa; paragraph 123, lines 7-13 describe the transit of the capsule in the stomach), at a frequency of between 10 and 650 Hz (paragraph 78, 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 34, lines 1-5 which describe the interfacing of the capsule with walls of the tract, and paragraph 123, lines 7-13 which describe the transit of the capsule in the stomach), 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 136, lines 1-6 for the vibration of the capsule via motor assembly, and note the modification of the biodegradable insulating membrane to dissolve in the stomach as discussed above).
Presently modified Srinivasan fails to explicitly disclose operating the capsule at a frequency which induces a feeling of satiety in the subject.
However, 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 illusory insufflation in the subject.
However, Ben-Tsur teaches the ingestible capsule (300) configured for placement and treatment in a subject’s stomach (paragraph 136, lines 1-6, note the radial movement of eccentric weight by the spin of the motor; paragraph 34, lines 1-5 describe the interfacing of the capsule with walls of the tract, where the walls are understood to include mucosa; paragraph 123, lines 7-13 describe the transit of the capsule in the stomach), at a frequency of between 10 and 650 Hz (paragraph 78, 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: claim 17-18 for the capsule; Ben-Tsur: note paragraph 34, lines 1-5 which describe the interfacing of the capsule with walls of the tract, and paragraph 123, lines 7-13 which describe the transit of the capsule in the stomach), 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 136, lines 1-6 for the vibration of the capsule via motor assembly, and note the modification of the biodegradable insulating membrane to dissolve in the stomach as discussed above).
Presently modified Srinivasan fails to discloses wherein the frequency induces an illusory insufflation in the subject.
However, given that Ben-Tsur discloses the frequency range of 10-650 Hz (Ben-Tsur: 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 modified Srinivasan device is capable of operating between 60 and 120 Hz, that the device of Srinivasan 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 Srinivasan 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 serotonin in the subject.
However, Ben-Tsur teaches the ingestible capsule (300) configured for placement and treatment in a subject’s stomach (paragraph 136, lines 1-6, note the radial movement of eccentric weight by the spin of the motor; paragraph 34, lines 1-5 describe the interfacing of the capsule with walls of the tract, where the walls are understood to include mucosa; paragraph 123, lines 7-13 describe the transit of the capsule in the stomach), at a frequency of between 10 and 650 Hz (paragraph 78, 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 34, lines 1-5 which describe the interfacing of the capsule with walls of the tract, and paragraph 123, lines 7-13 which describe the transit of the capsule in the stomach), 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 136, lines 1-6 for the vibration of the capsule via motor assembly, and note the modification of the biodegradable insulating membrane to dissolve in the stomach as discussed above).
Presently modified Srinivasan fails to discloses wherein the frequency induces serotonin release in the subject.
However, 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 modified Srinivasan device is capable of operating between 60 and 120 Hz, that the device of modified Srinivasan 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 Srinivasan 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 causes the ingestible capsule to stimulate 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 stimulation of mucosal receptors in the subject.
However, Ben-Tsur teaches the ingestible capsule (300) configured for placement and treatment in a subject’s stomach (paragraph 136, lines 1-6, note the radial movement of eccentric weight by the spin of the motor; paragraph 34, lines 1-5 describe the interfacing of the capsule with walls of the tract, where the walls are understood to include mucosa; paragraph 123, lines 7-13 describe the transit of the capsule in the stomach), at a frequency of between 10 and 650 Hz (paragraph 78, 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: claism 17-18 for the capsule; Ben-Tsur: note paragraph 34, lines 1-5 which describe the interfacing of the capsule with walls of the tract, and paragraph 123, lines 7-13 which describe the transit of the capsule in the stomach), 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 ofor the capsule and biodegradable insulating membrane, modified to be dissolvable in the stomach per Gross; Ben-Tsur: paragraph 136, lines 1-6 for the vibration of the capsule via motor assembly, and note the modification of the biodegradable insulating membrane to dissolve in the stomach as discussed above).
Presently modified Ben-Tsur fails to discloses wherein the frequency causes the ingestible capsule to stimulate mucosal receptors in the stomach.
However, 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 modified Srinivasan device is capable of operating at 80 Hz, that the device of modified Srinivasan 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 Srinivasan 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. 18/182,832 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
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, lines 5-6).
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, s applied to claim 17 above, in view of Ben-Tsur (US 2020/0315541).
Regarding claim 18, Srinivasan discloses 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
However, Ben-Tsur further teaches wherein when the ingestible capsule (300) is in a subject’s stomach, the vibrator (310+shaft+312) is configured to rotate the weight (312) about the longitudinal axis of the shaft to generate a centrifugal force, thereby rotating the capsule (300), and stroking a portion of mucosa in the subject’s stomach with the ingestible capsule (300) (paragraph 136, lines 1-6, note the radial movement of eccentric weight by the spin of the motor; paragraph 34, lines 1-5 describe the interfacing of the capsule with walls of the tract, where the walls are understood to include mucosa; paragraph 123, lines 7-13 describe the transit of the capsule in 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 and rotate the capsule, thereby stroking a portion of mucosa in the subject’s stomach with the ingestible capsule, and producing the 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.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
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
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/PAIGE KATHLEEN BUGG/Examiner, Art Unit 3785