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 .
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 28 July 2026 has been entered.
Status of Claims
This office action is responsive to the amendment filed 28 July 2026.
Claims 8-13 and 23-58 are canceled.
Claims 1-7, and 14-22 are presently pending in this application.
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.
Claims 1-31 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu et al. (US Patent Publication No. 20230017603 A1), hereinafter Shimizu.
Regarding claim 1, 3, and 4, Shimizu discloses a drug delivery device (Shimizu: Fig. 2, ingestible device 200) configured for administration to a subject (para. 0118), the device (Fig. 2, device 200) comprising: a reservoir (Fig. 2, fluid volume 204) configured to contain an active pharmaceutical ingredient (para. 0118); a potential energy source (Fig. 2, drive force generator 214); a trigger (Fig. 2, triggering mechanism 212) operatively associated with the potential energy source (when triggering mechanism 212 is triggered, drive force generator 214 applies pressure; para. 0131), wherein the trigger (Fig. 2, triggering mechanism 212) is configured to actuate within a stomach of the subject (delivery can occur at any desired location in the GI tract, which includes the stomach; para. 0132); and an outlet (Fig. 2, nozzle 206) in fluid communication with the reservoir (Fig. 2, fluid volume 204 is delivered through nozzle 206), wherein when the trigger (Fig. 2, triggering mechanism 212) is actuated the potential energy source (Fig. 2, drive force generator 214) compresses the reservoir (when triggering mechanism 212 is triggered, drive force generator 214 applies pressure to drive coupling 216, which then applies pressure to the fluid volume 204, thus jetting the volume through the nozzle 206; para. 0131) to jet the active pharmaceutical ingredient (para. 0118) from the reservoir (Fig. 2, fluid volume 204) through the outlet (Fig. 2, fluid volume 204 is delivered through nozzle 206) with a velocity sufficient to penetrate a tissue of the stomach adjacent to the outlet (the device delivers a jet capable of trans-epithelial delivery, which penetrates stomach tissue; para. 0104); wherein the outlet (Fig. 2, nozzle 206), the reservoir (Fig. 2, fluid volume 204), and the potential energy source (Fig. 2, drive force generator 214) are configured to form a depot (Fig. 1B, medicament is delivered directly into the lamina propria in the form of a single bolus; para. 0106) in the submucosal tissue (Fig. 1B, medicament is delivered directly into the lamina propria before the muscularis mucosae; para. 0106); wherein the outlet (Fig. 2, nozzle 206), the reservoir (Fig. 2, fluid volume 204), and the potential energy source (Fig. 2, drive force generator 214) are configured to form a depot in the submucosal tissue (nozzle 206 and generator 214 are configured to form a depot; para. 0155) with a depot efficiency of at least 50% (Shimizu discloses that all of the substance is delivered to the target tissue, which is interpreted to be a depot efficiency of 100%, which is at least 50%; para. 0102).
P
o
w
e
r
W
a
t
t
s
=
F
o
r
c
e
N
e
w
t
o
n
s
F
*
V
e
l
o
c
i
t
y
m
s
V
Shimizu is silent regarding a range of peak power provided by the potential energy source to form the jet of the active pharmaceutical ingredient that is between 9 W and 130 W. However, Shimizu does disclose a range of peak power between about 0.63 W to about 29.12 W (Equation above; claim 3 and 4).
It would have been obvious to one having ordinary skill in the art at the time the invention was made that the peak power provided by the potential energy source to form the jet of the active pharmaceutical ingredient was between 9 W and 130 W. One of ordinary skill in the art would have found it obvious to modify the peak power to be 9 W to 130 W in order to modify the jet pressure or jet force, as the parameters are interconnected and are variable to achieve trans-epithelial delivery in the submucosa of the GI tract (para. 0007, 0105, 0156, and 0159). It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Additionally, the applicant has not disclosed that this limitation produces any unexpected results and it appears that the device would perform equally well with other ranges, as disclosed in the present application (present application: para. 0043-0044). This particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 2, Shimizu teaches a drug delivery device (Shimizu: Fig. 2, ingestible device 200) configured for administration to a subject (para. 0118), the device (Fig. 2, device 200) comprising: a reservoir (Fig. 2, fluid volume 204) configured to contain an active pharmaceutical ingredient (para. 0118); a potential energy source (Fig. 2, drive force generator 214); a trigger (Fig. 2, triggering mechanism 212) operatively associated with the potential energy source (when triggering mechanism 212 is triggered, drive force generator 214 applies pressure; para. 0131), wherein the trigger (Fig. 2, triggering mechanism 212) is configured to actuate in response to one or more predetermined conditions (triggering can occur under one more triggering conditions, such as pH level, presence of enzymes, or temperature; para. 0125); and an outlet (Fig. 2, nozzle 206) in fluid communication with the reservoir (Fig. 2, fluid volume 204 is delivered through nozzle 206), wherein when the trigger (Fig. 2, triggering mechanism 212) is actuated the potential energy source (Fig. 2, drive force generator 214) compresses the reservoir (when triggering mechanism 212 is triggered, drive force generator 214 applies pressure to drive coupling 216, which then applies pressure to the fluid volume 204, thus jetting the volume through the nozzle 206; para. 0131) to jet the active pharmaceutical ingredient (para. 0118) from the reservoir (Fig. 2, fluid volume 204) through the outlet (Fig. 2, fluid volume 204 is delivered through nozzle 206) with a velocity between 20 m/s and 250 m/s (Shimizu: the peak jet velocity is between 35-112 m/s; claim 3); wherein the outlet (Fig. 2, nozzle 206), the reservoir (Fig. 2, fluid volume 204), and the potential energy source (Fig. 2, drive force generator 214) are configured to form a depot (Fig. 1B, medicament is delivered directly into the lamina propria in the form of a single bolus; para. 0106) in the submucosal tissue (Fig. 1B, medicament is delivered directly into the lamina propria before the muscularis mucosae; para. 0106); wherein the outlet (Fig. 2, nozzle 206), the reservoir (Fig. 2, fluid volume 204), and the potential energy source (Fig. 2, drive force generator 214) are configured to form a depot in the submucosal tissue (nozzle 206 and generator 214 are configured to form a depot; para. 0155) with a depot efficiency of at least 50% (Shimizu discloses that all of the substance is delivered to the target tissue, which is interpreted to be a depot efficiency of 100%, which is at least 50%; para. 0102).
Shimizu is silent regarding a range of peak power provided by the potential energy source to form the jet of the active pharmaceutical ingredient that is between 9 W and 130 W. However, Shimizu does disclose a range of peak power between about 0.63 W to about 29.12 W (Equation above; claim 3 and 4).
It would have been obvious to one having ordinary skill in the art at the time the invention was made that the peak power provided by the potential energy source to form the jet of the active pharmaceutical ingredient was between 9 W and 130 W. One of ordinary skill in the art would have found it obvious to modify the peak power to be 9 W to 130 W in order to modify the jet pressure or jet force, as the parameters are interconnected and are variable to achieve trans-epithelial delivery in the submucosa of the GI tract (para. 0007, 0105, 0156, and 0159). It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Additionally, the applicant has not disclosed that this limitation produces any unexpected results and it appears that the device would perform equally well with other ranges, as disclosed in the present application (present application: para. 0043-0044). This particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 5, 6, and 22, Shimizu teaches the device above.
Shimizu is silent to a range of peak power provided by the potential energy source to form the jet of the active pharmaceutical ingredient is between 9 W and 130 W. However, Shimizu does disclose a range of peak power between about 0.63 W to about 29.12 W (Equation above; claim 3 and 4).
It would have been obvious to one having ordinary skill in the art at the time the invention was made such that the peak power is between 9 W and 70 W, or 9 W and 12 W, or 9 W and 130 W. One of ordinary skill in the art would have found it obvious to modify the peak power to be 9 W to 130 W in order to modify the jet pressure or jet force, as the parameters are interconnected and are variable to achieve trans-epithelial delivery in the submucosa of the GI tract (para. 0007, 0105, 0156, and 0159). It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Additionally, the applicant has not disclosed that this limitation produces any unexpected results and it appears that the device would perform equally well with other ranges, as disclosed in the present application (present application: para. 0043-0044).
Regarding claim 7, Shimizu teaches the device above, wherein the outlet (Fig. 2, nozzle 206), the reservoir (Fig. 2, fluid volume 204), and the potential energy source (Fig. 2, drive force generator 214) are configured to form a depot of the active pharmaceutical ingredient (Fig. 1B, medicament is delivered directly into the lamina propria in the form of a single bolus; para. 0106) in a tissue of the stomach without perforating a muscularis layer of the stomach (Fig. 1B, medicament is delivered directly into the lamina propria before the muscularis mucosae; para. 0106).
Regarding claim 14, Shimizu teaches the device above, wherein the velocity of the jet is between 80 m/s and 130 m/s (the peak jet velocity is between 35-112 m/s; claim 3).
Regarding claim 15, Shimizu teaches the device above, wherein a maximum transverse dimension of the outlet is between 50 um and 450 um (nozzle diameter is between 0.1 mm to 2 mm, or 100 um to 2000 um; para. 0149).
Regarding claim 16, Shimizu teaches the device above, wherein the potential energy source (Fig. 2, drive force generator 214) comprises at least one of a compressed gas, a spring, an explosive, and a reaction chamber (drive force generator 214 can be compressed gas, spring, chemical reaction, or an explosion; para. 0128).
Regarding claim 17, Shimizu teaches the device above, wherein an overall volume of the drug delivery device is less than 3000 mm3 (device can contain a volume of 50-800 uL, which is 50-800 mm3; para 0147).
Regarding claim 18, Shimizu teaches the device above, further comprising the active pharmaceutical ingredient (para. 0118) disposed in the reservoir (Fig. 2, fluid volume 204 contains medicament; para. 0118).
Regarding claim 19, Shimizu teaches the device above, wherein the subject is a human subject (subject is human; para. 0118).
Regarding claim 20, Shimizu teaches a method of administering an active pharmaceutical ingredient to a subject (para. 0118) (Fig. 2, device 200), the method (Fig. 2, device 200) comprising: triggering deployment of a jet of the active pharmaceutical ingredient (when triggering mechanism 212 is triggered, drive force generator 214 applies pressure to drive coupling 216, which then applies pressure to the fluid volume 204, thus jetting the volume through the nozzle 206; para. 0131) within a stomach of the subject (delivery can occur at any desired location in the GI tract, which includes the stomach; para. 0132); and penetrating a tissue of the stomach of the subject with the jet (the device delivers a jet capable of trans-epithelial delivery, which penetrates stomach tissue; para. 0104) to create a depot (Fig. 1B, medicament is delivered directly into the lamina propria in the form of a single bolus; para. 0106) of the active pharmaceutical ingredient (Fig. 1B, medicament is delivered directly into the lamina propria in the form of a single bolus; para. 0106) within the tissue without perforating a muscularis layer of the stomach (Fig. 1B, medicament is delivered directly into the lamina propria before the muscularis mucosae; para. 0106), wherein the depot (Fig. 1B, medicament is delivered directly into the lamina propria in the form of a single bolus; para. 0106) in the submucosal tissue (Fig. 1B, medicament is delivered directly into the lamina propria before the muscularis mucosae; para. 0106) has a depot efficiency of at least 50% (Shimizu discloses that all of the substance is delivered to the target tissue, which is interpreted to be a depot efficiency of 100%, which is at least 50%; para. 0102). When the prior art device is the same as a device described in the specification for carrying out or being made by the claimed method, it can be assumed the device will obviously perform or be made by the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). MPEP 2112.02.
Shimizu is silent regarding a range of peak power provided by the potential energy source to form the jet of the active pharmaceutical ingredient that is between 9 W and 130 W. However, Shimizu does disclose a range of peak power between about 0.63 W to about 29.12 W (Equation above; claim 3 and 4).
It would have been obvious to one having ordinary skill in the art at the time the invention was made that the peak power provided by the potential energy source to form the jet of the active pharmaceutical ingredient was between 9 W and 130 W. One of ordinary skill in the art would have found it obvious to modify the peak power to be 9 W to 130 W in order to modify the jet pressure or jet force, as the parameters are interconnected and are variable to achieve trans-epithelial delivery in the submucosa of the GI tract (para. 0007, 0105, 0156, and 0159). It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Additionally, the applicant has not disclosed that this limitation produces any unexpected results and it appears that the device would perform equally well with other ranges, as disclosed in the present application (present application: para. 0043-0044). This particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 28 July 2026 and affidavit filed 28 July 2026, with respect to the rejection of claims 1-7 and 14-22 under 35 USC 112(a) have been fully considered and are persuasive; the rejection has been withdrawn.
Applicant's arguments, see pages 7-9, filed 28 July 2026, with respect to the rejections of claims 1-7 and 14-22 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant argues that the rejection relies upon impermissible hindsight by reducing the claimed power range to be achievable through routine optimization without any support of the cited reference.
Shimizu states that the parameters, such as peak jet power, are interconnected and are variable to achieve trans-epithelial delivery in the submucosa of the GI tract (para. 0007, 0105, 0156, and 0159). Specifically, peak jet power is determined by the amount necessary to achieve trans-epithelial delivery into the specific tissue of the desired location in the GI tract (para. 0105 and 0159). Further, Shimizu discloses a peak power range of 0.63 – 29.12 W as cited above. Thus, one of ordinary skill in the art would have achieved the claimed peak jet power through routine optimization.
Applicant argues that the device of Shimizu is not specifically designed for use in the stomach and, therefore, there is no reasonable expectation of success for modifying the power of Shimizu to achieve the claimed efficiency in the specific location of the stomach.
Shimizu clearly states that trans-epithelial delivery can be achieved at any desired location within the GI tract (para. 0132), which includes the stomach (para. 0106). The specific tissue desired to be delivered to requires specific jet parameters for trans-epithelial delivery (para. 0007, 0105).
Applicant's arguments in the affidavit, see pages 5-7, filed 28 July 2026, with respect to the rejections of claims 1-7 and 14-22 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant argues that the specified range was a result of experimentation and, thus, are considered unexpected results, and that a person of ordinary skill in the art would not be able to predict the tissue-specific windows, or the magnitude required, and, therefore, the claimed power range is beyond routine optimization. Applicant also argues that the device of Shimizu would be rendered inoperable for its intended purpose if modified to use the claimed range.
It is clear from the art of Shimizu that the parameters for specific tissues, such as peak power, is a result-effective variable, dependent on the desired delivery location in the GI tract (para. 0007, 0105, 0156, and 0159). Additionally, the applicant has not disclosed that this limitation produces any unexpected results and it appears that the device would perform equally well with other ranges, as disclosed in the present application (present application: para. 0043-0044).
Therefore, the rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI GONZALEZ whose telephone number is (703)756-5908. The examiner can normally be reached 7:30am - 4:00pm (CT).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
