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 1-24 are currently pending examination.
Claim Objections
Claims 5, 10, and 13-14 are objected to because of the following informalities:
At claim 5, line 2, it is suggested that the comma after “motor” be deleted for clarity.
At claim 10, line 2, it is suggested that “the small intestine” be replaced with “a small intestine” as the limitation has not yet been introduced.
At claim 10, line 5, it is suggested that “a therapeutic agent” be replaced with “the therapeutic agent” as the limitation was previously introduced in line 1.
At claim 13, line 2, it is suggested that “the” before “dissolving” be eliminated for clarity.
At claim 13, line 2, it is suggested that “the” before “delivery” be eliminated for clarity.
At claim 14, line 2, it is suggested that “the” before “moving” be eliminated for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592).
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, and 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 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 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)).
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).
Claims 11-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592), as applied to claim 10 above, in view of Gross (US 2005/0058701).
Regarding claim 11, Ben-Tsur discloses the method of claim 10, as discussed above.
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), wherein ingestible capsule (30) 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 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 discloses the method of claim 10, as discussed above.
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), wherein ingestible capsule (30) 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 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 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 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 the dissolving the biodegradable coating (46A) includes the delivering the therapeutic agent (Gross: paragraph 272, lines 1-10).
Regarding claim 15, Ben-Tsur discloses the method of claim 10, as discussed above.
Ben-Tsur fails to explicitly disclose wherein the therapeutic agent has an oral bioavailability less than about 10%.
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 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 discloses the method of claim 10, as discussed above.
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 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), as applied to claim 10 above, in view of Trovato (US 2009/0306632).
Regarding claim 11, Ben-Tsur discloses 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 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 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 a textured outer surface (paragraph 235, lines 1-3, see apertures 124 on housing 120 for texture, and see 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 a biodegradable coating disposed on the textured 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), 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 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 provided a biodegradable coating on the housing of the ingestible capsule of Ben-Tsur enabling dissolution of the biodegradable coating disposed on the housing of the ingestible capsule, including the textured outer surface, 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 Gross disclose the ingestible capsule of claim 17, as discussed above.
Ben-Tsur further discloses wherein the textured outer surface 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 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 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 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 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 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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592) in view of Gross (US 2005/0058701), as applied to claim 19 above, in further view of Yokoi (US 2003/0181788).
Regarding claim 20, Ben-Tsur in view of Gross disclose the ingestible capsule of claim 19, as discussed above.
Ben-Tsur fails to disclose wherein the at least one protrusion or depression includes a helical depression.
However, Yokoi teaches an ingestible capsule (1) which includes each of a protrusion (37B) and 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; 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 protrusion forming 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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Tsur (US 2020/0214592) in view of 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 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.
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 10 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-20 of copending Application No. 18/182,832, in view of Ben-Tsur (US 2020/0214592).
Examiner notes that citations of Srinivasan are given relative to Pre-Grant Publication US 2023/0284929.
This is a provisional nonstatutory double patenting rejection.
Regarding claim 10, Srinivasan discloses a method of stimulating the stomach mucosa (claim 19, lines 1-4), wherein the mucosa is moved with an ingestible capsule 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 (claim 19, lines 3-6 and claim 20, lines 8-11).
Srinivasan fails to explicitly disclose wherein a therapeutic agent is delivered to the subject, that the luminal mucus of the small intestine is moved, and while moving the portion of the luminal mucus, delivering the therapeutic agent from the ingestible capsule to the small intestine.
However, Ben-Tsur teaches 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 (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 1-7 for the frequency; 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) in order to preferentially dispense medicament to the small intestine while using vibration to improve the absorption of the agent (paragraph 264, lines 1-7).
Therefore, given that Srinivasan discloses the frequency range of 50-120 Hz, and Ben-Tsur teaches similar stimulation of the luminal mucus of the small intestine with a vibrator, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the device of Srinivasan at the prescribed frequency in the small intestine and during delivery of a therapeutic agent, as taught by Ben-Tsur, in order to preferentially dispense medicament to the small intestine while using vibration to improve the absorption of the agent.
Regarding claim 14, Srinivasan in view of Ben-Tsur disclose the method of claim 10, as discussed above.
Modified Srinivasan further discloses closing a circuit connecting a power supply and a vibrator in the ingestible capsule to induce the moving by dissolving, with intestinal fluid, a biodegradable insulating membrane disposed in electrical series between the power supply and the vibrator (Srinivasa: claim 20, lines 1-6 and Ben-Tsur: paragraph 264, lines 1-7 for small intestine teaching).
Claims 11-13 and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-20 of copending Application No. 18/182,832 in view of Ben-Tsur (US 2020/0214592), as applied to claim 10 above, in further view of Gross (US 2005/0058701).
Examiner notes that citations of Srinivasan are given relative to Pre-Grant Publication US 2023/0284929.
Regarding claim 11, Srinivasan in view of Ben-Tsur disclose the method of claim 10, as discussed above.
Modified Srinivasan 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), wherein ingestible capsule (30) 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 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 Srinivasan, 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.
Regarding claim 12, Srinivasan in view of Ben-Tsur disclose the method of claim 10, as discussed above.
Modified Srinivasan 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), wherein ingestible capsule (30) 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 Srinivasan 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, Srinivasan in view of Ben-Tsur and Gross disclose the method of claim 12, as discussed above.
Modified Srinivasan further discloses wherein the biodegradable coating (46A of Gross on ingestible capsule of Srinivasan) includes the therapeutic agent, such that the dissolving the biodegradable coating (46A) includes the delivering the therapeutic agent (Gross: paragraph 272, lines 1-10).
Regarding claim 15, Srinivasan in view of Ben-Tsur disclose the method of claim 10, as discussed above.
Modified Srinivasan fails to explicitly disclose wherein the therapeutic agent has an oral bioavailability less than about 10%.
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 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 modified Srinivasan could reasonably be a drug with a bioavailability of less than 10%, such as insulin, as taught by Gross, and given that both modified Srinivasan 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 Srinivasan device and method.
Regarding claim 16, Srinivasan in view of Ben-Tsur disclose the method of claim 10, as discussed above.
Modified Srinivasan 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 Srinivasan 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 modified Srinivasan 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 Srinivasan device and method.
Claims 17-19 and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 12 of copending Application No. 18/182,832 in view of Ben-Tsur (US 2020/0214592) and Gross (US 2005/0058701).
Examiner notes that citations of Srinivasan are given relative to Pre-Grant Publication US 2023/0284929.
Regarding claim 17, Srinivasan discloses an ingestible capsule (claim 1, line 1) comprising:
a housing forming a cavity and having a textured outer surface (claim 1, line 2; claim 10, lines 1-3);
a vibrator disposed in the cavity (claim 1, line 3);
a power supply disposed in the cavity and configured to power the vibrator (claim 1, lines 1-8).
Srinivasan fails to explicitly disclose a therapeutic agent disposed in or on the housing, where the therapeutic agent is exposed following dissolution of the coating, and further fails to discloses a biodegradable coating disposed on the textured 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, Ben-Tsur teaches an ingestible capsule (110) (paragraph 233, lines 1-4; Fig. 1) with a therapeutic agent (102) disposed in the housing (112+120) for treatment of the subject by the therapeutic agent (paragraph 232, lines 1-6; paragraph 234, lines 1-4; Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Srinivasan to include a therapeutic agent disposed in the housing of the Srinivasan device, as taught by Ben-Tsur, in order to treat the subject by the therapeutic agent.
Modified Srinivasan still fails to explicitly disclose a biodegradable coating disposed on the textured 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), 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 9, thereby exposing the therapeutic agent (36) (paragraph 272, lines 1-15).
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 housing of the ingestible capsule of modified Srinivasan enabling dissolution of the biodegradable coating disposed on the housing of the ingestible capsule, including the textured outer surface, 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 18, Srinivasan in view of Ben-Tsur and Gross disclose the ingestible capsule of claim 17, as discussed above.
Srinivasan further discloses:
a biodegradable insulating membrane disposed in electrical series between the vibrator and the power supply and in fluid communication with an exterior of the housing, the biodegradable insulating member configured to dissolve in a fluid having a pH of about 2 to about 9, thereby closing a circuit connecting the power supply and the vibrator (claim 1, lines 5-11, where 1.5-9 overlaps the claimed range with sufficient specificity and is thus anticipated, see MPEP 2131.03 II).
Regarding claim 19, Srinivasan in view of Ben-Tsur and Gross disclose the ingestible capsule of claim 17, as discussed above.
Srinivasan further discloses wherein the textured outer surface comprises a protrusion (claim 10, lines 1-3; claim 12, lines 1-3).
Regarding claim 22, Srinivasan in view of Ben-Tsur and Gross disclose the ingestible capsule of claim 17, as discussed above.
In the relied-on dependency chain, 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.
However, Ben-Tsur further teaches wherein a vibrator (114) of the capsule (110) 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).
Given that both Srinivasan and Ben-Tsur describe vibrators used within 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 as a mechanism including a motor having a shaft, and a weight mechanically coupled to the shaft and radially offset from a longitudinal axis of the shaft, as taught by Ben-Tsur, as a known and reliably predictable mechanism for providing vibration to a device and subject body.
Regarding claim 23, Srinivasan in view of Ben-Tsur and Gross disclose the ingestible capsule of claim 22, as discussed above.
Srinivasan does not specifically limit the range of frequency to about 5-120 Hz as claimed.
However, Ben-Tsur further teaches a frequency range of 10-650 Hz (paragraph 40, lines 1-2).
Given 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 modified the device of modified Srinivasan 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, Srinivasan in view of Ben-Tsur and Gross disclose the ingestible capsule of claim 22, as discussed above.
Srinivasan does not specifically limit the frequency to about 80 Hz as claimed.
However, Ben-Tsur further teaches a frequency range of 10-650 Hz (paragraph 40, lines 1-2).
Given 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 modified the device of modified Srinivasan 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 20 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 12 of copending Application No. 18/182,832 in view of Ben-Tsur (US 2020/0214592) and Gross (US 2005/0058701), as applied to claim 19 above, in further view of Yokoi (US 2003/0181788).
Regarding claim 20, Srinivasan in view of Ben-Tsur and Gross disclose the ingestible capsule of claim 19, as discussed above.
Srinivasan fails to disclose wherein the at least one protrusion or depression includes a helical depression.
However, Yokoi teaches an ingestible capsule (1) which includes each of a protrusion (37B) and 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; 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 modified Srinivasan to further include a helical protrusion forming 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.
Claim 21 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 12 of copending Application No. 18/182,832 in view of Ben-Tsur (US 2020/0214592) and Gross (US 2005/0058701), as applied to claim 19 above, in further view of Gross (US 2010/0021536), hereinafter referred to as Gross ‘536.
Regarding claim 21, Srinivasan in view of Ben-Tsur and Gross disclose the ingestible capsule of claim 17, as discussed above.
Modified Srinivasan 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 Srinivasan 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.
Allowable Subject Matter
Claims 1-9 are allowed.
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 an examiner’s statement of reasons for allowance: The closest prior art combination for the features presented in claim 1 would be Ben-Tsur (US 2020/0214592), Gross (US 2005/0058701), and Shigeyasu (US JP-H06296624).
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 a textured outer surface (paragraph 235, lines 1-3, see apertures 124 on housing 120, and see Figs. 1-2B; paragraph 291, lines 4-7, note the “threaded engagement” of housings 112 and 120, and note that in threaded engagements, each threaded member includes depressions and protrusions for creating the threaded fit, when 112 and 120 are not cooperated, the threads on at least one member would be on its outer surface), the textured outer surface forming a depression and a protruding portion disposed in the depression (paragraph 235, lines 1-3, see apertures 124 on housing 120, and see Figs. 1-2B; paragraph 291, lines 4-7, note the “threaded engagement” of housings 112 and 120, and note that in threaded engagements, each threaded member includes depressions and protrusions for creating the threaded fit, when 112 and 120 are not cooperated, the threads on at least one member would be on its outer surface, with protrusions from the other member disposed within the depression for threaded male/female engagement of the two housing portions 112 and 120);
a therapeutic agent (102) disposed in the housing (112+120) (paragraph 234, lines 1-4; Fig. 1).
Ben-Tsur fails to explicitly disclose a biodegradable coating disposed on the textured 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), 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 9, thereby exposing the therapeutic agent (36) (paragraph 272, lines 1-15).
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 housing of the ingestible capsule of Ben-Tsur enabling dissolution of the biodegradable coating disposed on the housing of the ingestible capsule, including the textured outer surface, 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.
The combination of Ben-Tsur and Gross still fails to contemplate a textured outer surface that specifically is formed as a helical depression with a plurality of protruding studs disposed in the helical depression.
Insofar as the threads of Ben-Tsur can be regarded as a portion of the textured outer surface, specifically forming a helical depression (i.e., the spaces between the raised threads), Ben-Tsur cannot be relied upon for the plurality of studs protruding from the helical depression, because the thread which would be mated with the depression would constitute a single helical protrusion fit into the helical depression rather than a plurality of studs.
Shigeyasu, does however, teach a capsule (1) (page 3: “the dental filling capsule of the present invention will be described below with reference to the drawings. Dental filling capsule 1; Fig. 1), that includes at least one helical depression (40) on one side of the capsule (1), and a plurality of protruding studs (30) on the other side of the capsule (1) in order to form a threaded engagement between housing parts of the capsule (page 3: “Further, four hemispherical protrusions 30 are provided on the middle portion of the outer surface of the upper portion 26 “ and “Further, four spiral grooves 40 with which the hemispherical projection 30 is engaged are provided on the inner surface of the lower cylindrical portion”; Fig. 3).
However, Shigeyasu includes four separate helical depressions (40) rather than a single helical depression as is required by the claim. This may have been overlooked under the broadest reasonable interpretation of the claim (i.e., having four helical depressions necessarily means that a single one is included) except the claim further requires a plurality of protruding studs disposed in the (single) helical depression, which Shigeyasu does not contemplate, since separate studs (30) are placed within separate helical depressions (40). Further, given that the threaded connection is relied on in Shigeyasu for the claimed matter, it is of note that the helical depressions are on an interior surface of the capsule rather than an outer surface. It is also noteworthy that reliance on this threaded engagement implicitly means that both the analogous depression and the analogous studs cannot simultaneously be disposed on the outer surface of the housing, as one of the mated portions must be on an inner surface of one housing portion for mated threaded to occur between the capsule portions.
Still further, Applicant places criticality on such an arrangement, noting that the helical depression with the plurality of studs specifically were added to the capsule in order to stimulate plicae, villi, and mucus to enhance drug delivery and absorption (see instant specification at each of paragraphs 110 and 113). In other words, placement of the helical depression and associated studs within it are not simply a matter of design choice selected by Applicant, rather these structural limitations serve a particular purpose in drug delivery and absorption within the claimed device.
Additional devices teach either helical depressions or studs (AU 1647001 to Duffield, see Figs. 13A-F; Yokoi-US 2003/0181788 as cited above; Stegemann-US 2017/0333358, see Figs. 1-5), but notably none of these devices include a helical depression and a plurality of protruding studs disposed in the helical depression as required by claim 1.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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/PAIGE KATHLEEN BUGG/Examiner, Art Unit 3785