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
This office action is responsive to the amendment filed 24 November 2025.
Claims 8-13 and 23-58 are canceled.
Claims 1, 2, 7, and 20 are amended.
Claims 1-7, and 14-22 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 and 14-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1, 2, and 20 recite the limitation “a depot in the submucosal tissue with a depot efficiency of at least 50%”. No embodiment within the specifications nor in the claims provides any clear relationship between the resulting depot efficiency and the associated independent variables within the claims, such as “peak power”, “the outlet”, “the reservoir”, and “the potential energy source”. The specifications describe depot efficiency to be a result of “selecting the operating parameters of the jet” (para. 0045). The specification seems to provide conjecture on what parameters may affect depot efficiency through experimentation (para. 0085-0088), rather than providing a clear relationship between the jet parameters and the depot efficiency. Therefore, the subject matter is not enabling to one skilled in the art to achieve a desired depot efficiency of the instant case.
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 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 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).
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 1 W to about 6 W (Shimizu: claim 1).
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. Although Shimizu discloses a peak power of up to about 6 W, one of ordinary skill in the art would have found it obvious to modify the peak power to be up to 9 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 solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with other ranges, as disclosed in the present application (present application: para. 0043-0044). Absent a teaching as to the criticality of a peak power range between 9 W to 130 W, 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 1 W to about 6 W (Shimizu: claim 1).
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. Although Shimizu discloses a peak power of up to about 6 W, one of ordinary skill in the art would have found it obvious to modify the peak power to be up to 9 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 solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with other ranges, as disclosed in the present application (present application: para. 0043-0044). Absent a teaching as to the criticality of a peak power range between 9 W to 130 W, 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 peak power is between about 1 W and about 6 W (Shimizu; claim 1).
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. Although Shimizu discloses a peak power of up to about 6 W, one of ordinary skill in the art would have found it obvious to modify the peak power to be up to 9 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 solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with other ranges, as disclosed in the present application (present application: para. 0043-0044). Absent a teaching as to the criticality of a peak power range between 9 W and 70 W, or 9 W and 12 W, or 9 W and 130 W, 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 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 1 W to about 6 W (Shimizu: claim 1).
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. Although Shimizu discloses a peak power of up to about 6 W, one of ordinary skill in the art would have found it obvious to modify the peak power to be up to 9 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 solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with other ranges, as disclosed in the present application (present application: para. 0043-0044). Absent a teaching as to the criticality of a peak power range between 9 W to 130 W, 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 page 6, filed 24 November 2025, with respect to rejection of claim 13 under 35 USC 112(b) have been fully considered and are persuasive. The rejection of claim 13 has been withdrawn.
Applicant's arguments, see page 6-8, filed 24 November 2025, with respect to the rejections of claims 1-7 and 14-22 have been fully considered but they are not persuasive.
Applicant argues:
“Regarding the Office Action's initial assertion that a power level between 9 W and 130 W would be obtained through routine optimization, Shimizu actively teaches maintaining the power well below the currently claimed ranges. Further, one of ordinary skill in the art would not arbitrarily and drastically increase the power of the API because such an increase could result in perforation of the API through the submucosa layer.”
Shimizu teaches a power level of between about 1 W and about 6 W (Shimizu; claim 1). However, the peak power of Shimizu is a result-effective variable 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). Therefore, it is a matter of routine optimization. Additionally, the disclosure of the present application does not describe any criticality to the range of 9 W to 130 W and, in fact, gives instances in the specification where lower peak power values may be desirable (present application: para. 0043-0044).
Applicant also argues:
“Shimizu does not teach or otherwise disclose the claimed high depot efficiency of 50%. Further, Shimizu does not provide disclosure, motivation, or any related consideration of the benefits of obtaining such efficiency. Accordingly, the Office Action entirely relies on the teachings of the current application to justify the connection of power to efficiency, and the motivation to adjust the power to obtain a desired efficiency value of 50%. Therefore, this basis for the rejection is completely improper as the Office Action actively admits that it is using impermissible hindsight based on the current application to motivate such a change which is well outside the teachings of Shimizu.”
As described above in the rejection of claims 1, 2, and 20 under 35 USC 112(a), there is no clear relationship between the jet parameters of the present application and the resulting depot efficiency. Peak power is stated by the applicant to be a parameter that affects depot efficiency alongside other parameters. Furthermore, 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). Therefore, the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783