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 .
Statis of Claims
The present Office action is responsive to the Request for Continued Examiantion filed on 08-07-2026. As directed, claims 1, 9-10, and 17 have been amended, no new claims have been added, and no claims have been canceled. Thus, claims 1-24 are currently pending examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08-07-2026 has been entered.
Response to Amendment
By amending claims 10 and 17, Applicant has overcome the previous provisional double patenting rejections of record, as the claims now recite divergent subject matter.
Due to the broadening nature of the amendment to claim 1, the previously indicated allowable subject matter has been withdrawn. New rejections of record are set forth hereinbelow.
Response to Arguments
Applicant argues, see Remarks as filed pages 8-9, that the present amendments obviate the 103 rejections of record over claims 10-13 and 15-16 employing Ben-Tsur and Gross, as the Office has already conceded that Ben-Tsur does not contemplate a textured outer surface, and Gross does not cure such a deficiency. Applicant advances similar arguments over claims 1-9.
While it is true that neither Ben-Tsur nor Gross contemplate the various alternative textured outer surfaces of claim 10, reliance on Duffield (US 2011/0250241) at Figures 13A-M is made below in rejecting the amended portions of claim 10. Dependent claims 12-13 and 15-16 will be rejected over respective portions of the Ben-Tsur and/or Gross disclosures as applied in the previous Office action. New rejections will be made over claims 1-9 in view of the broadening amendments thereto. These rejections similarly employ Duffield.
Applicant argues, see page 10, that neither Ben-Tsur nor Gross contemplate the protruding studs of amended claim 17. Thus, Applicant alleges that each of claims 17, 19, and 22-24 distinguish over the prior art.
As above, reliance on Duffield (US 2011/0250241) at Figures 13A-M is made below in rejecting the amended portions of claim 17. Dependent claims 19 and 22-24 will be rejected over respective portions of the Ben-Tsur and/or Gross disclosures as applied in the previous Office action
Applicant argues, see Remarks as filed page 10, that Trovato does not cure the Ben-Tsur/Gross deficiencies.
As above, reliance on Duffield (US 2011/0250241) at Figures 13A-M is made below in rejecting the amended portions of claims 10 and 17. Dependent claims 14 and 18 will be rejected over respective portions of Trovato previously relied upon.
Applicant argues, see Remarks as filed page 10, that Yokoi does not cure the Ben-Tsur/Gross deficiencies.
As above, reliance on Duffield (US 2011/0250241) at Figures 13A-M is made below in rejecting the amended portions of claim 17. Dependent claims 19-20 will be rejected over respective portions of Yokoi previously relied upon.
Applicant argues, see Remarks as filed page 11, that Gross does not cure the Ben-Tsur/Gross deficiencies.
As above, reliance on Duffield (US 2011/0250241) at Figures 13A-M is made below in rejecting the amended portions of claim 17. Dependent claim 21 will be rejected over respective portions of Gross previously relied upon.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding each of claims 1 and 10, the claims each refer to “studs extending out from the outer surface” (claim 1, lines 7-8; claim 10, lines 13-14 and 5-16) which renders each claim indefinite. This is because the studs themselves are described and defined as the textured outer surface, and thus it is unclear how the studs reasonably extend from and are defined relative to themselves.
In order to overcome these rejections, it is suggested that “extending out from the outer surface” be replaced with “extending in a direction away from the ingestible capsule”. The claims will be interpreted as such.
Claims 2-9 and 11-16 are rejected by virtue of their respective dependency on either of claims 1 or 10.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-4 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592) in view of Duffield (US 2011/0250241) and Gross (US 2005/0058701).
Regarding claim 1, Ben-Tsur discloses an ingestible capsule (110) (paragraph 233, lines 1-4; Fig. 1) comprising:
a housing (112+120) forming a cavity (see space within 112+120) (paragraph 233, lines 1-4, note that 112 has components disposed therein; paragraph 234, lines 1-4, note that housing 120 is “hollow”; Fig. 1) and having an outer surface (paragraph 235, lines 1-3; Figs. 1-2B);
a therapeutic agent (102) disposed in the housing (112+120) (paragraph 234, lines 1-4; Fig. 1).
Ben-Tsur fails to explicitly disclose wherein the outer surface is textured, the textured outer surface comprising at least one of:
(i) a helical depression and a plurality of protruding studs disposed in the helical depression;
(ii) a protruding helical pattern with a pitch of 2 mm to 9 mm;
(iii) a plurality of protruding studs, each stud of the plurality of protruding studs extending out from the outer surface;
(iv) an intruding helical pattern with flat edges and a plurality of protruding studs, each stud of the plurality of protruding studs extending out from the outer surface;
(v) an intruding fin turbine helical pattern; or
(vi) an intruding helical pattern with scalloped points;
and a biodegradable coating disposed on the outer surface of the housing, the biodegradable coating configured to dissolve in a fluid having a pH of 1.5 to 9, thereby exposing the therapeutic agent.
However, Duffield teaches capsular containers (see Figs. 13A-M; paragraph 6, lines 1-5; paragraph 218, lines 1-9) wherein the outer surface is textured (paragraph 218, lines 1-9; Figs. 13A-M), the textured outer surface comprising at least one of:
(iii) a plurality of protruding studs, each stud of the plurality of protruding studs extending out from the outer surface (see Fig. 13C and H; paragraph 218, lines 5-6); or
(v) an intruding fin turbine helical pattern (see Fig. 13G and J; paragraph 218, lines 7-9), for the purpose of distinguishing the capsule visually or tactilely, and imbuing the capsule with different properties, for example different solubility (paragraph 106, lines 1-10; paragraph 108, lines 1-6; paragraph 110, 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 modified the ingestible capsule of Ben-Tsur to include a textured outer surface comprising (iii) a plurality of protruding studs, each stud of the plurality of protruding studs extending out from the outer surface or an intruding fin turbine helical pattern, as taught by Duffield, for the purpose of distinguishing the capsule visually or tactilely, and imbuing the capsule with different properties, for example different solubility.
Ben-Tsur fails to explicitly disclose a biodegradable coating disposed on the outer surface of the housing, the biodegradable coating configured to dissolve in a fluid having a pH of 1.5 to 9.
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 the 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 configured to dissolve in a fluid having a pH of 1.5 to 9, thereby exposing the therapeutic agent (36) (paragraph 272, lines 1-15, note that Gross contemplates dissolution in acidic stomach environments with pH 1.2-3.5, in the small intestine with pH values ranging from 4.7-6.5, and further contemplates dissolution in the large intestine with pH varying between 7.5 and 8, and thus several values within the claimed range are anticipated per MPEP 2131.03 II).
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 outer surface of the ingestible capsule of modified Ben-Tsur to have provided a biodegradable coating on the housing of the ingestible capsule of Ben-Tsur in order to facilitate dissolution of the biodegradable coating disposed on the housing of the ingestible capsule in a solution between 1.5 and 9 pH, as taught by Gross, in order to allow for release and absorption of the therapeutic agent into the desired portion of the GI tract.
Regarding claim 2, Ben-Tsur in view of Duffield and Gross disclose the ingestible capsule of claim 1, as discussed above.
Modified Ben-Tsur further discloses wherein the textured outer surface includes a plurality of slits (Duffield: see Fig. 13G and J; paragraph 218, lines 7-9).
Regarding claim 3, Ben-Tsur in view of Duffield and Gross disclose the ingestible capsule of claim 1, as discussed above.
Ben-Tsur further discloses:
a motor disposed in the cavity and having a shaft (paragraph 255, lines 1-7, see “electric motor” and “shaft”); and
a weight mechanically coupled to the shaft and radially offset from a longitudinal axis of the shaft (paragraph 255, lines 1-7, see “unbalanced weight”, understood to be an eccentric mass by virtue of the term “unbalanced” and the radial oscillation that is applied, and thus offset from the axis of the shaft).
Regarding claim 4, Ben-Tsur in view of Duffield and Gross disclose the ingestible capsule of claim 3, as discussed above.
Ben-Tsur further discloses a power supply disposed in the cavity and electrically coupled to the motor (paragraph 255, lines 1-7; Fig. 1).
Regarding claim 6, Ben-Tsur in view of Duffield and Gross disclose the ingestible capsule of claim 3, as discussed above.
Ben-Tsur further discloses wherein the shaft is configured to rotate about the longitudinal axis of the shaft (paragraph 255, lines 1-7), but fails to disclose a frequency of about 2 Hz to about 400 Hz.
However, given that Ben-Tsur discloses the frequency range of 10-650 Hz (paragraph 40, lines 1-2), and that the claimed range of about 2 Hz to about 400 Hz overlaps 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 about 2-400 Hz, which lies within the claimed range, 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 7, Ben-Tsur in view of Duffield and Gross disclose the ingestible capsule of claim 1, as discussed above.
Modified Ben-Tsur further discloses wherein the biodegradable coating is configured to dissolve in gastric fluid having a pH from 1.5 to 3.5 (Gross: paragraph 272, lines 13-15, note that 1.5-3.5 lies within the range of 1.2-3.5; see MPEP 2131.03 I).
Regarding claim 8, Ben-Tsur in view of Duffield and Gross disclose the ingestible capsule of claim 1, as discussed above.
Modified Ben-Tsur further discloses wherein the biodegradable coating is configured to dissolve in intestinal fluid having a pH from 6 to 7.4 (Gross: paragraph 272, lines 6-10, note that 6-7.4 overlaps the range of 4.7-6.5; see MPEP 2131.03 II).
Regarding claim 9, Ben-Tsur in view of Duffield and Gross disclose the ingestible capsule of claim 1, as discussed above.
Modified Ben-Tsur does not explicitly teach wherein the protruding studs each have a diameter of about 200 micrometers to 800 micrometers.
However, given that Duffield is relied upon for capsular containers that are to be ingested and are therefore understood to be of a particular size (see paragraph 74, where the entire capsule has an outer diameter between 5-10 mm), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention based on the relative size of the studs in each of Figures 13C and H, that the plurality of studs should be provided with a diameter less than the overall diameter of the capsule. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have chosen the stud diameter to be in the range of 200 micrometers to 800 micrometers as a matter of design choice capable of being discovered via routine experimentation in order to optimize the tactile/visual indicia on the capsule (Duffield: paragraph 106, lines 1-10; MPEP 2144.04 IV(B) and MPEP 2144.05 II(A-B)).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592) in view of Duffield (US 2011/0250241) and Gross (US 2005/0058701), as applied to claim 4 above, in further view of Glage (US 4,059,100).
Regarding claim 5, Ben-Tsur in view of Duffield and Gross disclose the ingestible capsule of claim 4, as discussed above.
Modified Ben-Tsur fails disclose one or more resistors disposed between the power supply and the motor to modulate a frequency of vibration of the motor.
However, Glage teaches a vibration-based massage device (Col. 2, lines 10-15; Fig. 1) with a power supply (42) and a motor (19) which further includes switch means combined with one or more resistors disposed between the power supply (42) and the motor to modulate a frequency of vibration of the motor (19) (Col. 2, lines 27-36).
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 modified Ben-Tsur to further include switch means combined with one or more resistors disposed between the power supply and the motor to modulate a frequency of vibration of the motor, as taught by Glage, in order to control the frequency and vibration of the motor manually.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592) in view of Duffield (US 2011/0250241).
Regarding claim 10, Ben-Tsur discloses a method of delivering a therapeutic agent (102) to a subject (paragraph 232, lines 1-5; paragraph 235, lines 1-7; paragraph 264, lines 1-7; Fig. 1), the method comprising:
stimulating the small intestine with an ingestible capsule (110) by radially oscillating the ingestible capsule (110) about a longitudinal axis of the ingestible capsule (110) at a frequency of about 50 Hz to about 500 Hz (paragraph 255, lines 1-7 describes radial oscillation of the capsule about its longitudinal axis when activated; paragraph 262, lines 1-6 describes the application of force by the capsule to walls of the GI tract; paragraph 264, lines 1-7 describes application of the vibration such that vibration transpires while the therapeutic agent is being absorbed; paragraph 299, lines 3-6 describes the absorption of the therapeutic agent in the small intestine; note paragraph 40, lines 4-5 for the frequency range of 50-500 Hz; Examiner notes that the instant specification at paragraph 11 provides that the luminal mucus is moved via radial oscillation in the prescribed frequency range of 50-120 Hz); and
while stimulating the small intestine, delivering a therapeutic agent (102) from the ingestible capsule (110) to the small intestine (paragraph 235, lines 1-7; paragraph 238, lines 1-8; paragraph 262, lines 1-6; paragraph 264, lines 1-7; paragraph 299, lines 3-6).
Ben-Tsur does not explicitly disclose moving a portion of the luminal mucus within the small intestine, specifically with a textured outer surface comprising at least one of:
(i) a helical depression and a plurality of protruding studs disposed in the helical depression;
(ii) a protruding helical pattern with a pitch of 2 mm to 9 mm;
(iii) a plurality of protruding studs, each stud of the plurality of protruding studs extending out from the outer surface;
(iv) an intruding helical pattern with flat edges and a plurality of protruding studs, each stud of the plurality of protruding studs extending out from the outer surface;
(v) an intruding fin turbine helical pattern; or
(vi) an intruding helical pattern with scalloped points;
and does not specifically limit the range of frequency to about 50-120 Hz as claimed.
However, in the case where the range disclosed by the prior art overlaps or lies within the claimed range, a prima facie case of obviousness exists (see MPEP 2144.05 I). In the instant case, the range of 50-120 Hz as claimed is overlapped by the disclosed range of 50-500 Hz from Ben-Tsur.
Thus, given that Ben-Tsur discloses the frequency range of 50-500 Hz (paragraph 40, lines 4-5), 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 for particular treatment since 1) 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)), and 2) since Ben-Tsur contemplates the discrete values within the range of 50-120 Hz in its overlapping range of 50-500 Hz.
Further, given that the “luminal mucus” in the GI tract is a secretion that forms on the walls of the tract, and since Applicant admits that the luminal mucus is moved “by radially oscillating the ingestible capsule about a longitudinal axis of the ingestible capsule at a frequency of about 50 Hz to about 120 Hz” (see instant application at paragraph 11), where Ben-Tsur contemplates radially oscillating the ingestible capsule (110) about a longitudinal axis of the ingestible capsule (110) (paragraph 255, lines 1-7) within the small intestine (paragraph 264, lines 1-7 and paragraph 299, lines 3-6), and as modified, achieves this oscillation at a frequency of 50-120 Hz, the device and method of modified Ben-Tsur is understood to be capable of moving the portion of luminal mucus in the small intestine as claimed (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).
As modified, Ben-Tsur fails to disclose wherein movement of the luminal mucus is achieved via a textured outer surface comprising at least one of:
(i) a helical depression and a plurality of protruding studs disposed in the helical depression;
(ii) a protruding helical pattern with a pitch of 2 mm to 9 mm;
(iii) a plurality of protruding studs, each stud of the plurality of protruding studs extending out from the outer surface;
(iv) an intruding helical pattern with flat edges and a plurality of protruding studs, each stud of the plurality of protruding studs extending out from the outer surface;
(v) an intruding fin turbine helical pattern; or
(vi) an intruding helical pattern with scalloped points.
However, Duffield teaches capsular containers (see Figs. 13A-M; paragraph 6, lines 1-5; paragraph 218, lines 1-9) wherein the outer surface is textured (paragraph 218, lines 1-9; Figs. 13A-M), the textured outer surface comprising at least one of:
(iii) a plurality of protruding studs, each stud of the plurality of protruding studs extending out from the outer surface (see Fig. 13C and H; paragraph 218, lines 5-6); or
(v) an intruding fin turbine helical pattern (see Fig. 13G and J; paragraph 218, lines 7-9), for the purpose of distinguishing the capsule visually or tactilely, and imbuing the capsule with different properties, for example different solubility (paragraph 106, lines 1-10; paragraph 108, lines 1-6; paragraph 110, 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 modified the ingestible capsule of Ben-Tsur to include a textured outer surface comprising (iii) a plurality of protruding studs, each stud of the plurality of protruding studs extending out from the outer surface or an intruding fin turbine helical pattern, as taught by Duffield, for the purpose of distinguishing the capsule visually or tactilely, and imbuing the capsule with different properties, for example different solubility.
As modified, since the capsule (110) of Ben-Tsur contacts and moves the luminal mucus (paragraph 255, lines 1-7 describes radial oscillation of the capsule about its longitudinal axis when activated; paragraph 262, lines 1-6 describes the application of force by the capsule to walls of the GI tract; paragraph 264, lines 1-7 describes application of the vibration such that vibration transpires while the therapeutic agent is being absorbed; paragraph 299, lines 3-6 describes the absorption of the therapeutic agent in the small intestine), and the outer surface of the capsule (110) is now imbued with the textured outer surface indicia as seen in the Duffield capsules, and because of the understood contact between the textured outer surface and the small intestine, movement of the luminal mucus in the small intestine is understood to be at least partially occurring based on contact between the luminal mucus and the textured outer surface of the modified Ben-Tsur device.
Claims 11-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592) in view of Duffield (US 2011/0250241), as applied to claim 10 above, in further view of Gross (US 2005/0058701).
Regarding claim 11, Ben-Tsur in view of Duffield disclose the method of claim 10, as discussed above.
Modified Ben-Tsur fails to explicitly disclose at least partially dissolving a biodegradable coating disposed on at least part of the ingestible capsule with 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 1-20, note first and second films 46A and 46B designed for dissolution at different places in the GI tract, e.g. the stomach and the small intestine; Fig. 15) which includes a biodegradable coating (46A) disposed on at least part of the ingestible capsule (30), and at least partially dissolved with stomach fluid (paragraph 272, lines 1-5 and 13-15), with a second biodegradable coating allowing for dissolution thereof at a more distal portion of the GI tract in order to allow therapeutic agent absorption at multiple desired portions of the GI tract (paragraph 272, lines 17-20).
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 a biodegradable coating on the ingestible capsule of modified Ben-Tsur, as taught by Gross, thereby enabling at least partial dissolution of the biodegradable coating disposed on at least part of the ingestible capsule with stomach fluid, in order to allow for release and absorption of the therapeutic agent into the stomach as desired, with the potential for further drug absorption in other areas of the GI tract, such as the small intestine.
Regarding claim 12, Ben-Tsur in view of Duffield disclose the method of claim 10, as discussed above.
Modified Ben-Tsur fails to explicitly disclose at least partially dissolving a biodegradable coating disposed on at least part of the ingestible capsule with intestinal 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 1-20, note first film 46A designed for dissolution in the GI tract, e.g. the small intestine; Fig. 15) which includes a biodegradable coating (46A) disposed on at least part of the ingestible capsule (30), and at least partially dissolved with intestinal fluid (paragraph 272, lines 1-10) in order to allow agent absorption at the small intestine as desired (paragraph 272, lines 1-10).
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 a biodegradable coating on the ingestible capsule of modified Ben-Tsur and containing the therapeutic agent, as taught by Gross, thereby enabling at least partial dissolution of the biodegradable coating disposed on at least part of the ingestible capsule with intestinal fluid, in order to allow for release and absorption of the therapeutic agent into the small intestine as desired.
Regarding claim 13, Ben-Tsur in view of Duffield and Gross disclose the method of claim 12, as discussed above.
Modified Ben-Tsur further discloses wherein the biodegradable coating (46A of Gross on ingestible capsule 110 of Ben-Tsur) includes the therapeutic agent, such that dissolving the biodegradable coating (46A) includes delivering the therapeutic agent (Gross: paragraph 272, lines 1-10).
Regarding claim 15, Ben-Tsur in view of Duffield disclose the method of claim 10, as discussed above.
Modified Ben-Tsur fails to explicitly disclose wherein the therapeutic agent has an oral bioavailability less than about 10%.
However, Gross further teaches an ingestible capsule (30) for delivery of a therapeutic agent into a desired portion of the GI tract (paragraph 272, lines 1-20, note first film 46A designed for dissolution in the GI tract, e.g. the small intestine; Fig. 15), and a therapeutic agent (36) that has an oral bioavailability less than about 10% (paragraph 315, lines 1-2 and 8, see insulin, where the bioavailability of insulin is on the order of 1-2% or less).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the therapeutic agent delivered by Ben-Tsur could reasonably be a drug with a bioavailability of less than 10%, such as insulin, as taught by Gross, and given that both Ben-Tsur and Gross detail drug delivery in the small intestine by their respective devices while avoiding dissolution of drug in the stomach, it would be with a reasonable expectation of success that the insulin could be properly administered at the small intestine by the modified Ben-Tsur device and method.
Regarding claim 16, Ben-Tsur in view of Duffield disclose the method of claim 10, as discussed above.
Modified Ben-Tsur fails to explicitly disclose wherein the therapeutic agent has molecular weight of about 10 kDa or less.
However, Gross teaches an ingestible capsule (30) for delivery of a therapeutic agent into a desired portion of the GI tract (paragraph 272, lines 1-20, note first film 46A designed for dissolution in the GI tract, e.g. the small intestine; Fig. 15), wherein the therapeutic agent (36) has a molecular weight of 10 kDa or less (paragraph 315, lines 1-2 and 8, see insulin, where the instant specification at paragraph 82 outlines the use of insulin as a drug in the given weight range).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the therapeutic agent delivered by modified Ben-Tsur could reasonably be a drug with a molecular weight of 10 kDa or less, such as insulin, as taught by Gross, and given that both Ben-Tsur and Gross detail drug delivery in the small intestine by their respective devices while avoiding dissolution of drug in the stomach, it would be with a reasonable expectation of success that the insulin could be properly administered at the small intestine by the modified Ben-Tsur device and method.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592) in view of Duffield (US 2011/0250241), as applied to claim 10 above, in further view of Trovato (US 2009/0306632).
Regarding claim 14, Ben-Tsur in view of Duffield disclose the method of claim 10, as discussed above.
Ben-Tsur further discloses a circuit connecting a power supply (“battery”) and a vibrator (114) in the ingestible capsule (110) (paragraph 255, lines 1-7; Fig. 1; see paragraphs 184-185 for the associated circuitry of the control element that affects the vibration agitation mechanism), wherein the vibrator induces moving the luminal mucus (paragraph 262, lines 1-6, and see the rejection of claim 10 above).
Ben-Tsur fails to explicitly disclose closing a circuit connecting the power supply and the vibrator to induce the moving by dissolving, with intestinal 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, with intestinal fluid, 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”, and water is known to have a pH of 7, and the delivery of the drug per claim 10 is in the small intestine, known to have a pH in the range of 6-7.4 depending on the location, and thus, the water soluble coating could reasonably dissolve along a portion of the small intestine by intestinal fluid; 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 modified Ben-Tsur to include closing a circuit to induce the moving by dissolving, with intestinal fluid, 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.
Claims 17, 19, and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592) in view of Duffield (US 2011/0250241), Yokoi (US 2006/0169293), and Gross (US 2005/0058701).
Regarding claim 17, Ben-Tsur discloses an ingestible capsule (110) (paragraph 233, lines 1-4; Fig. 1) comprising:
a housing (112+120) forming a cavity (see space within 112+120) (paragraph 233, lines 1-4, note that 112 has components disposed therein; paragraph 234, lines 1-4, note that housing 120 is “hollow”; Fig. 1) and having an outer surface (paragraph 235, lines 1-3; Figs. 1-2B);
a vibrator (114) disposed in the cavity (paragraph 233, lines 1-8; Fig. 1);
a power supply disposed in the cavity and configured to power the vibrator (114) (paragraph 255, lines 1-7; Fig. 1);
a therapeutic agent (102) disposed in the housing (112+120) (paragraph 234, lines 1-4; Fig. 1).
Ben-Tsur fails to explicitly disclose wherein the outer surface is textured with a plurality of protruding studs, wherein at least one of:
the plurality of protruding studs are distributed radially at 30- to 60-degree increments;
the plurality of protruding studs are axially distributed at 1 mm to 6 mm increments; or
each protruding stud in the plurality of protruding studs has a length of about 200 micrometers to about 1200 micrometers;
and a biodegradable coating disposed on the outer surface of the housing, the biodegradable coating configured to dissolve in a fluid having a pH of 1.5 to 9, thereby exposing the therapeutic agent.
However, Duffield teaches capsular containers (see Figs. 13A-M; paragraph 6, lines 1-5; paragraph 218, lines 1-9) wherein the outer surface is textured with a plurality of protruding studs, each stud of the plurality of protruding studs extending out from the outer surface (see Fig. 13C and H; paragraph 218, lines 5-6), for the purpose of distinguishing the capsule visually or tactilely, and imbuing the capsule with different properties, for example different solubility (paragraph 106, lines 1-10; paragraph 108, lines 1-6; paragraph 110, 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 modified the ingestible capsule of Ben-Tsur to include a textured outer surface including a plurality of protruding studs, each stud of the plurality of protruding studs extending out from the outer surface, as taught by Duffield, for the purpose of distinguishing the capsule visually or tactilely, and imbuing the capsule with different properties, for example different solubility.
Modified Ben-Tsur fails to explicitly disclose wherein the plurality of protruding studs, at least one of:
the plurality of protruding studs are distributed radially at 30- to 60-degree increments;
the plurality of protruding studs are axially distributed at 1 mm to 6 mm increments; or
each protruding stud in the plurality of protruding studs has a length of about 200 micrometers to about 1200 micrometers;
and a biodegradable coating disposed on the outer surface of the housing, the biodegradable coating configured to dissolve in a fluid having a pH of 1.5 to 9, thereby exposing the therapeutic agent.
However, Yokoi teaches helical protrusions (37B) on a capsule (Figs. 21A-22D) wherein the length of the protrusions (37B) is set to be 2 millimeters or less (see paragraph 75, where the height is taken to be the height as the claim has not defined what the length is relative to).
Given that the disclosed range of 2 millimeters or less corresponds to a value of 2000 micrometers or less, the prior art disclosed range overlaps the claimed range of 200-1200 micrometers. In the case where the prior art disclosed range overlaps the claimed range, a prima facie case of obviousness exists (see MPEP 2144.05 I).
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 length of the plurality of studs of modified Ben-Tsur to be in the range of 2000 micrometers or less, as taught by Yokoi, as a known dimension for protrusions lying on the surface of an ingestible capsule.
Modified Ben-Tsur fails to explicitly disclose a biodegradable coating disposed on the outer surface of the housing, the biodegradable coating configured to dissolve in a fluid having a pH of 1.5 to 9, thereby exposing the therapeutic agent.
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), with 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 configured to dissolve in a fluid having a pH of 1.5 to 9, thereby exposing the therapeutic agent (36) (paragraph 272, lines 1-15, note that Gross contemplates dissolution in acidic stomach environments with pH 1.2-3.5, in the small intestine with pH values ranging from 4.7-6.5, and further contemplates dissolution in the large intestine with pH varying between 7.5 and 8, and thus several values within the claimed range are anticipated per MPEP 2131.03 II).
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 outer surface of the ingestible capsule of modified Ben-Tsur to have provided a biodegradable coating on the housing of the ingestible capsule in order to enable dissolution of the biodegradable coating in a solution between 1.5 and 9 pH, as taught by Gross, in order to allow for release and absorption of the therapeutic agent into the desired portion of the GI tract.
Regarding claim 19, Ben-Tsur in view of Duffield, Yokoi, and Gross disclose the ingestible capsule of claim 17, as discussed above.
Ben-Tsur further discloses wherein the outer surface further comprises a depression (124) (paragraph 235, lines 1-3, see apertures 124 on housing 120 for texture, and see Figs. 1-2B).
Regarding claim 22, Ben-Tsur in view of Duffield, Yokoi, and Gross disclose the ingestible capsule of claim 17, as discussed above.
Ben-Tsur further discloses wherein the vibrator (114) comprises:
a motor having a shaft (paragraph 255, lines 1-7, see “electric motor” and “shaft”); and
a weight mechanically coupled to the shaft and radially offset from a longitudinal axis of the shaft (paragraph 255, lines 1-7, see “unbalanced weight”, understood to be an eccentric mass by virtue of the term “unbalanced” and the radial oscillation that is applied, and thus offset from the axis of the shaft).
Regarding claim 23, Ben-Tsur in view of Duffield, Yokoi, and Gross disclose the ingestible capsule of claim 22, as discussed above.
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 40, lines 1-2), and that the claimed range of about 5 Hz to about 120 Hz overlaps 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, which lies within the claimed range, 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 24, Ben-Tsur in view of Duffield, Yokoi, and Gross disclose the ingestible capsule of claim 22, as discussed above.
Ben-Tsur does not specifically limit the frequency to about 80 Hz as claimed.
However, given that Ben-Tsur discloses the frequency range of 10-650 Hz (paragraph 40, lines 1-2), and that the claimed value of 80 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 80 Hz, which lies within the claimed range, since it has been held that in the case where the claimed ranges/values "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)).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592) in view of Duffield (US 2011/0250241), Yokoi (US 2006/0169293), and Gross (US 2005/0058701), as applied to claim 17 above, in further view of Trovato (US 2009/0306632).
Regarding claim 18, Ben-Tsur in view of Duffield, Yokoi, and Gross disclose the ingestible capsule of claim 17, as discussed above.
Ben-Tsur further discloses a circuit connecting a power supply (“battery”) and a vibrator (114) in the ingestible capsule (110) (paragraph 255, lines 1-7; Fig. 1; see paragraphs 184-185 for the associated circuitry of the control element that affects the vibration agitation mechanism), wherein the vibrator induces the walls of the GI tract (paragraph 262, lines 1-6).
Ben-Tsur fails to explicitly disclose 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 about 2 to about 9, thereby closing a circuit connecting the power supply to 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, with intestinal fluid, a biodegradable insulating membrane disposed in electrical series between two electrical contacts, in fluid communication with an exterior of the capsule, and configured to dissolve in a fluid with a pH of about 7, 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 II, further the coating is understood to be in fluid communication with the exterior 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 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.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592) in view of Duffield (US 2011/0250241), Yokoi (US 2006/0169293), and Gross (US 2005/0058701), as applied to claim 17 above, in further view of Yokoi (US 2003/0181788).
Regarding claim 19, Ben-Tsur in view of Duffield, Yokoi, and Gross disclose the ingestible capsule of claim 17, as discussed above.
Modified Ben-Tsur fails to disclose wherein the outer surface further comprises a helical depression.
However, Yokoi teaches an ingestible capsule (1) which includes a helical depression (37A) on the outer surface thereof for allowing fluid in the body cavity to flow through, and to allow the surface of the protrusion to smoothly contact the interior of the body cavity (paragraph 90, lines 1-12, see “spiral grooves 37A”; Figs. 3D-4A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to have modified the outer surface of the ingestible capsule of Ben-Tsur to further include a helical depression, as taught by Yokoi, in order to allow fluid in the body cavity to flow through the depression, and to allow the surface of the protrusion to smoothly contact the interior of the body cavity after ingestion.
Regarding claim 20, Ben-Tsur in view of Duffield, Yokoi, Gross, and Yokoi disclose the ingestible capsule of claim 19, as discussed above.
Modified Ben-Tsur discloses wherein the at least one depression (see 37A of Yokoi ‘788) includes a helical depression (Yokoi: paragraph 90, lines 1-12; Figs. 3D-4A).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592) in view of Duffield (US 2011/0250241), Yokoi (US 2006/0169293), and Gross (US 2005/0058701), as applied to claim 17 above, in further view of Gross (US 2010/0021536), hereinafter referred to as Gross ‘536.
Regarding claim 21, Ben-Tsur in view of Duffield, Yokoi, and Gross disclose the ingestible capsule of claim 17, as discussed above.
Modified Ben-Tsur fails to disclose wherein the biodegradable coating comprises gelatin.
However, Gross ‘536 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 coating of the modified Ben-Tsur device to be gelatin, as taught by Gross ‘536, as a known material for constructing a coating of an ingestible capsule that allows for the predictable dissolution in the small intestine.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Examiner further notes that Yokoi (US 2006/0169293) extensively refers to particular pitch dimensions of the helical protrusion within the range claimed in claim 1 (see paragraphs 90 and 99).
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.
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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.
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/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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